PUNE, India, Nov. 13, 2019 /PRNewswire/ -- This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials.The analysis indicates that the global Regenerative Medicine Market was worth $28 billion in 2018 and will grow to over $81 billion by 2023, with a CAGR of 23.3% between this time frame. Within this market, the stem cell industry will grow significantly. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in 700 pages report at https://www.reportsnreports.com/reports/974420-global-regenerative-medicine-market-analysis-forecast-to-2021-stem-cells-tissue-engineering-biobanking-car-t-industries.html

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Executive Summary

Regenerative medicine's main objective is to heal and replace organs/cells that have been damaged by age, trauma or disease. Congenital defects can also be addressed with regenerative medicine. Therefore, it's market encompasses dermal wounds, cardiovascular disease, specific cancer types and organ replacement. To that end, regenerative medicine is a broader field and manipulates the body's immune system and regeneration potential to achieve its requirement. Financially speaking, investment into this space is dominated by grants, private investors and publicly traded stocks. Looking forward, the regenerative medicine market is promising for a number of robust reasons including:

Of course restrictions to this market include strict regulations in certain geographies, and also the level of investment required to support R&D, clinical research, trials and commercialization. Reimbursement strategies are also paramount to success of the overall space.

There are over 700 regenerative medicine companies globally at present. At present, the total regenerative medicine market has more than 500 products commercialized. The Regenerative Medicine Marketencompasses a number of key technology submarkets including:

Reconstructive surgeries for bones and joints is the mainstay of the regenerative medicine market. Geographically speaking, due to the dominance of the bone and joint reconstruction market, the US has the biggest space. This is followed by Europe. However, due to recent positive legislation in Japan and Europe, the stem cell arena will grow more substantially in these regions over the next five years. By 2023, it is possible that Europe will surpass the US market with respect to stem cell applications, and this will become more likely if the Trump Administration restricts legislation and funding.

Market Applications & Opportunities for Regenerative Therapies

Regenerative medicine, including cellular and gene therapies will have a significant impact on the expenditure of payers once reimbursement schemes are optimized. To that end, a number of conditions that regenerative medicine tackles is synonymous with an aging population such as:

Global Financial Landscape

The last few years have been busy for regeneration medicine, cellular therapeutics and the gene therapy industry, with high investment from pharma giants such as Eli Lilly, BMS, Astra Zeneca and Sanofi. Company partnerships were also in motion that included Kite Pharma and Bluebird/Five Prime, Juno and Fate Therapeutics/ Editas Medicine.

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Stem Cell Market Analysis & Forecast to 2023

Today the stem cell and regenerative medicine industries are interlinked and over the last number of years have grown substantially. Regenerative medicine replaces or regenerates cells, tissues or organs and in order to achieve this, uses produces from the pharmaceutical, biologics, medical device and cell therapy spaces. Therefore, cell therapy and stem cells come under the umbrella market of regenerative medicine. Cell therapy is a platform by which regenerative medicine can achieve its aim and concentrates on using cells as therapeutics to treat disease.

Tissue Engineering Market Analysis and Forecast to 2023

Tissue engineering was the forerunner of the present regenerative medicine market. The area of biomaterials was developed to use cells and biological material and incorporate them into scaffolds and functional tissues. Some of the main applications of tissue engineered products include artificial skin and cartilage and so this area dominates the dermatology, bone and joint submarket. Wound repair is also a significant area for tissue engineering, with products such as Dermagraft in the market.

Tissue engineering is being driven by the increase in technology of biomaterials, bioscaffolds and bio 3D printing. The rise in the amount of orthopedic transplantations is demanding the market to produce more innovative solutions such as 3D printed organs. In the long term future, Kelly Scientific forecasts the advance of cutting edge 3D bioprinters in this market place.

Biobanking Market Analysis

The biobanking industry is made up of over 500 public and private blood banks globally. These companies and institutions collect, store and distribute adipose tissue, cord blood and birth tissues, musculoskeletal tissues, pericardium, skin, bone, vascular tissue, autologous and allogeneic cells and other biological samples. They operate by charging a collection fee and then a storage fee, which is usually operational for 20 years. Private banking costs between $1,350 to $2,300 as an initial fee, and then between $100 to $175 per annum for storage. Public banking is free, and a number of hybrid models have been introduced in Europe and Asia to date.

CAR-T Industry

The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? Some patients do indeed show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity. The main players within the CAR-T market are Juno Therapeutics, Kite Pharma, Novartis and Cellectis. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capital and small clinical studies. From 2017, Kelly Scientific forecasts that CAR-T therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR-T therapy ahead. However, recent deaths in the Juno ROCKET trial are creating questions amongst investors. How will the CAR-T space influence the total immunotherapy industry going forward? This comprehensive report scrutinizes the total market and provides cutting-edge insights and analysis.

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Key Questions Answered

Companies Mentioned

Related Research Report Conference:

4th Annual MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine Congress

Date: 10th 11th March 2020Location: London UK

In the 4th edition of MarketsandMarkets Bioprocessing of Advanced Cellular Therapies & Regenerative Medicine we would be focusing on the pre-clinical, manufacturing, clinical and regulatory aspects of cell therapies and regenerative medicine. This Congress event will be held on 10th and 11th March 2020 in London -UK

Regenerative therapies are proving its acceptance in potential of cell-based therapies for chronic disorders. Since our past three editions, our aim through this conference is to provide illustrative approach to recent developments in technologies of bioprocessing of cellular therapies, to process development and addressing qualitative and regulatory hurdles.

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Global Regenerative Medicine Market to Grow Over $81 Billion by 2023 and Market Driven by Stem Cells - PharmiWeb.com

Recommendation and review posted by Bethany Smith

If you're a science fiction enthusiast, then chances are, you already have a clear picture of what the future holds for humanity. Be it space travel, robots, or some weird means of extradimensional communication, sci-fi films have given us a glimpse of future technologies and events one way or another. In fact, each decade, sci-fi movies' futuristic predictions keep growing more accurate.

RELATED:Ranked: 10 Scariest '90s Sci-Fi Movie Monsters

By the 2000s, some of them have already gotten a little too prophetic and hauntingly precise. Needless to say, they are definitely worth watching for their predictions alone. So, we present you with 10 sci-fi films from the 2000s that got the future right in one or more aspects. These masterpieces have not only entertained us but also prepared us for the coming years.

Crime is one of the favorite subject matters of sci-fi media because it allows for creative twists in the otherwise exhaustive genre.Minority Report(2002)and its Pre-crime system is a good example. It's basically a prediction of who will commit crimes or become criminals based on their psychological background and allows authorities to stop crim before they even happen.

As it turns out, Pre-crime is not entirely far-fetched as a law-enforcement system. Japan (who'd have thought?) has something quite similar but less advanced, from A.I. cameras that can detect shoplifters before they do the deed to a "crime analytics" system which predicts where crime will happen. Their police force only began using such tech during this decade.

A.I. Artificial Intelligenceis one of the most philosophical sci-fi films of all time and doesn't shy away from questioning the nature of humanity and what makes us human. In that regard, it paints a rather familiar scene of the future where humans are using robots for prostitution.

RELATED:10 Sci-Fi Movies That Will Make You Think As Much As Inception

In the film, this becomes apparent as soon as Jude Law's robot character, Gigolo Joe, gets introduced. You can probably guess what he does for a living. You'll either be pleased or weirded out to know that bots like Gigolo Joe exist today. There are now official sex dolls who can talk and even give compliments, there's even a brothel full of dolls. Who knows what a few more years of robotics and primal human urges can bring?

Many things inWall-Efrom 2008 are now starting to become true today. Well, perhaps they were already true back then, but they're definitely becoming a lot more apparent today. We're talking about the Earth becoming a giant landfill, advertisements everywhere there's a breathing human being, drivable chairs, and of course, rising obesity rates.

Oh, there's also the fact that certain Governments and even corporations are most likely already looking for a way out of Earth (andto Mars) before things get too messy. In a way,Wall-Eis already happening and we really should be more alarmed now, shouldn't we?

You've probably never heard ofThe Islandbefore and that's due to the film not having the best marketing. In any case,The Islandis about a man who struggles to fit in at an isolated compound he lives in. He soon discovers that everyone was a clone of someone else and that they were merely being harvested for their organs to treat the social elite.

RELATED:10 Best Sci-Fi Movies of the '90s, According to IMDb

Surprise, surprise, there have been scientific and medical breakthroughs about the exact same thing. Scientists have been able to use human cloning to create stem cells that were used to regenerate the skin cells of a 75-year-old man. Further studies and developments are needed and we're still stuck with experimenting on pigs at the moment.

I, Robot was a cinematic flop but was still impressive enough to get its own meme culture more than a decade later. Critics often hailed it as a rip-off ofBlade Runner but in hindsight,I, Robot was a little more radical in how it gave us a picture of future societies. In the film, corporations ruled everything, with automation and A.I. replacing many jobs, making lots of humans unemployed.

Sadly, robots might actually soon take our jobs. We're not just referring to blue-collar work being replaced by heavy machinery; A.I. is learning fast and might take over some administrative jobs and basically everything that requires routine and repetition. It's time to re-evaluate your career options.

It's more romance than sci-fi butEternal Sunshine of the Spotless Mindhas that one plot device (metaphorical or not) which makes quality as science fiction. That would be the memory deletion procedure which a mad neuro-surgeon in the film invented. It allows him to delete people's memories of other people, basically selective amnesia with consent; the first application the filmmakers thought for that technology was moving on from a heartbreak.

RELATED:10 Worst Sci-Fi Movies, According To IMDb

Turns out, there are more practical uses for such a procedure in the real world. Scientists have successfully erased some traumatic memories for mice back in 2013 by locating a gene. They do hope to apply the same procedure to ease the mental pain of patients with post-traumatic stress disorders (PTSD), rather than just for couples with breakup difficulties.

Unfortunately,The Matrixwas released back in 1999, which makes it a year short of qualifying as a 2000s movie. Still, it had sequels and an animated anthology spin-off calledThe Animatrixthat basically explored the same ideas. One notable technology thatThe Matrixfranchiseprophesized (see what we did there?) is virtual reality.

The protagonists ofThe Matrixfranchise basically plug themselves into computers to sort of act as viruses that can bring down their machine enemies. To an extent, we do have this tech today in the form of VR headsets. It's not as immersive as sticking a huge needle into your spine, of course.

Marvel'sIron Manback in 2008 kicked off many great and influential things that we enjoy today and among those is a rekindled interest in robotics and military engineering. Apart from Robert Downey Jr. as Tony Stark, the biggest star inIron Manwas his self-sustaining and relatively compact armor; it's basically the equivalent of a whole country's army controlled by one man.

RELATED:10 90s Sci-Fi Masterpieces Youve Probably Never Seen

We don't have anything that advanced today; it's practically impossible at the moment with our limited resources and lack of further frontal lobe development but the U.S. Army is trying nonetheless with its exo-suit. These allow soldiers a better physical edge on the battlefield. They did try to re-create something more similar to the Iron Man suit but failed and ended up wasting millions of dollars.

The idea of visiting, recording, and manipulating dreams was popularized in Hollywood by films likeInception; however,Inception's primary inspiration was a Japanese anime film calledPaprika(2006), which also explored the same concept of entering, viewing, and interfering with dreams.

These days, such a feat is no longer limited to daydreaming; in 2011, a team of scientists at UC Berkeley was able to view someone else's dream. The scientists recordedthe subjects'brain activity and then translated the whole thing into a video. There were also scientists in Kyoto, Japan who managed to predict another person's dream into a picture which was 60 percent accurate. No more forgetting your dreams sooner or later.

You're probably tired of seeingChildren of Menin movie lists over and over again but it can't be helped, it's such a revelatory masterpiece that we can learn a lot from it. It's more modern dystopia than sci-fi, meaning most of what the film foresaw are political and socio-economic struggles similar to what we're experiencing today.

Apart from the rapidly declining birth rate which is happening to a certain country today,Children of Menalso painted a picture of a disturbing immigration crisis where people of wartorn countries are rushing like animals to the only countries with functioning governments left in the world. Oh, and resources are also in decline and everyone's out for themselves.Sounds eerily familiar.

NEXT:10 Times 90s Sci-Fi Movies Predicted The Future

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10 Times 2000s Sci-Fi Movies Predicted The Future | ScreenRant - Screen Rant

Recommendation and review posted by Bethany Smith

Cryonics Technology Market Report 2019

The Cryonics TechnologyMarket research report providesinformative datafor evaluating various market phenomena, Sheds light on the various market opportunities, and also supports strategic and a calculated decision-making process. This report additionally recognizes that in this continually regularly switching condition a la mode showcase data is critical and fundamental to settle on different key choices which are a proportion of development and benefit.

Cryopreservation technology is used for the preservation of living cells and tissues at very low temperature.

The following manufacturers have covered: , Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom Biogenic Systems, Oregon Cryonics, Alcor Life Extension Foundation, Osiris Cryonics, Sigma-Aldrich, Southern Cryonics

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The product business is stepping along a great development way and has entered the positions of a portion of the worlds driving ventures with monstrous development prospects soon. With applications over the fields of mechanical technology, Internet-of-things, and computerization ascending at an empowering pace, the industry is required to proceed with its bullish keep running in the following couple of years also, affecting the development prospects of various specialty markets it obliges.

The Type Coverage in the Market are :, Slow freezing, Vitrification, Ultra-rapid,

Market Segment by Applications, covers: , Animal husbandry, Fishery science, Medical science, Preservation of microbiology culture, Conserving plant biodiversity,

Geographically, thisCryonics Technologyreport is segmented into several key regions, with sales, revenue, market share (%) and growth rate (%) of the Cryonics Technologyin these regions,covering

The Cryonics Technology market report additionally exhibits the thorough examination ofkey showcase sections and sub-fragments, Evolving market patterns and elements, changing free market activity situations, Quantifying market openings through Cryonics Technology market estimating and advertise gauging, Tracking current patterns/openings/challenges, Competitive bits of knowledge, Opportunity mapping regarding innovative leaps forward.

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Important Questions Covered in this Report:1. What will the market size be in 2024?2. What are the key factors driving the market?3. What are the challenges to market growth?4. Who are the key players in the market?5. What are the market opportunities and threats faced by the key players?6. What will be the growth rate in 2024?7. Which strategies are used by top players in the Cryonics Technologymarket?

The report covers all important aspects:1. The Market Introduction, product scope, market overview, market opportunities, market risk, and market driving force;2. The top market players of a Cryonics Technology, with sales, revenue, and price;3. The competitive situation among the top manufacturers, with sales, revenue, and market shares;4. To show the market by regions, with sales, revenue and market share of a Cryonics Technology, for each region;5. To analyze the market by countries, by type, by application, and by manufacturers, with sales, revenue and market share by key countries in these regions;6. To show the market by type and application, with sales market share and growth rate by type, application;7. The Cryonics Technologymarket forecast, by regions, type, and application, with sales and revenue;

In the end, It focuses on the various market trends and developments of the market as well as the materials and the ever-changing nature of the Cryonics TechnologyMarket.

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Cryonics Technology Market to be valued at USD Millions by 2024: Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific,...

Recommendation and review posted by Bethany Smith

Cryonics Technology market research report provides the details about Industry Chain structure, Market Competition, Market Size & Share, SWOT Analysis, Technology, Cost, Raw Materials, Consumer Preference, Development & Trends, Regional Forecast, Company & Profile and Product & Service.

Cryonics Technology market research report also gives information on the Trade Overview, Policy, Regional Market, Production Development, Sales, Regional Trade, Business Operation Data, Market Features, Investment Opportunity, Investment Calculation and other important aspect of the industry.

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The main objectives of the research report elaborate the overall market overview on Cryonics Technology market dynamics, historic volume and value, robust market methodology, current & future trends, Porters Five Forces Analysis, upstream and downstream industry chain, new technological development, cost structure, government policies & regulations, etc. Major companies, company overview, financial data, products and services, strategy analysis, key developments market competition, industry competition structure analysis, SWOT Analysis, etc.

