The Autologous Stem Cell Based Therapies Market report makes available Today and Forthcoming technical and financial details of this industry. Few of those chief insights of this business report include; different analysis of the market drivers & restraints, major market players engaged like industry, detailed analysis of their market segmentation & aggressive evaluation. It quotes CAGR values in percentages which help to be familiar with increase or fall occurring in the market for particular product for the particular forecast period. Global Autologous Stem Cell Based Therapies Market report also encompasses tactical profiling of important players on the market, systematic analysis of the core competencies & brings a competitive landscape for the market.

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The Autologous Stem Cell Based Therapies Market report can be employed by both Conventional and new players from the market for whole knowhow of this marketplace. The business analysis report brings into consideration important industry trends, market size, market share estimates, and revenue volume that assist industry to speculate the strategies to increase return on investment (ROI). In addition, the market document holds a considerable significance as it is all about describing market definition, classifications, software and engagements. Together with the study of competitor analysis conducted in this Autologous Stem Cell Based Therapies Market report, industry can get fluency of these plans of key players on the market which includes new product launches, expansions, arrangements, joint ventures, partnerships, and acquisitions.

Market Evaluation: Global Autologous Stem Cell Based Therapies Market

Global Autologous Stem Cell Based Therapies economy is set to see a substantial CAGR Of XX percent in the forecasted period of 2019-2026. This increase in the market can be attributed because of improvement in autoimmune identification and technology advancement in the business.

The following players are covered in this report:

Regeneus

Mesoblast

Pluristem Therapeutics Inc

US STEM CELL, INC.

Brainstorm Cell Therapeutics

Tigenix

Med cell Europe

Autologous Stem Cell Based Therapies

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Breakdown Data by Type

Embryonic Stem Cell

Resident Cardiac Stem Cells

Umbilical Cord Blood Stem Cells

Autologous Stem Cell Based Therapies Breakdown Data by Application

Neurodegenerative Disorders

Autoimmune Diseases

Cardiovascular Diseases

Table of Contents : Autologous Stem Cell Based Therapies Market

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

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Ready To Use Autologous Stem Cell Based Therapies Market Industry Analysis, Trend and Growth, 2020-2020 - Royal Sutton News

Recommendation and review posted by Bethany Smith

Basel, October 30, 2020 Novartis today announced the receipt of marketing authorization from Japans Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan. This approval makes FBRI the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia.

Behind our efforts to reimagine medicine with CAR-T cell therapy lies a commitment to build a manufacturing network that brings treatment closer to patients, commented Steffen Lang, Global Head of Novartis Technical Operations. The expertise and infrastructure of FBRI, a world-leading manufacturing organization, allows us to bring CAR-T manufacturing to Asia. With the Japan MHLW commercial manufacturing approval, the recent capacity expansion in the US and our ongoing efforts to optimize and evolve our processes, we are well-positioned to deliver this potentially curative treatment option to more patients around the world.

Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) recently approved a further increase in manufacturing capacity.

Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia, which was first-of-its-kind in CAR-T research and development.

About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 26 countries and at more than 260 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut fr Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.

ImportantSafety information from the Kymriah SmPC

EU Name of the medicinal product:

Kymriah 1.2 x 106 6 x 108 cells dispersion for infusion

Important note: Before prescribing, consult full prescribing information.

Presentation: Cell dispersion for infusion in 1 or more bags for intravenous use (tisagenlecleucel).

Indications: Treatment of pediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse posttransplant or in second or later relapse. Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Dosage and administration:

B-cell patients: For patients 50 kg and below: 0.2 to 5.0 x 106 CAR-positive viable T-cells/kg body weight. For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T-cells (non-weight based).

DLBCL Patients: 0.6 to 6.0108 CAR-positive viable T-cells (non-weight based).

Pretreatment conditioning (lymphodepleting chemotherapy): Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is 1,000 cells/L. The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.

Precautions before handling or administering Kymriah: Kymriah contains genetically modified human blood cells. Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

Preparation for infusionThe timing of thaw of Kymriah and infusion should be coordinated. Once Kymriah has been thawed and is at room temperature (20C 25C), it should be infused within 30minutes to maintain maximum product viability, including any interruption during the infusion.

Administration Kymriah should be administered as an intravenous infusion through latexfree intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20mL per minute by gravity flow. If the volume of Kymriah to be administered is 20mL, intravenous push may be used as an alternative method of administration.

All contents of the infusion bag(s) should be infused.

Clinical assessment prior to infusion: Kymriah treatment should be delayed in some patient groups at risk (see Special warnings and precautions for use).

Monitoring after infusion: Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurological events. After the first 10 days following the infusion, the patient should be monitored at the physicians discretion. Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.

Elderly (above 65 years of age): Safety and efficacy have not been established in B-cell patients. No dose adjustment is required in patients over 65 years of age in DLBCL patients.

Paediatric patients: No formal studies have been performed in paediatric patients with B-cell ALL below 3 years of age. The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established in DLBCL. No data are available.

Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV): There is no experience with manufacturing Kymriah for patients with a positive test for HIV, active HBV, or active HCV infection. Leukapheresis material from these patients will not be accepted for Kymriah manufacturing.

Contraindications: Hypersensitivity to the active substance or to any of the excipients of Kymriah. Contraindications of the lymphodepleting chemotherapy must be considered.

Warnings and precautions: Reasons to delay treatment: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), significant clinical worsening of leukaemia burden or rapid progression of lymphoma following lymphodepleting chemotherapy. Blood, organ, tissue and cell donation: Patients treated with Kymriah should not donate blood, organs, tissues or cells.

Active central nervous system (CNS) leukaemia or lymphoma: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma. Therefore the risk/benefit of Kymriah has not been established in these populations. Risk of CRS: Occurred in almost all cases within 1 to 10 days post infusion with a median time to onset of 3 days and a median time to resolution of8 days. See full prescribing information for management algorithm of CRS. Risk of neurological events: Majority of events, in particular encephalopathy, confusional state or delirium, occurred within 8 weeks post infusion and were transient. The median time to onset of neurological events was 8 days in B-cell ALL and 6 days in DLBCL; the median time to resolution was 7 days for B-cell ALL and 13 days for DLBCL. Patients should be monitored for neurological events. Risk of infections: Delay start of therapy with Kymriah until active uncontrolled infections have resolved. As appropriate, administer prophylactic antibiotics and employ surveillance testing prior to and during treatment with Kymriah. Serious infections were observed in patients, some of which were life threatening or fatal. After Kymriah administration observe patient and ensure prompt management in case of signs of infection Risk of febrile neutropenia: Frequently observed after Kymriah infusion, may be concurrent with CRS. Appropriate management necessary. Risk of prolonged cytopenias: Appropriate management necessary. Prolonged cytopenia has been associated with increased risk of infections. Myeloid growth factors, particularly granulocyte macrophage colony stimulating factor (GM CSF), not recommended during the first 3 weeks after Kymriah infusion or until CRS has been resolved. Risk of secondary malignancies: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer and should be monitored lifelong for secondary malignancies. Risk of hypogammaglobulinemia or agammaglobulinemia: Infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be managed per age and standard guidelines. In patients with low immunoglobulin levels preemptive measures such as immunoglobulin replacement and rapid attention to signs and symptoms of infection should be implemented. Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment was not studied. Vaccination with live virus vaccines is not recommended at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah. Risk of tumor lysis syndrome (TLS): Patients with elevated uric acid or high tumor burden should receive allopurinol or alternative prophylaxis prior to Kymriah infusion. Continued monitoring for TLS following Kymriah administration should also be performed. Concomitant disease: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions of Kymriah and require special attention. Prior stem cell transplantation: Kymriah infusion is not recommended within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of potential risk of worsening GVHD. Leukapheresis for Kymriah manufacturing should be performed at least 12weeks after allogeneic SCT. Serological testing: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV. Screening for HBV, HCV and HIV, must be performed before collection of cells for manufacturing. Hepatitis B virus (HBV) reactivation, can occur in patients treated with medicinal products directed against B cells and could result in fulminant hepatitis, hepatic failure and death. Prior treatment with anti CD19 therapy: There is limited experience with Kymriah in patients exposed to prior CD19 directed therapy. Kymriah is not recommended if the patient has relapsed with CD19 negative leukaemia after prior anti-CD19 therapy. Interference with serological testing: Due to limited and short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result. Sodium and potassium content: This medicinal product contains 24.3 to 121.5mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2g sodium for an adult. This medicinal product contains potassium, less than 1mmol (39mg) per dose, i.e. essentially potassium free. Content of dextran 40 and dimethyl sulfoxide (DMSO): Contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration. Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.

Interaction with other medicinal products and other forms of interaction

Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females: Pregnancy status for females of reproductive potential should be verified prior to starting treatment with Kymriah. Consider the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.

Pregnancy: There are no data from the use of Kymriah in pregnant women. It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B cell lymphocytopenia. Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnant women should be advised on the potential risks to the foetus. Pregnancy after Kymriah therapy should be discussed with the treating physician. Pregnant women who have received Kymriah may have hypogammaglobulinaemia. Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.

Breast feeding: It is unknown whether Kymriah cells are excreted in human milk, a risk to the breast fed infant cannot be excluded. Women who are breast feeding should be advised of the potential risk to the breast fed infant. Breast-feeding should be discussed with the treating physician.

Fertility: There are no data on the effect of Kymriah on fertility.

Effects on ability to drive and use machinesDriving and engaging in hazardous activities in the 8 weeks following infusion should be refrained due to risks for altered or decreased consciousness or coordination.

Adverse drug reactions:

B-Cell ALL patients and DLBCL patients:

Very common (10%): Infections - pathogen unspecified, viral infections, bacterial infections, fungal infections, anaemia, haemorrhage, febrile neutropenia, neutropenia, thrombocytopenia, cytokine release syndrome, hypogammaglobulinaemia, decreased appetite, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, anxiety, delirium, sleep disorder, headache, encephalopathy, arrhythmia, hypotension, hypertension, cough, dyspnoea, hypoxia, diarrhoea, nausea, vomiting, constipation, abdominal pain, rash, arthralgia, acute kidney injury, pyrexia, fatigue, oedema, pain, chills, lymphocyte count decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, aspartate aminotransferase increased.

Common (1 to 10%): Haemophagocytic lymphohistiocytosis, leukopenia, pancytopenia, coagulopathy, lymphopenia, infusion-related reactions, graft versus host disease, hypoalbuminaemia, hyperglycaemia, hyponatraemia, hyperuricaemia, fluid overload, hypercalcemia, tumor lysis syndrome, hyperkalaemia, hyperphosphataemia, hypernatraemia, hypermagnesaemia, dizziness, peripheral neuropathy, tremor, motor dysfunction, seizure, speech disorder, neuralgia, ataxia, visual impairment, cardiac failure, cardiac arrest, thrombosis, capillary leak syndrome, oropharyngeal pain, pulmonary oedema, nasal congestion, pleural effusion, tachypnea, acute respiratory distress syndrome, stomatitis, abdominal distension, dry mouth, ascites, hyperbilirubinaemia, pruritus, erythema, hyperhidrosis, night sweats, back pain, myalgia, muscolosceletal pain, influenza-like illness, asthenia, multiple organ dysfunction syndrome, alanine aminotransferase increased, blood bilirubin increased, weight decreased, serum ferritin increased, blood fibrinogen decreased, international normalized ratio increased, fibrin D dimer increased, activated partial thromboplastin time prolonged, blood alkaline phosphate increased, prothrombin time prolonged.

Uncommon: B-cell aplasia, ischaemic cerebral infarction, flushing, lung infiltration.

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DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visithttps://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com

References

1.Kymriah (tisagenlecleucel) Summary of Product Characteristics (SmPC), 2018.

# # #

Novartis Media RelationsE-mail: media.relations@novartis.com

Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

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Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia - GlobeNewswire

Recommendation and review posted by Bethany Smith

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

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Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

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Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe are Vericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc. A large number of players are anticipated to enter the global market throughout the forecast period.

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Regenerative Medicine Market Poised to Garner Maximum Revenues During 2025 - The Think Curiouser

Recommendation and review posted by Bethany Smith

Fremont, CA , Oct. 28, 2020 (GLOBE NEWSWIRE) -- APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT). The meeting, which included CBER OTAT staff together with the APstem team, focused on the development plan for AP-Skin-01, a novel off-the-shelf allogeneic stem cell product derived from adult pluripotent stem cells (APSCs) for the initial treatment of diabetic ulcers.

Previous efforts to treat diabetic ulcers have been hampered by persistent inflammation, ischemia and delayed re-epithelialization, which together have posed an insurmountable challenge for drug developers. APstems proprietary stem cell technologies and unique attributes of APSCs may circumvent these obstacles. Preclinical results generated to date by APstem support the potential of AP-Skin-01 to treat difficult-to-heal diabetic ulcers by accelerating healing. AP-Skin-01 is designed to provide full skin structural reconstruction with less scar formation, promote angiogenesis and reduce inflammation during the repair process.

The INTERACT meeting we conducted with the FDA is an important first step in our development of AP-Skin-01. We considered the meeting to be very successful, with productive feedback from the FDA reviewers and strong alignment of APstems development approach for AP-Skin-01, said Dr. Min Hu, CEO and president of APstem Therapeutics. I would like to thank the reviewers from FDA CBER OTAT for their time and helpful guidance. We look forward to continuing our planned pre-clinical work into 2021.

Dr. Jane Lebkowski, APstems scientific advisor and an expert in the development of cell and gene therapies, added: The field of chronic diabetic wounds remains a critical unmet medical need in the expanding diabetic population worldwide. This new therapy has high potential to accelerate full skin regeneration. Therefore, we are grateful for FDAs positive feedback to accelerate the development of this product that could treat millions of patients.

INTERACT is the first available FDA interaction and is a key step in the pathway towards an Investigational New Drug (IND) application, the first regulatory step before experimental therapies may be tested in human clinical studies.

About APstem Therapeutics, Inc.

APstem Therapeutics is a biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing novel stem cell therapies. APstems breakthrough stem cell therapy platform using our unique APSCs can be applied to multiple indications, including skin (diabetic ulcers), liver, lungs, bone/cartilage, heart, neuron and other tissues. For more information, please visit http://www.apstemtx.com.

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APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an Off-the-Shelf Allogeneic Stem Cell Product for the Treatment of...

Recommendation and review posted by Bethany Smith

Medical skin care products are used for beautifying or to address some other skin care problems. The cosmetic industry is booming and skin care forms a very huge part of this industry. The aesthetic appearance is so important that people spend a lot on skin care products and treatment. People being more technologically aware of the various new skin care products trending in the market. In addition to the aesthetic application, the medical skin care products are also used to address issues such as acne, pimples or scars.

Medical Skin Care Products Market: Drivers and Restraints

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

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Medical Skin Care Products Market: Segmentation

On the basis of product type the medical skin care products market can be segmented as:

On the basis of application, the medical skin care products market can be segment as:

On the basis of distribution channel, the medical skin care products market can be segment as:

Medical Skin Care Products Market: Overview

Medical skin care products are used to address basic skin problems ranging from acne to scars. There are various advancements in the ingredients used to offer skin care products to the consumers. For instance, the use of hyaluronic acid and retinoids is the latest development in the industry. The anti-aging creams are at the forefront as the help treating issues such as wrinkles, scars, acne, and sun damage. Another, product in demand is the probiotic skincare which include lactobacillus and bifidobacterium.

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Medical Skin Care Products Market: Region-wise Outlook

In terms of geography, medical skin care products market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America dominated the global medical skin care products market as international players are acquiring domestic companies to make their hold strong in the U.S. LOral is accelerating its U.S. market by signing a definitive agreement with Valeant Pharmaceuticals International Inc. to acquire CeraVe, AcneFree and Ambi skin-care brands for US$ 1.3 billion. The acquisition is expected LOreal to get hold of the brands in the price-accessible segment. Asia Pacific is expected to be the fastest growing region owing to the increasing disposable income and rising awareness towards the skin care products.

Medical Skin Care Products Market: Key Market Participants

Some of the medical skin care products market participants are Avon Products Inc., Beiersdorf AG, Colgate-Palmolive Company, Kao Corporation, LOral S.A., Procter & Gamble, Shiseido Company, The Estee Lauder Companies Inc., Unilever PLC, Revlon, Clinique Laboratories, llc., Murad, LLC., SkinCeuticals, RMS Beauty, J.R. Watkins and 100% PURE.

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The Medical Skin Care Products market to grow on a prudent note from 2017 to 2025 - TechnoWeekly

Recommendation and review posted by Bethany Smith

(Image: Sunny Ng/Unsplash) By Chloe Pek October 30, 2020

Thanks to epigenetic research, it turns out that 70 to 75 per cent of skin ageing is up to your environment and lifestyle, instead of genes. We ask Prof Augustinus Bader, co-founder of his eponymous skincare brand, and Dr Nadine Pernodet, Este Lauder's vice president of Skin Biology and BioActives more

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Heres a piece of good news and not so great news. Thanks to epigenetic research, studies have found that while genes play a role in your skin type and how it ages, 70 to 75 per cent of skin ageing is actually dependent of environment and lifestyle factors. The goodyou have a chance at achieving youthful skin. The badyoull have to put in some extra effort for it.

Epigenetics refers to modifications that change the expression of genes but do not directly alter the DNA sequence. The science of epigenetics shows that factors such as environment and lifestyle can change your gene expression, Dr Nadine Pernodet, vice president of Skin Biology & BioActives at the Este Lauder Companies, explains.

(Related: Glow Recipe in Singapore: The Founders Reveal How To Achieve Glass Skin and More)

The genes in your skin are set. You were born with it, and it is a given, but you caninfluence them, says Prof Augustinus Bader, founder of his eponymous skincare brand.

Lifestyle factors, such as what youeat, where you live, when yousleep, how youexercise, evenageingcan eventually cause chemical modifications around the genes that will turn those genes on or off over time.

