Page 29«..1020..28293031..»

Archive for the ‘Regenerative Medicine’ Category

Bioheart and Ageless Regenerative Partner to Advance Stem Cell Field With New Laboratory Training Program on June 23 …

SUNRISE, Fla., May 29, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (OTCBB:BHRT.OB - News) announced today that it will offer another laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine, on Saturday/Sunday June 23-24, 2012. Attendees will participate in hands on, in depth training in laboratory practices in stem cell science at Bioheart, Inc.'s corporate headquarters and clean room in Sunrise, Florida. The course was designed for Laboratory technicians, Students, Physicians and Physician Assistants.

"Attendees will graduate from this one-of-a-kind course with an extensive understanding of stem cell science laboratory practices," said Kristin Comella, Chief Scientific Officer, Bioheart, Inc. "Previous attendees described the course as incredibly well orchestrated providing comprehensive know how for laboratory start up."

An emerging field with tremendous opportunities, adult stem cell research has been shown to regenerate and repair injured or diseased structures via the release of bioactive tissue growth factors and cytokines. This is the second time that The Ageless Regenerative Institute has partnered with Bioheart, Inc. to provide hands-on training in a stem cell laboratory. This course provides instruction regarding how to grow stem cells and perform quality control testing in an actual cGMP facility following FDA regulations.

The course goals and objectives include reviewing stem cell types and characteristics; learning cell culture including plating, trypsinization and harvesting, and cryopreservation; learning quality control tests including cell count, viability, flow cytometry, endotoxin, mycoplasma, sterility; and learning and performing cGMP functions including clean room maintenance, gowning and environmental monitoring.

For information on costs and to register, visit http://www.agelessregen.com or email: info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Visit link:
Bioheart and Ageless Regenerative Partner to Advance Stem Cell Field With New Laboratory Training Program on June 23 ...

Fat-Derived Stem Cells Show Promise for Regenerative Medicine, Says Review in Plastic and Reconstructive Surgery(r)

But Reviewers Urge Caution in Development and Clinical Use of Adipose Stem Cells

Newswise Philadelphia, Pa. (May 29, 2012) Adipose stem cells (ASCs)stem cells derived from fatare a promising source of cells for use in plastic surgery and regenerative medicine, according to a special review in the June issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

But much more research is needed to establish the safety and effectiveness of any type of ASC therapy in human patients, according to the article by Dr. Rod Rohrich of University of Texas Southwestern Medical Center, Dallas, and colleagues. Dr. Rohrich is Editor-in-Chief of Plastic and Reconstructive Surgery.

Adipose Stem CellsExciting Possibilities, but Proceed with Caution The authors present an up-to-date review of research on the science and clinical uses of ASCs. Relatively easily derived from human fat, ASCs are "multipotent" cells that can be induced to develop into other kinds of cellsnot only fat cells, but also bone, cartilage and muscle cells.

Adipose stem cells promote the development of new blood vessels (angiogenesis) and seem to represent an "immune privileged" set of cells that blocks inflammation. "Clinicians and patients alike have high expectations that ASCs may well be the answer to curing many recalcitrant diseases or to reconstruct anatomical defects," according to Dr. Rohrich and coauthors.

However, even as the number of studies using ASCs increases, there is continued concern about their "true clinical potential." The reviewers write, "For example, there are questions related to isolation and purification of ASCs, their effect on tumor growth, and the enforcement of FDA regulations."

Dr. Rohrich and coauthors performed an in-depth review to identify all known clinical trials of ASCs. So far, most studies have been performed in Europe and Korea; reflecting stringent FDA regulations, only three ASC studies have been performed in the United States to date.

Many Different Uses, But Little Experience So Far Most ASC clinical trials to date have been performed in plastic surgerya field with "unique privileged access to adipose tissues." Plastic surgeon-researchers have used ASCs for several types of soft tissue augmentation, such as breast augmentation (including after implant removal) and regeneration of fat in patients with abnormal fat loss (lipodystrophy). Studies exploring the use of ASCs to promote healing of difficult wounds have been reported as well. They have also been used as a method of soft tissue engineering or tissue regeneration, with inconclusive results.

In other specialties, ASCs have been studied for use in treating certain blood and immunologic disorders, heart and vascular problems, and fistulas. Some studies have explored the use of ASCs for generating new bone for use in reconstructive surgery. A few studies have reported promising preliminary results in the treatment of diabetes, multiple sclerosis, and spinal cord injury. No serious adverse events related to ASCs were reported in either group of studies.

Although many of the results are encouraging, the reviewers emphasize that all of these applications are in their infancy. Around the world, for all uses, less than 300 patients have been treatedwith no standard protocol for the preparation or clinical applications of ASCs.

See the original post:
Fat-Derived Stem Cells Show Promise for Regenerative Medicine, Says Review in Plastic and Reconstructive Surgery(r)

Princess opens stem cell centre

28 May 2012 Last updated at 09:14 ET

A 54m cutting-edge stem cell research centre in Edinburgh has been officially opened by the Princess Royal.

The Royal opened the Scottish Centre for Regenerative Medicine as well as the 24m bio-incubator facility, Nine, in the Edinburgh BioQuarter.

Research into conditions such as multiple sclerosis and heart and liver disease will benefit from the new facilities in Little France.

The Princess Royal unveiled plaques at the centres.