Further Cryonics Technology market research report provides regional marketanalysis with production, sales, trade & regional forecast. it also provides market investment plan like product features, price trend analysis, channel features, purchasing features, regional & industry investment opportunity, cost & revenue calculation, economic performance evaluation etc.

The Cryonics Technology industry development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered.

Report Scope

The tunnel ventilation market has been segmented based on different types and application. In order to provide a holistic view on the market current and future market demand has been included in the report.

Major players covered in this report: Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom Biogenic Systems, Oregon Cryonics, Alcor Life Extension Foundation, Osiris Cryonics, Sigma-Aldrich, Southern Cryonics

Major players profiled in the report are Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom Biogenic Systems, Oregon Cryonics, Alcor Life Extension Foundation, Osiris Cryonics, Sigma-Aldrich, Southern Cryonics.

On the basis of products, report split into, Cryonics Technology.

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including Animal husbandry, Fishery science, Medical science, Preservation of microbiology culture, Conserving plant biodiversity.

Different regions covered in this market research report are North America, Europe, Asia Pacific, Middle East & Africa, Latin America etc. Major Countries are United States, Canada, Germany, France, United Kingdom, Russia, Italy, Spain, Rest of Europe, China, India, Japan, Rest of Asia Pacific, GCC, South Africa, Rest of Middle East & Africa, Brazil, Argentina, Rest of Latin America etc.

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Cryonics Technology Industry Global Market Research and Analysis 2019-2137 - 99Newsindustry

Recommendation and review posted by Bethany Smith

(Getty Images)

Does Justin Bieber hope to be frozen alongside Hailey Baldwin so they can live together forever? Thats the ridiculous claim in one of this weeks tabloids. Gossip Cop has learned its completely made-up.

According to NW, Bieber has been exploring cryonics, the process of freezing a persons dead body with the goal of resuscitating them in the future. An alleged insider tells the magazine that the singer recently surprised his wife by purchasing HisnHers cryogenic frozen pods. The supposed tipster adds, Hailey thought he was joking, but Justins already put deposits down.

He really wants them to do it one day, adds the seemingly phony source. Hes read up a lot about cryogenics and has already spoken to his team regarding the best way to go about it. The outlet, however, further maintains that Baldwin isnt too on board with the idea. Justin thought it would be a huge romantic gesture, but he didnt get the reception he was hoping for, says the suspicious source. Once the shock wore off, Hailey pretty much hasnt stopped laughing and now she loves offering him ice in his drinks, even the hot ones!

The tabloids report is total fiction. Gossip Cop checked in with a source close to the situation, who dismisses the report as total nonsense. Its possible this article was concocted because Bieber has reportedly tried cryotherapy in the past. Cryotherapy involves sitting in a freezing cold tank for a few minutes for therapeutic benefits. Many celebrities and athletes have taken part in the fad. However, we can confirm that Bieber has no intention of freezing himself and his wife for eternity.

NW has already proven to have zero insight into the couples relationship. In August, Gossip Cop busted the magazine for falsely claiming Baldwin refused to have a wedding with Bieber because she was grossed out by his pimples. Just two months after we debunked the utterly ridiculous report, the spouses walked down the aisle.

Earlier this year, Gossip Cop called out the tabloid for wrongly reporting Baldwin was forcing Bieber to go to rehab. That never happened. Going back to last year, the unreliable outlet insisted Bieber and Baldwin were breaking up. The publication seems to come up with its storylines as it goes along.

Its also worth noting, this isnt the first time weve had to bust a tabloid for a cryogenics-related article. Earlier this year, Gossip Cop busted the Globe for making up a story about Cher freezing her body when she dies in the hopes of being brought back to life. Theres no validity to this recurring theme.

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Justin Bieber Wants To Be Frozen With Hailey Baldwin So They Can Live Together Forever? - Gossip Cop

Recommendation and review posted by Bethany Smith

CRISPR, the revolutionary ability to snip out and alter genes with scissor-like precision, has exploded in popularity over the last few years and is generally seen as the standalone wizard of modern gene-editing. However, its not a perfect system, sometimes cutting at the wrong place, not working as intended and leaving scientists scratching their heads. Well, now theres a new, more exacting upgrade to CRISPR called Prime, with the ability to, in theory, snip out more than 90% of all genetic diseases.

Just what is this new method and how does it work? We turned to IEEE fellow, biomedical researcher and dean of graduate education at Tuft Universitys school of engineering Karen Panetta for an explanation.

CRISPR is a powerful genome editor. It utilizes an enzyme called Cas9 that uses an RNA molecule as a guide to navigate to its target DNA. It then edits or modifies the DNA, which can deactivate genes or insert a desired sequence to achieve a behavior. Currently, we are most familiar with the application of genetically modified crops that are resistant to disease.

However, its most promising application is to genetically modify cells to overcome genetic defects or its potential to conquer diseases like cancer.

Some applications of genome editing technology include:

Of course, as with every technology, CRISPR isnt perfect. It works by cutting the double-stranded DNA at precise locations in the genome. When the cells natural repair process takes over, it can cause damage or, in the case where the modified DNA is inserted at the cut site, it can create unwanted off-target mutations.

Some genetic disorders are known to mutate specific DNA bases, so having the ability to edit these bases would be enormously beneficial in terms of overcoming many genetic disorders. However, CRISPR is not well suited for intentionally introducing specific DNA bases, the As, Cs, Ts and Gs that make up the double helix.

Prime editing was intended to overcome this disadvantage, as well as other limitations of CRISPR.

Prime editing can do multi-letter base-editing, which could tackle fatal genetic disorders such as Tay-Sachs, which is caused by a mutation of four DNA letters.

Its also more precise. I view this as analogous to the precision lasers brought to surgery versus using a hand-held scalpel. It minimized damage, so the healing process was more efficient.

Prime editing can insert, modify or delete individual DNA letters; it also can insert a sequence of multiple letters into a genome with minimal damage to DNA strands.

Imagine being able to prevent cancer and/or hereditary diseases, like breast cancer, from ever occurring by editing out the genes that are makers for cancer. Cancer treatments are usually long, debilitating processes that physically and emotionally drain patients. It also devastates patients loved ones who must endure watching helpless on the sidelines as the patient battles to survive.

Editing out genetic disorders and/or hereditary diseases to prevent them from ever coming to fruition could also have an enormous impact on reducing the costs of healthcare, effectively helping redefine methods of medical treatment.

It could change lives so that long-term disability care for diseases like Alzheimers and special needs education costs could be significantly reduced or never needed.

How did the scientific community get to this point where did CRISPR/prime editing come from?

Scientists recognized CRISPRs ability to prevent bacteria from infecting more cells and the natural repair mechanism that it initiates after damage occurs, thus having the capacity to halt bacterial infections via genome editing. Essentially, it showed adaptive immunity capabilities.

Its already out there! It has been used for treating sickle-cell anemia and in human embryos to prevent HIV infections from being transmitted to offspring of HIV parents.

IEEE engineers, like myself, are always seeking to take the fundamental science and expand it beyond the petri dish to benefit humanity.

In the short term, I think that Prime editing will help generate the type of fetal like cells that are needed to help patients recover and heal as well as developing new vaccines against deadly diseases. It will also allow researchers new, lower cost alternatives and access to Alzheimers like cells without obtaining them post-mortem.

Also, AI and deep learning is modeled after human neural networks, so the process of genome editing could potentially help inform and influence new computer algorithms for self-diagnosis and repair, which will become an important aspect of future autonomous systems.

Continued here:
Youve heard of CRISPR, now meet its newer, savvier cousin CRISPR Prime - TechCrunch

Recommendation and review posted by Bethany Smith

PHOTO: BARBARA RIES FOR UCSF

There are key moments in the history of every disruptive technology that can make or break its public perception and acceptance. For CRISPR-based genome editing, such a moment occurred 1 year agoan unsettling push into an era that will test how society decides to use this revolutionary technology.

In November 2018, at the Second International Summit on Human Genome Editing in Hong Kong, scientist He Jiankui announced that he had broken the basic medical mantra of do no harm by using CRISPR-Cas9 to edit the genomes of two human embryos in the hope of protecting the twin girls from HIV. His risky and medically unnecessary work stunned the world and defied prior calls by my colleagues and me, and by the U.S. National Academies of Sciences and of Medicine, for an effective moratorium on human germline editing. It was a shocking reminder of the scientific and ethical challenges raised by this powerful technology. Once the details of He's work were revealed, it became clear that although human embryo editing is relatively easy to achieve, it is difficult to do well and with responsibility for lifelong health outcomes.

It is encouraging that scientists around the globe responded by opening a deeper public conversation about how to establish stronger safeguards and build a viable path toward transparency and responsible use of CRISPR technology. In the year since He's announcement, some scientists have called for a global but temporary moratorium on heritable human genome editing. However, I believe that moratoria are no longer strong enough countermeasures and instead, stakeholders must engage in thoughtfully crafting regulations of the technology without stifling it. In this vein, the World Health Organization (WHO) is pushing government regulators to engage, lead, and act. In July, WHO issued a statement requesting that regulatory agencies in all countries disallow any human germline editing experiments in the clinic and in August, announced the first steps in establishing a registry for future such studies. These directives from a global health authority now make it difficult for anyone to claim that they did not know or were somehow operating within published guidelines. On the heels of WHO, an International Commission on the Clinical Use of Human Germline Genome Editing convened its first meeting to identify the scientific, medical, and ethical requirements to consider when assessing potential clinical applications of human germline genome editing. The U.S. National Academy of Medicine, the U.S. National Academy of Sciences, and the Royal Society of the United Kingdom lead this commission, with the participation of science and medical academies from around the world. Already this week, the commission held a follow-up meeting, reflecting the urgent nature of their mission.

Where is CRISPR technology headed? Since 2012, it has transformed basic research, drug development, diagnostics, agriculture, and synthetic biology. Future CRISPR-based discoveries will depend on increased knowledge of genomes and safe and effective methods of CRISPR delivery into cells. There needs to be more discussion about prioritizing where the technology will have the most impact as well as equitable, affordable access to its products. As for medical breakthroughs, clinical trials using CRISPR are already underway for patients with cancer, sickle cell disease, and eye diseases. These and many other future uses of genome editing will involve somatic changes in individuals, not heritable changes that are transmissible. But the rapidly advancing genome editing toolbox will soon make it possible to introduce virtually any change to any genome with precision, and the temptation to tinker with the human germ line is not going away.

The CRISPR babies saga should motivate active discussion and debate about human germline editing. With a new such study under consideration in Russia, appropriate regulation is urgently needed. Consequences for defying established restrictions should include, at a minimum, loss of funding and publication privileges. Ensuring responsible use of genome editing will enable CRISPR technology to improve the well-being of millions of people and fulfill its revolutionary potential.

* J.D. is a cofounder of Caribou Biosciences, Editas Medicine, Scribe Therapeutics, and Mammoth Biosciences; scientific advisory board member of Caribou Biosciences, Intellia Therapeutics, eFFECTOR Therapeutics, Scribe Therapeutics, Mammoth Biosciences, Synthego, and Inari; and director at Johnson & Johnson. Her lab has research projects sponsored by Biogen and Pfizer.

The rest is here:
CRISPR's unwanted anniversary - Science Magazine

Recommendation and review posted by Bethany Smith

Susanna M. Hamilton/Broad Communications

Susanna M. Hamilton/Broad Communications

It's not easy to treat viral infections. Just ask anyone with a bad cold or a case of the flu.

But scientists in Massachusetts think they may have a new way to stop viruses from making people sick by using what amounts to a pair of molecular scissors, known as CRISPR.

It's a gene editing tool based on a molecule that occurs naturally in microorganisms.

CRISPR comes in many "flavors" that perform a variety of functions inside cells. The Cas9 flavor has been widely used as a tool for editing DNA inside cells. It's already shown promise for medical therapies such as treating sickle cell disease.

What's different is that the antiviral approach researchers at the Broad Institute in Cambridge are using involves a form of CRISPR called Cas13 that targets specific regions of RNA, not DNA.

RNA is a chemical cousin of DNA. Many viruses, including flu and Zika, package their genetic instructions in RNA instead of DNA.

When a virus infects a cell in our bodies, it hijacks the cell's molecular machinery to make copies of itself. Those new viruses can go on to spread the infection through your body.

So for therapy, "we need to be able to cut the virus at a fast enough rate to slow down replication or to stop replication from happening," says Cameron Myhrvold, a postdoc at the Broad Institute.

Finding the right target is key. There's a lot of RNA inside cells that is necessary for the cell to survive, so it's important to find an RNA target that's unique to the virus you're trying to control.

Myhrvold says RNA viruses are particularly difficult to control because they are a bit like shape-shifters: They tend to change their genetic sequences when you try to pin them down. That's one of the reasons people need a new flu vaccine each year.

Understanding how the virus changes in response to Cas13 treatment should be informative.

"That could potentially teach us about what parts of the virus are particularly important for its function," says Catherine Freije, a doctoral student at the Broad Institute. And that in turn will show the best places to target the virus in order to disable it.

So far, Freije and Myhrvold say they've only shown their antiviral treatment works in cells.

But Pardis Sabeti, head of the lab they work in, is bullish about using the CRISPR Cas13 system to treat viral infections in people.

"There's still a bunch of things we want to work out, but we feel pretty confident that this will work as a therapy if it can be delivered in the right way," Sabeti says.

By delivering, she means getting the CRISPR Cas13 tool into the right cells inside an infected patient.

Since CRSIPR Cas13 specifically targets RNA, it will only be useful for illnesses caused by RNA.

Janice Chen says researchers are now finding a variety of CRISPRs with different properties. Chen is chief research officer at Mammoth Biosciences, a company that hopes to capitalize on CRISPR technology.

"Having a broader CRISPR toolbox is really important to figure out what is the specific need for any given application," Chen says.

Progress in building that toolbox has proceeded quite quickly. After all, it's only been six years since scientists first became aware of how powerful a tool CRISPR could be.

Go here to read the rest:
CRISPR Could Stop Replication Of Viruses That Cause Illness, Researchers Say : Shots - Health News - NPR

Recommendation and review posted by Bethany Smith

These three health and technology stocks are on the move and pointing higher.

Advanced Micro Devices Inc. AMD, +0.55% jumped 81 cents to $37.52 on 67 million shares traded Wednesday. On Tuesday, the chip maker announced Tencent TCEHY, +0.20% will use its latest server processors. The stock has been in a steep rising channel since its recent low below $28 in early October. Next target is the rising channel top near $40.

Amarin Corp. PLC AMRN, +11.77% followed through on Wednesday, up 55 cents to $21.49 after popping 23% on Tuesday. An FDA advisory committee is scheduled to meet today to help decide the fate of the companys fish-derived cardiovascular drug. While trading has been halted this morning in advance of the meeting, the chart points to a test of the July high in the $23.50-$24.00 zone next.

Crispr Therapeutics AG CRSP, +3.29% rose $1.42 to $55 on 1 million shares Wednesday. The move, on no news from the company, continued the gene-editings stocks month-long rally from around $36. It also followed through on Tuesdays breakout of a mini-wedge. Watch for a move to $58 next.

See Harrys video-chart analysis on these stocks.

The writer has no holdings in any securities mentioned.

Harry Boxer is founder of TheTechTrader.com, a live trading room featuring his stock picks, technical market analysis and live chart presentations.

Read more here:
AMD, Amarin and Crispr are three stocks to watch for potentially higher prices - MarketWatch

Recommendation and review posted by Bethany Smith

In Europe, we dont do things the way the Americans do

Oral proceedings in the opposition against UC Berkeleys (UCs) main European patent EP2800811 are scheduled for all of three (!) days in February of 2020 at the European Patent Office (EPO). The opposition divisions (ODs) preliminary and non-binding opinion, provided on the 30th of August 2019 in preparation for the hearing, is favorable to the patentee. In its opinion, the OD sides with UC Berkeley and dismisses the main arguments of the seven opponents. Arguments relating to minor issues of added subject matter have been accepted by the OD, however UC is likely to be able to overcome these. Thus, there is a chance that UC Berkeley will keep their strong hold on rights to general platform Crispr technology in Europe.