Though cell care isnt a new concept, it has increasingly taken centre stage in the skincare industry in recent years.

Este Lauder most recently reformulated its well-loved Advanced Night Repair Serum, boasting a new Chronolux Power Signal Technology that is powered by a proprietary blend of New Adansonia digitata extract and other plant-derived ingredients to boost cellular communication.

Through seven years of research, Este Lauder has proved for the first time that a specific micro-signalling molecule is essential to the skins natural repair and promotes multiple vital anti-ageing pathways.

Significantly, this molecule, helps skin increase its natural renewal of fresh cells and boosts its natural collagen production, Dr Pernodet shares.

Hollywood favourite Augustinus Bader, whose star product is The Cream, has also always been informed by cellular science since its founding. The brand officially launched in Singapore in September.

Our skincare technology works with the skin's own intrinsic repair needs by delivering various active ingredients that control and influence the skin cells in a targeted manner. This combination of active ingredients makes up our proprietary Trigger-Factor Complex 8 (TFC8), Prof Bader shares.

TFC8 functions like GPS: utilising a novel transporting mechanism made up of ceramide structures to deliver these nutrient compounds to the right location within the skin cell microenvironment. In short, the cream naturally causes the skin to undergo a physiological process of remodelling. When you can do that, you can influence epigenetic factors that enable the body to fix your skin according to your own needs.

We find out more from both experts about skin ageing, and how to optimise your environment and lifestyle for a more youthful complexion.

(Related: Celebrity Facialist Joanna Czech Shares Her Self-Care Routine and Tips to Prevent Maskne)

Signs of ageing skin is mainly characterised by dryness, dullness, lack of elasticity, and fine lines. According to Dr Pernodet, this can be influenced by the environment, such as UV and blue light, pollution and ozone, travel, and varied climates as well as lifestyle choices, like diet and sleep patterns.

Environmental factors such as UV and blue light exposure and pollution can result in oxidative stress on the skin, manifesting as wrinkles, roughness, pigmentation, and yellowish or greyish-yellow complexion.

Diets heavy in fat, tobacco, alcohol, sugar and baked goods can also compromise the skins barrier function, cause skin inflammation, and affect its lipid composition.

The skin completely renews itselfapproximately every 27 days. Since our skin is living tissue, it is also not a permanentstructure; it is nourished and rebuilt every day. This rebuilding is called remodelling, Prof Bader explains.

Ageingcorrelates with a lack of elasticity due to a different form of remodelling of the skin over time.Positively rebuilding our skin can be achieved by returningessential components to the cells of our skin.

The cells can then follow their natural role of rebuilding the skin in a healthy way, gradually replacing hardened forms of collagens in aged skin with elastin.

(Related: Biohack Your Way To Beauty And Health Using Your DNA And Stem Cells At These Wellness Retreats Around The World)

We often hear about the term circadian rhythm, and its more than just a body clock that determines when you wake up or sleep. As every cell in our body has a circadian rhythm, it can impact everything from our hormones and moods to our skin.

This means that different processes are occurring to your skin at different periods of the day, making them more susceptible to certain types of skincare at each period.

According to both Prof Bader and Dr Pernodet, night time is when the skins natural process is at its peak, and its barrier becomes more permeable for products to absorb effectively.

Nighttime is when the skins moisture barrier is at its thinnest, causing the most moisture loss. Dehydration can also accelerate skin damage. That is why hydration is so critical before bed to creating the optimal environment for skin to maximise its natural nightly repair of visible skin damage, Dr Pernodet advises. The Este Lauder Advanced Night Repair Synchronised Multi-Recovery Complex includes a high level of hyaluronic acida moisture magnetthat promises to offer 72 hours of hydration. The night serum also offers eight hours of antioxidant power.

Products rich in antioxidants defend skin against further trauma from free radical damage and oxidative stress, which helps to improve signs of ageing.

Life inflicts little traumas on the skin all the time. Your stem cells are there to heal these traumas. As you get older, your skin becomes less adept at healing itself, instead often favouring scarringwhich you experience as your skin looking more aged, Prof Bader shares.

Augustinus Baders The Cream is designed to target these traumas inflicted by everyday stressors by providing the cells with everything they need to help fix the things that go wrong. It does this with TFC8 complex, which replenishes key nutrients with a blend of natural amino acids, medical-grade vitamins, and synthesized molecules that are naturally found on the skin. The addition of antioxidant vitamins C and B5, as well as hydrolysed rice protein also helps to hydrate, condition and heal the skin.

See original here:
You Can Influence The Way Your Skin AgesHere's How - Tatler Singapore

Recommendation and review posted by Bethany Smith

The latest specialized intelligence report published by KandJ Market Research with the titleGlobal Skin Care Cosmetic Market Report 2020 by Key Players, Types, Applications, Countries, Market Size, Forecast to 2026 (Based on 2020 COVID-19 Worldwide Spread)has the ability to help the decision-makers in the most important market in the world that has played a significantly important role in making a progressive impact on the global economy. The Global Multi-band Antenna Market Report presents and showcases a vital vision of the global scenario in terms of market size, market potentials, and competitive environment. The study is derivative from primary and secondary statistical data and consists of qualitative and quantitative analysis of the industry and key players.

The latest report includes Post Impact of Coronavirus(Covid-19) on the Skin Care Cosmetic Industry, it includes on Industry Upstream, Industry Downstream, Industry Channels, Industry Competition, and finally on Industry Employment.

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The segmentation plays a prominent role in dealing with the growth of the Skin Care Cosmetic market where as severalSkin Care Cosmetic Industrytypes and applications are nurturing better understanding of the market. This segmentation has a solid foundation in volume-wise and value-wise data, which support the process of understanding the market scenario with numbers. The market has been explored through properly to get all the factors in line. TheSkin Care Cosmeticreport has been enhanced interviews as a direct strategy of getting information. These interviews include chats with top market players, market experts, suppliers, people in the field of research and development and others, due to which the reliability of the report has increased significantly.

Some of the prominent players operating in the global Skin Care Cosmetic market include:Beiersdorf AG, LOreal S.A., Unilever PLC, Procter & Gamble, Avon Products Inc, Johnson & Johnson, The Estee Lauder Companies Inc, Kao Corporation, The Body Shop International PLC

Skin Care Cosmetic Market Segmentation by Product Types:Sensitive Skin Care, Dry Skin Care, Infants Skin Care, Others

Skin Care Cosmetic Market Segmentation by Applications:Stem Cells Protection Against UV, Flakiness Reduction, Rehydrate the Skin Surface, Minimize wrinkles, Increase the viscosity of Aqueous

Read More Detailed Information regarding Skin Care Cosmetic Industry with latest updates @www.kandjmarketresearch.com/reports/526547

Regional market analysis of the report has supported the study of different regions as an endeavour to understand growth pockets that can be favourable for the market. The regional analysis has import, export, and other secured processes. Players who are engaging in the market for superior growth are looking for these growth pockets to capitalize on the provided opportunities and find new opportunities for growth. Certain countries have been followed in detail to monitor them carefully as they can be significant markets in the coming years. Benefits like better infrastructure, cost-effective labor, access to raw materials, they offer have become attracting factors for many players of the market and they want to expand their business to these regions to increase their profit margin or overall revenue.

Reasons to invest in this report:1. Complete analysis on market dynamics, market status, and competitive Skin Care Cosmetic view is offered.2. Forecast of Skin Care Cosmetic Industry trends will present the market drivers, constraints and growth opportunities.3. This research report will help to understand how the market will grow in the future years lets say next 5-6 years and so on.4. All dynamic Skin Care Cosmetic Industry verticals are existing in this study like Product Type, Applications and Geographical Regions.5. This in-depth market study will help to analyze and take informed decision in their respective field.

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Global Growth Trends and Competitive Analysis of Skin Care Cosmetic Research Report from 2020-2026 - KYT24

Recommendation and review posted by Bethany Smith

In tough times, you can help yourself by boosting the brain chemicals associated with happiness.

In this new normal (aka life in a pandemic) a few simple rituals always make me happy: that first sip of coffee, cuddles with my puppy, reading before work, and getting some exercise. I don't think I've ever left a dance workout class in a bad mood. Now more than ever, I'm leaning into these small things that make a difference in my day.

While a cup of coffee won't change whether you feel truly fulfilled, in uncertain times, there's value in boosting your mood when you can.

There are four main hormones (a type of chemical your body makes) that trigger feelings of happiness, and each chemical is connected to specific events or rewards. Understanding these chemicals and how they work can help you figure out even small ways to feel better amid such a stressful time.

To explain exactly how these "happiness" chemicals work, I spoke to Loretta Breuning, founder of the Inner Mammal Institute and author of Habits of a Happy Brain.

Almost everything that makes you feel "happy" is linked to one of the four happiness hormones: dopamine, serotonin, endorphin and oxytocin. Here are some ways you can boost them.

The hormone dopamine is associated with motivation and reward. It's why you feel gumption when you set an exciting or important goal, and why it feels good to reach that goal. On the flip side, if you have low dopamine (which experts say can occur with depression), it can explain feelings of low motivation or loss of interest in something you used to enjoy.

Committing to a hobby or sport can boost your dopamine.

"Approaching a reward triggers dopamine. When a lion approaches a gazelle, her dopamine surges and the energy she needs for the hunt is released. Your ancestors released dopamine when they found a water hole," Breuning says. "The expectation of a reward triggers a good feeling in the mammal brain, and releases the energy you need to reach the reward."

How to boost it:

There are some not-so-healthy habits that increase dopamine -- like drinking caffeine, eating sugar or taking certain recreational drugs. But you can find ways to kick this hormone up without turning to potentially unhealthy or addictive substances.

"Embrace a new goal and take small steps toward it every day. Your brain will reward you with dopamine each time you take a step. The repetition will build a new dopamine pathway until it's big enough to compete with the dopamine habit that you're better off without," Breuning says.

You may already have goals set around your career, work or how much money you'd like to make. But don't forget personal goals. Committing to a rewarding hobby or sport can be just as gratifying as professional goals. Don't just set a few big goals that will take longer to complete -- also adopt shorter-term goals so you stay motivated.

"Set a short-run, long-run, and middle-term goal so you will always be approaching one when another is blocked. Focus on things you have control over and don't wait for others to set your goals for you," Breuning says.

Serotonin is a neurotransmitter that plays a role in mood, but it also helps regulate other functions in your body like digestion, sleep and bone health. When it comes to happiness and how you feel every day, serotonin is important for reducing depression and regulating anxiety.

How to boost it:

"Confidence triggers serotonin. Monkeys try to one-up each other because it stimulates their serotonin. People often do the same," Breuning says. You've probably never thought about confidence on a neurochemical level, but according to Breuning, if you don't prioritize confidence, your serotonin levels could take a hit.

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If you are trapped in a cycle of low self-esteem or have had others undermine your confidence, it can be hard to build it back up. It may sound strange, but don't ignore your need for respect and status.

"You can develop your belief in your own worth. If you focus on your losses you will depress your serotonin, even if you're a rock star or a CEO. You can build the habit of focusing on your wins. Your serotonin will suffer if you don't," Breuning says.

Besides focusing on what you've achieved in life, you can also build confidence in other ways. One way to do this is by working out or adopting a new exercise routine, which helps bolster your confidence when you stick to it over time. Something else you can try is finding ways to get out of your comfort zone each day. Every day that you challenge yourself to adapt to something new, even if it feels uncomfortable at first, you build more confidence.

Oxytocin is sometimes called the "love" hormone and is associated with how people bond and trust each other. Certain activities like kissing, hugging and having sex can trigger the release of oxytocin in the brain.

It explains why you feel happy when you pet or cuddle with your pets. It's important in childbirth since oxytocin helps the mother's uterus contract to deliver the baby, and oxytocin plays a role in breastfeeding too. It also helps parents bond with a baby after birth.

How to boost it:

You can boost oxytocin by being physically intimate with others. But besides the physical aspect, it's important to know that there's an emotional connection to how oxytocin is released.

Loretta Breuning, author of Habits of a Happy Brain

"Social trust is what triggers oxytocin. If you hug someone you don't trust, it doesn't feel good. Trust comes first. You can build social trust by taking small positive steps toward people," Breuning says.

You can reach out to a friend or contact you'd like to get to know better. Send someone a thank you note or a card just to tell them you're thinking about them. "Take a small step toward someone each day, and they may reciprocate months later, but if you keep doing it you will build trust networks," Breuning says.

Endorphins are notoriously linked with exercise -- it's the phenomenon that explains the runner's high or post-workout endorphin "rush." They function as "natural painkillers" that help minimize pain and maximize pleasure. This chemical experience can explain why a runner may be able to push through a race with an injury that they don't notice until it's over.

"In the state of nature, it helps an injured animal escape from a predator. It helped our ancestors run for help when injured. Endorphins evolved for survival, not for partying. If you were high on endorphins all the time, you would touch hot stoves and walk on broken legs," Breuning explains.

How to boost it:

Laughter is one way to boost endorphins naturally -- so is eating dark chocolate, watching your favorite drama on Netflix, working out and meditating.

Endorphins are released in response to pain, but that doesn't mean you should seek out ways to cause yourself harm (like by overexercising or pushing yourself beyond your limits) just to feel good.

"Inflicting harm on yourself to stimulate endorphins is a bad survival strategy. Fortunately, there are better ways: laughing and stretching. Both of these jiggle your innards in irregular ways, causing moderate wear and tear and moderate endorphin flow," she says.

Editors' note: This week, we're running a special report on the science of happiness and how to strive for it during difficult, complex times. Read more about what the research says about how to be happy,everyday ways people are perking themselves up during the pandemic, and how chasing happiness too single-mindedly could actually make you feel worse.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Link:
How to boost happiness hormones like serotonin and dopamine in everyday life - CNET

Recommendation and review posted by Bethany Smith

While were still learning about new research on cannabidiol (CBD), what we know so far is promising.

People take CBD for a bunch of different reasons. Some claim it helps with anxiety and chronic pain. Others find CBD helpful for dealing with nausea.

Below, we take a look at the research on CBD and nausea. We also include a list of our top CBD picks for nausea and some pointers on how to shop for this kind of CBD product.

A lot of the research on CBD and nausea focuses on its benefits for people with cancer. Nausea and vomiting are often a side effect of chemotherapy treatment.

Animal studies suggest that CBD might help quell nausea because it interacts with serotonin receptors. This hormone influences how you feel namely, your mood and general sense of well-being.

While CBD may play a part in reducing nausea, researchers conclude that tetrahydrocannabinol (THC), the main psychoactive component of cannabis, does more of the heavy lifting when it comes to helping with nausea and vomiting.

Human studies also show that a combination of CBD and THC may provide relief from nausea in people going through chemotherapy.

The American Cancer Society includes cannabinoids on its list of drugs for managing nausea and vomiting at home. It explains that theyre helpful in cases where regular anti-nausea and vomiting drugs dont work.

Chemotherapy can also affect your appetite, and cannabinoids can help with this, too.

Currently, there are two synthetic cannabis-derived drugs approved by the Food and Drug Administration (FDA) for chemotherapy-related nausea and vomiting. They are Nabilone and Dronabinol.

Because the research shows that THC is probably more effective at reducing nausea than CBD, full-spectrum CBD products are your best CBD option for quelling queasiness.

Full-spectrum CBD has all the beneficial, naturally occurring cannabinoids from the cannabis plant, including teeny tiny amounts of THC up to 0.3 percent in federally legal products.

When choosing a CBD product, youll want to select a form of CBD that appeals to you. If youre feeling nauseous, you wont want to take something that makes you want to gag.

For instance, if youre having trouble keeping food down, opt for a tincture or oil that you place under your tongue rather than a flavored gummy.

We chose these products based on criteria we think are good indicators of safety, quality, and transparency. Each product in this article:

As a part of our selection process, we also considered:

Price: $

Each bottle of this CBD oil includes a measured dropper, making dosing easy. It comes in two flavors, but the lemongrass ginger variety may be a bit more palatable than the natural flavor if youre dealing with nausea.

Papa & Barkley sources its hemp from Colorado, Oregon, and Vermont farms. The company offers customers a 30-day, money-back guarantee. You can access the COA directly from the product page.

Price: $$$

Each full dropper of Lion Xs CBD oil delivers 50 milligrams of CBD. Lion X uses organic hemp extract to make its products.

In addition to full-spectrum CBD, the oil is also naturally flavored with peppermint. You can take it directly by mouth or drop it into beverages.

To access the COA, check the product page. One thing to note is that the final product is only tested for potency and the cannabinoid profile.The crude CBD oil is tested for contaminants, but that COA is only available upon request. Since contaminants can be introduced during the manufacturing process, those that are immunocompromised may want to choose a product from another company that tests its final product.

Price: $$

Some people dont like the taste of oils. If you can keep food down and prefer to take a capsule, you might want to try these gel capsules from Lion X. Lion X recommends that you take one soft gel per day.

Like the oil, you can find the cannabinoid and potency COA on the product page. If you want to review the contaminant COA from the raw CBD oil, youll have to email the company. Since contaminants can be introduced during manufacturing, if youre immunocompromised its best to buy from a brand that does comprehensive testing on its final products.

Price: $

This refreshing peppermint-flavored spray is easy to administer. Each spray provides 2 milligrams of CBD. PureKana recommends taking three to four sprays at a time up to three times a day.

The CBD spray also contains liposomal vitamin D complex and is made with organic Kentucky-grown hemp. Research suggests that liposomal vitamin D may be better absorbed than other forms.

You can access the COA for this spray via the product page.

Price: $

We understand that you may not want to take a CBD product that contains THC even in trace amounts which is why we included this broad-spectrum, peppermint-flavored tincture on our list. You can take it under your tongue as you would any other tincture.

GoGreen Hemp uses organic hemp grown in Colorado and has a 14-day return policy. The COA is available on the product page.