Edinburgh University's Scottish Centre for Regenerative Medicine is the first large-scale, purpose-built facility of its kind and provides accommodation for up to 250 stem cell scientists.

The centre, funded by Edinburgh University, Scottish Enterprise, the Medical Research Council (MRC) and the British Heart Foundation through its Mending Broken Hearts Appeal, is being opened by the Princess Royal in her role as Chancellor of Edinburgh University.

It includes the most up-to-date facilities in the UK, which meet the highest guidelines, to manufacture stem cell lines that could be used for patient therapies.

Nine, which has been jointly funded by Scottish Enterprise and the UK government's department for business, innovation and skills, has 85,000 sq ft of laboratory and office space for both established biotechnology companies and start-up ventures.

The Edinburgh BioQuarter is in the city's Little France area and includes the Royal Infirmary of Edinburgh and Edinburgh University's Queen's Medical Research Institute and Chancellor's Building.

Continue reading here:
Princess opens stem cell centre

Muscle Atrophy, a Major Problem with Arthritis, is Now being Treated at The Center for Regenerative Medicine

Miami, FL (PRWEB) May 26, 2012

Muscle atrophy a major problem with arthritis, could be treated with regenerative medicine, according to A.J. Farshchian MD from the Center for Regenerative Medicine.

Muscle atrophy also known as Muscle wasting Is common in arthritis and is usually due to loss of muscle tissue which could be caused by disease or lack of use. Mostly it is caused from disuse. Some of the other causes of atrophy are: diabetes (diabetic neuropathy) burns poliomyelitis amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) Guillain-Barre syndrome muscular dystrophy myotonia congenita myotonic dystrophy some atrophy that occurs normally with aging cerebrovascular accident (stroke) spinal cord injury peripheral nerve injury (peripheral neuropathy) prolonged immobilization rheumatoid arthritis prolonged corticosteroid therapy

The Center for Regenerative Medicine in Miami, Florida concentrates on helping arthritic and injured people to get back to a functional level of life and their activities using non-surgical techniques and Orthopedic medicine. The center's expertise is in treatment of conditions of spine, knees, shoulders and other cartilage damages. We have developed non-surgical and rehabilitation techniques focused on treatment and management of joint pain. Our team includes health professionals organized around a central theme:

See more here:
Muscle Atrophy, a Major Problem with Arthritis, is Now being Treated at The Center for Regenerative Medicine

Can regenerative medicine firm TNGN conjure a Medtronic partnership?

Regenerative medicine company Tengion (NASDAQ:TNGN) has always planned to take its novel tissue generating technology as far as early-stage clinical studies before finding a partner to finance later-stage work.

The companys lead program treating patients who have had their bladder removed is expected to finish phase 1 enrollment by years end. A preclinical kidney program could start human studies next year. CEO John Miclot said his goal is to adhere to those timelines. But therein lies the problem. When Tengion released first quarter financial results, the company said it has $7.3 million in cash left enough to last until September.

Tengions programs are still early stage. But apparently theyre far enough along to catch interest. In further discussing the companys financials, Miclot dropped a hint: We are also actively engaged in discussions with potential strategic partners for both of our leading programs, he said.

The Nasdaq gave Tengion a different warning last week. The exchange said Tengion does not meet the minimum shareholders equity requirement, a measure of the equity stake a companys shareholders have in a company. Tengion has until June 29 to submit a plan to regain compliance with that requirement or face delisting. If the plan is accepted, Tengion would have 180 days from the May 15 notification to regain compliance.

Tengions technology is based on research licensed from Wake Forest Universitys Institute for Regenerative Medicine and the company has made steady scientific progress despite the financial challenges. Tengions Neo-Urinary Conduit program is intended to help bladder cancer patients who have had their bladders removed. Tengion is using its technology to fashion a new conduit to carry urine from the body. Tengions preclinical Neo-Kidney Augment program, intended to help patients who have advanced chronic kidney disease, is moving toward human studies. Miclot said the goal is to file an investigational new drug application with the U.S. Food and Drug Administration in the first half of 2013 with proof of concept data from a phase 1 study expected in 2014.

If the timeline sounds aggressive, it could be because regulators are more comfortable with Tengions technology. Chief Scientific Officer Tim Bertram said on the call that the FDA has reviewed Tengions pre-clinical data from animal studies. The company had run studies on pharmacology work in animals for up to one year. The FDA is now asking the company to do studies in half that time. It illustrates to us their confidence in our work and allows us to proceed quite quickly into humans, Bertram said.

But meeting those timelines will require new financing. If Miclot is talking to potential partners, Medtronic (NYSE:MDT) must be one of them. In March 2011 Tengion raised $31.4 million in a private placement that included the Minnesota medical device maker. As part of the agreement, Medtronic has the right of first refusal to license or acquire Tengions Neo-Kidney Augment program.

Tengion has flirted with the possibility of working with another company before. In Feburary 2011, the company disclosed that discussions with another unnamed publicly-traded company for a stock-for-stock merger had terminated. At the time, the company said it had enough money to last until April of that year. The private placement that included Medtronic came just before Tengion ran out of cash.

Now, the clock is ticking again for Tengion. The company could raise more capital by issuing more stock, but it must first regain Nasdaq compliance. Medtronics rights to license or buy Tengions kidney program expire on October 31, 2013. While Tengions pressing cash needs weaken its negotiating position it can counter with the strong progress made by the kidney program. Tengion has pulled off deals under financial pressure before. By September the company will need to do one again, if not with Medtronic then with someone else.