UC Berkeleys patent claims priority from four provisional US applications. The question of whether the priority from the first provisional application P1 is valid or not lies at heart of the case.

According to European practice, G2/98, the requirements of claiming priority of the same invention in the meaning of Art 87(1) EPC mean that priority can only be acknowledged if the skilled person can derive the subject matter directly and unambiquously, using common general knowledge (CGK), from the previous application as a whole. In addition, the priority document must provide an enabling disclosure, in other words, all essential elements needed to carry out the invention must be disclosed in the priority document.

The opponents argue that P1 fails to provide an enabling disclosure, as it does not disclose or exemplify elements which are essential for the workability of the Crispr-Cas9 system in eukaryotic cells. At the heart of this issue is the protospacer adjacent motif (PAM), a 2-6 base pair DNA sequence which immediately follows the target DNA sequence and is an essential targeting component. The opponents argue that without knowledge of a PAM sequence, a person skilled in the art was not in a position to design an appropriate guide RNA and would therefore not have been able to achieve cleavage of target DNA (as the Cas9 endonuclease will not recognize target DNA without the PAM).

UC replies that the requirement of a PAM to be located downstream of the target DNA sequence was CGK at the date of filing of P1 and therefore the omission of any reference to PAM is of no detriment to the disclosure of P1. UC states that the skilled persons understanding of this was confirmed by the sequences disclosed in P1, wherein the amino acid sequences corresponding to PAMs are present immediately downstream of the target DNA.

If the priority claim from P1 is found to be invalid, the effective date of the patent at hand would be after UCs scientific paper on Crispr-Cas9 was published in Science. This would be detrimental to the patentability of at least some of the claims.

However, UC was successful during the examination before the EPO, as well as in the corresponding UK cases, in arguing that PAM was part of CGK. By accepting in their preliminary opinion that PAM was part of the CGK at the time of filing of P1, the OD has provisionally concluded that the disclosure of P1 is enabling over the whole claim scope, encompassing eukaryotic applications.

Concerning what actually was CGK at the time, UC argues that CGK was represented by review and research articles in the fast-evolving new technology area. UC holds that such articles confirm that the requirement for PAM in the target DNA was CGK. Although full of references to CGK and the skilled person, the preliminary opinion does not dwell on the identity of the skilled person. Establishing the identity of the skilled person is likely to be important during the oral proceedings. Not limited to PAM, the opponents argue that several lines of technical information are missing in P1 and that a skilled person operating within the limits of what is explicitly defined in P1 would be confronted with an inacceptable degree of failure.

The OD has also come to the preliminary view that the claims are novel and exhibit inventive step. The inventive step analysis is based on the problem-solution approach starting from a prior art document from the TALEN field of gene editing, and not from the Crispr-field, based on the purpose of the UC invention. The technical problem solved by the invention is considered to be to provide a more versatile gene editing system. The OD adds that the Examples in the patent show that UCs invention achieves this, or at least renders the achievement credible, also for eukaryotic cells.

UCs position is that P1 not only claimed a new class of endonucleases, but also provided ample guidance on how to use the endonuclease complex for example in eukaryotic systems as, amongst other things, P1 disclosed expression systems including vectors suitable for eukaryotic expression. They point to the fact that several groups in the scientific community quickly, upon publication of the Science paper, confirmed that the Crisp-Cas9 system could be used for gene editing in eukaryotic cells.

Interestingly, the OD takes no notice of UC inventors Doudnas and Charpentiers public statements, made upon publishing of the Science paper, about unpredictability and technical challenges of adapting the Crispr-Cas9 system to eukaryotic gene editing. In fact, the OD underlines the difference between the question of obviousness in the US interference proceedings by exclaiming under US law! in the opinion and the question of plausibility in the present case. Although plausibility is not a term used in the European Patent Convention, it is increasingly more discussed. According to case law, however, the question of plausibility only comes into play if experimental data is lacking. The OD states in its opinion that this does not apply to present case, because the disclosure does contain experimental data.

Nevertheless, plausibility, as well as the identity of the skilled person, are likely to be discussed during the oral proceedings. Is the skilled person going to be someone from the TALEN field? If so, would they be expected to know all the details and nuances of the Crispr-Cas9 field or not? The identity of the skilled person may have implications on several aspects of the case.

For now, it appears that the differences between the European and US patent landscape in the Crispr-Cas9 field may remain, at least as indicated by the non-binding and preliminary opinion of the OD.

See the rest here:
The Crispr-Cas9 patent tussle continues: The case of UC Berkeley at the EPO - Lexology

Recommendation and review posted by Bethany Smith

Over the last few years, thousands of studies have employed CRISPR/Cas systems to edit, or transcriptionally regulate, individual genetic targets. But a new study has taken CRISPR to soaring heights.

CRISPR/Cas is remarkably simple in principle: a protein, usually Cas9, can bind to an RNA molecule, such as a single guide RNA (sgRNA), which has a sequence complementary to a target site in the genome. When the Cas9:sgRNA complex binds to its target site, it cleaves the target DNA. By mutating specific amino acids in Cas9, DNA cleavage activity is abolished, thus converting it into a transcriptional repressor (called dCas9).

Though many research groups have explored methods to increase the number of sgRNAs that can be expressed at once in vivo, it has been a difficult challenge, in part, because sgRNAs have very repetitive elements. One part of the sgRNA, called the handle, is a 42-nucleotide strand of RNA that physically associates with Cas9. Unfortunately, most DNA synthesis manufacturers are unable to synthesize these repetitive elements, thus limiting the number of sgRNAs that can be assembled and expressed in living organisms.

In a new study, published in Nature Biotechnology, researchers from Penn State University have devised a method that enables 22 distinct sgRNAs to be expressed at once in bacterial cells. The solution? Design and characterize hundreds of non-repetitive genetic parts, including new sgRNA handles, that maintain their function but can actually be synthesized by DNA manufacturers.

I sat down with Alex Reis and Sean Halper (joint first authors) and Howard Salis (corresponding author and Associate Professor at Penn State University) to learn more about multiplexed CRISPR, how nonrepetitive parts are designed, and their plans for the future.

This interview with Alex Reis, Sean Halper and Professor Howard Salis on Simultaneous repression of multiple bacterial genes using nonrepetitive extra-long sgRNA arrays, published in Nature Biotechnology, has been edited for clarity. Words in parentheses are my own.

***

Niko McCarty: Can you tell me a bit about the inspiration behind this study? What was the impetus that made you look at the CRISPR multiplexing field and say, I bet we can improve the number of sgRNAs expressed at once in living cells?

Alex Reis: Well, five years ago, Sean Halper (co-first author) and I took a graduate level course with Professor Howard Salis, and we were exploring different ideas for scalable genetic circuit design. We kept going back to CRISPR because it is a scalable system; all you need to do to build complex CRISPR-based genetic circuits is express one protein regulator (Cas9), and a whole bunch of single-guide RNA regulators (sgRNAs). That was a very powerful idea to us, and we really wanted to scale that up. So this project was motivated from an application side, the desire to build larger genetic circuits.

Professor Howard Salis: When looking at this long DNA sequence or genetic circuit that we had designed for this class project, we basically saw that there were quite a few long regions of repetitive DNA. And if you were to copy-paste that sequence into an order form for any gene synthesis provider, it would immediately tell you, We cant make this. Its too long, too repetitive. So we knew that this was going to be a challenge for the CRISPR field as groups try to multiplex sgRNAs. If you redesign the whole system so that there is no more repetitive DNA, you would be able to build it easier, assemble it faster, and you would be able to express a lot more CRISPR regulators simultaneously.

Niko: Can you walk me through the key advancements from the paper, especially the things that you set out to do and what you accomplished?

Alex: After we identified that repetitive DNA was going to be a key bottleneck in cloning sgRNA arrays, we decided that the first step would be to identify and characterize non-repetitive parts for both genetic expression and the sgRNA handles themselves. The first thing we did was to design and characterize non-repetitive promoters and non-repetitive terminators. But a key challenge that that we faced was to identify non-repetitive handle sequence for sgRNAs. What sequences will enable handle sequence variants to still bind to the Cas9 or dCas9 protein?

To design these non-repetitive sgRNA handles, we carried out multiple rounds of a design, build, and test cycles and imposed specific constraints. In the first design round, the constraint was purely structural we told our algorithm that the sgRNA had to fold into a structure that could be recognized by the Cas9 structure. After that round, we applied a machine learning technique called linear discriminant analysis to identify which mutations would cause handle failure. With that, we identified two nucleotides in the sgRNA handle, G43 and G52 that, when mutated, would abolish handle function. After iterating through these processes a few times, we ultimately characterized 28 highly functional, non-repetitive handle variants. And these handles work equally well for Cas9 and dCas9.

Grace Vezeau, another author on the paper, ran a bunch of cleavage assays to verify, measure and quantify how well these different non-repetitive sgRNA handles were able to load up into Cas9 and cleave DNA.

Niko: After you verified these non-repetitive sgRNA handles, you then used them for three different engineering applications. Can you walk me through those?

Sean Halper: We built three different ELSAs (extra long sgRNA arrays), the longest of which contained 22 distinct sgRNAs. We wanted to come up with some applications that would show the power of scaling up the number of sgRNAs using nonrepetitive handles in E. coli. Our first proof-of-concept was to aerobically produce succinate using a knockdown of six different genes. At first, when we targeted these six genes, it didnt work. We troubleshooted the problem, and found that we had to increase the expression of dCas9, after which we saw a 1000-fold knockdown on some of the genes that we were targeting. This incidentally also showed that, once you start expressing many sgRNAs at once, you need to have enough Cas9 or dCas9 to handle that many simultaneous RNA regulators.

In a second example, we used an ELSA to target different amino acid biosynthesis pathways. We really wanted to see if we could use CRISPRi knockdowns to impose auxotrophy-like behavior. For the third example, we knocked down different stress response genes to explore how a broad spectrum perturbation would affect the behavior and response of E. coli.

Howard: Part of this effort was also to develop algorithms that allow us to design DNA sequences that can be readily synthesized by commercial service providers. Some of these ELSAs have over 20 promoters, 20 terminators, and so forth. Terminators can form hairpins and may contain palindromic sequences, however, so if you ask a gene synthesis provider to synthesize any old DNA with lots and lots of hairpins, theyre going to balk at you. But if you design the system correctly, if you draw from a large enough pool or toolbox of genetic parts, and you arrange those genetic parts just right, you can meet your target metrics for what can be synthesized. As long as your DNA sequence is within those target metrics, then these companies can actually deliver the DNA fragments to you. By the end of this project, we were able to synthesize 33 DNA fragments up to 3 kilobases each, all containing ELSAs, with about a 90% success rate and turnaround time, which is about five days.

Niko: Do you have any plans for designing non-repetitive ribozymes or cleavage sites, which may enable you to express many sgRNAs from a single promoter?

Howard: Let me just start off by saying that we started this project four or five years ago, and we have made some important advancements since then. Another graduate student in our group, Ayaan Hossain, developed an algorithm called the Non-Repetitive Parts Calculator, which formalizes how you can go about designing very large toolboxes of non-repetitive genetic parts. With this algorithm, weve been able to design, construct and characterize huge toolboxes of non-repetitive parts, including 4300 non-repetitive E. coli promoters, 1917 non-repetitive yeast promoters, at least 600 non-repetitive ribozymes with near wildtype cleavage activities, and about 2000 non-repetitive Cas9 handles.

So, is it possible to design many more non repetitive parts? It is absolutely possible. We know that for sure. Theoretically, there are about 100,000 non-repetitive sgRNA handles out there for Cas9. We clearly havent characterized 100,000 yet, weve only characterized 2000, but that kind of gives you an order of magnitude for the possibilities. Now, it should be possible to arrange all these genetic parts in an array and build ELSAs that are about 500,000 bases long, which is smaller than many yeast chromosomes that labs have already built. So its possible to build these very long sgRNA arrays, and there are many applications for them across industrial metabolic engineering and in the biomedical space.

Niko: And what about the different authors on the paper? Were there specific skillsets brought by individuals?

Alex: Sean, myself and Phillip Clauer, a former undergraduate, did the bulk of the cloning and characterization of the parts, but most of the lab pitched in and helped out. Daniel Cetnar helped with RNA level characterization, including a lot of the early RT-qPCR on the CRISPRi knockdowns.

Sean: Ayaan Hossain was really helpful in terms of helping us expand our non-repetitive part libraries for the promoters and terminators especially, as well as helping with some of the machine learning analysis. But it was definitely a collaborative effort over the last five years.

Niko: What are your plans for after graduation?

Sean: I actually defended my PhD just a couple of weeks ago. Im part of the SMART Scholarship for Service program, which is a fellowship with the Department of Defense. Once I wrap up here, I plan on beginning work soon with my sponsoring facility, the Army Research Lab in Adelphi, Maryland.

Alex: Im wrapping up a project or two and then will hopefully graduate and move on to the next thing. I love synthetic biology, so I am looking at postdocs along those lines. Im also thinking about some entrepreneurial aspects that I could pursue.

Niko: This study is so appealing to me, in part, because of its collaborative nature. It seems like most people in the group helped out can you tell me a bit about that?

Howard: Well, we have a very relaxed environment. While some people in the synthetic biology field have groups with 30-40 people, our group has less than 10. This means that everyone knows everyone else, and we all help each other. I intentionally set up my lab so that new people come in, and they receive training not just from myself, but from other graduate students and postdocs. Because of this, many students feel the obligation to pay it forward and help out other people. If youre really good at something, and you can carry out some set of experiments quickly, then you should help out your colleagues in the lab. In our group, a lot of sharing goes on, and thats what makes work like this possible.

***

Biographies:

Howard Salis is an Associate Professor of Biological and Chemical Engineering and Synthetic Biology at Penn State University. Research in the Salis laboratory focuses on the development of rational design methods for engineering synthetic biological systems metabolic pathways, genetic circuits, and genomes.

Sean Halper is a graduate student at Penn State University, and co-first author on this study. He recently defended his PhD in Chemical Engineering.

Alex Reis is a graduate student at Penn State University, and co-first author on this study.

The rest is here:
Science Behind the Scenes: Multiplexed CRISPR and sgRNA Arrays with the Howard Salis Lab | PLOS Synthetic Biology Community - PLoS Blogs

Recommendation and review posted by Bethany Smith

The research report provides valuable insights into demand drivers, geographical outlook, and competitive landscape of the CRISPR and Cas Genes Market over the forecast period. Further, it throws light on restraints as well discusses opportunities at length that are likely to come to the fore over the forecast period. The analysis thus provided helps market stakeholders with business planning and to gauge scope of expansion in the CRISPR and Cas Genes Market over the forecast period.

The report discusses the market structure, including prevailing trends, size of the market vis--vis revenue and volume, and finally forecasts values. Vital information, facts, and statistical figures provided for the CRISPR and Cas Genes Market are based on extensive primary and secondary research. Analysts also reached out to industry experts for their insightful inputs on the CRISPR and Cas Genes Market.

Further, the report provides a comparative analysis of historical and current trends prevailing in the CRISPR and Cas Genes Market. This helps to estimate growth trends in the CRISPR and Cas Genes Market over the assessment period. Such comparative analysis is provided using an exhaustive collection of tables and graphical representations.

The report delves into the vendor landscape of the CRISPR and Cas Genes Market. The research report on the CRISPR and Cas Genes Market provides valuable insights on the competitive landscape of the CRISPR and Cas Genes Market. Besides this, the research report provides deep insights into growth strategies employed by key players, along with impact of these strategies on future business growth.