There are so many CBD products out there that shopping for them is enough to give anyone a headache. Weed out the good from the bad by keeping these things in mind:

This depends a bit on the form of CBD youve chosen.

You can take tinctures and oils by mouth using a dropper. Just place them under your tongue and hold it there for a few seconds before swallowing. Swallow capsules whole as you would any other pill, or chew on gummies.

Most companies give you an idea of how much or how often to take their CBD product. If youre new to taking CBD, though, its best to start with the smallest dose.

Need more guidance on how much CBD to take? Check out our guide on dosage.

Research finds that most people will have no trouble when taking CBD, but there is a chance you may experience side effects, including:

Taking CBD alongside a high-fat meal may increase the risk of side effects, according to some research.

Before you take CBD for nausea, talk to your healthcare provider. CBD can interact with certain medications, so its a good idea to be open and honest with your physician.

Its also worth having a chat with your doctor if youre interested in trying CBD for nausea and vomiting due to chemotherapy. There may be other medications or strategies you can try first.

Theres some evidence that CBD might help with nausea, but the current research is limited. THC may be more helpful.

That said, some people use CBD to successfully manage nausea.

If youve tried other treatments, havent found relief for your nausea, and want to try CBD, opt for full-spectrum products made with organic U.S.-grown hemp that have been tested by a third-party lab.

Is CBD Legal? Hemp-derived CBD products (with less than 0.3 percent THC) are legal on the federal level, but are still illegal under some state laws. Marijuana-derived CBD products are illegal on the federal level, but are legal under some state laws. Check your states laws and those of anywhere you travel. Keep in mind that nonprescription CBD products are not FDA-approved, and may be inaccurately labeled.

Steph Coelho is a freelance writer with chronic migraine who has a particular interest in health and wellness. When shes not click-clacking away on her keyboard, shes probably nose-deep in a good book.

Read more from the original source:
CBD for Nausea: Research and Best Products - Healthline

Recommendation and review posted by Bethany Smith

Whether you want to lose 10 pounds or 50, shedding extra weight is tough. If you've tried before and fell short of your goal, it can be hard to stay motivated.

But you don't necessarily need to lose a ton of weight to experience health benefits, says Mir Ali, MD, a bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center.

In fact, research shows losing as little as 5% of your body weight can improve your health in many ways. Here are 10 proven health benefits of weight loss and tips for how to lose weight safely.

Losing weight improves insulin sensitivity in people with type 2 diabetes, says Preeti Pusalkar, a certified clinical nutritionist with Hudson Medical Center, a primary care provider in New York City.

Excess body fat leads to an increase in adipose tissue, which causes inflammation and interferes with the function of insulin the hormone that helps regulate blood sugar levels.

Weight loss reduces adipose tissue, which allows the body to manage blood sugar more effectively. Plus, you don't have to lose that much weight to see results. Research has found that just a 5% reduction in body weight improved blood sugar levels in adults.

Losing weight can also improve heart health by reducing pressure on arteries, meaning the heart doesn't have to work as hard to pump blood through the body. The result is lower blood pressure and low-density lipoprotein (LDL) cholesterol levels the "bad" kind of cholesterol that can increase your risk of heart disease, Pusalkar says.

And it doesn't matter if you lose weight through diet and exercise or weight-loss surgery like metabolic surgery you'll reap benefits regardless, according to a large 2020 study.

Researchers examined the effects of weight loss surgery on obese patients who either had weight loss surgery or who lost weight through lifestyle changes. The risk of heart disease for the surgical group decreased after a 5% to 10% loss of body weight while the nonsurgical group saw a decrease after losing about 20% of body weight.

Excess weight can increase blood pressure, and therefore your risk of stroke. This is because high blood pressure puts a strain on your blood vessels, making them stiffer and more likely to cause blood to clot.

"Losing weight helps improve the efficiency of the heart due to less constricted blood vessels," Pusalkar says.

Overweight people are more likely to suffer from sleep apnea a disorder characterized by disrupted breathing while sleeping. Excess weight can increase fat deposits in your neck, which can obstruct your airways.

If you suffer from sleep apnea, losing weight likely won't entirely cure the condition. However, losing just 10% to 15% of your body weight can improve sleep quality and reduce the severity of sleep apnea in moderately obese patients, according to the National Sleep Foundation.

Losing weight alleviates pressure on knees and joints, which can improve mobility, Pusalkar says. A large 2012 study of obese adults with type 2 diabetes found as little as a 1% drop in weight cut mobility limitations, such as difficulty walking or climbing stairs, by more than 7%.

While there is no direct correlation between weight loss and self-esteem, some studies show that weight loss can improve mood and self-confidence.

A 2014 review examined 36 studies to determine the psychological benefits of weight loss. Researchers found consistent improvements in body image, self-worth, and general well-being among subjects who lost weight.

Excess weight can cause joints to become stressed, damaged, and inflamed but losing weight can help.

A 2018 study examined obese adults with arthritis pain in their knees. Researchers found that losing 10% to 20% of body weight resulted in less pain and improved joint function than losing just 5% of body weight, which did not show any significant joint pain benefits.

The reason likely has to do with how quickly joints wear down when under additional stress from excess weight. "As the smooth surface at the ends of bones, or cartilage, becomes damaged and worn, you feel pain and stiffness in the joint," Pulsalkar says.

Because weight loss can improve sleep, you might also feel more energized during the day, Pulsalkar says. Excess weight also means your body has to work harder to move. Therefore, shedding some pounds means you use less energy to move. It also improves respiratory function, which can also make you feel more energized.

While research on the correlation between excess weight and sex drive is still emerging, weight gain has been shown to increase sex hormone-binding globulin (SHBG) levels in your blood. This can lower free testosterone levels and decrease your libido, Pulsalkar says.

According to the American Cancer Society, excess body weight is thought to be the cause of about 11% of cancers in women and about 5% of cancers in men. Obesity increases your risk of developing several different cancers, including:

The exact link between excess weight and cancer is still unknown, but researchers believe inflammation due to visceral fat the fat surrounding vital organs is to blame. Losing weight could lower your risk of developing these cancers.

Some people may need to lose significantly more weight to experience some of these benefits, Ali says. But for the most part, losing as little as 5% of your body weight can lead to many health benefits, like improved heart health and decreased risk of diabetes. But, before starting any weight loss program, it's important to talk with your doctor about the right plan and goals for you.

Original post:
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Recommendation and review posted by Bethany Smith

Trophoblast cell surface antigen 2 (Trop-2) is a glycoprotein that spans the epithelial membrane surface and plays a role in cell self-renewal, proliferation, and transformation.1,2 Encoded by the TACSTD2 gene, Trop-2 is a 35-kDa protein composed of a large extracellular domain, a single transmembrane domain, and a short intracellular tail that is the functionally dominant part of the protein.1-4

Under physiological conditions, Trop-2 plays an essential role in embryonic development, placental tissue formation, embryo implantation, stem cell proliferation, and organ development.2 A low basal expression level of Trop-2 is found on the surface of multiple normal epithelial tissues, including skin and oral mucosa.1,3 Trop-2 can promote tumor growth and its overexpression is common in many types of malignant epithelial tumors.1,2,4

Expression of Trop-2 is regulated by several pro-oncogenic transcription factors (eg, CREB1, nuclear factor [NF]B, and HOXA10) via positive feedback relationships.2 Trop-2 expression may be upregulated because of the inactivation of several transcription factors (eg, HNF4A, TP63/TP53L, ERG, HNF1A/TCF-1, and FOXP3).1,2 Overexpression of Trop-2 accelerates the cancer cell cycle and drives cancer growth. Knocking out the TACSTD2 gene disturbs the proliferation of tumor cells, further validating the role of Trop-2 in tumorigenesis.1

Trop-2 was first elucidated as a transducer of intracellular calcium signals; however, it is now known to function in a variety of cell signaling pathways associated with tumorigenesis (Figure 1).1,2,4 Expression of Trop-2, as a calcium signal transducer, causes calcium to be mobilized from internal stores. Increased intracellular calcium levels activate MAPK, which in turn increases levels of phosphorylated ERK1 and ERK2.2,4 ERK1 and ERK2 are important mediators of cell cycle progression, angiogenesis, cell proliferation, cell invasion, and metastasis.2,4 Intracellular calcium also activates the NF-B pathway, which is involved in stimulation of cell growth, and the RAF pathway, which is essential for the upregulation of FOXM1, one of the most commonly overexpressed genes in human solid tumors.2

In addition to stimulating calcium release and MAPK signaling, Trop-2 is involved in several other pro-oncogenic signaling pathways, leading to tumor cell growth and proliferation. Activation of cyclin E and D further promotes cell cycle progression.4Alteration of the Notch, Hedgehog, and Wnt pathways may discourage appropriate stem cell proliferation and differentiation.2,4 Trop-2 signaling also appears to be dependent on -catenin.5 Direct interaction between -catenin and the intracellular domain of Trop-2, through -catenin signaling, enhances stem celllike properties (eg, self-renewal and transformation) of cancer cells.5 Attenuation of IGF-1 receptor signaling by Trop-2 encourages cancer growth and malignancy, particularly in lung cancers.2

Trop-2 is inextricably linked to cancer progression and metastasis because of its role as a key regulator of the hallmarks of cancer, including cell growth, proliferation, migration, invasion, and survival.4 A variety of human epithelial cancer cells are characterized by Trop-2 overexpression, including breast, lung, urothelial, gastric, colorectal, pancreatic, prostatic, cervical, head and neck, and ovarian carcinomas.2,3 In an analysis of 702 tissue samples from patients with breast cancer, Trop-2 expression was detected via immunohistochemistry (IHC) across a wide range of breast cancer subtypes.6 Trop-2 expression is substantially higher in hormone receptorpositive/HER2-negative (HR+/HER2-) disease and triple-negative breast cancer (TNBC) compared with other breast cancer subtypes, including HER2-positive disease.7

Trop-2 overexpression is also common in nonsmall cell lung cancer (NSCLC).8 Using IHC on tissues collected from the tumors of 68 patients with NSCLC, Trop-2 expression was significantly higher in NSCLC tissues compared with matched healthy tissues (P < .05). Moreover, its overexpression was associated with worse tumor, node, metastasis stage (P = .012), lymph node metastasis (P = .038), and histologic grade (P = .013).9

Bladder cancer, the most common urothelial cancer, is also marked by elevated Trop-2 expression.10,11 In a study of 102 transitional cell bladder cancer samples, IHC staining for Trop-2 demonstrated increased Trop-2 expression compared with noncancerous samples, and this expression pattern was significantly associated with worsened tumor grade (P = .001), stage (P < .0 01), and bladder cancer recurrence (P = .0 3).11

Molecular markers that influence the biological progress of tumors often serve as important prognostic indicators. Overexpression of Trop-2 has been associated with more aggressive disease, poorer overall survival (OS), and worse disease-free survival in patients with solid tumors.4 A meta-analysis conducted in 2016 explored the association of Trop-2 expression and prognosis in patients with a variety of solid tumors (N = 2569). Results from the study showed that high Trop-2 expression negatively affected OS (hazard ratio, 1.896; 95% CI, 1.599-2.247; P < .001) and disease-free survival (pooled hazard ratio, 2.336; 95% CI, 1.596-3.419; P < .0 01).12

Specific to breast cancers, increased Trop-2 mRNA is a strong predictor of lymph node involvement, distant metastasis, and poor OS.13,14 Trop-2 is expressed across all breast cancer subtypes; however, overexpression appears more common in aggressive disease subtypes, including HR+/HER2- disease and TNBC.7

Trop-2 overexpression is also associated with poor outcomes in patients with urothelial cancer. In an analysis of 102 tissue samples collected from patients with noninvasive bladder cancer, Trop-2 expression was higher in samples from patients who experienced disease recurrence compared with those who did not have recurrent disease (P = .0 3). Additionally, patients with Trop-2 overexpression had significantly lower rates of recurrence-free survival (P = .0 01).11 In a separate study, high Trop-2 expression analyzed by IHC was strongly correlated with bladder cancer severity and worsened disease prognosis, with particularly strong Trop-2 expression in muscle-invasive bladder cancer tissues compared with normal bladder tissues (P < .0 01).15

Taken together, the data indicate that Trop-2 is a potentially valuable therapeutic target, given the connection between its overexpression and poor prognosis in various solid tumors.4,15 Its value as a prognostic indicator and potential target for therapeutic development is particularly evident in advanced cancers that have limited or few treatment options available, such as TNBC and metastatic urothelial cancers.

Metastatic TNBC

TNBC is an aggressive form of invasive breast cancer that accounts for 15% to 20% of all breast cancers and a disproportionate number of deaths due to breast cancer.16-18 Its prevalence is particularly high in premenopausal women and those of African American and Hispanic descents.17,19 TNBC is characterized by a lack of estrogen and progesterone receptors and a low expression of HER2; therefore, TNBC cannot be effectively treated with standard hormone-based therapies and HER2-targeted agents.16, 20Although chemotherapy has shown promising results in early TNBC, the majority of patients relapse and progress to metastatic TNBC within the first 3 to 5 years after initial treatment.18 The treatment of metastatic TNBC remains a clinical challenge, as no standard-of-care chemotherapy exists for previously treated patients.17,18 There is an urgent unmet need for effective treatment options in patients with metastatic TNBC.18

Metastatic Urothelial Cancer

In the United States, an estimated 81,400 new cases of urothelial cancer will be diagnosed in 2020, and approximately 18,000 Americans will die from the disease.21 The majority of urothelial cancers arise in the bladder, and established risk factors for bladder cancer include older age, male gender, Caucasian race, family history, and smoking.22,23 Muscle-invasive and meta-static urothelial cancers represent 25% of urothelial carcinoma cases and are characterized by substantially worse prognostic outcomes.23,24 Current chemotherapeutic options for metastatic disease offer a modest median OS of 15 months and a 5-year survival of less than 5%.23,24 Long-term survival is infrequent, and newer treatment modalities that target distinct molecular biomarkers are warranted.24,25

As Trop-2 is a clinically relevant cell surface antigen among several solid tumor types, its overexpression on cancer cells makes it an ideal candidate for targeting by specific therapies.26 One targeted approach involves the use of antibody-drug conjugates (ADCs), a technology that has revolutionized the approach to cancer chemo-therapy over the past 2 decades.26

An ADC is designed to contain 3 components: a monoclonal antibody (mAb), a cytotoxic drug called a payload, and a linker that connects the mAb to the cytotoxin. The mAb binds specifically to its tumor-associated antigen (eg, Trop-2), thereby delivering the cytotoxin to the surface of the tumor cell. Once bound, the ADC is internalized through receptor-mediated endocytosis. Lysosomal degradation of the ADC ensues, facilitating the release of the cytotoxin and enabling it to bind to its intracellular target and induce apoptotic cell death (Figure 2).26,27 The targeted nature of ADCs allows potent therapy to be delivered to the cancer cell itself, limiting systemic exposure. The result is fewer adverse effects (AEs), a wider therapeutic window, and reduced exposure of the drug to efflux mechanisms that can increase drug resistance.26,27

Sacituzumab govitecan-hziy is the only FDA-approved Trop-2targeted ADC, and several other agents are under preclinical and clinical development.28

Sacituzumab govitecan-hziy is an ADC that binds to Trop-2 and delivers a potent cytotoxic drug into tumor cells.29,30 The FDA recently granted it accelerated approval for the treatment of metastatic TNBC, and it has also received fast track designation for metastatic urothelial carcinoma, NSCLC, and small cell lung cancer.28,30-32

The composition of sacituzumab govitecan-hziy has been optimized to effectively target tumors expressing Trop-2. A humanized monoclonal antibody (hRS7) binds to Trop-2 and delivers govitecan (SN-38) to the cell surface. SN-38 is the active metabolite of irinotecan and functions as a DNA topoisomerase I inhibitor. A hydrolysable CL2a linker covalently binds SN-38 to h R S 7.30 When released intracellularly, SN-38 causes double-stranded DNA breaks that lead to apoptosis.29 Additionally, the hydrolysable linker allows a portion of the SN-38 payload to be released into the tumor microenvironment, leading adjacent tumor cells to be killed via a bystander effect.31,32

Sacituzumab govitecan-hziy delivers SN-38 in its most active nonglucuronidated form. Because of its moderate toxicity profile, SN-38 is conjugated to hRS7 at a high drug-to-antibody ratio of up to 8 SN-38 molecules per antibody, allowing for greater drug delivery than systemic irinotecan can achieve.29,32 Irinotecan causes grade 3 to 4 diarrhea in approximately one-third of patients, whereas the lower toxicity of SN-38 may confer an improved therapeutic index.29,30 This high level of drug delivery may overcome the ability of Trop-2expressing tumors to repair DNA breaks.30

On April 22, 2020, sacituzumab govitecan-hziy received accelerated approval from the FDA for the treatment of adult patients with metastatic TNBC who have received at least 2 prior therapies for metastatic disease.28 Approval was based on findings of the phase 1/2, single-arm, multicenter IM-T-IMMU-132-01 trial (NCT01631552), in which sacituzumab govitecan-hziy produced durable responses in a subset of patients with heavily pretreated metastatic TNBC.31,33

The IM-T-IMMU-132-01 trial enrolled 108 patients with metastatic TNBC who had received at least 2 prior treatments for metastatic disease. In the study population, the median number of prior systemic therapies in the metastatic setting was 3, and the majority of patients received prior taxanes (98%) and anthracyclines (86%) in the neoadjuvant or metastatic setting. The median age of study patients was 55 years (range 31-80); 99% were female, and 76% were Caucasian.31Brain metastases were present in 23% of patients, and visceral metastases were present in 77% of patients; these included metastases in the lung/pleura (57%), the liver (42%), and other visceral organs (adrenal glands, pancreas, and kidney; 7%).31