Read the original post:
Can regenerative medicine firm TNGN conjure a Medtronic partnership?

Biostem U.S., Corporation Announces $5,000,000 Financing Agreement Through Private Placement of Stock

CLEARWATER, FL--(Marketwire -05/24/12)- Biostem U.S., Corporation, (HAIR.PK) (HAIR.PK) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announces a $5,000,000 financing agreement through private placement of stock.

CEO, Dwight Brunoehler, announced today that the company has signed an agreement with a funder to issue 20,000,000 shares of the company's common stock in exchange for $5,000,000 in cash or 25 cents ($.25) per share. No other considerations will be granted to the funder in exchange for the cash payment.

In announcing the funding agreement, Mr. Brunoehler commented, "We consider the eagerness of the funder to acquire Biostem shares at a price above the current market to be a tribute to our proven proprietary technology to enhance hair re-growth using human stem cells. Although we anticipated funding the company through the sale of a convertible debenture, the funder insisted on being able to acquire stock at a set price now, rather than risk having to convert at higher prices later. Although Rule 144 sale restrictions usually cause private placements of stock to be executed at a discount to the market, Biostem feels that its current share price is not truly reflective of the value of its proprietary technology; as well as the fact that the technology is already being employed, and the overall size of the hair replacement marketplace. It was for this reason that the company and the funder were able to come to an agreement to price the private placement above the current share price."

About Biostem U.S., Corporation

Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group 310-974-6821.

See the article here:
Biostem U.S., Corporation Announces $5,000,000 Financing Agreement Through Private Placement of Stock

Cardium to Present at Sachs Associates 2012 Science, Partner, and Investment Forum: Gateway for the Global Life Sciences

SAN DIEGO, May 17, 2012 /PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today announced that Christopher J. Reinhard, Chairman & CEO will present a corporate overview and participate in a Regenerative Medicine Panel being held at the Sachs 2012 Science, Partner, and Investment Forum: Gateway for the Global Life Sciences in West Palm Beach, FL May 21 22, 2012. The Regenerative Medicine Panel, chaired by Bernard Siegel, Executive Director, Genetics Policy Institute and Jeffrey Cohen, Director, Ladenburg Thalmann & Co, Inc., will take place on May 22 at 9:15 a.m. ET and Cardium's investor presentation is scheduled for 10:40 a.m. ET on the same day in Ballroom B.

(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)

An updated investor presentation is now available on Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium's current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium Health Sciences healthy lifestyle product platform. The Company's lead commercial product Excellagen topical gel for wound care management recently received FDA clearance for marketing and sale in the United States. Cardium's lead clinical development product candidate Generx is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release or the referenced investor presentation are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there can be no assurance that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2012 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com.

Cardium Therapeutics, Generx, Cardionovo, Tissue Repair, Gene Activated Matrix, GAM, Excellagen, Excellarate, Osteorate, MedPodium, Appexium, Linee, Alena, Cerex, D-Sorb, Neo-Energy, Neo-Carb Bloc, Neo-Chill, and Nutra-Apps are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

View post:
Cardium to Present at Sachs Associates 2012 Science, Partner, and Investment Forum: Gateway for the Global Life Sciences

Maryland Stem Cell Research Commission Funds 40 New Proposals in FY 2012

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital

Posted May 17, 2012

Awards to advance regenerative medicine address diverse, debilitating diseases and conditions

COLUMBIA, Md. - The Maryland Stem Cell Research Commissionhas completed its review of the 179 applications received in response to its three FY 2012 Requests for Applications (RFAs). The board of directors of the Maryland Technology Development Corporation (TEDCO) approved the Commission's recommendation to fund 40 new proposals with the Maryland Stem Cell Research Fund's (MSCRF) $12.4 million FY 2012 budget.

"We are pleased to announce our grant awards for FY 2012," said Margaret Conn Himelfarb, MPH, chair of the Commission. "These projects address a diverse array of debilitating and costly diseases and conditions, some of which are traditionally underfunded. Maryland's investment in cutting-edge stem cell research continues to advance the field and strengthens our State's national leadership position in the life sciences. We are grateful to Governor Martin O'Malley and the Maryland General Assembly for recognizing the tremendous economic and humanitarian benefits of this pioneering research."

This funding cycle, the Commission gave priority to proposals that focus on advancing regenerative medicine by selecting promising research that targets sickle cell anemia, schizophrenia, type 1 diabetes, nerve injury, Parkinson's disease, Crohn's disease, multiple sclerosis (MS), heart disease, osteoarthritis, Lou Gehrig's disease (ALS), retinal disease, and other debilitating medical conditions. Continuing the collaboration initiated last year with the California Institute of Regenerative Medicine (CIRM), the MSCRF will also support a Maryland researcher working with CIRM-funded scientists to study stem cell differentiation and bone repair.

This year's MSCRF awards include:

9 Investigator-Initiated Research Grants (RFA-MD-12-1) - providing up to $600,000 in direct costs over a maximum of three years to investigators with preliminary data to support their hypotheses.

17 Exploratory Research Grants (RFA-MD-12-2) - providing up to $200,000 in direct costs over a maximum of two years to researchers with novel approaches, mechanisms or models that may differ from current thinking in the field and/or new hypotheses that have little or no preliminary data.