The SWOT analysis of key vendors along with a detailed profile of key vendors based on business overview, financial status, and product portfolio helps to gauge competitive dynamics in the CRISPR and Cas Genes Market. This analysis helps to gauge growth strategies to be employed by prominent vendors in the CRISPR and Cas Genes Market, and scope of collaborations and partnerships between these players.

Request a PDF Sample Here

https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=26417

The report includes an exhaustive list of top players in the CRISPR and Cas Genes Market are Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

Further, market share projections and changing competitive hierarchy in the CRISPR and Cas Genes Market until the end of the forecast period are vital offerings of this report.

Key Questions Answered in the Report

Continued here:
CRISPR and Cas Genes Market Estimated to Rise at a Lucrative CAGR of 20.1% During 2018-2026 - TheFinanceTime

Recommendation and review posted by Bethany Smith

If you happen to follow any of Texas' Republican leadership on Twitter and God bless you if you do you've likely encountered the state GOP's latest causeclbre: a child-custody dispute in Dallas County between a mom who says that one of her two 7-year-old twins is a trans girl and a dad who insists that the child chooses to dress and live as a boy when they're at the father's house.

A family court jury in the case initially awarded sole custody to the child's mother,Anne Georgulas, in late October before a state district judge overruled their decision and gave Georgulas and the child's father, Jeffrey Younger, joint custody, including joint responsibility over medical decisions affecting the child.

In the wake of the judge and jury's decisions, conservative media outlets like the Washington Examiner, The Texan and The Daily Wirepounced on the story, suggesting that Georgulas' and Younger's child might be "chemically castrated" or "mutilated" if left in Georgulas' care.

Politicians like Sen. Ted Cruz and Gov. Greg Abbott hopped on the bandwagon.

Comments like Cruz's are representative of the backlash against Georgulas. They're also screaming to be corrected.

Georgulas does not, as her representatives are careful to point out, intend to have her child placed on hormone blockers. Seven-year-olds don't go on hormone blockers, because they don't have sex hormones to block unless they're going through premature puberty, a condition for which doctors commonly prescribe hormone blockers.

"There are no medical interventions for prepubescent gender diverse children. The only thing to do at this stage is love and support your child,"Dr. Jack Turban, resident physician in psychiatry at Massachusetts General Hospital, where he researches the mental health of transgender youth, told the Observervia email.

Even for pubescent kids who do take hormone blockers, the drugs' effects can hardly be described as a medical transition. The drugs have been used for decades, according to Turban, and are safe.

"The risks associated with dysphoria toward puberty are typically much higher," he says.

If a kid elects to go off the blockers, they simply go through puberty.

"The only significant side effect is that the adolescent may fall behind on bone density. For this reason, doctors will regularly check bone density while the patient is on the medication," Turban wrote in an article published by Vox in October 2018. "If the medication is stopped, bone density catches up to normal after a few years as the child goes through the puberty of their gender assigned at birth."

Sex hormones if they are administered to teenagers at all are rarely started before a patient is 16, Turban says.

"Endocrine Society guidelines recommend age 16. In some instances where the gender history is very clear, estrogen or testosterone may be started as early as age 14," Turban says.

The only irreversible effects of sex hormone therapy, for teenagers or anyone else, are cosmetic changes like body fat redistribution and changes in body hair, Turban says.

"The greatest predictor of these kids doing well is when their parents love and accept them. Support your child and do not try to change them," Turban says. "If your child has questions about gender-affirming medical interventions, take them to a doctor who is knowledgeable about these options. Do not rely on information online, as much of it is misinformation."

Stephen Young has written about Dallas news for the Observer since 2014. He's a Dallas native and a graduate of the University of North Texas.

See more here:
Everything You've Heard About Viral Texas Custody Case Is Wrong - Dallas Observer

Recommendation and review posted by Bethany Smith

- Reflects company values and commitment to patients living with hypoparathyroidism -

- Top-line data from expanded PaTH Forward Trial expected in first quarter of 2020 -

- Company expects to exceed targeted enrollment of 40 subjects -

COPENHAGEN, Denmark, Nov. 14, 2019 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address unmet medical needs, today announced a protocol addendum designed to facilitate enrollment of subjects previously treated with NATPARA (parathyroid hormone) for Injection in the United States (US) in PaTH Forward, a global phase 2 trial evaluating the safety, tolerability and efficacy of TransCon PTH in adult subjects with hypoparathyroidism (HP). TransCon PTH is an investigational long-acting prodrug of parathyroid hormone (PTH) in development as a potential once-daily replacement therapy for HP.

Previously, patients treated with NATPARA were required to undergo a long washout period prior to entering screening in PaTH Forward. In response to the recent recall of NATPARA in the US, Ascendis has been evaluating pathways to help enroll patients affected by the recall. Under the protocol addendum, patients previously treated with NATPARA in the US will now have an expedited pathway to enroll in PaTH Forward. As a result, the company expects to exceed targeted enrollment of 40 subjects in the trial.

This has been one of the most challenging times in the history of the hypoparathyroidism community, as we have navigated both the emotional and physical impact of the only PTH replacement therapy available being recalled in the US, said Deb Murphy, President and Vice Chair of the Board of Trustees of the HypoPARAthyroidism Association, Inc. We are grateful and very excited about Ascendis Pharmas efforts to expedite participation in the PaTH Forward Trial for additional patients.

Patients interested in participating in PaTH Forward in the US should discuss it with their physician, or visit pathforwardtrial.com, where they may contact a clinical representative who will refer them to a participating clinical investigator.

The unexpected recall of NATPARA in the US has had a major impact on my patients who have not been optimally controlled on standard of care with vitamin D and calcium supplements, said Mishaela Rubin, M.D., a PaTH Forward investigator. Patients living with hypoparathyroidism have an acute need to manage both their short-term symptoms and reduce risk of long-term complications. The PaTH Forward Trial is an opportunity for patients to participate in evaluation of a new potential treatment option for this debilitating disease.

PaTH Forward is a global, phase 2, randomized, double-blind, placebo-controlled, parallel group trial that will evaluate safety and efficacy of three fixed doses of TransCon PTH. The goal of PaTH Forward is to evaluate TransCon PTH control of serum and urinary calcium, and identify a titration regimen for complete withdrawal of standard of care (i.e., active vitamin D and calcium supplements). The trial will include adult subjects with HP who are currently receiving standard of care or were previously treated with parathyroid hormone therapies at up to 40 sites worldwide. The PaTH Forward Trial will introduce a ready-to-use pre-filled pen device and assess disease-specific patient-reported outcomes. After four weeks of dosing, all subjects may enter an open-label extension period with the opportunity to receive TransCon PTH to evaluate long-term safety and efficacy.

About TransCon Technology

TransCon refers to transient conjugation. The proprietary TransCon platform is an innovative technology to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic pH and temperature conditions initiate the release of the active, unmodified parent drug in a predictable release manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.

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About Hypoparathyroidism (HP)

Hypoparathyroidism (HP) is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH), resulting in low calcium and elevated phosphate levels in the blood. HP affects approximately 80,000 patients in the United States, the majority of whom develop the condition following damage or accidental removal of the parathyroid glands during thyroid surgery. Patients often experience decreased quality of life. In the short term, symptoms include weakness, severe muscle cramps (tetany), abnormal sensations such as tingling, burning and numbness (paresthesia), memory loss, impaired judgment and headache. Over the long term, this complex disorder can increase risk of major complications, such as extraskeletal calcium depositions occurring within the brain, lens of the eye, and kidneys, which can lead to impaired renal function.

Until recently, HP remained among the few hormonal insufficiency states not treated by replacement of the missing hormone. Standard of care with active vitamin D analogs and calcium supplementation do not fully control the disease and may contribute to risk of renal disease. As a result, patients with HP have an estimated 4-fold to 8-fold greater risk of renal disease compared to healthy controls.

About Ascendis Pharma A/S

Ascendis Pharmais applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies.

Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates in clinical development and has established oncology as its second therapeutic area of focus. Additionally,Ascendis Pharma has multi-product collaborations withSanofiin diabetes and Genentech in the field of ophthalmology and continues to expand into additional therapeutic areas for both internal and external development.

Ascendis is headquartered in Copenhagen, Denmark, with offices in Heidelberg, Germany and Palo Alto, California.

For more information, please visit http://www.ascendispharma.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the timing of the topline data from the PaTH Forward Trial, (ii) our ability to apply our platform technology to build a leading, fully integrated biopharma company, (iii) our expectations regarding our ability to create new and potentially best-in-class therapies and (iv) our product pipeline. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of TransCon hGH, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies and potential commercial sale, if approved; and our ability to obtain additional funding, if needed, to support our business activities. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, theU.S. Securities and Exchange Commission(SEC), including our Annual Report on Form 20-F for the year endedDecember 31, 2018, which we filed with theSEConApril 3, 2019. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma group.November 2019 Ascendis Pharma A/S.

Internal contact: Scott T. Smith Chief Financial Officer (650) 352-8389ir@ascendispharma.com

Media contact:Ami KnoeflerHead of Global Communications(650) 739-9952 ack@ascendispharma.com

Investor contact:Patti BankWestwicke Partners(415) 513-1284patti.bank@westwicke.com

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Ascendis Pharma Expands TransCon PTH Phase 2 PaTH Forward Clinical Trial to Expedite Enrollment of Subjects Previously Treated with NATPARA in the...

Recommendation and review posted by Bethany Smith

What to anticipate from Intercourse After Having A Baby

Pregnancy and distribution modification great deal regarding the human anatomy, along with your sex-life.

Postdelivery hormone changes will make tissue that is vaginal and much more sensitive and painful. Your vagina, womb, and cervix have actually to return to size that is normal too. And when youre nursing, that may reduce libido.

Theres no timeline that is definitive says just how long you really need to wait to possess intercourse after having a baby. Nonetheless, many health practitioners suggest ladies wait 4 to 6 months carrying out a genital distribution.

After your medical professional has provided you the all clear to resume intimate tasks, you might still have to take things gradually. Keep in mind: as well as recovery that is physical youll also be adjusting up to a brand new member of the family, less rest, and a modification of your regular routine.

Its also possible to need certainly to wait much longer when you yourself have a perineal episiotomy or tear. An episiotomy is really a medical cut to widen the canal that is vaginal. Going back to intercourse too quickly may raise your chance of problems, such as for example postpartum hemorrhage and uterine infection.

Keep reading to find more info on the results of being pregnant and distribution on intercourse, and just how to possess a healthy, satisfying sex life after infant.

Intercourse after distribution shall feel various. One study that is small 2005 discovered that 83 % of females skilled sexual dilemmas in the 1st 90 days after their very very first distribution.

Nonetheless, that quantity will continue to fall due to the fact months that are post-pregnancy.

Hormones perform a large role in postdelivery data recovery and a come back to normal sexual intercourse.

When you look at the days childbirth that is immediately following estrogen falls to pre-pregnancy amounts. If nursing, estrogen levels might sink below pre-pregnancy levels. Estrogen helps provide natural lubrication that is vaginal therefore lower levels associated with hormone raise the probability of vaginal dryness.

Dry muscle can cause discomfort, also bleeding, while having sex. This increases your chance of illness.

Genital delivery can temporarily extend the muscle tissue associated with the canal that is vaginal. These muscles require time and energy to recover their stability and strength.

You may have a longer recovery if you had a perineal tear or episiotomy during vaginal birth. Making love too early can boost your threat of an infection.

A cesarean distribution also can impact sensation that is vaginal your brides website. Equivalent hormone problems could make the cells for the vagina dry and thin, perhaps resulting in painful intercourse.

Plus, youll be coping with stomach surgery, therefore youll desire to ensure that the incision web site has precisely healed before resuming intercourse.

You may get expecting interestingly quickly after delivering an infant. One research discovered the first ovulation for women that werent nursing is about six days. Some females ovulated even early in the day.

If youre nursing, the hormonal advantages of medical can behave as a natural type of contraceptive when it comes to first 4 to 6 months after distribution.

But, no more than 1 in 4 ladies who utilize this lactational amenorrhea method (LAM), or nursing as birth prevention, do therefore properly. That increases their danger for maternity.

If youre going to possess intercourse after pregnancy but dont want to risk another child therefore soon, intend to make use of a dependable approach to birth control.

A barrier technique, such as for instance a condom, might be good to use in the beginning. An implant or IUD can be used also. But, hormone choices may impact nursing and that can additionally have particular dangers, such as for example an increased danger for bloodstream clots.

Consult with your medical professional concerning the right selection for you.

Getting pregnant too rapidly after one maternity can place you at an elevated danger for premature birth or delivery defects.

Healthcare experts encourage ladies to place their pregnancies. Any office of Womens wellness suggests waiting at the least one year between each maternity. In addition to March of Dimes suggests waiting eighteen months.

If youre reasoning about another child, speak to your medical care pro. Theyll certainly be many acquainted with your wellbeing history and provide more recommendations that are personalized.

Some regular bleeding as your uterus heals in the weeks immediately following childbirth, youll likely experience. Intercourse could potentially cause some blood loss that is additional.

Likewise, your vagina may be drier and more sensitive and painful in the early days after childbirth. This is why the muscle tissue slimmer, that may lead to tearing or damage. The vagina may also become inflamed and swollen. During these cases, bleeding is not uncommon.

In the event that bleeding during intercourse does stop within four nt to six months or it worsens, see your medical practitioner. Youve probably an irritation or tear that needs treatment before starting having sex once again.

The hormones estrogen and progesterone are necessary to your babys development that is healthy maternity. Additionally they are actually crucial to your sexual interest.

Quantities of these hormones are extremely high during maternity. When the child is born, they decrease considerably, back again to levels that are pre-pregnancy.

Which means you might not feel any desire that is sexual a couple of months. However you ought to be waiting 4 to 6 months anyhow, as the human body recovers.

After your medical professional has offered you the all clear to resume activities that are sexual you may possibly opt to wait much longer before reigniting your sex-life. One research unearthed that 89 per cent of females had resumed sexual intercourse within 6 months of pregnancy.

If youre nursing, it may simply simply take additional time for the libido to go back than it might for females whom arent nursing. Thats because nursing keeps estrogen levels low.

Estrogen supplements are discouraged if youre nursing as it may affect milk manufacturing.

You and your partner may not feel like intimacy is even on the books when you couple changes in hormones with the fatigue of being a parent to a newborn.

As the human body adjusts to its brand brand new normal or once you stop breastfeeding, the hormones will start working once again, along with your libido should get back.

Pregnancy contributes to large amount of real modifications to your system. Thats why it is crucial to offer your self 4 to 6 days after distribution just before have sexual intercourse once again.

Throughout your recovery duration, the womb will shrink, hormones will come back to pre-pregnancy amounts, and muscle tissue will regain power and security.

Once youve been because of the go-ahead by the medical practitioner, be sure to simply take returning to intercourse to your time.

If any pain is experienced by you or symptoms that persist, consult with your physician. Painful intercourse may be an indicator of other conditions unrelated to pregnancy data data recovery.

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What to anticipate from Intercourse After Having A Baby - ESPBR

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SPOKANE A federal judge in Spokane today ruled that the White House Administrations conscience rule is unlawful, granting summary judgment in Attorney General Bob Fergusons legal challenge. The rule would have given health care professionals broad discretion to refuse lawful and medically necessary care to patients for religious or moral reasons, even when the patients life is at risk.

This case represents the Washington Attorney Generals 25th consecutive legal victory against the Administration.

The court agreed that all Washingtonians deserve to receive the full range of health care services, Ferguson said. This rule would have disproportionately harmed rural and working poor Washington families, who have no alternatives to their local health care providers, as well as LGBTQ individuals, who already face discrimination when they seek medical care.

The lawsuit, filed in U.S. District Court for the Eastern District of Washington, argued that the rule would jeopardize access to reproductive health care, particularly for low-income, rural and working poor patients and allow providers to discriminate against LGBTQ individuals.