Patients received sacituzumab govitecan-hziy 10 mg/kg administered intravenously on days 1 and 8 of 21-day cycles. Treatment continued until disease progression or unacceptable toxicity. The primary efficacy end point was objective response rate (ORR) assessed according to RECIST 1.1 tumor criteria. The secondary efficacy end points included time to response, duration of response, clinical benefit rate (defined as a complete or partial response or stable disease for 6 months), progression-free survival (PFS), and OS.31

After a median follow-up duration of 9.7 months, an objective response occurred in 36 of 108 patients (ORR, 33.3%; 95% CI, 24.6%-43.1%), including a complete response in 3 patients.31 The median time to response was 2 months (range 1.6-13.5). The median response duration was 7.7 months (95% CI, 4.9-10.8), with 55.6% of patients responding at 6 months and 16.7% of patients still responding at 12 months.31,34 An independent central review of the data found a similar ORR and median response duration (34.3% and 9.1 months, respectively).31 The clinical benefit rate, including stable disease for at least 6 months, was 45.4%. Median PFS was 5.5 months; the estimated probability of PFS at 6 and 12 months was 41.9% and 15.1%, respectively. Median OS was 13 months (95% CI, 11.2-13.7); the estimated probability of survival at 6 and 12 months was 78.5% and 51.3%, respectively.31

The most common AEs of any grade were nausea (67%), neutropenia (64%), diarrhea (62%, predominantly grade 1), and fatigue (55%). Of grade 3 or 4 AEs, the most common were neutropenia, decreased white cell count, and anemia (occurring in 42%, 11%, and 11% of patients, respectively).31 Serious AEs occurred in 32% of patients, with the most common being febrile neutropenia (7%), vomiting (6%), nausea (4%), diarrhea (3%), and dyspnea (3%). Occurrence of AEs led to treatment interruption in 44% of patients, dose reductions in 34%, and discontinuation of treatment in 3%.31,34

IM-T-IMMU-132-01 Trial HR+/HER2- Subpopulation Analysis

Treatment with sacituzumab govitecan-hziy showed encouraging results in a prespecified subpopulation of patients with histologically confirmed HR+/HER2- metastatic breast cancer from the IM-T-IMMU-132-01 trial.32

A total of 54 patients with histologically confirmed HR+/HER2- metastatic breast cancer were enrolled. Eligible patients had received at least 1 line of hormone-based therapy and at least 1 prior chemotherapy in the metastatic setting. The median age of enrollees was 54 years (range, 33-79); aside from required prior hormone-based therapy, previous chemotherapies included a taxane (85%), an anthracycline (67%), capecitabine (65%), a CDK4/6 inhibitor (61%), an mTOR inhibitor (44%), and an immune checkpoint inhibitor (1.9%). After a washout period of at least 2 weeks since prior treatment, sacituzumab govitecan-hziy was dosed at 10 mg/kg via intravenous infusion on days 1 and 8 of 21-day cycles.32

The primary efficacy end point was ORR. Of the 54 patients enrolled, 17 patients achieved partial responses during a median follow-up duration of 11.5 months (ORR, 31.5%; 95% CI, 19.5%-45.6%). In the key secondary outcomes, patients experienced a median PFS of 5.5 months (95% CI, 3.6-7.6) and a median OS of 12.0 months (95% CI, 9.0-18.2). The median time to response was 2.1 months (95% CI, 1.4-7.8), and median duration of response was 8.7 months (95% CI, 3.7-12.7). Of the 17 responders, 4 achieved a response lasting more than 12 months (24%). The clinical benefit rate was 44.4% (95% CI, 30.9%-58.6%), with 7 patients showing stable disease for at least 6 months.32

Safety analyses showed a manageable AE profile for sacituzumab govitecan-hziy. There were no reports of cardiac toxicity or severe peripheral neuropathy. The most common grade 3 or higher treatment-related AE was neutropenia, which occurred in 50% of patients. The incidence of diarrhea was 46% and was mild overall. Grade 3 diarrhea was reported in 4 patients, with no reports of grade 4.32 Serious AEs occurred in 2 patients, who experienced febrile neutropenia and 1 case each of neutropenia, viral pneumonia, sepsis, diarrhea, nausea, vomiting, dehydration, and acute respiratory failure.32

ESMO 2020 Data: ASCENTTrial in Metastatic TNBC (NCT02574455)

Final results of the international, multicenter, open-label ASCENT trial (NCT02574455) were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. ASCENT was the first phase 3 study of an ADC to show improvement in PFS and OS compared with standard-of-care chemotherapy in patients with previously treated metastatic TNBC.35,36

A total of 529 patients with metastatic TNBC were randomized 1:1 to receive either sacituzumab govitecan-hziy or physicians choice of single-agent chemotherapy (capecitabine, eribulin, vinorelbine, or gemcitabine). The dose of sacituzumab govitecan-hziy was 10 mg/kg intravenously on days 1 and 8 of 21-day cycles. All patients had histologically or cytologically confirmed TNBC refractory to or relapsed after at least 2 prior chemotherapies including a taxane. The median age of the study population was 54 years, and the median number of prior chemotherapies received was 4.

In the primary end point, sacituzumab govitecan-hziy significantly improved median PFS (hazard ratio, 0.41; P< .0001) compared with chemotherapy. The sacituzumab govitecan-hziy treatment group achieved a median PFS of 5.6 months compared with 1.7 months in the chemotherapy treatment group. Compared with chemotherapy, sacituzumab govitecan-hziy treatment also significantly improved key secondary end points of OS (12.1 vs 6.7 months; hazard ratio, 0.48; P < .0001) and ORR (35% vs 5%; P < .0001).35,36

The most common treatment-related grade 3 or higher AEs with sacituzumab govitecan-hziy compared with chemotherapy were neutropenia (51% vs 33%, respectively), diarrhea (10.5% vs < 1.0%), anemia (8% vs 5%), and febrile neutropenia (6% vs 2%). No treatment-related deaths were reported, and no cases of neuropathy or interstitial lung disease greater than grade 3 occurred with sacituzumab govitecan-hziy.35

ESMO 2020 Data: Sacituzumab Govitecan-hziy in Combination with Talazoparib for Patients with Metastatic TNBC (NCT04039230)

At the ESMO Virtual Congress 2020, investigators presented the trial design, objectives, and status of a phase 1/2, open-label study that will investigate the efficacy and safety of sacituzumab govitecan-hziy in combination with the PARP inhibitor talazoparib for patients with metastatic TNBC.37 PARP is involved in repairing damaged DNA and is required for clearance of Trop-2 cleavage complexes; thus, PARP inhibitors may be complementary therapeutic partners with sacituzumab govitecan-hziy.37, 38

This study will include a dose escalation in phase 1b followed by a dose expansion in phase 2. Patients will receive sacituzumab govitecan-hziy on days 1 and 8 of 21-day cycles and talazoparib daily on days 15 to 21 of each cycle.38 The primary objective of phase 1b is to assess the dose-limiting toxicity rate and maximum tolerated dose of sacituzumab govitecan-hziy when given in combination with talazoparib. From these data, investigators will determine the recommended phase 2 dose. During phase 2, investigators will assess the ORR, PFS, OS, and clinical benefit rate. As of August 30, 2020, the trial was undergoing active recruitment, and a total of 20 patients were enrolled.37, 38

ESMO 2020 Data: Sacituzumab Govitecan-hziy for Breast Cancer Brain Metastases (NCT03995706)

SN-38, the cytotoxic payload delivered by sacituzumab govitecan-hziy, crosses the blood-brain barrier and is often included in central nervous system (CNS) cancer regimens.39 Investigators hypothesized that sacituzumab govitecan-hziy would yield therapeutically relevant SN-38 concentrations within the CNS of patients under-going craniotomy for breast cancer brain metastases or recurrent glioblastoma.39,40

In this single-center, nonrandomized, phase 0 study (NCT03995706), patients receive a single 10-mg/kg intravenous dose of sacituzumab govitecan-hziy the day prior to craniotomy and then resume therapy (on days 1 and 8 of 21-day cycles) after recovery. To date, 14 patients have been treated. For patients with recurrent glioblastoma (n = 7), the mean SN-38 concentration was 420 nM; for patients with breast cancer brain metastases (n = 7), the mean SN-38 concentration was 626 nM. Among those patients with residual measurable disease, 2 partial intracranial responses have been observed in each group after 12 weeks of treatment (ORR, 28% and 50% for glioblastoma and breast cancer brain metastases, respectively). As of September 2020, recruitment for this trial was ongoing.39,40

The metastatic urothelial cancer cohort of the IM-T-IMMU-132-01 trial reported encouraging activity with sacituzumab govitecan-hziy monotherapy (ORR, 31%; median PFS, 7.3 months; and median OS, 18.9 months).41Sacituzumab govitecan-hziy has FDA fast track desig-nation for metastatic urothelial cancer and is currently under further investigation in the phase 2 TROPHY U-01 trial (NCT03547973) and the upcoming phase 3 TROPiCS-04 trial (NCT04527991).42-45

Final data for cohort 1 and the trial design for cohort 3 were presented at the ESMO Virtual Congress 2020 for the pivotal phase 2, open-label, multicohort TROPHY U-01trial. The TROPHY U-01trial is investigating the safety and efficacy of sacituzumab govitecan-hziy in patients with heavily pretreated metastatic urothelial cancer across several cohorts. The study population across the TROPHY U-01 trial includes patients with disease progression despite treatment with platinum (PLT)-based chemotherapy, checkpoint inhibitors, or both. For all cohorts, the primary efficacy end point is ORR, and key secondary end points include PFS, OS, duration of response, and safety analyses.44,45

Cohort 1

Cohort 1 included a total of 113 patients who were treated with sacituzumab govitecan-hziy. The study population included patients who experienced disease progression after both PLT-based chemotherapy and checkpoint inhibitor therapy.44 Overall, patients in cohort 1 were previously treated with a median of 3 therapies and were a median of 66 years of age. In the results presented at ESMO 2020, a total of 31 patients had achieved an objective response (ORR, 27%; 95% CI, 19%-37%), of which 6 were complete responses and 25 were partial responses. The median duration of response was 5.9 months (95% CI, 4.7-8.6); median PFS and OS were 5.4 months (95% CI, 3.5-6.9) and 10.5 months (95% CI, 8.2-12.3), respectively. Sacituzumab govitecan-hziy demonstrated manageable toxicity. Key grade 3 or higher AEs were neutropenia (35%), anemia (14%), febrile neutropenia (10%), and diarrhea (10%).44

Cohort 3

As of March 2020, cohort 3 had started enrollment and is ongoing. The study plans to enroll a total of 61 patients with metastatic urothelial cancer who are nave to checkpoint inhibitor agents and have experienced disease progression or recurrence after PLT-based chemotherapy.45 As checkpoint inhibitors are the stan-dard-of-care therapy for patients who have failed on PLT-based chemotherapy, this study will investigate combination therapy with sacituzumab govitecan-hziy and the checkpoint inhibitor pembrolizumab. Exclusion criteria include active autoimmune disease or a history of interstitial lung disease, given the coadministration of pembrolizumab. A 10-patient lead-in cohort will determine standard the recommended phase 2 dose of sacituzumab govitecan-hziy (given on days 1 and 8 of 21-day cycles), to be given along with pembrolizumab 200 mg on day 1 of each cycle. The primary end point of ORR and secondary end points of PFS, OS, clinical benefit rate, duration of response, and safety will be assessed.45

The phase 3, global, open-label TROPiCS-04trial aims to enroll 482 patients to investigate the efficacy and safety of sacituzumab govitecan-hziy in patients with metastatic or locally advanced unresectable urothelial cancer who have progressed despite prior therapy with PLT-based chemotherapy and a PD-1 or PD-L1 checkpoint inhibitor. Sacituzumab govitecan-hziy will be compared with physicians choice of chemotherapy (paclitaxel, docetaxel, or vinflunine). The primary outcome measure will be OS; secondary outcomes will include PFS, ORR, safety, and quality of life. As of August 2020, the trial was not yet recruiting patients.43

Evaluation of novel and existing ADCs has revealed that success is not based on the use of any one particular cytotoxic compound or conjugate platform. Factors such as the consistency and level of target-antigen expression, tumor progression, and specific properties of the cancer and stage of disease also play important roles.46 Several additional Trop-2targeted ADCs are currently being investigated in solid tumors (Table).33,36,37,40,42,43,47-51

DS-1062a is a Trop-2directed ADC that contains the cytotoxic compound DXd, a derivative of exatecan that acts as a DNA topoisomerase I inhibitor.52 It is currently being investigated for the treatment of advanced NSCLC in an ongoing phase 1, multicenter, open-label study (NC T 03 401385).48

The study involves a dose-escalation phase and a dose-expansion phase. Dose-limiting toxicity, maximum tolerated dose, and AEs will be explored in both phases.47 Eligible patients have experienced disease progression or recurrence despite previous treatments, have measurable disease per RECIST 1.1 criteria, and are able to provide a sufficient tumor tissue sample for Trop-2 measurement. Patients with multiple primary malignancies or untreated brain metastases are ineligible for the study.48

As of November 2018, a total of 22 patients had been treated with 1 of 3 escalating doses of DS-1062a. Nearly 82% of patients experienced at least 1 treatment-emergent AE, with fatigue being the most common complaint. Fatigue was the only reported grade 3 or higher AE and was reported by 1 patient. Of 18 tumor-evaluable patients, 1 showed a partial response and 8 showed stable disease. Maximum-tolerated dose has not been achieved, and investigators will continue to monitor for safety and disease progression.47, 48

RN927C

RN927C, also known as PF-06664178, is an ADC composed of a Trop-2directed antibody conjugated with the cytotoxic microtubule inhibitor PF-06380101. Release of PF-06380101 leads to mitotic arrest, apoptosis, and cell death.3 Preclinical studies demonstrated the ability of RN927C to induce cell death among various tumor cell lines, including those from the skin, lung, head and neck, breast, ovary, and colon.3

RN927C was investigated in a phase 1, open-label, nonrandomized dose-escalation study (NCT02122146)of patients with advanced or metastatic solid tumors that were unresponsive to current therapies or for whom no standard therapy was available. The primary objective of the study was to determine the maximum tolerated dose and recommended phase 2 dose. Secondary outcomes included safety and preliminary evidence of antitumor activity. A total of 31 patients were enrolled and received treatment with escalating doses of RN927C. Stable disease was noted in 11 patients (39%), but no partial or complete responses were seen. Doses of 3.6 mg/kg, 4.2 mg/kg, and 4.8 mg/kg were considered intolerable, primarily because of skin reactions and development of neutropenia. The next-lower dose of 2.4 mg/kg was well tolerated, but the study was terminated early because of minimal anti-tumor activity and excessive toxicities.50

BAT8003

BAT8003 is an ADC composed of a Trop-2directed antibody conjugated to a potent cytotoxic maytansine derivative. The ADC has been optimized to facilitate site-specific conjugation, which allows for a more controllable drug-antibody ratio. In addition, a fucosylation of the Fc region of the antibody enhances its antibody-dependent cell-mediated cytotoxicity effect. In preclinical xenograft and primate models, BAT8003 demonstrated strong inhibition of tumor growth at doses of 5 mg/kg and 15 mg/kg, with a highest nonseverely toxic dose of 20 mg/kg given once every 3 weeks.51, 53

Given the promising preclinical data, a phase 1 dose-escalation study (NCT03884517) is currently investigating the safety, tolerability, and pharmacokinetics of BAT8003 in patients with advanced epithelial cancer who are either ineligible for standard therapy or have disease refractory to standard therapy.Eligible patients will receive escalating doses of BAT8003 (0.2-10.0 mg/kg) on day 1 of each 21-day cycle. The study will be divided into 3 periods: (1) the first 21-day cycle, which will examine the safety of a single BAT8003 administration, observe for dose-limiting toxicities, and establish preliminary pharmacokinetic parameters; (2) cycles 2 through 8, which will examine safety, immunogenicity, and preliminary efficacy of escalating doses of BAT8003; and (3) an expansion period, which could include an additional 10 to 30 cases to further assess safety and efficacy once a safe and effective dose has been established. As of the last update on March 21, 2019, the trial was actively recruiting patients.51

Trop-2 has established itself as a clinically meaningful biomarker among several types of solid malignancies. Its ability to promote self-renewal, proliferation, and cell invasion makes it an ideal candidate for targeted anti-tumor therapies, including ADCs.

Sacituzumab govitecan-hziy is the first Trop-2directed ADC to receive FDA approval for the treatment of metastatic TNBC. In the pivotal IM-T-IMMU-132-01 trial, sacituzumab govitecan-hziy showed encouraging results in patients with multiple difficult-to-treat solid tumor types, including TNBC, HR+/HER2- metastatic breast cancer, and metastatic urothelial cancer.31,32,41 Sacituzumab govitecan-hziy and other Trop-2directed ADCs represent a novel strategy to improve outcomes among these populations of patients with few therapeutic options. Data from additional trials of sacituzumab govitecan-hziy were presented at the ESMO Virtual Congress 2020. In the ASCENT trial, sacituzumab govitecan improved response rates and survival outcomes in patients with metastatic TNBC compared with standard-of-care therapy.35 Data from a cohort of patients with metastatic urothelial cancer in the TROPHY U-01 trial indicated positive survival impacts with manageable toxicity.44 Additional trials of sacituzumab-govitecan-hziy (as monotherapy or in combination with PARP inhibitors or checkpoint inhibitors) are under way in patients with metastatic TNBC, breast cancer brain metastases, and metastatic or locally advanced urothelial cancer.37,40,43,45 Other Trop-2directed ADCs are under investigation in NSCLC and advanced epithelial cancers.47, 51

Read more:
Role of Trop-2 as an Actionable Biomarker in Solid Tumors - OncLive

Recommendation and review posted by Bethany Smith

Hormone therapy is one of the many types of treatment used in the fight against breast cancer. Hormone therapy helps address breast cancers that are affected by hormones like progesterone and estrogen. With such cancers, the breast cancer cells have receptor proteins that attach to estrogen and progesterone to help the cancer cells grow. Hormone therapy treatments, also called endocrine therapy, help stop the hormones from attaching to receptors. The therapy also can decrease the bodys production of certain hormones.