14 Post-Doctoral Fellowship Research Grants (RFA-MD-12-3) - providing post-doctoral fellows up to $55,000 per year, for up to two years.

Read more:
Maryland Stem Cell Research Commission Funds 40 New Proposals in FY 2012

Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.

Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).

Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.

This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

Follow us on Twitter: http://twitter.com/castemcell

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50281529&lang=en

Originally posted here:
Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

ANN ARBOR, Mich., May 17, 2012 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM - News), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that company president and CEO Tim Mayleben will be presenting at the World Stem Cells & Regenerative Medicine Congress at the Park Plaza hotel in London, UK. The presentation entitled "Phase 3 Development of a Cellular Therapy Product" will take place on Monday, May 21, 2012 at 4:40 pm (BST).

The Aastrom presentation will cover the benefits of a special protocol assessment and offer insights on achieving manufacturing readiness. The presentation will also address the role of clinicians and patients in the Phase 3 development process.

About Aastrom Biosciences

Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and a planned Phase 2b clinical trial in patients with ischemic dilated cardiomyopathy. For more information, please visit Aastrom's website at http://www.aastrom.com. For more information on the pivotal REVIVE Phase 3 clinical trial, please visit the trial website at http://www.revivecli.com.

The Aastrom Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3663

This document contains forward-looking statements, including, without limitation, statements concerning clinical trial plans and progress, objectives and expectations, clinical activity timing, intended product development, the performance and contribution of certain individuals and expected timing of collecting and analyzing treatment data, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory approval requirements, competitive developments, and the availability of resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom's Annual or Transition Report on Form 10-K or 10-K/T, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. These forward-looking statements reflect management's current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

More:
Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.

Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).

ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

About SMD, Dry AMD and Degenerative Diseases of the Retina

Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

More here:
Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Fibrocell Science, Inc. and Top University Investigators Form Scientific Initiative to Assist in Securing Grant …

EXTON, Pa.--(BUSINESS WIRE)--

Fibrocell Science, Inc. (OTCBB:FCSC.OB) announced today the formation of the Clinical Investigations for Dermal Mesenchymally-Obtained Derivatives (CIDMOD) Initiative (www.CIDMOD.org) in collaboration with researchers from a number of different universities across the U.S. The CIDMOD Initiative will facilitate the collaboration of scientists, clinical researchers and private entities, including Fibrocell, to secure funding that will advance clinical research programs that may one day lead to new personalized cell therapies or diagnostic tools for a variety of diseases and conditions. The group will also submit grant requests to the California Institute of Regenerative Medicine (CIRM) and seek additional funding for the development of clinical research programs that use Fibrocells deep knowledge and expertise in cell isolation, purification and expansion via use of its proprietary technology.

Fibrocell Science is excited to support the CIDMOD Initiative. We believe the future work conducted by the Initiatives members will positively impact Fibrocells overall stem cell research strategy and significantly impact the future of personalized medicine, said David Pernock, Chairman and CEO of Fibrocell Science, Inc.

Co-directors of the CIDMOD Initiative include:

About Fibrocell Science Technology

Fibrocell Science has developed an innovative technology to isolate, purify and multiply a patients own fibroblast cells (a type of skin cell that makes collagen) for injection. Initially, this patented, proprietary technology was applied for use via the companys first product on the market, LAVIV (azficel T). The technology is also being used to study the composition of skin tissue samples to identify, isolate, purify and multiply specialized dermal cell types, such as mesenchymal stem cells (MSCs) and SSEA3-expressing regeneration-associated (SERA) cells. SERA cells may play a role in the regeneration of human skin in response to injury, and MSCs are being investigated for their ability to differentiate into cells that can form bone, cartilage and fat. Finding these specialized cells within skin cell cultures is important because rather than undergoing a surgical organ or tissue transplantation to replace diseased or destroyed tissue, patients may one day be able to benefit from procedures by which stem cells are extracted from their skin, differentiated into specific cell types, and re-implanted into their bodies to exert a therapeutic effect.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB:FCSC.OB) is an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit http://www.fibrocellscience.com.

Forward-Looking Statements

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, whether the Initiative will be successful in securing funding, and whether future work conducted by the Initiatives members will positively impact Fibrocells overall stem cell research strategy and significantly impact the future of personalized medicine. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2011, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.

Originally posted here:
Fibrocell Science, Inc. and Top University Investigators Form Scientific Initiative to Assist in Securing Grant ...

AxoGen, Inc. Announces Record First Quarter 2012 Revenues

ALACHUA, Fla.--(BUSINESS WIRE)--

AxoGen, Inc. (AXGN.OB), a leading regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced revenues for the first quarter ended March 31, 2012 of $1.65 million, a 47% increase over 2011 first quarter revenues of $1.12 million.

This quarters record performance has been the direct result of our increase in sales and marketing activity, commented Karen Zaderej, Chief Executive Officer of AxoGen, Inc. During the first quarter we continued to expand our sales force, while continuing to get hospital approval for AxoGen products and training and developing the sales team. Our growing base of sales representatives, combined with increasing surgeon awareness of our technologies and clinical data, creates a strong environment for our continued growth.

Revenues Revenues for the period increased to a record $1.65 million, or 47%, compared to $1.12 million in 2011. The improved results were primarily due to an increase in new accounts as well as stronger sales penetration into key accounts.

Revenues increased 21% over fourth quarter revenues of $1.36 million.