The conscience rule would have allowed health care workers to deny a patient access to medical care and services including reproductive care, end-of-life decisions, and care for transgender patients for moral or religious reasons, with no exception for medical emergencies. Under the rule, if the federal government believed Washington, its health care institutions, or other recipients of federal health care funds violated the rule, the federal government would be allowed to cut off all health care funding to the state more than $10 billion per year.

Ferguson filed the lawsuit in federal court in Spokane because rural communities, including those in Eastern Washington, have fewer health care providers and would be more likely to be harmed by the rule.

On Nov. 6, a federal judge in New York found the rule was unlawful and struck it down nationwide. Todays ruling provides an extra layer of protection against appeal by the Administration.

The conscience rule

The rule would have significantly expanded the number of individuals eligible to make refusals based on religious or moral beliefs. The rule applies to any employee providing any service to any patient, from ambulance drivers to receptionists to customer service representatives at insurance companies.

Some examples of potential impacts under the rule:

-A woman experiencing a life-threatening miscarriage calls an ambulance to her home. The EMT or paramedic who arrives could refuse to transport her to the hospital because they may terminate the pregnancy, despite the risk to the health of the mother and the fact that the pregnancy is not viable.

-A patient in need of an IUD to treat a condition such as endometriosis could be denied coverage by her insurance company on moral grounds because an IUD is also birth control. The patient would be responsible for the entire cost of her treatment.

-A patient who suffers debilitating pain with menstruation, or constant menstruation, could be cured with a surgery to remove her uterus. Her doctor could refuse to tell her about that option if he or she personally opposed sterilization.

-An employer could offer unmarried employees only health coverage that does not cover birth control, or choose to provide only plans that do not cover birth control at all.

-A receptionist, citing religious or moral objections, could refuse to schedule an appointment for an LGBTQ patient.

-A pharmacist could refuse to fill a prescription for hormone therapy for a transgender person.

-If a doctor who objects to physician-assisted suicide on religious grounds treats a patient with a painful, terminal disease who wants to use Washingtons Death with Dignity Act, the doctor may refuse to transfer that patients medical records to a participating provider.

Impacts on Washington

The rule threatened severe sanctions on states that do not comply. Any failure or apparent failure to follow the rule would jeopardize all federal health care funding, which states rely on to provide critical and often life-saving care.

Washington receives $8.2 billion annually for its Medicaid and Childrens Health Insurance programs, and more than $10.5 billion every year in federal funding from the U.S. Department of Health and Human Services. Washington relies on those funds for essential public health programs, including the Childrens Health Insurance Program, HIV/AIDS and STD prevention and education, and substance abuse and mental health treatment.

The rule provided no information on how the federal government will determine the rule has been violated.

The rule would have substantially increased the risk of discrimination against patients on the basis of sex, sexual orientation or gender identity. Transgender patients already face discrimination in the health care industry, including denial of routine medical care, like physicals, diabetes treatments and flu shots. The rule would give providers more leeway to refuse to provide care to transgender patients and discriminate based on gender identity.

Washington has a network of laws that balances patients right to health care treatment with respect for personal conscience. These laws allow medical professionals to refuse to provide certain services based on conscience, except in an emergency to save a human life. They also require health care institutions and providers to ensure that no one is denied information about or timely access to health care, by, for example, advising patients of all options required by todays medical standards.

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'Conscience rule' that puts providers' personal beliefs ahead of patient's emergency needs deemed unlawful - Northern Kittitas County Tribune

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Theres new evidence that mind-body interventions can help reduce pain in people who have been taking prescription opioids and lead to reductions in the drugs dose.

In a study published this month in JAMA Internal Medicine, researchers reviewed evidence from 60 studies that included about 6,400 participants. They evaluated a range of strategies, including meditation, guided imagery, hypnosis and cognitive behavioral therapy.

Mindfulness, cognitive behavioral therapy and clinical hypnosis appear to be the most useful for reducing pain, says study author Eric Garland, a professor at the University of Utah. The reductions in dose were modest overall, he says, but the study is a signal that this approach is beneficial.

And Pamela Bobb, who lives in Fairfield Glade, Tenn., can attest to the benefits. Shes 56 and has endured decades of pain. Oh, I had been suffering terribly for years, Bobb tells us.

She was born with a malformation in her pelvis that led to pain. Over the span of two decades, she underwent more than a dozen major surgeries, yet none of them gave her relief; each procedure left more scar tissue and nerve damage.

I felt desperate, Bobb says. I didnt feel like I had any control.

She couldnt do basic things such as cook or take care of her family.

I was completely debilitated, Bobb says. And when you get to that point, you cant see beyond the pain youre just surviving.

She was put on high doses of opioids to ease the constant pain, but then a few years ago she thought, There just has to be a better way. Ultimately, she found help at a clinic that specializes in complementary and alternative medicine.

We offer a variety of things, explains Wayne Jonas, a physician who treated Bobb at the Fort Belvoir Community Hospital Pain Clinic in Fairfax County, Va.

We offer physical therapy, behavioral medicine, acupuncture, yoga and mind body practices, Jonas says. None of these is a cure-all, he adds, but the idea is that there are lots of tools in the toolkit for people to try.

Jonas is a longtime proponent of an integrated, mind-body approach to treating pain and the author of How Healing Works, a book that describes the science behind these approaches.

He says that when someone is in severe pain, their bodys normal defenses are down.

It bumps up a variety of dysfunctions, Jonas says. Pain increases levels of the stress hormone cortisol and increases inflammatory processes in the body, too. This starts a continual negative feedback loop that produces more pain, Jonas explains.

Its not a surprise, he says, that techniques such as meditation or yoga can be helpful. If you engage in a deep mindfulness and relaxation it will counter those stress responses, Jonas says.

Think of meditation as a form of mental exercise.

Its almost like weightlifting for your brain, says Garland. Just as curling a dumbbell strengthens the bicep, he says, meditation is almost a way of, sort of curling the dumbbell of the mind to strengthen the minds self control.

And this can change the way the brain perceives the input from the body. If you can change the way the brain perceives signals from the body you can actually change the experience of pain, Garland says.

But theres a trick here: Learning to meditate takes time, effort and some training. Its more complicated than swallowing a pill. Pamela Bobb has stuck with it. She has tried a bunch of these alternative mind-body strategies, including acupuncture and biofeedback, and now starts every morning with a meditation practice.

Its 4:45 in the morning and Ive just awakened, she says in a recording she made of her practice, so I could listen in. She sounds centered, and calm. Im allowing my body to feel as relaxed as it possibly can.

Bobb has also overhauled her diet, now eating a lot more greens, fruits and vegetables and herbs and spices with anti-inflammatory properties. On the day we talk, shes making a spinach saute with ginger, mint and rosemary.

I swear you can smell each of those spices. They smell so good! she says.

Bobb is so at ease now that, just hanging out with her, youd never guess all that she has endured. And she feels so much better, she says.

Its empowering to [have] come all this way, Bobb says. She says shes made a fundamental transition in her mind: Instead of waiting for doctors to heal her with surgeries or injections, she now realizes that many of these alternative therapies have empowered her to help herself.

So much of it does lie within me, she says.

Bobb accepts that she may never be completely pain-free, but now feels she has control over the discomfort.

She has reduced her opioid dose by 75%. She says she still benefits from a small maintenance dose of the medication. And her doctors say that for her, the benefits of the medicine outweigh potential harms.

In the midst of an opioid epidemic, Bobbs story may seem unlikely. But many people who have taken opioids for a prolonged period have similar stories. And last month, the Department of Health and Human Services released new guidelines urging doctors to take a deliberate approach to lowering doses of opioids for chronic pain patients.

The guidelines point to the potential harms of forcing patients off the medications.

The goal is not necessarily to get off of all opioids but to reduce it to a dose [that is] safe, Adm. Brett P. Giroir, a physician and assistant secretary for health at HHS, told NPR. We asked him about Bobbs case. He is not her doctor, but after hearing her story he said, The fact that shes been able to reduce her opioids substantially is a success story.

Giroir says this kind of comprehensive approach that includes alternative therapies could be a model for what we want to do nationwide. He points out that earlier this year, the Centers for Medicare & Medicaid Services proposed covering acupuncture for Medicare patients who have chronic lower back pain.

As the evidence accumulates, Giroir says, there will be more attention placed on covering alternative therapies.

A 2017 Gallup Poll found that 78% of people would prefer to try other ways to address their physical pain before they take pain medication.

And doctors groups such as the American College of Physicians recommend that doctors offer more nonpharmacological treatments to pain patients, such as those who have chronic lower back pain.

Yet, a paper published last year finds that most insurers have not adopted policies that are consistent with these guidelines, and many dont pay for coverage of these services. An accompanying editorial argues that its time for that to change.

Its clear that when it comes to tackling pain, it takes all of the tools in the toolkit. And when it comes to opioids, the approach neednt be all or nothing. Bobb says she has learned that, for her, the combination of medicine plus mind-body therapies works best.

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Meditation Reduced The Opioid Dose She Needs To Ease Chronic Pain By 75% - WABE 90.1 FM

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Endocrine Testing Market Outlook provides thoughtful analysis of current issues facing the industry, along with current facts and statistics about the production and application in Endocrine Testing Market..

The Global Endocrine Testing Market is poised to grow strong during the forecast period 2017 to 2027. Endocrine Testing market is the definitive study of the global Endocrine Testing industry. The report content includes technology, industry drivers, geographic trends, market statistics, market forecasts, producers, and raw material/equipment suppliers.

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The Endocrine Testing industry study concludes with a list of leading companies/suppliers operating in this industry at different stages of the value chain.

List of key players profiled in the report:

Abbott Laboratories, AdnaGen, Beckman Coulter/Danaher, Biomedical Diagnostics, BioMerieux, Bio-Rad, Dako, DiaSorin, Eiken, Fujirebio, Instrumentation Laboratory, Kyowa Medex, Matritech, Ortho-Clinical Diagnostics, Roche, Siemens, Sysmex, Thermo Fisher, Tosoh, Wako, Wallac/PE,

By TestEstradiol (E2) Test, Follicle Stimulating Hormone (FSH) Test, Human Chorionic Gonadotropin (hCG) Test, Luteinizing Hormone (LH) Test, Dehydroepiandrosterone sulfate (DHEAS) Test, Progesterone Test, Testosterone Test, Thyroid Stimulating Hormone (TSH) Test, Others (Gastrin, Thymosin, Secretin, etc.)

By TechnologyTandem Mass spectrometry, Immunoassay (Enzyme immunoassays, Radioimmunoassays (RIA)) Technologies, Monoclonal and Polyclonal Antibody Technologies, Sensor (Electrochemical, Biosensors, etc.) Technologies, Clinical Chemistry Technologies, Others (Liquid Chromatography + Mass Spectrometry (LC-MS),

By End UserHospitals, Commercial Laboratories, Ambulatory Care Centers, Home Based Tests, Physician Offices

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The Endocrine Testing market research report provides a concise and clear overview of this complex and often dynamic industry. The report dives into the trends in the specialty Endocrine Testing industry by looking at the market from a regional perspective, application perspective, and materials point of view. As a market with significant growth potential, we look not only at the market today, but also at how it will develop over the next three years and the trends and developments that will drive growth.

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Global and Regional Endocrine Testing Industry Production, Sales and Consumption Status and Prospects Professional Market Research Report 2019-2024 -...

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Jim Gaffigan, comedian, writer and actor, worries about his health. "I want to lose weight. I figure ... [+] I have a good seven to ten years of performing at the present level." (Photo by Chris Pizzello/Invision/AP)

Okay, I confess. I went for a provocative title. Are comics infected with the bubonic plague? Nope. Are they dropping like flies? Of course not. However, it may be tempting to think this way because a tragically large number of beloved comedic talents have died suddenly and prematurely: John Candy, Bill Hicks, Freddy Prinze, Patrice ONeal and many others.

After interviewing several stand-up comics, comedic actors and writers during the New York Comedy Festival (which wrapped up November 10, 2019), I have a better understanding of the highly atypical lifestyle led by these immensely talented individuals, the wide range of health issues they face, and the role of medical professionals in addressing their medical and mental health concerns.

There is a thin line that separates laughter and pain, comedy and tragedy, humor and hurt.

The plethora of headlines reporting yet another comedians death at the hands of drugs or suicide tempts us to believe that addiction and mental illness are epidemics within the comedy world. Lenny Bruce, Jim Belushi, Chris Farley, Greg Giraldo, Mitch Hedberg and Robin Williams are just a few in a long list of funny folks who have all sadly succumbed to drug overdose, depression and suicide. In fact, the high number of premature deaths prompted the Laugh Factory in Hollywood to hire an on-site psychologist. To get more clarity on this issue, I posed a series of questions to several comedians.

Why do so many comedians experience addiction and mental illness?

This is nothing new, according to comic superstar Jim Gaffigan. There is nothing normal about going onstage and making a crowd of strangers laugh. The Pale Tourist comic compared comedy to addiction: Stand-up is an endorphin rush probably similar to a drug. Its also a strange combination of control (you have a mic) and no control (the reaction of the audience).

Comedian and breast cancer survivor Jenny Saldana.

Stand-up comedian Jenny Saldana: Its really hard to be ON all the time. The breast cancer survivor and patient advocate explained, We struggle with our onstage persona and our personal lives. Combine these issues with access to drugs in the late-night scene, says Saldana, and addiction lurks around the corner.

According to comedian Jim Mendrinos, there are plenty of risk factors: Isolation, long periods of traveling without a support system, and crazy-easy access to drugs and booze. The Gotham TV Writing instructor added, As with all true artists, we feel too much. Most comics I know suffer from some type of depression.

Comedian Jim Mendrinos has experienced multiple health issues including concussions and facial ... [+] surgery.

If youve experienced addiction or mental illness, what kind of treatment did you receive? How did you achieve recovery? If you havent, how did you avoid both conditions?

Pakistani-American comedian Mona Shaikh is well aware of the connection between trauma and addiction. The comedy community has a lot of trauma and pain. A survivor of significant verbal and physical abuse that led to suicidal thoughts, Ms. Shaikh is crystal clear about her recovery: Therapy singlehandedly saved my life. She also finds comedythe love of my lifevery empowering as it allows her to share her pain and trauma.

Comedian and event emcee Mona Shaikh speaks at the Women's March, San Francisco. Abused by her ... [+] father, brother and ex-husband, Shaikh uses comedy to share her trauma, pain and resilience. (Photo by Kelly Sullivan/Getty Images)

Therapy was a recurring theme. According to Gaffigan, therapy helped a lot. Comedians, like most humans, have demons. He added, my wife [and writing partner, Jeannie Gaffigan] has been invaluable in keeping me grounded.

The tragedy of life is what dies inside a man while he lives.

Comedy Cellar regular, Ian Fidance, credits medications and counseling to his long-term recovery from alcohol use disorder. Naltrexone saved my life. He also praised the Greenwich House for providing him with much-needed care. Fidancelike many people with addictionfaced tremendous stigma: I had to divorce myself from the moral-failing paradigm.

Stand-up comic Ian Fidance takes part in SiriusXM host Ron Bennington's annual Thanksgiving Special ... [+] at the Hard Rock Cafe in New York City. (Photo by Cindy Ord/Getty Images for SiriusXM)

What health issues do comedians worry about?

Alas, comedians are people, too. And just like all of us, they experience a wide range of health issues beyond anxiety and drugs.

Jeannie Gaffigan, writer and executive producer of The Jim Gaffigan Show, cited poor diet and lack of sleep affecting her husband. For an internationally touring comedian, waking up at the same time every morning is impossible. As a television writer, she would be awake until 3 a.m., order Indian food. Then during the day, the mother of five young children would receive calls from school about a childs strep throat. Its a manic existence.

Ms. Gaffigan, author of the recently released memoir, When Life Gives You Pears: The Healing Power of Family, Faith, and Funny People, shared her life-altering journey with a pear-size brain tumor, followed by intubations, infections and vocal cord dysfunction. So how, if at all, did this major neurosurgical health problem impact her life, including comedy writing? It made me bolder. She publicly discusses J-tubes, PEG tubes, colonoscopies and other humiliating topics that arent exactly dinner conversation. The comedic power couple documented their post-hospitalization dietary ritual in a very funny and candid YouTube series, Feeding Frenzy.