The Mayo Clinic says hormone therapy is only used for breast cancers that are found to have receptors for estrogen or progesterone. Doctors refer to these types of cancers as estrogen receptor positive (ER positive) or progesterone receptor positive (PR positive). Doctors who specialize in analyzing blood and body tissue will study a sample of cancer cells to see if they have receptors for estrogen or progesterone.

It is important not to mistake hormone therapy for breast cancer with menopausal hormone therapy, which is sometimes called hormone replacement therapy, advises the National Cancer Institute. With menopause treatments, progesterone and estrogen may be used to relieve symptoms of menopause. Cancer hormone treatment does the opposite. The therapy blocks the growth of ER or PR positive breast cancer cells. Typically, drugs are used to stop estrogen and progesterone from helping breast cancer cells grow; otherwise, drugs or surgery will be used to keep the ovaries from making these hormones. Radiation therapy aimed at the ovaries also may help stop hormone production.

Various drugs may be used during the course of hormone therapy. These include aromatase inhibitors that block estrogen production. Other drugs called selective estrogen receptor modulators bind to estrogen receptors to prevent estrogen from attaching to cancer cells.

The NCI notes that research has shown that adjuvant hormone therapy after surgery for ER-positive breast cancer causes reduced risks of breast cancer recurrence, including new breast cancer in the other breast, for at least five years. Sometimes hormone therapy can be used to prevent breast cancer in women who are at increased risk of developing the disease.

The Mayo Clinic says that an oncologist will determine the type of hormone therapy that will be right for a particular type of receptor positive breast cancer. There are some side effects of hormone therapy that depend on the type of treatment. Hot flashes, night sweats, vaginal dryness, mood swings, loss of libido, and risk of blood clots may be possible. Doctors can weigh the risk between the benefits and side effects of hormone therapy.

In addition to chemotherapy, radiation and surgery, hormone therapy may help some patients overcome a breast cancer diagnosis.

Go here to read the rest:
Hormone therapy is an option to treat breast cancer - WV News

Recommendation and review posted by Bethany Smith

From breathwork to walking, positive affirmations to writing letters, these are the acts of self care those in the know are doing at the moment

Back in March, pre-lockdown, we spoke to doctors and health experts about the steps they were taking to stay well at a time when uncertainty was flying around about Covid19. They filled us in on the best ways to prepare ourselves for the months ahead, from the supplements they were taking to breathwork techniques to stay calm. Armed with a wealth of knowledge we felt better prepared to take on the next few months.

With more than half of the UK on local lockdown according to Sky News, we caught up with wellness experts on what theyre doing to stay mentally and physically fit as we live in the midst of the second wave.

Prior to lockdown I took regular breaks abroad and spent time socialising with friends as a way to decompress from work. When this was no longer an option I found myself doing little else but working. Our (now virtual) clinic has been busier than ever over the last few months and I'm grateful that we are in a position to be able to continue to support our clients, old and new, but I am also more aware than ever of the importance of taking time out for myself. I now plan ahead and block out 'restorative time' in my diary to ensure I commit to it. I have been accused (more than once!) of being a workaholic so this isn't as easy as it sounds!

Before lockdown my workouts were varied; in a typical week I'd do spin, play tennis, go to the gym and work out at home with my trainer. During lockdown, this stopped and I upped my online PT sessions. I still do five sessions a week with my trainer - four of those are training and one is a stretch session in an effort to compensate for so much time spent at my computer.

I also take my dog Lily for walks twice a day which is great for helping me maintain a routine. The impacts of nature and natural light on our health and wellbeing cannot be underestimated.

I'm a nutritionist so of course supplements form a part of my health routine! I'm currently taking personalised supplements from Bioniq. I love their concept as they take regular blood tests and tailor your nutritional supplements based on your unique needs. I'm particularly keen to ensure my levels of vitamin D, C and zinc are optimal throughout the winter. I also take Omega 3 essential fats.

At this time of year, like many of us, I gravitate towards warming comfort foods. I like to batch cook stews and soups using my Ninja Foodi Max Multi-Cooker which does EVERYTHING! I try to eat seasonally as much as possible which is made easier thanks to weekly organic vegetable box deliveries from Riverford.

I aim to meditate daily and I find it makes such a difference to my state of mind when I do. My go-to meditation app is Meya which uses sound wave therapy to help get you into a meditative state and make you more receptive to affirmations. I alternate between this app and a meditation process known as 'Isha Kriya' that I learnt when I spent time at the yoga centre Isha Life Ashram in India last year.

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I regularly use a magnesium spray (Better You Magnesium Oil Spray, 13), lotion (Neom Organics Perfect Night's Sleep Magnesium Body Butter, 36) or bath soak (Westlab Pure Magnesium Flakes, 6.99) to try to counteract the effects of the stress hormone cortisol which leaches magnesium from the system.

MORE GLOSS: The best magnesium supplements

I take Symprove as this bolsters immunity by improving the quality and diversity of our own gut microbiome and prevents nasty bugs from sticking in the system (I also eat/drink one of kefir, kombucha, sauerkraut or sourdough bread on an alternating daily basis as they are food sources of pro- and pre-biotics).

As well as Heights' Smart Supplement for brain health, which also contains vitamin C, at the beginning of lockdown I was taking a high dose vitamin C supplement (Micro Liposomal C by Allergy Research Group, 29.81) but I took a break from that over the summer because I only add extra when it's cold and flu season. I'll start taking Altrient Liposomal Vitamin C 100mg, 39.99, now that we are entering the season again.

I cannot over-emphasise the importance of taking this for a host of reasons including anti-inflammation, cancer prevention and the fact that lack of it is associated with higher mortality rates with Covid 19.

MORE GLOSS: The best vitamin D supplements to support immunity

For mood and self-care I love the Aromatherapy Associates Rose range, particularly the Bath and Shower Oil, 49, which I apply to my major organs (heart, lungs, liver and kidneys) after dry body brushing, and also the Oil to Milk Body Cleanser, 26, that feels like a hug in a bottle! Immersing yourself in warm water or feeling lovely textures on your skin releases the bonding hormone oxytocin which can help alleviate loneliness or lack of physical affection.

MORE GLOSS: Skin hunger: how lack of touch in lockdown affects us

I only use non-toxic candles such as soy, coconut or beeswax. My favourites include Neom Organics, Bamford or Gold and Black.

MORE GLOSS: Long-lasting scented candles that are worth every penny

My phone is always on silent and I never watch the news and only very occasionally read it - it is too stress-inducing and repeatedly looking at bad news has been shown to cause PTSD. I keep up to date by getting the headlines from my husband or friends as the human interaction with loved ones counteracts all the negativity!

I invested in a Peloton during lockdown as I was getting way too sedentary doing so much more work on my laptop than I used to when I walked from meeting to meeting in central London. It has changed my life! I use it in the morning to boost productivity or in the evening to create a boundary between work and life. Along with this I have been using a foam roller to pinpoint and release tension in my body - either from a day at the desk or due to the stress of the global situation.

There have been a lot of reports of shallow, rapid breathing or even breath-holding due to stress. I focus on my breath throughout the day or if I meditate and make sure the exhale is longer than the inhale.

MORE GLOSS: 6 breathing techniques to help you calm anxiety

I always wear a face mask if I go out to the shops or a restaurant (which is rare). They get washed at 60c after maximum four hours use. I used to wear gloves and wipe everything that entered our home but since we know more about the mechanisms of Covid19 contagion (breath particles more than droplets), I have relaxed on that but always wash my hands thoroughly and/or use Neals Yard Organic Natural Defence Hand Rub, 5.75, after contact with anything outside my home.

Buy Dr Tara Swart's book The Source: Open your Mind, Change your Life

Affirmations are a powerful way to speak to our sub-conscious which is where our self-confidence and self-love are formed. I listen to an affirmation playlist when Im lying in bed as Im waking up or while Im doing my skincare routine in the morning. You can find them on YouTube or have I have a collection on my website too. You dont have to actively listen and it still does the job which is great.

I've been doing breathwork sessions with Breathe With James. I always cry the next day; its a really powerful tool for releasing emotions. Emotions and trauma sit within our body and shaking therapy and breathwork unlock the trauma, release and let it go essential after the year we've all had!

MORE GLOSS: Shaking is the stress-busting trend that everyone can benefit from

I wasnt a runner at all, but its really changed my relationship with my body. My cardiovascular health is improving and so is my mental clarity. Its great for setting yourself goals and also understanding how your body is different each day. Some days Ill run two KM and Im done and another day Ill do 11 KM. Its a good reminder to listen to your body. I dont think we check in with our bodies in the same way when youre doing a HIIT class whereas with running youre really aware of how youre feeling and being able to be at one with you body

Im really getting into CBD at the moment; I started using it as drops and I was instantly relaxed. I love CBD drinks too, especially Meda. It relaxes and makes me feel much calmer. I get really bad anxiety and it has definitely helped me in recent months.

MORE GLOSS: CBD - the cannabis supplement taking the wellness world by storm

My bedtime routine really helps me feel well at the moment. At 6pm I light incense bought from Amazon as my signal to wind down from the day. Im an early to bed person I can be asleep by 9:20 pm. I read before bed and it makes me such a nice tired. Watching anything too stimulating gives me a really disturbed sleep and I feel my body naturally wants to be away from my phone before bed. Scrolling aimlessly makes me feel uncentred and I dont sleep well if I do that, so putting my phone on aeroplane mode really improves my sleep.

Find Roxie's positive affirmation playlist on her website

I make sure I go for daily walks, especially if I dont feel like it or its miserable outside. Luckily for me, theres a park nearby and it only takes 20 minutes to walk there and around it, it helps me feel like I can focus again and stops me feeling so fatigued and burnt out. I never take my phone when I go for my walk because I know Im only going to be 20 minutes. It helps with mindfulness, noticing whats going on around you, the change in seasons, the smells, it all helps you feel more connected and grounded.

Another thing I started doing at the start of lockdown, and something Ive continued doing is sending letters again. Writing by hand especially, because you have to think about your thoughts and put them down carefully to avoid having to scribble something out, not like on a computer where you can delete and add as you please. Its more mindful and thoughtful. It helps you feel more of a connection to the person youre writing to and theres nothing better than receiving a handwritten letter by family or friends.

Ive never been a smoothie person, I admit however Ive been getting a weekly local veg box for years, but Ive found that even working from home Im so busy that I just dont always have time to cook something nutritious. So I can just throw some of my fruit and veg into a blender and make a smoothie, it really gives me peace of mind knowing Ive at least had some fruit and vegetables on a daily basis even when Im run off my feet.

I really like giving myself time to have a bath, with bubbles and I use the Healthspan Magnesium Bath Soak, it makes it feel like a ritual, setting your bath up exactly how you like it so you can just soak and relax. Rituals are fantastic for making us feel grounded and its all about giving yourself some mental space and time in the bath.

Find out more about Dr Meg Arroll on her website

MORE GLOSS: SAD: The experts' toolbox for boosting your happiness levels

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What wellness experts are doing to stay... well at the moment - Get The Gloss

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Lisa C. Searle began attending an Assemblies of God church in 9th grade, not too long after she began volunteering at a Goldsboro, North Carolina, hospital helping mothers of newborns. The experience in the labor and delivery unit only strengthened her resolve to someday become a midwife who could help women deliver their babies.

After graduating from high school, Searle entered Barton Nursing School in nearby Wilson. As she neared completion of her studies, she realized she needed practical gynecological office experience in order to realize her midwife dream. Even before she graduated, a womens health clinic hired her in 1995. But Searle faced a dilemma: she would be assisting in women undergoing surgical abortions.

Although such a job conflicted with her religious beliefs, Searle tried to justify accepting the position: it paid good money and she would gain valuable health-care experience to further her career. Searle kept her new employment a secret from her parents.

I was in a rebellious phase, Searle recalls. I was young, and for the first time I felt like I could make my own decisions and do what I wanted to do.

But the more she worked at the facility, the more miserable Searle became. She already had stopped attending church before taking the job.

All they did was abortions, Searle says of the clinic. I really struggled with the babies I saw. There was so much sadness and darkness in the recovery room.

A solution seemed to come in 2000 with federal government approval of a two-part drug that induces a chemical abortion at home. A pregnant female first takes mifepristone (RU-486), which blocks the effects of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg. One or two days later, the woman takes a second drug, misoprostol, which expels the developing baby from the uterus.

The RU-486 abortion is becoming an increasingly popular alternative to traditional abortion. Of the estimated 1 million abortions that will happen in the U.S. this year, 400,000 are expected to be the chemically induced type in a clients residence, rather than a surgical abortion at a facility.

The facility granted Searles request that she be put in charge of the program administering the abortion pills. That way, she reasoned, she wouldnt have to see the aborted babies.

By 2005, married to her husband, Michael, and pregnant with their son Costin, Searle left the profession she had known for a decade. She felt she couldnt work in an industry that destroyed babies as she felt one moving inside her.

Still, the heaviness didnt lift.

I was buried in guilt and shame, disgusted with myself, remembers Searle, now 47. It was a very dark time in my life. I was far, far from God.

Ultimately, Searle cried out to God for forgiveness, which put her on the road to recovery. In 2009, the Searles began attending Church Alive in Fuquay Varina southwest of Raleigh.

Searle didnt reveal her secret past life with founding co-pastor Laura A. Lee until a year ago. Lee convinced her to speak about it in March on a womens ministries panel at the church.

Three years ago, Searle went through a Bible study with former Planned Parenthood clinic director Abby Johnson, which brought her more healing. Searle says Johnsons ministry And Then There Were None provides multiple phases of healing retreats for those who have been damaged or exploited by the abortion industry. A counselor is available by phone anytime.

Johnson, who wrote the book Unplanned which details her transformation into becoming an anti-abortion activist urged Searle to become involved in abortion pill reversal.

Starting in 2013, Searle spent four years as a nurse manager of a pregnancy resource center. For two years, she worked as a nurse consultant for the hotline, before being hired a year ago at Heartbeat International. As health care team manager, she oversees the Abortion Pill Rescue Network. Heartbeat International, which is affiliated with 2,700 pregnancy care centers around the world, has administered the Abortion Pill Reversal Network since 2012.

In 2016, the U.S. Food and Drug Administration expanded the use of mifepristone and misoprostol an additional three weeks up to 70 days into a pregnancy.

However, pregnant women still have a last resort if they decide to not end their pregnancy soon after taking the first pill.

Females who have misgivings after ingesting the first dose can call the around-the-clock hotline and be referred by a trained nurse or consultant to a medical provider in her area. That physician will start the pregnant woman on a medication called progesterone, which can safely reverse the effects of mifepristone. If intervention can occur within 48 hours of taking the first pill, this will reverse the effects of the abortion pill for two-thirds of the cases. More than 1,000 babies have been saved as a result of the abortion pill reversal. There is no increased risk of harm to the baby caused by taking the drug, doctors say.

Heartbeat's Abortion Pill Rescue Network from Heartbeat International on Vimeo.

Searle, who with her husband also has an 8-year-old son, Asher, no longer advocates keeping quiet about the topic.

So many Christians dont talk about abortion, but we need to be real, Searle says. We need to teach our children and congregations that it is not just a sin, not just against Gods will, but it is the taking of a human life.

Lee, 48, agrees, noting that an estimated one in four church-attending women has had an abortion. Church Alive recently raised over $40,000 toward the purchase an ultrasound machine for a local pregnancy care center, which will show expectant mothers a detailed image of their unborn child.

Meanwhile, Searles urges Christian women struggling emotionally with a past abortion to seek help. SaveOne is an AG-affiliated abortion recovery ministry.

It is so important that people do not suffer in silence because of the shame and guilt that abortion causes, Searle says.

Photo: Lisa Searle (far right) spoke on a panel that included (from left) Sarah Johnson, Keisha Spivey, Laura Lee, and Susan Ross.

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(USA) Official Web Site | Reversing Abortion - AG News

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Nadine Dirks is an intersectional feminist, writer, and advocate for sexual reproductive health and rights (SRHR). In this opinion piece, she shares her views on unsafe abortions as a public health issue.

Researchers have referred to unsafe abortions as a preventable pandemic one that affects the health and lives of women, transgender people, and non-binary individuals alike.

It is a global health and human rights issue that is not treated with the seriousness that it deserves. Through a reproductive justice lens, there are many intersecting issues that have caused this pandemic.

One of the reasons that people seek unsafe abortions to begin with is the stigma associated with family planning. We see this stigma and discrimination playing out in federal government cuts and pledges to defund organizations such as Planned Parenthood, which works to ensure womens health and right to autonomy.

When world leaders stigmatize organizations that allow for equal access to family planning, citizens cannot expect to see positive changes in societal attitudes and behavior.

Even where contraceptive services do exist, women may not be able to access them safely and avoid pregnancy. For example, they may be faced with pro-life protesters lobbying outside organizations, hurling insults and referring to people as baby killers for providing or accessing the healthcare that they know is right for them be it condoms, contraception, or a safe abortion.

If you would like to check your registration status or register to vote, we have added some useful links at the bottom of this article.

Alongside abortions, organizations such as Planned Parenthood also provide many other services. These include:

By defunding organizations such as Planned Parenthood, we have to face the fact that we are putting members of our community at risk of health complications, and that extends beyond allowing women to choose and access the services they need.

Abortions remain one of the most stigmatized medical procedures worldwide yet according to the Guttmacher Institute, nearly 1 in 4 women in the United States will have an abortion by age 45.