Gross Profit Gross profit reached $1.21 million, a 55% increase, for first quarter 2012 up from $0.78 million reported for the same period 2011. The higher gross profit reflects lower manufacturing and labor cost and the absence of one-time manufacturing startup expenses reported during the first quarter of 2011. The gross profit margin increased to 73% compared to 70% for the same quarter last year.

Sales and Marketing Expenses As a result of the Company's investment in additional sales and marketing resources, sales and marketing expenses during the first quarter of 2011 increased to $1.63 million, compared to $0.86 million reported during the same period last year. As of the end of the period, the Company reported 16 direct and 21 independent sales representatives and distributors.

Research and Development Expenses Research and development expenses increased to $0.30 million during the first quarter of 2012. Substantially all of the research and development expenses relate to expenditures for clinical activity.

General and Administrative Expenses General and administrative expenses increased to $1.23 million for the quarter, compared to $0.72 million reported last year. This increase was largely driven by payroll and benefit increases and expenses associated with being a public company.

Operating Loss The Company reported a net loss of $2.11 million, or $0.19 per common share, compared to a net loss of $2.3 million, or $2.21 per common share, reported during the same period in 2011.

Original post:
AxoGen, Inc. Announces Record First Quarter 2012 Revenues

Histogenics’ NeoCart for Patients with Knee Cartilage Damage Demonstrates Continued Efficacy for Periods of Up to Five …

WALTHAM, Mass.--(BUSINESS WIRE)--

Regenerative medicine company Histogenics Corporation, announced today the presentation of intermediate term data supporting the clinical efficacy of the Companys NeoCart Autologous Cartilage Tissue Implant (ACTI) for periods of up to five years with no evidence of severe treatment-related adverse events in patients with grade III chondral injury to the femur (cartilage damage in the knee). Dennis Crawford,M.D., Ph.D.,Assistant Professor and Surgical Director of Sports Medicine Programs in the Department of Orthopedics and Rehabilitation at Oregon Health Science University presented the findings An Autologous Cartilage Tissue Implant (ACTI) NeoCart for Treatment Grade III Chondral Injury to the Femur. Intermediate Term Results from Initial FDA Trials. at the International Cartilage Repair Society (ICRS) 2012 Annual Meeting in Montreal Canada on Sunday, May 13, 2012. NeoCart is an autologous bioengineered neocartilage grown outside the body using the patients own cells for the repair of full thickness cartilage lesions.

These results suggest that NeoCart has significant potential to act as a first-line surgical treatment option for focal cartilage repair or replacement and, as such, may provide an alternative to microfracture type procedures, said Dr. Crawford. For the patients in this cohort with knee cartilage injuries treated with NeoCart, we reported improvement in all patient reported outcomes as soon as six months following surgery, as patients were released to full activity, and these therapeutic gains weresustained throughout a median study period of 48 months. The first patients treated with NeoCart have had similar gains for five years. These improvements are seen across a spectrum of validated, ICRS-recommended outcome measures, including pain, function and associated activity of daily living performance.

This analysis continues to add to an already impressive NeoCart data set and further supports our ongoing Phase 3 study, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. There is clearly a need in the market for longer-term, effective solutions for cartilage injury and we are hopeful that NeoCart may be able to play a role in filling this treatment void.

The primary purpose of the analysis was to summarize the safety and efficacy experience of all patients treated with NeoCart up to five years using ICRS-recommended patient reported scores, as well as general health assessments. Subjects were pooled from previously-completed, Company-sponsored Phase 1 and 2 multi-center clinical trials. Eligible patients were between the ages of 18-55 years of age and had one or two symptomatic ICRS grade III chondral lesion(s) on the femoral condyle. Validated and ICRS-recommended patient reported outcome measures were obtained at each follow up visit. These included the following: Knee Injury and Osteoarthritis Outcome Score, Visual Analog Scale, Short Form Health Survey, and International Knee Documentation Committee subjective. Serious and adverse events were recorded for all patients. Data on twenty-nine patients was reported in the cohort, including eight patients through 60 months and 20 patients at a minimum of 36 months; one patient was lost to follow up after 12 months. The median follow up time period was 48 months.

Significant improvement (p<0.0001) was seen in the mean measures of all patient reported outcomes across all time points up to four years and at final follow up for each patient. Measures included the International Knee Documentation Committee, Short Form Health Survey, all five domains of the Knee injury and Osteoarthritis Outcome Score and the Visual Analog Scale (VAS) average and highest. Significant decreases from baseline (p<0.05) were reported for average VAS pain scores (1718, p=0.031) at six weeks and for highest VAS pain scores at three months (2331, p=0.004), and sustained through final visit (p<0.0001) for both. Range of motion did not decrease in any patient and, in fact, improved with a mean change from baseline of 68 degrees at final follow-up (p<0.001). Serious adverse events were limited to four and not related to the implant.

About NeoCart

NeoCart is an autologous bioengineered neocartilage grown outside the body using the patients own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met and a favorable safety profile was demonstrated.

About Histogenics

Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company Prochon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts, and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement, including lead candidates NeoCart, an autologous bioengineered neocartilage grown outside the body using the patients own cells for the regeneration of cartilage lesions, and VeriCart, a three-dimensional cartilage matrix designed to stimulate cartilage repair in a simple, one-step procedure. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

Link:
Histogenics’ NeoCart for Patients with Knee Cartilage Damage Demonstrates Continued Efficacy for Periods of Up to Five ...

Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

DENVER, May 14, 2012 /PRNewswire/ -- Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences' clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx Physician Network.

Regenerative Sciences' Regenexx procedures utilize a patient's own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.

"We are proud of our accomplishments in the field of regenerative interventional orthopedics and it's exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist," said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. "Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use."

Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.

About Regenerative Sciences

Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: http://www.regenexx.com

About John C. Malone, PhD

Dr. John C. Malone holds a bachelor's degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master's degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.

Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.

Contact:

View original post here:
Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

Avita Medical Initiates US FDA Study of Its ReCell® Spray-On-Skin™ for Reconstructive and Aesthetic Indications

NORTHRIDGE, Calif. & CAMBRIDGE, England--(BUSINESS WIRE)--

Avita Medical Ltd. (ASX: AVH), (OTC: AVMXF), (OTCQX: AVMXY),the regenerative medicine company, today announced that it has commenced enrolment in the US FDA-approved feasibility study for the use of ReCell Spray-On-Skin in the treatment of hypertrophic dyspigmented scars (raised and/or discoloured scars).

The initial three patients were treated by Dr Rajiv Sood, at the Richard M. Fairbanks Burn Center of Wishard Hospital, Indiana University, Indianapolis, Indiana, for scarring resulting from previous grafting due to burn injuries.

The approved FDA protocol permits the Company to treat 20 patients with scars at up to four U.S. study sites; patients will be assessed for healing and pain on a weekly basis during the initial four weeks post-treatment; at weeks 12 and 24 the treatment site will be assessed for healing and aesthetic outcomes by both the patient and an independent observer.

"Commencement of the FDA scar study is an important milestone for Avita," said Dr William Dolphin, Avita Medicals CEO. "ReCell has shown the potential to provide significant benefits over current options in the treatment of acute and chronic wounds and for a wide range of skin defects. We are confident that this study will demonstrate the effectiveness of ReCell in the corrective treatment of scars, making ReCell directly applicable and immediately relevant to the very large aesthetic markets.

The feasibility study is primarily designed to confirm the effectiveness of ReCell for the treatment of scars in a single session in comparison to the current standard of care involving dermabrasion of the scar and often requiring multiple treatment sessions; study endpoints are time-to-healing and aesthetic outcomes. Following completion of the study, Avita will submit the feasibility data and seek FDA approval for a statistically powered, pivotal clinical trial.

The study is funded by the US Department of Defense in partnership with the OSD Manufacturing Technology Program and Rapid Fielding Directorate for the Limb Salvage and Regenerative Medicine Initiative. The contract is a Technology Investment Agreement that is focused on the transition of the capability to meet DoD needs. ReCell was selected as it has the potential to be a quantum advance over the existing ability to treat and re-grow tissue and to substantially reduce the effects and appearance of scarring and thereby profoundly assist in the treatment and rehabilitation of wounded warriors suffering from disfigurement and impeded function due to combat injuries.

An interview with Dr Sood regarding the use of ReCell in treatment of scars and acute wounds is available at http://soundmedicine.iu.edu/segment/3245/Spray-on-Skin.

ABOUT AVITA MEDICAL LTD.

Avita Medical (www.avitamedical.com) develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects. The companys lead product, ReCell Spray-On-SkinTM, is used in a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell is patented, CE-marked for Europe, TGA-registered in Australia, and SFDA-cleared in China. ReCell is not available for sale in the United States; in the U.S. ReCell is an investigational device limited to investigational use.

The rest is here:
Avita Medical Initiates US FDA Study of Its ReCell® Spray-On-Skin™ for Reconstructive and Aesthetic Indications

Regenerative medicine company begins enrollment in critical limb ischemia trial

Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.

The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.

Juventas technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.

Advertisement

CLI has become a very exciting clinical opportunity, Aras said. Its becoming a growing area of interest for a number of biotech and pharma companies.

Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.

Among the top advantages of Juventas CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the companys therapeutic in an easy procedure at a physician office, and the approach doesnt require bone marrow aspiration to obtain patients own stem cells or complex cell processing as some competing therapeutics do.

Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.

The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.

Read more from the original source:
Regenerative medicine company begins enrollment in critical limb ischemia trial

Takeda to invest in regenerative medicine startup Juventas’ next round

Takeda Pharmaceuticals is a strategic investor in regenerative medicine company Juventas Therapeutics upcoming series B round of funding.

Juventas CEO Rahul Aras discussed the investment during a panel at a meeting of the Ohio Venture Association on Friday.

If you think venture capital due diligence is difficult Aras joked, I think [Takeda] called my mother.

Advertisement

Aras has previously said that the Cleveland-based Juventas was targeting about $25 million in the round.

Juventas is a Cleveland Clinic spinoff and is based on technology pioneered by former Clinic cardiologist Marc Penn.

The companys technology, JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

The company is investigating JVS-100 for the treatment of patients who suffer from heart failure and critical limb ischemia.

One panelist asked Aras whether Takedas investment means its likely to be Juventas eventual acquirer. I dont assume anything about an exit, Aras said. I just focus on developing the company and figure someone will eventually want to buy us.

Go here to see the original:
Takeda to invest in regenerative medicine startup Juventas’ next round

Advanced Cell Technology Announces 2012 First Quarter Results

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB:ACTC), a leader in the field of regenerative medicine, announced today first quarter financial results for the period ended March 31, 2012. The Company reported a loss from operations of $(5.4) million compared to a loss from operations of $(4.8) million in the 2011 first quarter.ACTreported a net loss of $(5.7) million or $(0.00) per share, compared to a loss in the same period in 2011 of $(3.3) million, or $(0.00) per share.