NEW YORK, NY: Jeannie Gaffigan and Jim Gaffigan visit SiriusXM Townhall at SiriusXM Studio on June ... [+] 28, 2016, in New York City. (Photo by Robin Marchant/Getty Images)

Many other health issues impact comedians. Stacy Kendro worries about back and neck pain as well as migraines. But lack of health coverage can be a barrier. Im mostly part-time with comedy and need to pay cash out of pocket. Ms. Saldana agreed: Most comedians dont access health care and go a long time without seeing a medical professional.

What would you like medical professionals to know? How can we better serve the comedy community?

Ms. Kendro: I would go to a therapist if I could afford one. Health insurance needs to be accessible to performers, especially those in the trenches, on the road, working clubs.

Mr. Mendrinos: Artists need help. We often dont have access to health insurance. I know five comics who have died by suicide. We tend to self-medicate with drugs and comedy.

Ms. Gaffigan: Doctors need to be creative in their advice. Tailor it to the comedians late-night work hours and travel schedule.

Ms. Saldana: I guarantee that if doctors started a free clinic at a comedy club, offering flu shots, STD screening and basic counseling, theyd be overbooked in minutes.

Comedian Stacy Kendro feels that "real comedy comes from pain." The funniest people she's ever known ... [+] "were the most emotionally fraught."

******************

Personally, I always found laughter to be therapeuticwell before I became a physician. From a young age, I gravitated toward funny films and television sitcoms. I cherishedin fact, enviedmy friends who had a natural ability to make others laugh. Years later, I became an avid fan of stand-up comedy. To this day, I have tremendous admiration for any person who courageously stands alone on stage and makes complete strangers laugh. A unique skill set I will never possess.

It turns out that comedians provide a genuinely therapeutic skilla reality that Im sure many comics discovered at least intuitively at a young age. Evidence shows that laughter has many short- and long-term health benefits. According to the Mayo Clinic, laughter acutely stimulates our heart, lungs and other organs by increasing oxygen intake; it also activates the brain to release endorphins (the happy hormone); and relieves tension by relaxing our muscles. In the long term, laughter can improve our immune system, which fights infections and illnesses; reduce pain; and improve mood.

Women enjoy a laughter yoga session at a laughing club in Kolkata, India. Laughter yoga helps to ... [+] increase happiness, but it also strengthens the immune system, reduces pain and lowers stress. (Photo by Avijit Ghosh/SOPA Images/LightRocket via Getty Images)

Substance abuse and mental illness are clearly underaddressed in the comedy community, not unlike the general population. The way to tackle this? I will reiterate Mr. Fidances remark: We need to reduce the stigma faced by people with addiction and mental illness. Globally, both remain THE most stigmatized social problems, according to the World Health Organization. A key way to decrease stigma is through widespread education. Addiction and mental illness are chronic illnesses of the brain, NOT signs of moral weakness or failure. Treatment like medications and behavioral therapies existand work! But health care access needs to be widely accessible. Perhaps comedians should have a union, as suggested by Ms. Kendro. Maybe comedy clubs could partner with local hospitals or clinics and offer basic health services. We need to be innovative.

The comedy and addiction medicine worlds taught me a key lesson: the importance of community. A common mantra in my line of work is The opposite of addiction isnt sobriety, its connection. The Gaffigans feeding tube videos led to an outpouring of stories. Pain and suffering are universal. People connect with openness and authenticity. On that note, I am deeply grateful to the comedians who have generously shared their stories. To every comedian out thereamateur and professionalyour humor is truly healing!

Read more:
If Laughter Is The Best Medicine, Why Are So Many Comedians In Poor Health? - Forbes

Recommendation and review posted by Bethany Smith

Docs who give sufferers with incurable breast most cancers a survival prediction are flawed virtually 80 per cent of the time, analysis reveals.

Main GPs are calling for victims to be given greatest and worst-case time frames to color a extra correct image of their future.

Nearly all of sufferers given a lethal prognosis need to know the way lengthy theyve left to dwell, based on Dr Belinda Kiely, an oncologist on the College of Sydney.

That is often in order that they know whether or not they need to cease working or promote their house, or if theyll attend a liked ones wedding ceremony, she claims.

However the GP mentioned the common life expectancy theyre given is barely correct 20 to 30 per cent of the time.

Docs within the UK and US, much like Australia, use their expertise to foretell how lengthy sufferers will survive. There is not one set mannequin.

Docs who give sufferers with incurable breast most cancers a mean survival time are flawed virtually 80 per cent of the time, analysis reveals

They think about affected person age, bodily situation and the way aggressive their most cancers is earlier than cross-referencing it with common survival occasions and adjusting.

The issue with common survival occasions is that theres a 50 per cent likelihood the affected person outlives this, based on Dr Kiely.

Talking on the Superior Breast Most cancers Fifth Worldwide Consensus Convention in Lisbon, she mentioned: Each week in my clinic, I meet ladies of all ages with superior breast most cancers.

They steadily ask, How long have I got? Theyve very sensible considerations and questions that they need assist with.

For instance, they may need to know whether or not they need to cancel a deliberate vacation, whether or not theyll be capable of attend their daughters wedding ceremony, or whether or not they need to cease working or promote their home.

Nevertheless, oncologists are generally uncertain about easy methods to assist.They might fear whether or not it is attainable to present correct data and the way greatest to speak about this with out destroying hope.

Dr Kielys analysis has proven that its higher to supply estimates for the best-case, worst-case and typical survival occasions.She mentioned this was extra correct and useful to sufferers.

It includes docs estimating the anticipated survival time for a affected person, dividing it by 4 to get the worst-case state of affairs and multiplying it by three to get the best-case end result.

The everyday life expectancy for superior breast most cancers sufferers is between a half and two occasions the docs estimate.

Dr Kiely informed the convention: If we inform a affected person that her estimated median survival time is six months, that conveys no hope of a attainable longer survival, regardless that she has a 50 per cent likelihood of dwelling longer.

Then again, offering three eventualities helps sufferers put together for the attainable worst-case and, on the similar time, hope for the attainable best-case.

That is extra useful for sufferers planning and selections for the long run.

Dr Kiely and her colleagues performed a trial with 33 oncologists who between them spoke to 146 sufferers with superior most cancers about their anticipated survival occasions.

Every affected person was supplied with a printed one-page abstract of their particular person best-case, typical and worst-case eventualities.

Ninety-one per cent of the sufferers mentioned they discovered the printed data useful, 88 per cent mentioned it helped them to make plans and 88 per cent mentioned it improved their understanding.

Seventy-seven per cent of sufferers mentioned the eventualities had been the identical or higher than theyd anticipated.

Primarily based on their findings, Dr Kiely and her colleagues at the moment are selling the three-scenario method with oncologists in Australia. They hope to encourage docs around the globe to do the identical.

Chair of the convention, Dr Fatima Cardoso, director of the breast unit of the Champalimaud Medical Centre in Lisbon, Portugal, endorsed the method.

Main GPs are calling for victims to be given best-case and worst-case time frames to color a extra correct image of their future

The physician,who was not concerned with the analysis, mentioned: This software for calculating and sharing the three eventualities provides docs the assistance they should talk with sufferers in a sensible and useful method.

Analysis reveals that sufferers who talk about these points with their physician have higher high quality of life, are much less more likely to bear aggressive end-of-life resuscitation and are much less more likely to die within the hospital.

However in the meanwhile, we additionally know that many sufferers will not be having these conversations.

Most sufferers with superior most cancers need some details about how lengthy theyre more likely to dwell, though many say they discover it tough to ask this query.

One in eight ladies within the UK and US will develop breast most cancers sooner or later of their lives, Most cancers Analysis UK statistics present.

Within the UK, triple unfavourable breast most cancers makes up 15 per cent of circumstances of the illness round 7,500 individuals annually.

And within the US, its chargeable for 10-to-20 per cent of breast cancers, based on Breastcancer.org

The probabilities of long-term survival are higher the sooner the most cancers is identified.

Round 9 out of 10 of girls dwell past 5 years if theyre identified with stage one breast most cancers.

Stage one describes a tumour lower than 2cm in size and most cancers that has not unfold across the physique.

However five-year survival charges plummet to at least one in 10 for these identified with stage 4 breast most cancers when most cancers has unfold to different organs across the physique.

Breast most cancers is without doubt one of the most typical cancers on the earth. Every year within the UK there are greater than 55,000 new circumstances, and the illness claims the lives of 11,500 ladies. Within the US, it strikes 266,000 annually and kills 40,000.However what causes it and the way can or not its handled?

Whats breast most cancers?

Breast most cancers develops from a cancerous cell which develops within the lining of a duct or lobule in one of many breasts.

When the breast most cancers has unfold into surrounding breast tissue its known as an invasive breast most cancers. Some individuals are identified with carcinoma in situ, the place no most cancers cells have grown past the duct or lobule.

Most circumstances develop in ladies over the age of 50 however youthful ladies are generally affected. Breast most cancers can develop in males although that is uncommon.

The cancerous cells are graded from stage one, which suggests a gradual progress, as much as stage 4, which is probably the most aggressive.

What causes breast most cancers?

A cancerous tumour begins from one irregular cell. The precise cause why a cell turns into cancerous is unclear. Its thought that one thing damages or alters sure genes within the cell. This makes the cell irregular and multiply uncontrolled.

Though breast most cancers can develop for no obvious cause, there are some threat elements that may improve the possibility of creating breast most cancers, similar to genetics.

What are the signs of breast most cancers?

The same old first symptom is a painless lump within the breast, though most breast lumps will not be cancerous and are fluid crammed cysts, that are benign.

The primary place that breast most cancers often spreads to is the lymph nodes within the armpit. If this happens youll develop a swelling or lump in an armpit.

How is breast most cancers identified?

In case you are confirmed to have breast most cancers, additional checks could also be wanted to evaluate if it has unfold. For instance, blood checks, an ultrasound scan of the liver or a chest x-ray.

How is breast most cancers handled?

Remedy choices which can be thought of embrace surgical procedure, chemotherapy, radiotherapy and hormone remedy. Typically a mix of two or extra of those remedies are used.

How profitable is remedy?

The outlook is greatest in those that are identified when the most cancers remains to be small, and has not unfold. Surgical removing of a tumour in an early stage might then give a superb likelihood of treatment.

The routine mammography provided to ladies between the ages of 50 and 70 imply extra breast cancers are being identified and handled at an early stage.

For extra data go to breastcancercare.org.uk or http://www.cancerhelp.org.uk

Read more from the original source:
Doctors who give advanced breast cancer patients an average survival time 'wrong 80% of the time' - Herald Publicist

Recommendation and review posted by Bethany Smith

Press release content from ACCESSWIRE. The AP news staff was not involved in its creation.

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CARLSBAD, CA / ACCESSWIRE / November 15, 2019 / International Stem Cell Corporation (OTCQB:ISCO) ( http://www.internationalstemcell.com ) (ISCO or the Company), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, today announced operating results for the three and nine months ended September 30, 2019.

As we mentioned before we completed the enrollment of the Phase I Parkinsons disease clinical trial and currently involved in reorganizing our revenue-generating subsidiaries. We expect that we will see positive results of this reorganization next year. - commented Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.

Year-to-Date Financial Highlights

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCOs core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology ( http://www.lifelinecelltech.com ), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: http://www.facebook.com/InternationalStemCellCorporation and http://www.twitter.com/intlstemcell

Safe Harbor Statement

Statements pertaining to anticipated developments, expected results of clinical studies, progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates,) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the companys business, particularly those mentioned in the cautionary statements found in the companys Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation and Subsidiaries Condensed Consolidated Balance Sheets (in thousands, except share data and par value) (Unaudited)

Assets

Cash

Accounts receivable, net

Inventory, net

Prepaid expenses and other current assets

Total current assets

Non-current inventory

Property and equipment, net

Intangible assets, net

Right-of-use assets

Deposits and other assets

Total assets

Liabilities, Redeemable Convertible Preferred Stock, and Stockholders' Equity (Deficit)

Accounts payable

Accrued liabilities

Operating lease liabilities, current

Related party payable

Advances

Warrant liability

Total current liabilities

Long-term deferred rent

Operating lease liabilities, net of current portion

Total liabilities

Commitments and Contingencies

Series D Redeemable Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and

outstanding, with liquidation preference of $4,300 at September 30, 2019

Stockholders' Equity (Deficit)

Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 250,000

issued and outstanding, with liquidation preferences of $423 and $411 at September 30, 2019 and

December 31, 2018

Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and

outstanding, with liquidation preference of $4,300 at December 31, 2018

Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and

outstanding, with liquidation preference of $5,000 at September 30, 2019 and December 31, 2018

Series I-1 Convertible Preferred stock, $0.001 par value, 2,000 shares authorized, 814 issued and

outstanding, with liquidation preferences of $814 at September 30, 2019 and December 31, 2018

Series I-2 Convertible Preferred stock, $0.001 par value, 4,310 shares authorized,

issued and outstanding with liquidation preference of $4,310 at September 30, 2019 and December 31, 2018

Common stock, $0.001 par value, 120,000,000 shares authorized, 7,533,083 and 6,933,861 shares

issued and outstanding at September 30, 2019 and December 31, 2018

Additional paid-in capital

Accumulated deficit

Total stockholders' equity (deficit)

Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)

International Stem Cell Corporation and Subsidiaries Condensed Consolidated Statements of Operations (in thousands, except per share data) (Unaudited)

Revenues

Product sales

Total revenues

Expenses

Cost of sales

Research and development

Selling and marketing

General and administrative

Total expenses

Loss from operations

Other income (expense)

Change in fair value of warrant liability

Interest expense

Miscellaneous income

Total other income (expense), net

Net income (loss)

Net income (loss) applicable to common stockholders

Net income (loss) per common share-basic

Net income (loss) per common share-diluted

Weighted average shares-basic

Weighted average shares-diluted

Contacts:

International Stem Cell Corporation

Russell A. Kern, PhD

Phone: 760-940-6383

Email:

SOURCE: International Stem Cell CORP

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International Stem Cell Corporation Announces Financial Results for the Three and Nine-Months ended September 30, 2019 - Associated Press

Recommendation and review posted by Bethany Smith

By Justin A. Varholick, Ph.D.

As we grow older theres an impending fear that we will slowly, but surely, begin to lose our vision. This slow loss of vision is clinically dubbed low vision and impacts more than 39 million Americans, costs $68 billion annually in direct health care costs, and is only growing in our population as baby boomers enter the at-risk age of 65 and older. Magnifiers can often be used to help people with acute issues of low vision, but are often inconvenient and frustrating. More serious issues of low vision such as cataracts, age-related macular degeneration, glaucoma, and diabetic retinopathy require advanced treatment and surgery. For example, cataracts can be improved or reversed by removing the cloudy lens and replacing it with an artificial one. Such surgeries are not always ideal, or convenient, and further contribute to the already hefty direct health care costs. But, a recent breakthrough by Japanese scientists, in correcting blurry vision, might reverse this bleak future.

Old cells can become new againOur story begins around the mid-20th century, in 1958. A young and aspiring scientist, named John Gurdon, was studying frogs at the University of Oxford in England. Not everyone thought Gurdon would end up actually becoming a scientist. In his early days his school master thought such a career was far-fetched for Gurdon. Indeed, he ranked last in his Biology class out of 250 students. Yet despite such poor grades, Gurdon found himself studying frogs at Oxford and earning a doctoral degree in Biology. And his studies would surprisingly lead to a breakthrough in vision, and likely many other issues in human health, like Parkinsons Disease, heart disease, and spinal cord injury.