Statistics also indicate higher rates of abortion among Black women and Hispanic women. Why is that? It is likely due to a lack of adequate contraceptive care given to women of color and a lack of disposable income to fork out on contraceptive methods, compared with white women.

Also, due to discrimination and racism in the medical field, healthcare professionals often overlook and ignore the medical needs of women of color sometimes going as far as assuming that Black people have higher pain thresholds than white people.

Abortion and access to other contraception methods is a political, human rights, and reproductive justice issue, underpinned by a lack of comprehensive sexual education in schools.

A report from the Centers for Disease Control and Prevention (CDC), for instance, found that in most states, fewer than half of high schools and just 1 in 5 middle schools teach all the essential sex education topics recommended by the CDC.

So, with only 4% of the recommended topics being taught in Arizona, for example, it is not surprising that people are wildly uninformed and lack the necessary tools and education to even ask for what they need in terms of contraception.

And even if a person knows that they want contraception, how are they expected to assert themselves and speak from a place of autonomy when their sexual and reproductive health education has either been stigmatized or avoided altogether? People can hardly be expected to access different methods of contraception safely if they are not first made aware of which options are available to them.

This lack of education and conservative outlook on sexual education furthers the culture of stigma. In such a culture, reports have shown that people feel that they cannot have conversations or ask questions because they fear being ostracized by their communities, either on religious or conservative grounds or due to prejudice, patriarchal views, or a lack of education on matters of sexual health.

As some researchers point out, Abortion stigma is usually considered a concealable stigma: It is unknown to others unless disclosed, and it is characterized by secrecy.

Furthermore, studies show that community members disapprove of abortion and that a womans age or marital status could exacerbate judgment, with younger or unmarried women bearing the brunt of these attitudes.

Sadly, a lack of information does not reduce the incidence of unprotected sex or rates of abortion. It does, however, mean that the abortions that people are accessing are more likely to be unsafe or unregulated.

An ample body of existing data suggests that, on a global level, restrictive abortion laws and a lack of education about contraceptive methods are associated with a higher rate of unsafe abortions.

For instance, physicians from Brigham and Womens Hospital in Boston, MA, warn that in the absence of education about contraception and the availability of legal and safe abortion, desperate women, facing the financial burdens and social stigma of unintended pregnancy and believing they have no other option, will continue to risk their lives by undergoing unsafe abortions.

Furthermore, a lack of education could mean that people miss key details in spotting an unsafe abortion versus a safe one. Some may even intentionally lean toward unsafe options because it may seem more concealed than going to a clinic during the day in the middle of the city center.

Unsafe abortions come with many potential health hazards, including infections, infertility, hemorrhages, and even death. They are also often performed in facilities that are not adequately equipped, or the procedure may be carried out by someone who lacks the necessary skillset. The tools or methods they use may also be outdated, unhygienic, or traumatic. Another concern is that these unsafe procedures may also be unnecessarily invasive due to the provider not being trained to safely administer healthcare.

Specifically, the World Health Organization (WHO) list uterine perforation (caused when the uterus is pierced by a sharp object) and damage to the genital tract and internal organs as some of the well-documented complications of unsafe abortions.

Issues of reproductive justice have deep, complex roots. On the surface, it may seem as though we have rights and are free to make our own choices, but many of us are still unable to access services due to our gender, race, sexual identity, or class. What good is a Constitution if some people can access services while others cannot?

Seemingly, in recent years, womens SRHR have become even more controversial in the U.S.

In an attempt to control a persons right to choose an abortion, limitations have been implemented that restrict the allocation of other federal and state funds, such as funds for STI testing and treatment and sex education in 12 states, according to the Guttmacher Institute. This causes further issues in addition to unintended pregnancies, limiting peoples access to STI testing and treatments.

With the looming possibility of Roe v. Wade being overturned, cis women, transwomen, and nonbinary folk alike are left fighting once again for the autonomy of their own bodies.

Attempting to control what people do with their bodies entirely erases the SRHR and reproductive justice work being done worldwide. It undermines not only human rights but also the 21 million American women who are likely in need of publicly supported contraceptive services and supplies, according to the Guttmacher Institute.

These intersecting issues of education, stigma, discrimination, healthcare, and reproductive justice are all at play in the upcoming U.S. election. With SRHR being under threat, it is now more important than ever for people in the U.S. to play their part in supporting human rights by casting their vote.

To check your voter registration status, click here to visit the website of VoteAmerica, a nonprofit, nonpartisan organization dedicated to increasing voter turnout. They can also help you register to vote, vote by mail, request an absentee ballot, or find your polling place.

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Election 2020: The importance of sexual and reproductive rights - Medical News Today

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Infantile Spasms Therapeutics Market report would come handy to understand the competitors in the market and give an insight into sales, volumes, revenues in the Infantile Spasms Therapeutics Industry & will also assists in making strategic decisions. The report also helps to decide corporate product & marketing strategies. It reduces the risks involved in making decisions as well as strategies for companies and individuals interested in the Infantile Spasms Therapeutics industry. Both established and new players in Infantile Spasms Therapeutics industries can use the report to understand the Infantile Spasms Therapeutics market.

In Global Market, the Following Companies Are Covered:

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Analysis of the Market:

An infantile spasm (IS), also known as West Syndrome, is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. The condition is usually observed in 2% of childhood epilepsies and 25% of epilepsies that start in the first year of life.

The global infantile spasms therapeutics market is growing at a slow pace. This is due to the increased availability of generic drugs and less approved therapies in the market and the less awareness of the disease and the available treatment options, especially in the low- and middle-income countries.

The classification of Infantile Spasms Therapeutics includes Oral, Injection. The proportion of Injection in 2016 is about 45%, and the proportion of Oral in 2016 is about 55%.

Based on application, the nitinol medical devices market is segmented into Hospital, Clinic and others. Clinic segment accounted for larger market share in terms of sales in 2016, Clinic segmented accounted for more than 45% of the market share in 2016.

United States is the largest consumption place, with a consumption market share nearly 83% in 2016. Following United States, Europe is the second largest consumption place with the consumption market share of 12.6% in 2016.

The US market is dominated by two approved products H.P. Acthar Gel (adrenocorticotropin hormone) and Sabril (vigabatrin). Sabril was the first drug to be approved by the Food and Drug Administration (FDA) in 2009 and H.P. Acthar Gel (adrenocorticotropin hormone) was approved for infantile spasms in 2010. Both have Orphan Drug Exclusivity (ODE) in the US.

In the future, the Infantile Spasms Therapeutics will have a good future; the price fluctuation has relationship with the raw material. The technology will more mature and the industry is more dispersion.

Market Analysis and Insights: Global Infantile Spasms Therapeutics Market

In 2019, the global Infantile Spasms Therapeutics market size was USD 138.9 million and it is expected to reach USD 178.4 million by the end of 2026, with a CAGR of 3.6% during 2021-2026.

Global Infantile Spasms Therapeutics Scope and Market Size

Infantile Spasms Therapeutics market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Infantile Spasms Therapeutics market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.

Segment by Type, the Infantile Spasms Therapeutics market is segmented into Oral, Injection, etc.

Segment by Application, the Infantile Spasms Therapeutics market is segmented into Hospital, Clinic, etc.

Regional and Country-level Analysis

The Infantile Spasms Therapeutics market is analysed and market size information is provided by regions (countries).

The key regions covered in the Infantile Spasms Therapeutics market report are North America, Europe, China, Japan, Southeast Asia, India and Central & South America, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of revenue for the period 2015-2026.

Competitive Landscape and Infantile Spasms Therapeutics Market Share Analysis

Infantile Spasms Therapeutics market competitive landscape provides details and data information by vendors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by player for the period 2015-2020. Details included are company description, major business, company total revenue and the revenue generated in Infantile Spasms Therapeutics business, the date to enter into the Infantile Spasms Therapeutics market, Infantile Spasms Therapeutics product introduction, recent developments, etc.

The major vendors include Mallinckrodt, H. Lundbeck, Insys Therapeutics, Orphelia Pharma, Valerion Therapeutics, Catalyst Pharmaceuticals, Anavex Life Sciences, Retrophin, GW Pharmaceuticals, etc.

This report focuses on the global Infantile Spasms Therapeutics status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Infantile Spasms Therapeutics development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

Infantile Spasms Therapeutics Market Breakdown by Types:

Infantile Spasms Therapeutics Market Breakdown by Application:

Critical highlights covered in the Global Infantile Spasms Therapeutics market include:

The information available in the Infantile Spasms Therapeutics Market report is segmented for proper understanding. The Table of contents contains Market outline, Market characteristics, Market segmentation analysis, Market sizing, customer landscape & Regional landscape. For further improving the understand ability various exhibits (Tabular Data & Pie Charts) has also been used in the Infantile Spasms Therapeutics Market report.

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In the end, Infantile Spasms Therapeutics Industry report provides the main region, market conditions with the product price,profit, capacity, production, supply, demand and market growth rateand forecast etc. This report also Present newproject SWOT analysis,investment feasibility analysis, andinvestment return analysis.

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How an Imaging Test Predicts Treatment Response

If youve already gone through a round of treatment for diffuse large B-cell lymphoma and it didnt work, or your cancer came back after treatment, your doctor might start talking to you about having an autologous stem cell transplant. This therapy involves getting high doses of chemotherapy to get rid of your cancer cells, followed by an infusion of stem cells taken from your blood or bone marrow before treatment, to replenish your bodys supply of healthy blood cells.

Related: What is Autologous Stem Cell Transplant?

A stem cell transplant can be a pretty grueling treatment that involves getting very high doses of chemotherapy, spending three to four weeks in the hospital, and enduring side effects like nausea, vomiting, mouth pain, infections, bleeding, and lung inflammation. And after all of that, you still may not get the results you want.

If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.

One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.

Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.

The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.

CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.

A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.

When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.

Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.

One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More

Related: What is Autologous Stem Cell Transplant?

If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.

One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.

Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.

The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.

CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.

A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.

When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.

Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.

One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More

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Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? - SurvivorNet

Recommendation and review posted by Bethany Smith

The latest Stem Cell Banking market research report offers a top to bottom analysis of this business sphere in terms of potential industry size, supply chain, growth dynamics, opportunity analysis, and competitive landscape. Furthermore, it extends through abstracts on various industry segments, inclusive of a rundown of the business scenario across the various regional markets. Additionally, the study provide insights into to the impact of Covid-19 pandemic and recommends strategies that could maximize ROI amid these uncertain times.

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What are sales, revenue, and price analysis of top manufacturers of Stem Cell Banking market?

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What are sales, revenue, and price analysis by types and applications of Stem Cell Banking Industry?

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Stem Cell Banking Market to witness an impressive growth during the forecast pe - News by aeresearch

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GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- NexImmune, a clinical-stage biotechnology company developing unique non-genetically-engineered T cell immunotherapies, announced today that it has signed a research initiative related to its AIM nanoparticle technology with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases.

City of Hope is a participating clinical site in the ongoing Phase 1/2 study of NEXI-001. The cancer center will leverage both patient samples from the ongoing NexImmune Phase 1/2 clinical study of NEXI-001 in acute myeloid leukemia (AML) patients with relapsed disease after allogeneic stem cell transplantation and the center’s tumor repository bank of primary leukemia samples, one of the largest collections in the world, to drive the research.

NEXI-001 is a cellular product candidate that contains populations of naturally occurring CD8+ T cells directed against multiple antigen targets for AML, and it is the first clinical product generated by the Company’s AIM nanoparticle technology.

NexImmune has developed a unique and versatile technology platform that lends itself very effectively to important areas of ongoing research in the field of AML,” said Guido Marcucci, M.D., Chair and Professor with City of Hope’s Department of Hematologic Malignancies Translational Science. Our collective goal is to translate future research findings into new, more effective T cell immunotherapies to the benefit of these very difficult to treat patients.”

A key objective of the research will focus on the identification of new antigen targets that are expressed on both leukemic blasts as well as leukemic stem cells, and those which represent survival proteins to both. Once identified, these antigen targets will be loaded on NexImmune AIM-nanoparticles to expand antigen-specific CD8+ T cells, and evaluated in pre-clinical models for anti-tumor potency, tumor-specific killing, and response durability.

In addition, the research initiative will aim to further understand different mechanisms of tumor escape, such as tumor antigen and human leukocyte antigen (HLA) downregulation due to immune pressure.

Research between NexImmune and City of Hope will inform a scientific understanding of how the immune system can address certain tumor escape mechanisms to more effectively fight aggressive cancers like AML, and how this might be accomplished with NexImmune’s AIM technology and T cell products,” said Monzr Al Malki, M.D., Director of City of Hope’s Unrelated Donor BMT Program and Haploidentical Transplant Program and an Associate Clinical Professor with Department of Hematology and Hematopoietic Cell Transplantation. Based on our current clinical experience with this technology, we’re excited to learn what more this research will tell us.”

City of Hope is a world-class clinical research institution that has built one of the largest banks of leukemia samples in the world,” said Han Myint, M.D., NexImmune Chief Medical Officer. The depth of expertise that Drs. Marcucci, Al Malki and their team bring to this research initiative will help NexImmune continue to develop innovative products that can help patients with AML and other hard-to-treat cancers.”

City of Hope is a leader in bone marrow transplantation . More than 16,000 stem cell and bone marrow transplants have been performed at City of Hope, and more than 700 are performed annually. City of Hope’s BMT program is the only one in the nation that has had one-year survival above the expected rate for 15 consecutive years, based on analysis by the Center for International Blood and Marrow Transplant Research.

About NexImmune NexImmune is a clinical-stage biotechnology company developing unique approaches to T cell immunotherapies based on its proprietary Artificial Immune Modulation (AIM) technology. The AIM technology is designed to generate a targeted T cell-mediated immune response and is initially being developed as a cell therapy for the treatment of hematologic cancers. AIM nanoparticles (AIM-np) act as synthetic dendritic cells to deliver immune-specific signals to targeted T cells and can direct the activation or suppression of cell-mediated immunity. In cancer, AIM-expanded T cells have demonstrated best-in-class anti-tumor properties as characterized by in vitro analysis, including a unique combination of anti-tumor potency, antigen target-specific killing, and long-term T cell persistence. The modular design of the AIM platform enables rapid expansion across multiple therapeutic areas, with both cell therapy and injectable products.

NexImmune’s two lead T cell therapy programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to > 3 prior lines of therapy, respectively. The Company’s pipeline also has additional preclinical programs, including cell therapy and injectable product candidates, for the treatment of oncology, autoimmune disorders, and infectious diseases.

For more information, visit http://www.neximmune.com.

Media Contact: Mike Beyer Sam Brown Inc. Healthcare Communications 312-961-2502 mikebeyer@sambrown.com

Investor Contact: Chad Rubin Solebury Trout +1-646-378-2947 crubin@soleburytrout.com

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NexImmune Establishes Research Initiative with City of Hope to Focus on Novel Immunotherapeutic Approaches to Acute Myeloid Leukemia - Stockhouse

Recommendation and review posted by Bethany Smith

Global Hematopoietic Stem Cell Transplantation Market Report from AMA Research highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.

Major Players in This Report Include,

Gilead Sciences Inc. (United States), Thermo Fisher Scientific (United States), PromoCell (Germany), CellGenix Technologie Transfer GmbH (Germany), Cesca Therapeutics Inc.(United States), R&D Systems (United States), Genlantis (United States), Lonza Group Ltd.(Switzerland), TiGenix N.V.(Belgium), ScienCell Research Laboratories (United States), Regen Biopharma Inc. (United States), China Cord Blood Corp (Hong Kong) and CBR Systems Inc. (United States).

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Analyst at AMA have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Hematopoietic Stem Cell Transplantation Market along with tables and graphs related to various country and segments showcasing impact on growth trends.

Definition

Despite the increasing availability of smart antineoplastic therapies in recent years, Hematopoietic stem cell transplantation (HSCT) remains an optimal treatment modality for many hematologic malignancies. HSCT is one of a range of therapeutic options which is available to patients suffering from various diseases. It is a widely accepted treatment for many life-threatening diseases. The treatment is available to patients who suffer from refractory or relapsing neoplastic disease and non-neoplastic genetic disorders, as well as from chronic bone marrow failure. Hematopoietic stem cells are young or immature blood cells which are found to be living in bone marrow. These blood cells when matures in bone marrow very few enters into bloodstream.

Global Hematopoietic Stem Cell Transplantation Market Report offers a detailed overview of this market and discusses the dominant factors affecting the growth of the market. The impact of Porters five armies on the market over the next few years has been discussed for a long time in this study. We will also forecast global market size and market outlook over the next few years.

Types of Products, Applications and Global Hematopoietic Stem Cell Transplantation Market Report Geographical Scope taken as the Main Parameter for Market Analysis. This Research Report Conducts an assessment of the industry chain supporting this market. It also provides accurate information on various aspects of this market, such as production capacity, available production capacity utilization, industrial policies affecting the manufacturing chain and market growth.

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In this research study, the prime factors that are impelling the growth of the Global Hematopoietic Stem Cell Transplantation market report have been studied thoroughly in a bid to estimate the overall value and the size of this market by the end of the forecast period. The impact of the driving forces, limitations, challenges, and opportunities has been examined extensively. The key trends that manage the interest of the customers have also been interpreted accurately for the benefit of the readers.

The Hematopoietic Stem Cell Transplantation market study is being classified by Type, Applicationsand major geographies with country level break-up that includes South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).

The report concludes with in-depth details on the business operations and financial structure of leading vendors in the Global Hematopoietic Stem Cell Transplantation market report, Overview of Key trends in the past and present are in reports that are reported to be beneficial for companies looking for venture businesses in this market. Information about the various marketing channels and well-known distributors in this market was also provided here. This study serves as a rich guide for established players and new players in this market.