Net cash used in operations for the 2011 first quarter was $4.8 million, compared to net cash used in operations of $3.4 million in the same period in 2011. The Company ended the 2012 first quarter with cash and cash equivalents of $10.8 million, compared to $13.1 million as of December 31, 2011.

Highlights from the first quarter of 2012 included:

We are very pleased with our progress in the clinic so far, said Chairman and CEO Gary Rabin. We are encouraged by the results we have seen from the early patients treated in each of our indications, and look forward to completing the trials on schedule.

Conference call and Webcast

The Company will hold a conference call tomorrow at 9 a.m. eastern time to discuss the first quarter results and business outlook. Interested parties may access the call live by dialing (888) 264-3177 and using conference ID 72827188. This event will be streamed via webcast. The webcast will be available at http://us.meeting-stream.com/advancedcelltechnology050912. A replay of the call will also be available via the same link.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visitwww.advancedcell.com.

Forward-Looking Statements

See original here:
Advanced Cell Technology Announces 2012 First Quarter Results

Tengion to Host Conference Call to Provide a Business Update and Report First Quarter 2012 Financial Results on May 7 …

WINSTON-SALEM, N.C., April 30, 2012 /PRNewswire/ -- Tengion, Inc. (TNGN), a leader in regenerative medicine, today announced it will host a conference call and live audio webcast on Monday, May 7, 2012, at 5:00 p.m. EDT to provide a business update and discuss its first quarter 2012 financial results.

To participate in the call, please dial 866-356-4281 (domestic) or 617-597-5395 (international) and reference access code 33248660.

The conference call can be accessed from the Investors section of the Company's website or directly at http://www.media-server.com/m/p/rf5nyqx7. The webcast will also be archived on the website.

About Tengion

Tengion, a clinical-stage regenerative medicine company, is focused on developing its Organ Regeneration Platform, to harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues and delay or eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. An initial clinical trial is ongoing for the Company's lead product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like urinary tissue for bladder cancer patients requiring a urinary diversion following bladder removal. The Company's lead preclinical candidate is the Neo-Kidney Augment, which is designed to prevent or delay dialysis kidney transplantation by increasing renal function in patients with advanced chronic kidney disease. Tengion has worldwide rights to its product candidates.

More here:
Tengion to Host Conference Call to Provide a Business Update and Report First Quarter 2012 Financial Results on May 7 ...

American CryoStem Announces ACS Laboratories Adipose Tissue and Adult Stem Cell Testing Services

RED BANK, NJ--(Marketwire -04/30/12)- American CryoStem Corporation (CRYO.PK - News) announced the launch of its new adipose tissue and adult stem cell testing services to assist physicians involved in tissue engraftment, regenerative medicine procedures and cellular therapies utilizing adult adipose derived stem cells. The new testing services provide physicians an affordable method for self assessment of their procedures and methods to better understand the relationship between tissue quality and engraftment success.

American CryoStem recognizes the need for independent testing services as reinforced by the increasing focus and scrutiny of physician office based tissue laboratories by the US Food and Drug Administration (FDA). The menu of testing services includes full 14 day sterility testing, viability testing, growth assay and additional tests for each selected service. The tests can be ordered individually or in multiples over time and are designed to allow physicians to self evaluate their current methods and performance, or to assess new methods or devices designed to improve procedure and tissue quality. Long term and customized programs are available upon request. Physicians enrolled as a provider of the Company's stem cell storage services can obtain discounts for individual and multi test programs.

"We are very excited about rolling these new services out to our existing providers and all participants in the tissue engraftment, regenerative medicine and cellular therapy markets. We believe that this is the first such program offered commercially and meets a critical need for the advancement of the regenerative and cellular therapy markets," said Anthony Dudzinski, the Company's COO. "Now there is a way for physicians to assess their own performance without the need to overcome the significant costs of purchasing and maintaining their own testing facilities."

The new testing services are offered by ACS Laboratories reflects the Company's increasing branding and commercialization of products and services developed around its proprietary clinical tissue processing and storage methodologies. ACS Laboratory incorporates its proprietary cGMP/cGTP aseptic methods and FDA guidance's into these services to ensure the highest quality and most useful information for physicians.

About American CryoStem: American CryoStem Corporation (CRYO.PK - News) markets clinical processing services and patented products for Adipose (fat) Tissue and Adipose Derived Adult Stem Cells. The Company's clinical processing, patented cell culture media products and cellular preservation platform supports the science and regenerative medicine applications being developed globally. The Company provides the highest quality, clinically processed cells assuring their purity, viability and growth capabilities, while at the same time developing cutting edge applications, therapies and patented laboratory products and services for consumer and commercial applications.

Read more:
American CryoStem Announces ACS Laboratories Adipose Tissue and Adult Stem Cell Testing Services

New Fund Established to Stimulate Regenerative Medicine Industry

MONTREAL, QUEBEC--(Marketwire -04/30/12)- With a shared goal of supporting development projects that will boost innovation in the growing field of stem cells and biomaterials-based products, Pfizer Canada and the Centre for Commercialization of Regenerative Medicine (CCRM) have established the Pfizer-CCRM Innovation Fund to accelerate regenerative medicine (RM) technologies for drug screening and therapeutic applications. The announcement is being made at the first annual Till & McCulloch Meetings (April 30-May 2), Canada's premier stem cell meeting, jointly hosted by the Stem Cell Network and CCRM.