At the time Gurdon was trying to test an age-old theory on cell development. Many scientists before him discovered that cells the smallest unit of life begin without a clear fate in the early stages of an embryo. Then as the cell develops, their fate becomes more clear. They become cells of the heart, of the brain, the kidneys, the stomach, the spinal cord, or the eyes. But they cannot go back to a time when they had no fate, or specialization. The cells can only develop in one direction, from no destiny, to a clear path, then to a mature adult cell; like one found in the heart. But you just cant take a heart cell and start the process over, maybe turning it into a brain cell.

In disagreement with this theory, Gurdon did a simple experiment. He knew that a tadpole has more adult cells than a frog egg. A tadpole has gills, a heart, eyes, etc., while a frog egg simply does not. So, he cut open the tadpole and removed a single cell from the intestine; an intestinal cell. He then cut open the intestinal cell and removed its nucleus; the seed of the cell carrying all the DNA. Very carefully, he did the same with the frog egg, and finally replaced the nucleus of the frog egg with the nucleus of the intestinal cell. According to the age-old theory, the intestinal nucleus should stop normal development of the frog egg. But thats not what happened.

Instead, the new frog egg continued to develop normally, becoming a tadpole that later became an adult frog. Gurdon thought this was unbelievably odd, and so did everyone else in science. After many more experiments doing the exact same procedure (i.e., replication), it seemed that what he saw was a real, replicable fact. For some reason the nucleus of the intestinal cell was able to reverse itself to have no fate and slowly develop into any other adult cell. The seed from the intestine somehow could become the seed of a heart, brain, kidney, or even an eye cell and of course, an intestinal cell too.

After many more experiments testing the same theory, on many more animals, it seemed the theory was true, but it just didnt work for mammals. Given that the same effect could not be repeated in a mammal, some believed this discovery did not apply to humans. But they were wrong.

The discovery of induced pluripotent stem cellsAlmost 45 years later, around the start of the millennium, Shinya Yamanaka and Kazutoshi Takahashi began running experiments that would translate Gurdons findings to humans. Born after Gurdons findings were already published and well known, Yamanaka and Takahashi grew up in a world in which the fact that old cells can become new again was widely knowna solid foundation for further hypotheses, experiments, and discovery. So, the scientists set out to do what no one had before: turn adult skin cells of mice into new cells without a clear fate.

Yamanaka, the lead investigator of the study, shared a similar early history with Gurdon. He first became a medical doctor in Japan but was frustrated by his inability to quickly remove small human tumors taking over an hour rather than the typical 10 minutes. Senior doctors gave him the nickname Jamanaka, a Japanese pun for the word jama meaning obstacle. He then found himself earning a PhD in pharmacology and becoming a post-doctoral scientist, but spent more time caring for mice than doing actual research. Frustrated again, his wife suggested he just become a practicing physician. Despite her advice, Yamanaka applied to become an Assistant Professor at Nara Institute of Science and Technology, in Japan, and won everyone over with his fantastical ideas of investigating embryonic stem cells; the cells without a clear fate.

Then the persistence paid off when Yamanaka with his assistant, Takahashi discovered how to induce adult skin cells from mice to return to an embryonic, or stem cell, state without a clear fate. They began their experiments knowing that gene transcription factors proteins that turn genes on and off were responsible for keeping embryonic cells in a state without a clear fate. They thought that by turning specific genes on and off with these factors, they could turn back time and make an adult cell embryonic again. So, they tried many different combinations of gene transcription factors and ultimately discovered that 4 specific ones were enough to induce an adult skin cell to a mouse to become an embryonic cell. Because these re-newed embryonic cells, or stem cells, originally came from adult cells they came up with a new name, induced pluripotent stem cell. Broken down, induced pluripotent stem cells means that the cell was induced to become pluripotent pluri meaning several, like plural, and potent meaning very powerful (and stem meaning to have the ability to turn into any cell in the body).

These induced pluripotent cells were thought to be very powerful indeed and scientists across the globe were excited by this great discovery. They had visions of taking a persons skin or blood, forming them into induced pluripotent cells, and then using them to grow a new liver or new parts of the brain. Laboratories across the world confirmed the results by repeating the experiment.

Human stem cells Just repeating the experiments in mice, or frogs, was not enough. They needed to begin making induced pluripotent stem cells from humans. Enter scientists from the University of Wisconsin-Madison. The lead scientist, James Thomson was already well known for deriving primate embryonic cells from rhesus monkeys in 1995 and the first human embryonic cell line in 1998. In fact, Thomsons accomplishment of isolating embryonic cells from monkeys was the first sound evidence that it was possible to do the same for humans. Such discoveries placed him on the forefront in ethical considerations for research using human embryos and the most obvious scientist to lead the path toward making induced pluripotent stem cells from humans.

Thomsons team made the first human derived induced pluripotent stem cells from adult skin, with Yamanaka as a co-scientist. They followed the same general principles set by Yamanaka, who did the procedure with mouse skin cells. Importantly to Thomson, this discovery helped to relieve some ethical controversy with using human embryos to make human stem cells. By being able to induce adult human skin to become pluripotent stem cells, much research on human stem cells could be done without human embryos albeit research with human embryos remains necessary.

Yet more important to the discussion at hand, the ability to induce human skin to become pluripotent stem cells placed us on the edge of a breakthrough. With some clinical trials in humans, the fantasy of growing a new liver, heart, or eye was more a reality than ever before.

The start of human trials In 2012, around the time both Gurdon and Yamanaka were presented with the Nobel Prize in Physiology and Medicine for their work leading to induced pluripotent stem cells, human clinical trials were beginning in Japan. The first clinical trial was for age-related macular degeneration, an eye condition leading to blindness. Unfortunately, this trial was quickly terminated when Yamanaka and his team identified small gene mutations in the transplanted induced pluripotent stem cells from the first patient. Although the procedure did cure the patient of macular degeneration, these small gene mutations worried the scientists because they could lead to tumor development.

But recently with the introduction of an inducible suicide gene that can signal cells with abnormal growth to die, human trials are starting up again. In October of 2018, Japanese scientists began trials with Parkinsons disease, a brain disease related to a shortage of neurons producing dopamine. Scientists took cells from the patients, made them into induced pluripotent stem cells, guided them to develop into dopamine producing cells, and then deposited them in the dopamine centers of the brain through surgery. The outcome is promising since similar procedures in monkeys have been successful.

Other trials in Japan have also started, including spinal cord injury and one for replacing the cornea of the eye. Early results replacing damaged corneas with induced pluripotent stem cells, thereby correcting blurry vision, were just announced at the end of August. Although it will take more patients and safety checks before all humans can get induced pluripotent cells to correct their damaged eyes, malfunctioning brains, or broken spinal cords, Takahashi the post-doctoral scientist working with Yamanaka thinks it might happen as early as 2023. So, it looks like that in our lifetime we just might be able to stay young and enjoy retirement because of great breakthroughs in animal research.Note, EuroStemCell is a great resource for learning more about the ethics and research currently being done with stem cells derived from human embryos.

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BREAKTHROUGH: Her vision was getting worse, then animal research made things clear - Speaking of Research

Recommendation and review posted by Bethany Smith

Wound healing is complex. Injured tissues undergo a multi-phase process from hemostasis to tissue remodeling. And defensin plays a role.

Basically, it's your natural mechanism for healing a wound, and it stimulates a specific stem cell, the LGR6+ stem cell, according to Greg Keller, M.D., who presented Clinical Data with Defensins at the Global Aesthetic Conference in Miami earlier this month.

After activation, LGR6+ stem cells physically migrate into the basal layer of the skin and create a new epidermis, and eventually, new, younger-acting skin, says Dr. Keller.

In her Cosmeceutical Critique of The role of defensins in treating skin aging, Leslie Baumann, M.D., writes, LGR6+ stem cells, which are dormant until they are activated to respond to damage, are stimulated by defensins.1

She effectively summarizes their role in anti-aging as:

Old fibroblast and keratinocytes are sluggish and lazy. Old cells do not hear signals as well as younger cells. LGR6+ stem cells repopulate the epidermis with new, young keratinocytes. Defensin stimulates LGR6+ stem cells. The defensin/LGR6+ pathway plays a role in keratinization. Using topical defensin can improve the skins appearance.

Theoretically, says Dr. Keller, hair follicles provide a way for defensins to enter the skin to activate the LGR6+ pathway, but We wanted to actually measure wrinkles and quantify how much better the skin was in terms of pore size, oiliness, wrinkles, and the like.

So he, Amy Taub, M.D., Vivian Bucay, M.D., Jay Williams, Ph.D, and Darius Mehregan, M.D., conducted a participant- and investigator-blinded, placebo-controlled, multi-center study with the defensin-containing DefenAge 3-step system (Progenitor Biologics) that includes the 2-Minute Reveal Masque, 24/7 Barrier Balance Cream and 8-in-1 BioSerum, on 44 women, 41-71 years of age with skin types I to V.2

References:

1. Taub A, Bucay V, Keller G, Williams J, Mehregan D. Multi-Center, Double-Blind, Vehicle-Controlled Clinical Trial of an Alpha and Beta Defensin-Containing Anti-Aging Skin Care Regimen With Clinical, Histopathologic, Immunohistochemical, Photographic, and Ultrasound Evaluation. J Drugs Dermatol. 2018;17(4):426-441.2. Bauman L. The role of defensins in treating skin aging. Cosmeceutical Critique. MDedge Dermatology. April 1, 2018. Accessed November 13, 2019. Available at: https://www.mdedge.com/dermatology/article/161149/aesthetic-dermatology/...

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Defensins and the dermis - Dermatology Times

Recommendation and review posted by Bethany Smith

1 Shiseido believes Drunk Elephant has only just scratched the surface of its potential

Japanese beauty conglomerate Shiseido is looking to accelerate US-based Drunk Elephants global footprint to maximise the brands opportunities for growth and development.

Shiseido reportedly beat out competitors such as the Estee Lauder Companies and Unilever to buy the clean beauty for $845m. This deal is expected to close by the end of this year.

Drunk Elephant founder Tiffany Masterson will continue in her role as Chief Creative Officer and assume the additional role of President, reporting directly to Marc Rey, CEO of Shiseido Americas and Chief Growth Officer of Shiseido.

This deal marks another large skin care acquisition this year, including LOccitane Groups $900m purchase of ELEMIS and Unilevers $500m deal for Tatcha.

Shiseido sees great value in Drunk Elephant and is well placed to continue to cultivate the brand growth under the Shiseido umbrella. The potential [of the brand] has only just been scratched, a spokesperson from Shiseido told CosmeticsDesign-Asia.

The head of Natura International has revealed the company plans to begin its international expansion with South East Asia as its starting point.

In September, the Brazilian company announced plans to form a new subsidiary in Singapore to manage its brands Aesop and The Body Shop.

This region is very important for us, not just for growth but also to help us learn more about consumers that are becoming more and more sophisticated. Singapore is a very important hub for this region. Not only does it connect nearby countries, it also is a place to create brand awareness for the region, said Daniel Silveira, head of Natura International.

Silveira told CosmeticsDesign-Asia that the company had ambitious goal of expanding into around 70 markets worldwide in the next 10 years and SEA was crucial to its plans.

This month, the firm launched its Natura brand in Malaysia, further strengthening its ties to the region.

The research arm of LVMH is collaborating with the Centre for iPS Cell Research and Application of Kyoto University (CiRA) to study the mechanism of skin metabolism for Parfums Christian Dior.

The aim of the joint project is to explore how oxidative metabolism affects skin keratinocyte self-renewal or differentiation capabilities.

The effects of age on mitochondrial status, skin regeneration and differentiation will be investigated with the hope of contributing to major therapeutic discoveries in the skin and cutaneous rejuvenation, said CiRA in a press statement.

Under the direction of Nobel Prize laureate Shinya Yamanaka, CiRA is a leading centre for induced pluripotent stem cell research.

According to CiRA, iPS cells are cells generated by introducing a small number of factors into body cells such as skin cells and blood cells.

Shiseido has found that yeast extract has the potential to keep skin capillaries healthy, which in turn boost collagen production and maintains skin elasticity.

The firms research team discovered this through its study of capillaries and its relation to skin elasticity.

This research was first presented at the International Federation of Societies of Cosmetic Chemists Conference 2019 in Milan where it won the top award in the Podium Presentation category.

Using the companys original 3D visualisation technology, researchers studied subjects aged around 20 and 60.

Subjects in the 20s with high elasticity in their skin were found to have thick and dense structure of capillaries as compared to older subjects.

Japanese cosmetics company Kao Corporation is looking to strengthen its global brand presence with the launch of the Curl skin care range in the UK and US.

The brand is part of the groups 11 strategic global brands of its G11 cosmetics portfolio. As such, it is crucial to the companys strategy to strengthen its presence in the global cosmetics market.

Hiwako Yoshino, a spokesperson for the company, told CosmeticsDesign-Asia that Curls entry into the UK is a starting point for a European expansion.

Kao plans to accelerate the growth of G11 in Asia and the European market, which continues to grow and have high cosmetic sensitivity. Curl, one of the G11, is following the strategy and starting the business in the UK as the beginning for Europe, said Yoshino.

Back in July, the firms cosmetics business reported mid-single digit growth in the first half of the year, largely due to the popularity of the prestige brand, Sensai.

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Brand story: Our top stories on the biggest beauty brands in APAC - CosmeticsDesign-Asia.com

Recommendation and review posted by Bethany Smith

Calling all carnivores: ever thought about getting a meat printer? Of hand-crafting delectable beef steaks at home from plant proteins, that have the same texture, appearance, and flavor as real meat, only without the distasteful killing part?

3D-printed steaks and chicken could be on the menu in European restaurants as early as 2020, with home-spun meat printers available to the consumer within a few more years. Israel-based Redefine Meat is already using advanced food formulations along with proprietary 3D printing technology to make what it calls the holy grail of alt-meat,reports Tech Radar Pro.

The idea sounds absurd, but its not so far-fetched, as three-dimensional printing technology goes in directions no-one could dream of, prior to the launch of 3D printing in the 1980s.

Uses

Put simply, 3D printing is a progression of 2D printing, where a third dimension is added to the printing of images on a flat surface (a regular ink-jet printer), adding depth and allowing the printer cartridge to move in all directions. A digital file is first created using modeling software, then sent to the printer, depositing layers of the chosen material - often plastic or wax - to build up the final product. Other printing materials include plastics, powders, filaments, paper, and even human or animal cells - used in the cutting-edge new field of bioprinting.

3D printing is also referred to as additive manufacturing because objects are made by injection-molding them to the desired size and shape, versus traditional manufacturing which invariably entails loading material into a machine to be cut to the required dimensions. With additive manufacturing, material is added, layer upon layer, without creating waste/ scrap.

3D Printer employs agood analogy for 3D printing, describing the process as similar to baking a multi-layered cake:

3D printers use a variety of very different types of additive manufacturing technologies, but they all share one core thing in common: they create athree dimensionalobject by building it layer by successive layer, until the entire object is complete. Its much like printing in two dimensions on a sheet of paper, but with an added third dimension: UP. The Z-axis.

Each of these printed layers is athinly-sliced, horizontal cross-section of the eventual object. Imagine a multi-layer cake, with the baker laying down each layer one at a time until the entire cake is formed. 3D printing is somewhat similar, but just a bit more precise than 3D baking.

Formerly known as stereolithography, 3D printing was invented in 1983 by Chuck Hull, co-founder of 3D Systems. Frustrated by how long it took to make small, custom parts, Hull suggested using his furniture companys UV lamps to create parts by curing photosensitive resin, layer by layer. Calling the technology stereolithography, Hull applied for a patent and was issued one in 1986.

Two years later, start-up 3D Systems manufactured the first 3D printer, the SLA-1.

It took over 30 years for the technology to become mainstream, but now 3D printing can be done by anyone with access to a base-model 3D printer, which can be purchased for under $500.

Among the more interesting items that have been 3D-printed are prosthetic limbs, fabricated firearms, electrical vehicles, steel parts (Caterpillar introduced thefirst 3D-printed excavatorin 2017), quick-build homes, parts for combat aircraft, spacecraft, and even decorative chocolates.