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Current Scenario Analysis for Decision Framework

Key Strategic Developments in Hematopoietic Stem Cell Transplantation Market:

The research includes the key strategic activities such as Research & Development (R&D) initiatives, Merger & Acquisition (M&A) completed, agreements, new launches, collaborations, partnerships & (JV) Joint ventures, and regional growth of the key competitors operating in the market at global and regional scale to overcome current slowdown due to COVID-19.

Key Market Features in Global Hematopoietic Stem Cell Transplantation Market

The report highlights Hematopoietic Stem Cell Transplantation market features, including revenue size, weighted average regional price, capacity utilization rate, production rate, gross margins, consumption, import & export, demand & supply, cost bench-marking in Hematopoietic Stem Cell Transplantation market share and annualized growth rate (Y-o-Y) and Periodic CAGR.

Extracts from Table of Contents

Global Hematopoietic Stem Cell Transplantation Market Research Report

Chapter 1 Global Hematopoietic Stem Cell Transplantation Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Revenue (Value, Volume*) by Region

Chapter 5 Global Supplies (Production), Consumption, Export, Import by Regions

Chapter 6 Global Revenue (Value, Volume*), Price* Trend by Type

Chapter 7 Global Market Analysis by Application

.continued

This report also analyzes the regulatory framework of the Global Markets Hematopoietic Stem Cell Transplantation Market Report to inform stakeholders about the various norms, regulations, this can have an impact. It also collects in-depth information from the detailed primary and secondary research techniques analyzed using the most efficient analysis tools. Based on the statistics gained from this systematic study, market research provides estimates for market participants and readers.

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Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button - Royal Sutton News

Recommendation and review posted by Bethany Smith

By Jolene Marriah-Maharaj Oct 28, 2020

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Durban - A Durban mother, who is the first black woman to graduate with a PhD in leisure and recreation from the University of KwaZulu Natal, is hoping to change the lives of children living with disabilities.

Khumbuzile Khumalo, fondly known as KK, recently graduated from the College of Health Sciences.

Her PhD is entitled The development of a policy framework for physical activity and sport for children with disabilities in schools in disadvantaged communities in KwaZulu-Natal.

Her study resulted in a policy framework for physical activity and sport for children with disabilities (CWD) in schools in disadvantaged communities in KZN.

The provision of sport facilities and equipment suitable for CWDs requires a collaborative effort between the Department of Sport and Recreation and the community stakeholders to address long-standing barriers, said Khumalo.

In developing the policy framework, Khumalo ensured that CWDs and their families contributed significantly, thereby ensuring that their voices were heard.

The new policy framework that aims to enhance the physical activity of CWDs will be presented to the Department of Sport and Recreation with the intention of it being adopted and implemented in KwaZulu-Natal, especially in schools based in poorly resourced communities.

I have a passion to work with people with disabilities. Currently, I am a member of the interim UKZN Division of Sport Union Executive Sport Organising Committee.

Last year, we launched the UKZN Disability Sports and Leisure Association. This association included all students with disabilities on all UKZN campuses.

Khumalo, who works at UKZN, was born in a township called Steadville in Ladysmith.

She has one son who graduated with a PhD in genetics from Stellenbosch University in 2017 and lives and works in Norway.

In her free time, Khumalo enjoys reading, socialising, travelling, and going to church.

She thanked all those who supported her during her studies, including family members, Bongiwe Gumede, colleagues, and Dr SB Radebe for their encouragement and inspiring words of support that enabled her to reach her final destination.

She described her supervisors, Professor Rowena Naidoo and Professor Verusia Chetty, as her beacons of hope.

Both my supervisors believed in my passion for CWDS, my ability to complete my PhD and supported me all the way.

Naidoo and Chetty said: We believe that team work is key, and as supervisors we believe that supporting a candidate and making them believe in themselves is key to succeeding.

We are excited to share KKs policy framework with the related governing structures.

IOL

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UKZN boast its first black female graduate with a PhD in leisure and recreation - IOL

Recommendation and review posted by Bethany Smith

This article was developed with help from Global Citizen fellows Aaron Rakhetsi, Ntombizodwa Lephuma, and Buhle Dlulane.

Why Global Citizens Should Care

Young people dont often view the agricultural sector as a viable and economically sustainable career path an oversight that could threaten the future of food production.

As a result of the massive reduction of young people entering the profession, agriculture as a whole has been on the decline at a time when the world faces enormous pressure to produce more food in a less hospitable climate. But a simple reconceptualization of the field an effort being undertaken by a crop of new farmers could change how young people view it.

Agriculture doesnt have to mean subsistence farming, even for family farms. With increased access to education, young people can be a force for innovation on family farms, increasing incomes and well-being for not only farmersbut also for their local communities.

By tapping into their skills, energy, creativity and willingness to take risks, African youth in particular could play a critical role in revitalising rural communities and enhancing agricultural productivity.

Global Citizen recently spoke with Gugulethu Mahlangu, a 27-year-old farmer in the town of Boksburg near Johannesburg, South Africa. In 2020, she launched her agricultural business, Harvest House, through which she farms spinach, rapeseed, green beans and hubbard squash.

Mahlangu answered questions about her career, views of agriculture, and what it takes to start a home garden.

Global CItizen: What inspired you to go into agriculture? Has it always been something that you thought you would end up doing?

Gugulethu Mahlangu:I studied it in my first year of university but left it to study human physiology, genetics, and psychology. I left university and I was not happy with my career choices. I realized that agriculture has always been a sign throughout my journey. My late grandmother was a farmer, and I enjoy nature, being independent, and working for myself. Agriculture was the light at the end.

GC: What type of farm do you own? Why did you choose this over the other types of farming?

Im already in my fifth year of being on a plant-based diet. Nutrition is very important to me, so choosing to grow vegetables was a natural choice for me.

Related Stories May 1, 2019 9 Reasons Why Plant-Based Meat Is the Food of the Future

GC: How would you describe your journey thus far as a young Black woman in farming?

A tough but rewarding experience. They say do what you love and youll never work a day in your life. Im proud to have been on this road as a young Black female because Ive made my family proud and have served as an inspiration for younger Black girls to join the agriculture sector. That has truly been rewarding for me, to see more young Black girls take up the space.

GC: What are the challenges you have faced since you started farming?

Funding has been a real challenge for me. Agriculture is a business and it's costly. I have currently not received any funding and Im working tirelessly to grow my business with the means I have.

GC: What are your views on sustainable farming and do you practice it at your farm?

Sustainable agriculture is important for every farmer to practice. We use recycling methods such as chicken manure and crop waste to make organic fertilizer which naturally enriches our soil. We also do crop rotation which helps maintain nutrients in the soil. I believe every farmer needs to farm with the consciousness of protecting the ecology of the land and promote foods conducive for public health.

GC: What would you say to other young people out there who want to go into farming?

I would say, go for it. Just make sure you are passionate about it because it is a lot of consistent hard work and it needs you to be focused. If its in you Id encourage them to take up space because their dreams are valid and the sector is big enough to enter, grow and be successful in.

GC: What type of farming would be best for someone without a background in agriculture?

I would advise to start a hobbyist farm. Start small. If youve always wanted to venture into agriculture as a career, its important that you learn. Whether you start with a few chickens or a small backyard garden, youll be able to distinguish how your dream will be achieved on a larger scale. You cannot do agriculture without some sort of experience so I would suggest that. Youll learn as you go and decrease your rate of failure with more time and cultivate a love for it. Soon youll want to expand and buy more chickens or seeds.

GC: Tips on how to start your own garden at home?

Start small;this will lower the risks of mistakes that might occur and costs. Talk to other farmers;this will allow you to not feel alone and get advice on things that you might have missed. Work at trying to get profit. Maximize your space by trying to get something out of it. This will help you learn agri economics, and it wouldnt hurt in case you might want to go bigger. Embrace sustainable practices. For example, get yourself a chicken waterer out of a plastic bucket instead of buying it. Read and research. Your garden will need you to have knowledge about at least the basics and it can save you a lot of time to just know some things, education is everything.

Related Stories June 5, 2019 This Community Garden Is Fighting Food Insecurity in Rural Benin

GC: Which crops are easier to maintain for a small home garden and why?

Tomatoesyou can harvest throughout the season. Basil, like most herbs you can grow it indoors, too. Spinach easy to grow and the mother plant gives you more leaves when cut. Bell peppers because theyare low maintenance crops that love the sun and heat to grow. Lettuce, old resistant crops that can grow and be planted directly in the soil.

GC: What methods would you advise someone to use to handle or control pests and weeds?

Mulching, because it suppresses weeds. Zero tilling because disturbed soil encourages weed growth so do less of it. Use a scarecrow for birds and choose resistant varieties to grow. Crop rotation which will help with reducing the pest population.

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This Young Farmer Has Advice for Anyone Who Wants to Grow Food - Global Citizen

Recommendation and review posted by Bethany Smith

Elections can be bad for your health.

Actually, any large-scale stressful event causes a national increase in the incidence of heart attacks and strokes, according to researchers who tracked hospitalizations for heart disease before and after the 2016 presidential election. They found that hospitalizations for cardiovascular events were 61% higher than the same two days of the preceding week. The results were the same regardless of corrections for age, race or gender.

The precise cause is unknown.

Obviously, the theory is stress spread broadly enough that it impacts nationwide numbers when examining millions of people is the reason. Common national events simply encompass the national consciousness of the entire population and its not simply elections that capture everyones attention. Cardiovascular disease event risk increases similarly after any traumatic public event, such as earthquakes or the terrorist attacks on the World Trade Center in 2001.

Anxiety is simply a psychological stressor associated with cardiovascular events and nearly 70% of respondents to a recent American Psychological Association survey said elections were a significant source of stress. This study was also the same regardless when correcting for age, race, gender or even political affiliation. Its a bi-partisan concern. The coronavirus pandemic that has filled headlines certainly only adds to the stress this time of year. We can call it a bit of headline stress as well. But there are some ways to cope.

First, prepare ahead for uncertainty. Stressful events leave a lot of questions. The unknown can be more stressful than reality. Mentally prepare in advance for things like election delays, favorite candidates winning or losing and simply expect uncertainty. If watching the news is stressful, do something less stressful. Try not to obsess over the uncertainty of evolving events. Plan ahead to be active doing less stressful activities.

Secondly, increase stress reducing efforts. This means eating extra healthy. Get sufficient sleep and exercise. Maintain social interactions and support.

Also, plan alternate activities around stressful events. This may mean unplugging from the news and reading a book, listening to music or planning an activity with family. Staying abreast of news is important. But fill time with less stressful activity as well.

Lastly, be hopeful. Regardless of whether or not the stressful event is an election or some other stressor, most Americans when surveyed report that they remain hopeful despite their stressors. This is encouraging. Having something to look forward to is important. Seeing the horizon helps get a person through many obstacles when they look positively toward the future rather than focusing on present distress.

Whether its election distress, headline distress or social media distress, the idea is to take a break from these stressors and engage in alternative pursuits during the period of stress. Limit consumption of news or social media if necessary. Rather than being consumed by immediate events, be hopeful about future possibilities.

Even though elections are over in November, holiday season is close behind. Stressors dont go away after elections, they simply change and the holiday season can be stressful for many. Treating yourself to relaxing activity is vital to prevent stressors from manifesting themselves into more serious cardiovascular events that are also present during holidays. It makes managing stress during election season and heavy news cycles even more important when Thanksgiving and Christmas soon follows the same year.

Phillip Stephens, DHSc, PA-C is affiliated with Carolina Acute Care & Wellness Center, P.A.