"CCRM was created on the premise that it would work with academia and industry on projects that will hopefully move RM technologies and innovations from the bench to the bedside," says Michael May, CEO of CCRM. "Canada is already a leader in this field and additional funding to advance novel research through early product development will only make us stronger. We're very pleased to be partnering with Pfizer Canada and appreciate their confidence in joining with us."

"Pfizer Canada is pleased to contribute to this new fund which will support important research here in Canada," explains Dr. Bernard Prigent, Vice-President and Medical Director, Pfizer Canada. "With the novel resources offered through CCRM's development capabilities, we hope to help advance the RM field in this country."

Pfizer Canada has contributed a total of $500,000 to the Pfizer-CCRM Innovation Fund and CCRM will contribute matching dollars to any approved projects undertaken in the duration of this fund.

About Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six institutional partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM translates scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

About Pfizer Canada

Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's leading biopharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc. invests more than US$7 billion annually in R&D to discover and develop innovative life-saving and life-enhancing medicines in a wide range of therapeutic areas. Our diversified health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. For more information, visit http://www.pfizer.ca

Read this article:
New Fund Established to Stimulate Regenerative Medicine Industry

South Korea steps up stem-cell work

South Korea's government is focused on boosting funds for stem-cell research this year.

Jo Yong Hak/Reuters

The South Korean health ministry announced last month that research into stem cells and regenerative medicine will receive a funding boost of 33 billion won (US$29 million) in 2012, four times that given in 2011. Overall, six different ministries will invest 100 billion won in stem-cell research this year.

Until last year, public investment in stem cells in South Korea was relatively low and targeted mainly at basic research. But the country's Ministry of Health and Welfare is now expanding its support for clinical research on stem cells, with the money being used to link basic research to intermediate or clinical studies. The aim is to commercialize the research at an early stage.

"From the current research atmosphere and infrastructure, the government has judged that stem-cell studies are now maturing," says Hyung Min Chung, president of Seoul-based biotechnology firm Cha Bio and Diostech and an adviser on the budget plan. He adds that his company is particularly pleased that government investment decisions on developing stem-cell therapies will be made more quickly.

The government money will be allocated to two areas: rare or incurable diseases for which there is little incentive for private investment, such as spinal cord damage; and common chronic conditions, such as arthritis, for which the aim is to help South Korean companies to capture part of the large potential market for treatments.

South Korea has been trying to restore its tarnished image in the field after the fall of one of its stellar stem-cell scientists, Woo Suk Hwang, who was convicted in 2009 for embezzlement and bioethics violations after falsifying results. The country has begun to regain confidence from a series of successful research projects, and is ranked in the world's top ten for stem-cell and regenerative medicine research in terms of number and quality of publications. The South Korean government thinks that the country can be a top global competitor if the field is given enough support.

In the past year, the South Korean Food and Drug Administration (FDA) has approved the worlds first three stem-cell treatments Hearticellgram-AMI, Cupistem and Cartistem which followed on the heels of clinical tests for human embryonic stem-cell therapies approved in 2010, according to the health ministry.

But many are still wary of those therapies. Clearly, there has been increased international focus on what is going on in the Korean regenerative industry since the approval of three stem-cell products in the past year, which I think caught many industry observers off guard, says Douglas Sipp, who works on stem-cell policy and ethics at the RIKEN Center for Developmental Biology in Kobe, Japan. "It appears that the Korean FDA has been focusing on fast-tracking products through the approval pathway, he says, adding that it will be interesting to see what other regulatory authorities think about these products.

Dong Wook Han, a professor of stem-cell biology at Konkuk University in Seoul, is worried about how the country regulates clinical research on stem cells. "Compared to a country like Germany, where I studied and where the regulations on embryonic stem cells are much stricter, South Korea has more freedom in regulation, which means it can explore more opportunities in clinical research. However, he emphasizes that instead of moving too quickly, South Korea needs to adopt the stricter regulations from other countries to test safety and efficacy.

Read the original post:
South Korea steps up stem-cell work

Regenerative Medicine Session at Sacramento Med Tech Showcase 2011 – Video

25-04-2012 23:54 Regenerative Medicine session at the 2011 Sacramento Med Tech Showcase by SARTA MedStart

See the original post here:
Regenerative Medicine Session at Sacramento Med Tech Showcase 2011 - Video

Advanced Cell Technology Announces Webcast of Corporate Presentation at Annual Shareholders’ Meeting Today

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT;OTCBB: ACTC), a leader in the field of regenerative medicine, announced that it will webcast todays corporate presentation at 9:15 a.m. PDT, after the formal portion of its Annual Shareholders Meeting has concluded. Prior to the webcast, proxy voting will be completed and the results announced to the shareholders in attendance. The meeting is open to shareholders of record as of March 1, 2012. After the corporate presentation, the Company will address questions from shareholders in attendance, as well as electronically via the webcast.

The webcast will be available live and via replay at: http://us.meeting-stream.com/advancedcelltechnology042612

The Presentation schedule is as follows:

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visitwww.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

Original post:
Advanced Cell Technology Announces Webcast of Corporate Presentation at Annual Shareholders’ Meeting Today

Archives