Relativity Space is 3D-printing rockets at its Los Angeles headquarters.

According to Wired,youll find four of the largest metal 3D printers in the world, churning out rocket parts day and night. The latest model of the companys proprietary printer, dubbed Stargate, stands 30 feet tall and has two massive robotic arms that protrude like tentacles from the machine. The Stargate printers will manufacture about 95 percent, by mass, of Relativitys first rocket, named Terran-1. The only parts that wont be printed are the electronics, cables, and a handful of moving parts and rubber gaskets.

Z-Morph Bloglists five more really cool, recently-printed 3D-printed objects:

Methods

From its mid-80s beginning, a number of 3D printing technologies have emerged.

The first, known asStereolithography (SLA), concentrates a beam of ultraviolet light onto the surface of a vat filled with liquid photocurable resin. The laser beam draws out the 3D model one layer at a time, with each slice hardening as the light hits the resin. The solidified structure is gradually dragged up by a lifting platform, while the laser continues to form a different pattern for each layer to create the desired shape of the object.

Digital Light Processing (DLP)is similar toStereolithography, butuses more conventional light sources. A liquid crystal display allows for a large amount of light to be projected onto the surface of the object being printed, and for the resin to harden quickly.

Fused Deposition Modeling (FDM)was invented in the late 1980s. The object is made by extruding a stream of melted thermoplastic material to form layers. The layers harden and fuse together almost immediately after leaving the extrusion nozzle.

InSelective Layer Sintering (SLS), powdered materials instead of liquid photopolymer is drawn from the vat, including polystyrene, ceramics, glass, nylon and metals such as steel, titanium, aluminum and silver. A layer of powdered material is placed on top of the previous layer using a roller and then the powdered material is fused or sintered according to a certain pattern.

PolyJetphotopolymershoots out a photopolymer liquid, similarly to an ink-jet printer, which is hardened with a UV light. This technology acquired by Stratasys allows for various materials and colors to be incorporated into single prints, and at high resolutions.

WithSyringe Extrusion, virtually any material with a creamy viscosity such as clay, cement or silicone, can be 3D-printed using syringe extruders. The syringe is heated or not heated, depending on the material.

Other variants of these technologies includeSelective Laser Melting (SLM),Electron Beam Melting (EBM)which uses an electron beam instead of a laser, andLaminated Object Manufacturing (LOM), where layers of paper, plastic or metal, coated with adhesive, are successively glued together and cut to shape.

Market

Sales related to 3D printing, including printers, materials and services, will move past $US2.7 billion in 2019 and hit $3 billion in 2020according to Deloitte Global, with a CAGR of 12.5%. Comparing that to the $12 trillion in global manufacturing revenues indicates the amount of growth potential in 3D printing and bioprinting.

The consulting firm explains that companies across multiple industries are increasingly using 3D printing for more than just rapid prototyping:

3D printers todayare capable of printinga greater variety of materials (which mainly means more metal printing and less plastic printing, although plastic will likely still predominate); they print objects faster than they used to, and they can print larger objects (build volume). A steady stream of new entrants is expanding the market. 3D printing is considered an essential ingredient in Industry 4.0, the marriage of advanced production and operations techniques with smart digital technologies that is being heralded as the Fourth Industrial Revolution.

Deloitte notes the number of materials used in 3D printing has more than doubled from five years ago, with mixed-material printers becoming more common. 3D printers are also about twice as fast in 2019 as they were in 2014.

It says the biggest shift is from plastic to metal printing: Plastic is fine for prototypes and certain final parts, but the trillion-dollar metal-parts fabrication market is the more important market for 3D printers to address. Plastics share of the 3D printing industry fell from 88 to 65% in 2017-18, and metal rose from 28 to 36%.

A recent technology called binder jet metal printing could halve the time required to produce each part, compared to the relatively slow and expensive selective laser sintering (SLS) method, states Deloitte.

Size capabilities are improving too. A few yearsagoa high-end metal printer could only build an object 10x10x10 cm or one cubic liter. In 2019 metal printers with the capacity to print 30x30x30 cm are available.

Companies

As 3D printing technology continues to advance, more and more companies are forming, eager to get in on the action. Three of the largest are Stratasys, 3D Systems and Proto Labs; these companies offer 3D printers and services to help manufacturers move prototypes into production.

Based in Minnesota,Stratasyshas over 600 granted or pending additive manufacturing patents, including for the FDM,Polyjetand WDM 3D printing technologies. Among the sectors Stratasys serves are healthcare, aerospace, automotive and education. The companyssubsidiaries include MakerBot,GrabCAD,RedEyeOnDemand and Solid Concepts.

Asmentioned3D Systemswas first out of the gate with a 3D printer, back in 1988. Along with pioneering stereolithography, 3D Systems has also developed selective laser sintering, multi-jet printing, film-transfer imaging, color jet printing, direct metal printing, and plastic jet printing. Divided into three business units - products, materials and services - 3D Systems offers small desk-top printers, metal printers and commercial printers that print in plastics and other materials.

Also headquartered in Minnesota isProto Labs, established in 1999. Building on automated solutions to develop plastic and metal parts used in manufacturing, in 2014 Proto Labs launched an industrial-grade 3D printing service, enabling software developers and engineers to quickly move prototypes into production. The company acquired Rapid Manufacturing in 2017 to further its efforts in sheet metal fabrication. It currently has 2,300 employees in 12 manufacturing hubs.

3D bioprinting - the next big thing in medical investing

According to the United Network for Organ Sharing, every day 21 people in the United States die waiting for an organ, and over 120,000 people are on organ transplant waiting lists.

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The situation is worse in Canada. While Spain has 43 donors per million people, the US has 26, Britain has 21, and Canada has just 20. Out of 4,500 Canadians waiting for an organ, about 260 will die each year, according toThe Organ Project. Thats five deaths per week.

Imagine if, instead of waiting for an organ from another person - possibly a relative but likely a stranger - you could walk into a doctors office and have one manufactured, with your cells. It sounds far-fetched, but the technology now exists for the tailor-made transplantation of organs through brand-new medicine called 3D bioprinting.

What is 3D bioprinting?

3D printing is a progression of 2D printing, where a third dimension is added to the printing of images on a flat surface (a regular ink-jet printer), adding depth and allowing the printer cartridge to move in all directions. A digital file is first created using modeling software, then sent to the printer, depositing layers of the chosen material - often plastic or wax - to build up the final product.

Among the more interesting items that have been 3D-printed are prosthetic limbs, fabricated firearms, electrical vehicles, steel parts (Caterpillar introduced thefirst 3D-printed excavatorin 2017), quick-build homes, parts for combat aircraft and spacecraft, and even decorative chocolates.

Bioprinting operates on the same principle as regular 3D printing but instead of plastic, wax or other matter, bioprinters deposit layers of living cells to build structures like blood vessels or skin tissue. The cells are taken from an animal or a human being and cultivated until there are enough to create bio-ink which is then loaded into the printer using mechanical syringes. Adult stem cells can also be utilized.

Key to the process is a dissolvable gel which acts as a kind of incubator for the cells to multiply - like an embryo growing in a womb. Researchers may also plant cells around 3D scaffolds made of biodegradable polymers or collagen, allowing them to develop into functional tissue. The cells use their inherent properties to seek out similar cells to join with. Researchersare able tocontrol the shape into which the cells form, and the printer builds the final structure.

After the tissues are fully grown and shaped, they are placed into a recipients body. The hope is that the 3D-printed object becomes as much a part of the patients body as the cells he or she was born with.

There are currently five common methods of 3D bioprinting:

- Inkjet bioprinting: Droplets of bio-ink are deposited, layer by layer, onto a culture plate. Cells that can help fight breast cancer have been successful printed using inkjet bioprinting.

- Extrusion bioprinting: Polymer or hydrogel is loaded in syringes and dispensed via pneumatic- or screw-driven force, onto a building platform. The motion is controlled by a computer. Extrusion bioprinting offers lower resolution than inkjet bioprinting but the fabrication speed is considerably higher, allowinganatomically-shapedobjects to be generated.

- Laser-assisted bioprinting: A laser is used to deposit the biomaterials into a receptor via a tape covered with biological material. The laser irradiates the tape, causing the biological material to evaporate and reach the receptor in the form of droplets. The droplets contain a biopolymer that acts as an adhesive to help the cells to grow. This high-resolution bioprinting method is being used in a partnership between French bioprinting companyPoietisand LOral to recreate a hair follicle that could lead to a cure for baldness.

- Stereolithography: Stereolithographic bioprinting uses a digital micro-mirror to direct ultraviolet light onto the printing surface. Light directed by the micro-mirrors triggers the formation of molecular bonds, which cause light-sensitive hydrogels to form into solid material.

- Bioprinting with acoustic waves: Using a device that allows cells to be manipulated with acoustic waves, researchers can manipulate where the waves will meet along three axes. The waves then form a trap that captures the cells, which are collected to create 3D patterns.

How far has it progressed?

Some of the most advanced work on bioprinting has been done at the Wake Forest Institute for Regenerative Medicine in California. One of the first major structures that Wake Forestbioprintedwas a human bladder. Made from cells extracted from a patient with a poor-functioning bladder, the 3D-printed bladder was successfully transplanted. The project built on custom-grown bladders that had previously been transplanted into seven patients suffering from spina bifida, a birth defect that affects the spinal cord.

Wake Forest staffers have also created an outer human ear, and implantedbioprintedskin, bone and muscle on laboratory animals that successfully grew into surrounding tissue.

The institutes director, AnthonyAtala, sees bioprinting astotalytransforming the relationship between the transplant patient and doctor, in much the same way that Dell changed the way consumers interacted with the computer company that sold PCs tailored to each customers unique needs. Patients could order replacement parts in much the same way they might order a new clutch for their Mazda.

Youd have companies that exist to process cells, create constructs, tissue. Your surgeon might take a CT scan and a tissue sample and ship it to that company,Atalasaid in afeature article on bioprinting in Smithsonian Magazine.

The company would then ship the organ back a week or so later, ready for implantation. Welcome to the new world of regenerative medicine: the plug and play human body.

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Atalasaid the technology is developing to the point where researchers are almost able to replicate simple organs like the outer ear and the trachea (windpipe). Importantly, there are no real surgical challenges, he told Smithsonian.

Challenges

The holy grail of 3D bioprinting would be to come up with a viable kidney for transplant. ProfessorAtala, of the Wake Forest Institute, created the first small-scalebioprintedkidney in 2002. However,Atalais the first to admit that his machine-produced kidney is nowhere near at the level it needs to be for a human transplant. A TED TalkAtalagave in 2011 about bioprinting, which culminated with a dramatic display of an object - really an over-sized bean - became controversial when the press gotaholdof it and printed enthusiastic, but wrong, stories about the technology eliminating the need for a kidney transplant.

Another potential roadblock is the cost. No-one yet knows what it would cost tobioprintand transplant a human organ on demand, and how accessible the procedure would be to the masses of patients requiring a transplant. And while there have been successful bioprinted organ transplants, there havent been enough to determine how well the human body will accept the new tissue or artificial organ.

Finally, one shouldnt underestimate the complexity and level of difficulty involved. Aspharmaforumpoints out, A complex network of cells, tissues, nerves and structures in a human organ need to be correctly positioned with a highest precision for it to function properly. From arranging the thousands of tiny capillaries in a liver, to printing a heart that beats, it is a long, difficult process.

Skin

Wake Forest is working on a skin-cell printer capable of printing live skin cells directly onto a burn wound. The procedure could replace skin-grafting, a procedure where healthy skin is harvested from an unburnt part of a patients body. Skin grafting can be hard to heal from, and in severe burn cases, there isnt enough healthy skin left to use.

This new printing technique only needs a patch of skin 10% the size of the burn, that is used to grow enough cells for 3D printing. The wound is then scanned for size and depth, information which the printer uses to print skin cells at the proper depths to cover the wound.

In 2017 scientists in Madrid created a prototype of a 3D bioprinter that can create functional human skin. The printer is adequate for transplanting skin and for testing cosmetic, chemical and pharmaceutical products,ScienceDaily reported.

Hearts

At the Texas Heart Institute in Houston, researchers are working with decelluarized pig hearts. The organs have been stripped of muscle and other living tissue, but the original architecture is intact. The idea is to use decelluarized pig hearts, repopulated with bioprinted human cells, for implantation into humans. Sofarthe institute has succeeded in injecting pig hearts with living bovine cells, then inserted them into cows where they worked successfully next to a cows heart.

Already, patients with a defective heart valve can have a pigs valve or a mechanical valve implanted. Doris Taylor, director of the institutes regenerative medicine research program, says thedecelluarizedmethod gets around the tricky process of printing at the extremely high resolution required for highly vascularized (containing many blood vessels) organs like the heart.

The tech is going to have to improve a great deal before were able tobioprinta kidney or a heart, and get blood to it, and keep it alive, Taylor told Smithsonian.

More recent developments though are moving in that direction. In 2016 Harvard researchers 3D-printed the first heart-on-a-chip. The tiny device contains living human heart cells that mimic the hearts functions.

In 2018, 3D printingstartupBioLife4D successfully produced human tissue in the form of a cardiac patch - derived from a patients white blood cells with multiple cell types contained in the human heart.According to pharmaforum, its another step towards bioprinting major organs for transplant.

Scientists at the American Friends of Tel Aviv University havereportedly 3D-printed a fully-vascularized heartusing fat cells from a donor. The fat cells were partially cultured and re-programmed into heart cells. This early-stage technology has only been able to print a heart the size of a rabbits, but researchers hope to test the printed hearts in other animals.

Ovaries

Northwestern University in Illinois debuted a 3D-printed ovary using the acoustic waves method described above, and in Sweden, researchers have successfully created human cartilage tissue, also using acoustic waves.

Thyroids

Russian scientists aboard the International Space Stationsuccessful bioprinted the first organ in space: a mouses thyroid. Spaces zero-gravity environment enables organs and tissues to mature faster than on Earth.

Bones/ cartilage

A team from the UKs Swansea University has apparently developed a bioprinting process that uses regenerative material to create an artificial bone matrix. The technology could replace bone grafting, a surgical procedure that replaces missing or damaged bones with synthetic materials. Unlike bone grafting, which doesnt allow new bone tissues to form, thus limiting mechanical integrity, 3D-printed bones are capable of fusing with, and even replacing over time, a patients natural bones.

Cartilage printing could revolutionize joint care through a hand-held cartilage printing device calledBioPen. Built by Australian researchers, theBioPencontains stem cells derived from a patients fat, which create custom scaffolds of living material into failing joints much like 3D-printed bones. So farBioPenhas only been tested on sheep but developers plan to accelerate it to regenerate functional human cartilage.

Corneas

Finally, a group of researchers in South Korea has 3D-printed prototype corneas fromdecelluarizedcorneal stroma and stem cells. Unlike artificial corneas currently available, made of substances like synthetic polymer which resist incorporation into the eye, printed corneas are made to mimic the material within natural corneas. The invention could replace the need for donors and synthetic corneas in cataract surgery and other sight complications.

Investment opportunity

3D bioprinting has come a long way since ProfessorAtalasfirst artificial bladder in 2002. At Ahead of the Herd, we think it is the next big thing in regenerative medicine. Science always starts out with experimentation, sometimes many years of it, before the technologies are commercialized. We want our subscribers to bewell awareof 3D bioprintings potential, putting them in a position to get in early to companies that are offeringbioprintedproducts.

While there are currently a handful of bioprinting firms, we see an entire ecosystem of small firms developing, with each focusing on a different aspect, technology or part of the body. It will not take 10 years for start-up pub-cos to IPO, seeking money to develop their technologies.

Currently valued at USD$685 million, within the next six years,the global bioprinting market is expected to expand by a CAGR of 26.2%, reaching $4.4 billion by 2026. The United States and Canada are the industry leaders, making bioprinting an ideal new sector for North America-focused investors.

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