Read more:
Help your health by taking breaks from stress - The Robesonian

Recommendation and review posted by Bethany Smith

Q3 2020 Energy Recovery Inc Earnings Call San Leandro Oct 30, 2020 (Thomson StreetEvents) -- Edited Transcript of Energy Recovery Inc earnings conference call or presentation Thursday, October 29, 2020 at 9:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Bob Mao * James Siccardi Energy Recovery, Inc. - VP of IR * Joshua Ballard Energy Recovery, Inc. - CFO ================================================================================ Conference Call Participants ================================================================================ * Pavel Molchanov * Ryan James Pfingst B. Riley Securities, Inc., Research Division - Associate ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the Energy Recovery Third Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions) Please note this conference is being recorded. I will now turn the conference over to your host, James Siccardi, Vice President of Investor Relations for Energy Recovery. Thank you, you may begin. -------------------------------------------------------------------------------- James Siccardi, Energy Recovery, Inc. - VP of IR [2] -------------------------------------------------------------------------------- Good afternoon everyone, and welcome to Energy Recovery's 2020 third quarter earnings conference call. My name is Jim Siccardi, Vice President of Investor Relations at Energy Recovery. I'm here today with our Chairman, President and Chief Executive Officer, Bob Mao; and our Chief Financial Officer, Joshua Ballard. During today's call, we may make projections and other forward-looking statements under The Safe Harbor provisions contained in the Private Securities Litigation Reform Act of 1995 regarding future events or the future financial performance of the Company. These statements may discuss our business, economic and market outlook, the Company's ability to commercialize VorTeq, growth expectations, new products and their performance, cost, structure and business strategy. Forward-looking statements are based on information currently available to us and on management's beliefs, assumptions, estimates or projections. Forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors. We refer you to documents the Company files from time to time with the SEC, specifically the Company's Form 10-K and Form 10-Q. These documents identify important factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements. All statements made during this call are made only as of today, October 29, 2020, and the Company expressly disclaims any intent or obligations to update any forward-looking statements made during this call to reflect subsequent events or circumstances, unless otherwise required by law. At this point, I would like to turn the call over to our Chairman, President and Chief Executive Officer, Bob Mao. Bob, the floor is yours. -------------------------------------------------------------------------------- Bob Mao, [3] -------------------------------------------------------------------------------- Thank you, Jim. And thank you everyone for joining us today. I want to start today's call as I did last quarter, with sincere hope that everyone listening and your families are safe and healthy. Once again, I am happy to report that the Energy Recovery team and our business remain healthy and strong. Energy Recovery is evolving well into a COVID inspired new normal, where we continue to steadily achieve growth those in our base business as well as in our new business initiatives. The disciplined finance financial and time bounded approach to our new initiatives as recorded in our last call is being strictly executed, which should translate to a greater bottom-line results and increase returns for our investors. Following the format of my previous earnings call report, I will provide you updates to our Water business and VorTeq development in our Oil & Gas business. In addition, in our last earnings call, we committed to provide more details on our intubation effort for the PX technology platform, which was started at the end of the first quarter of this year. Today, we are happy to report our one of the efforts ZLD, Zero Liquid Discharge, which has just graduated into commercialization with receipt of the first purchase order. Let's begin with our water business, which continues to be healthy and strong, riding on incredibly strong global desalination grows even amidst the COVID pandemic. This third quarter was ERII's biggest water revenue generating quarter, eclipsing last year higher quarter record by 26%. At this time, we feel competent increasing our previously projected 20% to 25% of water's revenue growth for fiscal year 2020, up to 25%. We also feel confident in increasing our 2021 growth outlook to 10% from the flat to 5% gross we communicated last quarter. Finally, adjusting desalination industry trends allows us to optimistically anticipate water revenue growth in 2022 similar to what we are achieving in 2020. The strong global seawater reverse osmosis desalination growth trend is anchored in equivalent need to provide access to clean water in many parts of the world. In addition to the basic need, three other trends are helping to grow in seawater reverse osmosis. First, the technological shifts, from inefficient thermal desalination plants for reverse osmosis is becoming the growing portion of our pipeline. Second, acceptance of private financing into desalination construction in places like Saudi Arabia, Dubai, Egypt and India is increasingly decoupling desalination projects to national fiscal budgets, which you may be susceptible to oil price increase and COVID-19. And finally, geopolitical shifts are creating an urgent strategically move for desalination in countries like Egypt, where the construction of Nile river dam in Ethiopia, to recognize Egypt's water independence. In addition to our fundamentally strong baseline seawater reverse osmosis outlook, our first incubation initiative Zero Liquid Discharge or ZLD is focused on our water business specifically with wastewater industry. In fact, we are excited to announce that we received our first commercial purchase order to our new water wastewater product from a customer in India just this last week, which is really encouraging. A global regulatory push is currently being led by China and India to implement more environmentally friendly practices in industrial wastewater treatment. Those countries are struggling less maintaining clean water sources and they are seeking to maximize the recovery of clean water and minimize the impact of wastewater disposal polluting theirs water wastes. ZLD allows for this by fully removing the harmful industrial waste from the water and reintroducing or recycling only clean water. The ZLD market is in its nascent stages. It is fragmented market and the multiple competing technologies, none of which has emerged as a dominant technology. Much like the desalination market, we believe our reverse osmosis is the upcoming solution. However, unlike desalination the pressures needed to achieve zero or minimum liquid discharge are nearly 2,000 psi or roughly double that our seawater desalination. To address this, we are using our PX technology platform to build our high pressure PX application, which we call the Ultra PX. We believe our technology has the potential to become the dominant solution in ZLD wastewater just like our legendary PX has dominated the seawater reverse osmosis market. Our preliminary ZLD market research identified existing wastewater applications of our Ultra PX. There is a potential total addressable market in China as high as $100 million, which would not include further annual growth as the market expense. We see a similar opportunity in India, where we recently received our first purchase order, and we believe that markets globally will move further toward those new and minimal discharged technology overtime as clean water becomes a more critical resource. Nowadays, it has achieved commercialization, ZLD will move out of incubation and into our water business unit. We're proud of our R&D and commercial teams and their ability to commercialize our new Ultra PX with the several months' initial incubation well below our three years project movement. ZLD should achieve and returns on investment far exceed 20% and we anticipate ultimately achieving margins at levels comparable to our base water business. Finally, we anticipate positive operating cash flow around the asset with our first purchase orders in hand. We're truly confident in the potential of our water business, as we look forward. Our business, our baseline seawater desalination business continues to enjoy a superior upswing. There's no end in sight over the next few years and we're excited about the potential of our new wastewater business efforts. We look forward to update you on both in the future. Next, we turn to our Oil & Gas business and VorTeq where I continue to view the progress we made with great pride. We have developed our production model 1.0, which was utilized during our previously reported few simulation frac with Liberty oil fuel services. However, the three hurdles we outline must to be clear before we commercialize. One, successfully complete 2 to 3 live fracs. Two, validate our customer value proposition. And three, maximize the amount of sand that can be pushed through the cartridges before repair or replacement. As I said beginning of live frac and by extension our value proposition, we are aggressively seeking to get out in live frac before year end as live frac verification is critical to establishing the VorTeq value proposition for our customers and to verify our VorTeq cartridge service spec. In addition to our ongoing dialogue with Liberty, we have taken calls from and hosted indicators for additional oilfield service companies interested in the potential use of VorTeq. We are pleased with the response companies are giving us and the willingness which they have introduced VorTeq to their own customers. We remain confident in our ability to achieve the live well requirements as outlined last quarter and quantifying our value proposition. As soon as we have achieved our first live well, we will let you know. With regard to the final hurdle, we're making solid progress in cartridge life extension and manufacturing insurance. We believe we identified a solution to achieve our cartridge life or as a minimum, a solution that will give us a material step forward to this end goal and we will be testing the solution as we end the year. We're continuing to remind ourselves the new to commercialize VorTeq by midyear 2021 or I'll stopping this. Our committed timeline has not changed. Next, we report on incubation. I discussed earlier our ZLD initiative, the first incubation efforts to graduate to an exciting business unit. In addition to the ZLD market, there are a multitude of potential applications for our ultra-high pressure PX in a variety of industries within and outside of water. We see significant future potential for our ultra-high pressures PX technology and believe it could become a significant percentage of our revenue in the coming years. We're also making progress on the second PX incubation initiatives targeted at a very large growth of industry currently undergoing regulatory driven transformation. While this product has the potential of being transformative in much the same manner, the PX transformed the desalination industry, we are at the technology feasibility stage and so we'll forego detail discussion at this time. We expect to report on the progress of incubation efforts when we speak to you again in March, at which time, we will have either prove out technically feasibility or seek investment. Finally, we mentioned last quarter that we are working on a project that will expand the aperture of our PX technology platform, thereby creating new PX applications in new industries. This project is a zero mixing PX. Zero mixing simply means that there is no commingling of fluids as columns of liquid transfer their pressures within the PX. Such mixing dose occur in our current applications in desalination and in oil and gas, but mixing however slight can exclude the PX from the applied in many applications such as gas processing or chemical among others where our technology could potentially help reduce energy consumption and thereby cost new existing systems. We have already proven the technical feasibility of this extension of our technology and we are now working on longer life and reliability. As we begin to apply this technology to new applications, we will update you on our progress and the potential of these new markets. With that, let's turn to ESG. As you know, we released our inaugural ESG report in September. While our business has always been aligned with sustainability issues such as addressing global water scarcity and improve access to affordable and clean energy. Our ESG report reflects our commitment to become more sustainable and resilient business. The initial guide to build our ESG program will base on our business growth as well as inputs from our key stakeholders. The pursuit of more efficient, sustainable customers' solutions has been the core of our DNA, since our founding more than 20 years ago. We're proud of the impact that our technology has been making desalination more efficient and sustainable particularly as our growth comes from growing water scarcity. Our new ventures will continue to focus our energy efficiency and endowment. As we use own pressure exchange technology to drive new growth opportunities, we desire to do so while providing new efficient and sustainable solutions to industrial needs. This is an exciting time at Energy Recovery. Our water team is focused on maintaining the momentum of our desalination business as well as expanding our reach with launch of the new ZLD product. Our Oil & Gas team is focused on finding finance and commercializing VorTeq. And finally, our incubation efforts are focused on achieving technical verification on one product that could prove transformative and another that could further expand the aperture of our PX phase platform. We're transitioning Energy Recovery into a growth company on the basis of our very versatile pressure exchanger. We are giving you insights to this transition by reporting our progress, our wins and our failures. We are investing our hard earned cash and you should know how and why we are investing it. We will continue to tell you what to expect, give you updates on our progress, and provide details on the outcomes. If we fail, you will know why. But when we succeed, you should not be surprised. In short, you will see every punch we land and every step we take, and we do not plan to take hand fist. With that, I hand other over to Joshua. -------------------------------------------------------------------------------- Joshua Ballard, Energy Recovery, Inc. - CFO [4] -------------------------------------------------------------------------------- Thank you, Bob. As you saw last quarter, each channel in the water business continues to experience different dynamics. Mega-projects remain dominant, growing 70% year-on-year in the quarter and an impressive 48% year-to-date. As expected both the OEM and aftermarket channels remain weak as compared to 2019, falling 22% and 40% respectively in the quarter from a year ago. Based on Bob's affirmation of at least 25% growth in our Water business this year, you should expect a very strong fourth quarter. I've mentioned in the past calls that it's hard to pinpoint quarterly trends in our business. In both 2018 and '19, we experienced the drop off in sales in the fourth quarter. However, this year, our fourth quarter sales should be comparable to that of the third quarter. As we looked at '21, and '22, we do expect to see our OEM and aftermarket channels recover; however, the extent of that recovery will largely depend on the global effects of COVID over this winter and next spring. While some industries will remain weak within these channels regardless, most notably travel and hospitality. At this time, we believe pent up demand and other industries may help return the OEM and aftermarket channels to more normalized levels, which is leaning toward increased confidence in projections for next year. I should also note that revenue from our new ZLD market is not yet included in these projections, as we build our pipeline and grow more comfortable, will provide more clarity. That being said, it's probably fair to assume that our initial revenue will be in the single digit millions the first couple of years, with considerably more growth in the future. Also note that these projects will be of a different nature than the larger Mega-project desalination plant driving our water growth today. A typical ZLD project will be in the range of $50,000 to $150,000 in revenue, with our potentially a much larger number of these projects than we've seen in desalination. For example, if we assume $100 billion market in China, as Bob outlined, this will imply roughly 100 projects, whereas in desalination it could be as low as 10. Our product gross margin decreased by 360 basis points as compared to Q3 2019 which showed a healthy 550 basis point increase from our low mark in the second quarter of this year and somewhat exceeded our expectations this quarter. Our margin strengthening over last quarter is largely due to our return to normal production levels at the end of Q2. While we did have a small effect from COVID due to delay in the commissioning of our new ceramics plant in Tracy, California, that effect was muted compared to prior quarters. We are pleased with how well our manufacturing team is operating within the restrictions of COVID and we continue to work under strict protocols to ensure the safety of our employees as well as the continuity of our business. In addition, our decreased OEM sales led to lower than expected sales of turbochargers and pumps, which proved accretive to margins as these products are less profitable than our PX sales in this channel. Last year, we mentioned some margin pressure owning the low ASPs as a result of bigger order sizes as we serve ever larger desalination process. We expect the trend to continue in Q4 and around the fiscal year with roughly 68% to 69% gross margin despite a reduced effect from COVID. As we look to 2021, the fundamentals of our gross margin will remain largely the same, excluding the potential of any temporary COVID-19 related effects. At this time, we don't expect to see a shift in our water business outside of this 68% to 70% range. Let's now turn to our operating expenditures where we have reported a decrease of 9% compared to Q3 2019. While our OpEx is somewhat lower than planned today due to COVID, the real story is an R&D where you will see a 23% decrease compared to Q3 last year and a similar decrease as compared to the first half of 2020. While our R&D expense may increase somewhat in Q4, we expected to remain roughly 15% to 20% lower than the first half of 2020. If there is a single thing at bottom I want you to hear, it is that of discipline, discipline in our R&D efforts as well as our operations and by extension, our expenses. For example, this year we terminated some projects altogether that were not achieved our commercial KPIs in expenses from these projects. And as we look at our OpEx going forward, while we expect OpEx to grow, you're focused on reducing our spend as a percentage of revenue over the next 2 to 3 years to a more normalized level as related to our peers in the market. Over the past decade, we have reported annual OpEx higher than 60% to 65% of revenue every year. It would have been in a similar range this year and after the second quarter termination of this Schlumberger contract and subsequent GAAP recognition of the remaining license and development revenue. We are targeting our OpEx to drop to a range of 35% to 40% of revenue by 2022, subsequently to reduce it to the low 30s, which will be more in line with our peers in the market. Sustaining of OpEx will be done in two ways. First, we will be capping our R&D as a percent of revenue in our baseline budget. Our R&D expenses averaged over 20% of revenue in the past few years due to our elevated spend on the VorTeq. In 2021, we'll be targeting a range closer to 15% to 20%, with the goal lowering it further in 2022 towards a 10% to 15% range. Keep in mind that this percentage will be decreasing despite the fact that we are guiding total revenues lower next year due to this year's increase in revenue from the termination of the Schlumberger contract. You can expect a clear reduction in R&D by the second half of next year, as we reduced spend on the VorTeq and wind down those R&D activities. In addition, based on R&D spend on our incubation projects is expected to remain in the single digit millions a far cry from the levels that we saw with the VorTeq. Second, we will continue to leverage our existing infrastructure, which will slow G&A growth in the coming years. We have invested significantly in the new systems past 18 months to better modernize our operations, to leverage our back office as we grow and we should see the fruits of this labor as we expect G&A spending growth to continue to lag that revenue. This year G&A spend is somewhat lower than plan due to COVID-19. Next year, we expect more normalized G&A spend and growth will generally occur from inflation and a reversion to the norm rather than increasing resources. I expect total G&A to grow more than 10% in 2021 and further decrease in growth on subsequent years as like R&D we aim to reduce G&A as a percent of revenue to the mid to high teens over the medium to long term. Sales and marketing spend is expected to stay roughly where it is today, around 10% to 12% of revenue. Lastly, as we concern OpEx, please keep in mind that our current levels spend is soon success with the VorTeq. If the VorTeq does not commercialize in 2021, our overall OpEx spend would decline considerably as we reduce activities in our Oil & Gas business unit and cease R&D. If modeling you keep similar levels of OpEx, you should then assume revenue from the commercialization of VorTeq. If we commercialized the VorTeq, we expect up to a 40% to 50% reduction in Oil & Gas OpEx spend overall, with about half of that reduction due to shifting spend in the cost of goods sold once we begin to generate revenue and the other half to decreased R&D. Also, this will result in an overall reduction in total R&D spend of at least 20% to 25% next year. Total reductions will depend on how quickly we commercialize or cease operations. Finally, a few words on our cash and investments position which ended at $160 million for the quarter. We continue to see no effect on cash from the global economic uncertainty. In fact, our accounts receivable is the cleanest it has ever been, which is reflective of the strong position the desalination industry finds itself in despite the strange times. For now we continue to shift our corporate bond portfolio into cash and securities mature. As the future becomes more certain, we'll revisit our longer term plans. CapEx investments look to finish the year in the middle lower end of the $8 million to $10 million I guided this time last year. Our baseline CapEx for 2021 is planned at $5 million to $7 million. Now this baseline excludes any CapEx related to potential commercialization of the VorTeq, which will become clear, if and when we commercialize and we'll provide more clarity at that time. With that, let's move to the question-and-answer portion of our call. Thank you. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Thank you. At this time, we will be conducting a question-and-answer session. (Operator Instructions) Our first question is from Pavel Molchanov with Raymond James. -------------------------------------------------------------------------------- Pavel Molchanov, [2] -------------------------------------------------------------------------------- I want to just review the guidance targets that you gave, make sure we all heard them right. Following 25% water revenue growth this year, it should slow to 10% growth next year, but then reaccelerate to 25% in '22. Is that correct? -------------------------------------------------------------------------------- Bob Mao, [3] -------------------------------------------------------------------------------- Correct. Yes, that is correct. -------------------------------------------------------------------------------- Pavel Molchanov, [4] -------------------------------------------------------------------------------- So what gives you the confidence that '22 will -- that will see the acceleration in the growth rate? Is it specific projects, specific geographies, specific customers? -------------------------------------------------------------------------------- Bob Mao, [5] -------------------------------------------------------------------------------- Actually, all of the above specific projects, specific geographies, and in fact, we already have some backlog going into 2022. So, it's not depending on macro market trends only, it is underground actually project by project, customer by customer. -------------------------------------------------------------------------------- Pavel Molchanov, [6] -------------------------------------------------------------------------------- And does it include retrofits of legacy plants? Or is it or are you only looking at greenfield new builds? -------------------------------------------------------------------------------- Bob Mao, [7] -------------------------------------------------------------------------------- Both. -------------------------------------------------------------------------------- Pavel Molchanov, [8] -------------------------------------------------------------------------------- My final question was about your comment about an industry that is being transformed by government regulation. And I'm sorry, if this is a silly question, but are you referring to the Oil & Gas industry or something else? -------------------------------------------------------------------------------- Bob Mao, [9] -------------------------------------------------------------------------------- We will clarify that next call as we are in the technical feasibility phase. -------------------------------------------------------------------------------- Operator [10] -------------------------------------------------------------------------------- Our next question is from Ryan Pfingst with B. Riley Securities. -------------------------------------------------------------------------------- Ryan James Pfingst, B. Riley Securities, Inc., Research Division - Associate [11] -------------------------------------------------------------------------------- In terms of your inventory of VorTeq equipment for the new single cartridge skin design, if the opportunity presented itself, could you simultaneously execute one well with Liberty and another with a different pressure pumper? If not, are you prioritizing the first attempted well with Liberty above all other options? Or if another interested party wanted to conduct the live well test before Liberty customers ready, would you move forward with that opportunity? -------------------------------------------------------------------------------- Bob Mao, [12] -------------------------------------------------------------------------------- We have enough inventories to those. So that pleasant opportunity always. -------------------------------------------------------------------------------- Ryan James Pfingst, B. Riley Securities, Inc., Research Division - Associate [13] -------------------------------------------------------------------------------- Okay. That's helpful. And then for hurdle numbers three on the path to commercialization, the buying of frac sand that the cartridge can process before needs to be repaired or replaced. How far along are you now towards your target? I know that by year-end, you aim to be at 50% with clear visibility, on raising a hundred percent. Could you give some insight on maybe what percentage you're at now or where you exited the third quarter? -------------------------------------------------------------------------------- Bob Mao, [14] -------------------------------------------------------------------------------- We are on track to reach those targets. -------------------------------------------------------------------------------- Ryan James Pfingst, B. Riley Securities, Inc., Research Division - Associate [15] -------------------------------------------------------------------------------- Okay. So on track for 100% visibility by your end. -------------------------------------------------------------------------------- Bob Mao, [16] -------------------------------------------------------------------------------- Yes. -------------------------------------------------------------------------------- Ryan James Pfingst, B. Riley Securities, Inc., Research Division - Associate [17] -------------------------------------------------------------------------------- Great. And then turning to the new PX derivative product developments, could you give some other examples of potential end users that you're investigating now? -------------------------------------------------------------------------------- Bob Mao, [18] -------------------------------------------------------------------------------- We shared particularly with zero mixing and that will open up additional end user into chemicals industry where no mixing is allowed at all. -------------------------------------------------------------------------------- Ryan James Pfingst, B. Riley Securities, Inc., Research Division - Associate [19] -------------------------------------------------------------------------------- All right. Thank you. And then maybe just one last one for Josh, could you please provide the third quarter breakdown for Water revenue by segments? -------------------------------------------------------------------------------- Joshua Ballard, Energy Recovery, Inc. - CFO [20] -------------------------------------------------------------------------------- Sure. It's 76% for the Mega-Projects, 15% for OEM and about 10% for aftermarket. -------------------------------------------------------------------------------- Operator [21] -------------------------------------------------------------------------------- (Operator Instructions) Our next question is from Ken Hirschberg, Private Investor. -------------------------------------------------------------------------------- Unidentified Analyst, [22] -------------------------------------------------------------------------------- Congratulations on the excellent quarter and all the progress you're making. Could you please give us an update on the commercialization of the IsoGen and IsoBoost? Thank you. -------------------------------------------------------------------------------- Bob Mao, [23] -------------------------------------------------------------------------------- On that one, we are in discussion with potential customers to deploy our standard product. And of course, our first project is fully in operation and the very happily accepted by our customers. So, what we look for here is for a standard product applicable to a larger base of customers rather doing individual almost custom-made projects. So, we're making progress. We expect to report more at the next earning call. -------------------------------------------------------------------------------- Unidentified Analyst, [24] -------------------------------------------------------------------------------- Is it for IsoGen and IsoBoost? -------------------------------------------------------------------------------- Bob Mao, [25] -------------------------------------------------------------------------------- Yes, both IsoGen and IsoBoost. Did I answer your question? -------------------------------------------------------------------------------- Unidentified Analyst, [26] -------------------------------------------------------------------------------- Yes, you did. Thank you very much. I appreciate that. -------------------------------------------------------------------------------- Bob Mao, [27] -------------------------------------------------------------------------------- Thank you. -------------------------------------------------------------------------------- Operator [28] -------------------------------------------------------------------------------- Ladies and gentlemen, we have reached the end of the question-and-answer session. Now, I'd like to turn the call back to James Siccardi for closing remarks. -------------------------------------------------------------------------------- James Siccardi, Energy Recovery, Inc. - VP of IR [29] -------------------------------------------------------------------------------- I want to thank everyone for joining us today. For your convenience, we've decided for our prepared remarks up on our website, you can access when you chance to get in. Thank you very much for joining us and we look forward to speaking with you again in March. Please be safe. Thank you. -------------------------------------------------------------------------------- Operator [30] -------------------------------------------------------------------------------- This concludes today's conference. We thank you for your participation. You may disconnect your lines at this time. Goodbye.

Excerpt from:
Edited Transcript of ERII.OQ earnings conference call or presentation 29-Oct-20 9:00pm GMT - Yahoo Finance

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