Stem Cell Research

Medistem, Inc. Appoints Herm Rosenman to Board of Directors

05/21 09:00 AM

SAN DIEGO, CA — (Marketwired) — 05/21/13 — Medistem, Inc. (MEDS:$1.20,00$0.00,000.00%) , today announced that it has appointed Herm Rosenman to its Board of Directors and Chairman of the Audit Committee. Mr. Rosenman was Senior Vice President and Chief Financial Officer of Gen-Probe, Inc., from 2001, through its IPO in 2002, until its acquisition by Hologic, Inc., in August 2012 for $3.7 billion.
“We welcome Herm to our Board of Directors and are also delighted that he has agreed to Chair our Audit Committee. He is a proven business leader and brings hands-on financial and operational experience to our Board. His financial expertise and knowledge of public healthcare companies comes at a critical time for Medistem (MEDS:$1.20,00$0.00,000.00%) as we transition to once again becoming a fully reporting company. Herm’s appointment is part of our strategy to transform Medistem (MEDS:$1.20,00$0.00,000.00%) into a leader in developing universal adult stem cells to treat Critical Limb Ischemia (CLI), Congestive Heart Failure (CHF) and Type 1 Diabetes,” said Alan J. Lewis, Ph.D., CEO of Medistem (MEDS:$1.20,00$0.00,000.00%) . “Herm’s considerable track record in building and managing successful companies will be a great asset to Medistem (MEDS:$1.20,00$0.00,000.00%) . The Board and I look forward to working with Herm to create value for our shareholders.”
“I am excited to join the Medistem Board of Directors. I believe Medistem (MEDS:$1.20,00$0.00,000.00%) has taken significant steps to becoming a leader in the adult stem cell sector. I look forward to working alongside my fellow directors and the Medistem (MEDS:$1.20,00$0.00,000.00%) management team to contribute to the Company’s success,” said Mr. Rosenman.
Prior to joining Gen-Probe, Mr. Rosenman served as Chief Executive Officer of two Nasdaq-listed companies and CFO of a Fortune 1000 NYSE-listed company, served on the boards of multiple healthcare companies and was a partner at Coopers & Lybrand (now PricewaterhouseCoopers). Mr. Rosenman, a CPA, received a B.B.A. in finance and accounting from Pace University and an M.B.A. in finance from the Wharton School of the University of Pennsylvania.
About Medistem, Inc. (MEDS:$1.20,00$0.00,000.00%)
Medistem, Inc. (MEDS:$1.20,00$0.00,000.00%) , is focused on the development of the Endometrial Regenerative Cell (ERC), a universal donor adult stem cell product. ERCs possess specialized abilities to stimulate new blood vessel growth and can differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. These unique properties have applications for treatment of critical limb ischemia (CLI), congestive heart failure (CHF), neurodegenerative diseases, liver failure, kidney failure, and diabetes. ERCs have been cleared by the FDA to begin studies in the United States. In January 2012, we announced the initiation of our RECOVER-ERC (Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy) Phase II clinical trial. This trial is being conducted at the Bakulev Scientific Center for Cardiovascular Surgery, Moscow, Russia. The trial is a 60 patient double blind placebo controlled study evaluating safety and efficacy of ERCs in end stage CHF patients.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Medistem, Inc. (MEDS:$1.20,00$0.00,000.00%) These can be identified by the use of forward‐looking words, such as “believes”, “expects”, “may”, “intends”, “anticipates”, “plans”, “estimates”, or any other analogous or similar expressions intended to identify forward‐looking statements. These forward‐looking statements and estimates as to future performance, estimates, and other statements contained herein regarding matters that are not historical facts, are only predictions and actual events or results may differ materially. We cannot assure or guarantee that any future results described in this presentation will be achieved, and actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company’s Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
John Salvador
john.salvador@medisteminc.com

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Some People Banking Stem Cells For Future Use To Stay Healthy

May 13, 2013 8:41 PM

GOLDEN, Colo. (CBS4) – In an effort to live a long and healthy life, some adults are now taking out a different kind of insurance policy. They are banking their stem cells for future use.

CBS4 Health Specialist Kathy Walsh watched one man go through the process. It’s relatively simple but it can set a person back several thousand dollars. Still, one retired engineer believes it is worth the investment.

“I am just a 54-year-old who’s trying to figure out how to get the most out of life,” Matt Rockwell said. “We’re told that we can live, at least machinery wise, we can live to 120. I’d like my 120.”

In fact, Rockwell is banking on that. In his doctor’s office in Golden, he is saving cells. Five vials of blood were collected. Then, Dr. Terry Grossman took a small sample of Rockwell’s skin cells.

Grossman practices nutritional and anti-aging medicine and has written three books about longevity.

“Right now, stem cell therapies are in their infancy,” Grossman said.

But Grossman believes the possibilities are endless.

“What’s going to be available in 10 to 20 years, it boggles the imagination,” he said.

So Grossman collects stem cells for patients and sends them away to be grown and cryopreserved. The belief is they may later be used to treat various diseases or conditions.

“Animals are having wonderful results and we are able to create, for instance, rat hearts and mouse hearts; and we are able to grow new cartilage for race horses,” Grossman said.

Rockwell was sold. He says his cells will never be younger. To him, $3,000 up front and a few hundred dollars a year is a bargain.

“I think this is the best insurance policy essentially I could buy today to ensure future health,” Rockwell said.

Some argue stem cell banking is just companies cashing in on the excitement surrounding stem cells. They say it’s not clear how useful they will be. But Rockwell says he couldn’t have dreamed of what a cellphone has become. He wants to be ready for what will be available in medicine when he turns 74

Alligator Stem Cell Study Gives Clues to Tooth Regeneration

May 14, 2013 — Alligators may help scientists learn how to stimulate tooth regeneration in people, according to new research led by the Keck School of Medicine of USC.

For the first time, a global team of researchers led by USC pathology Professor Cheng-Ming Chuong, M.D., Ph.D., has uncovered unique cellular and molecular mechanisms behind tooth renewal in American alligators. Their study, titled “Specialized stem cell niche enables repetitive renewal of alligator teeth,” appears in Proceedings of the National Academy of Sciences, the official journal of the United States National Academy of Sciences.

“Humans naturally only have two sets of teeth — baby teeth and adult teeth,” said Chuong. “Ultimately, we want to identify stem cells that can be used as a resource to stimulate tooth renewal in adult humans who have lost teeth. But, to do that, we must first understand how they renew in other animals and why they stop in people.”

Whereas most vertebrates can replace teeth throughout their lives, human teeth are naturally replaced only once, despite the lingering presence of a band of epithelial tissue called the dental lamina, which is crucial to tooth development. Because alligators have well-organized teeth with similar form and structure as mammalian teeth and are capable of lifelong tooth renewal, the authors reasoned that they might serve as models for mammalian tooth replacement.

“Alligator teeth are implanted in sockets of the dental bone, like human teeth,” said Ping Wu, Ph.D., assistant professor of pathology at the Keck School of Medicine and first author of the study. “They have 80 teeth, each of which can be replaced up to 50 times over their lifetime, making them the ideal model for comparison to human teeth.”

Using microscopic imaging techniques, the researchers found that each alligator tooth is a complex unit of three components — a functional tooth, a replacement tooth, and the dental lamina — in different developmental stages. The tooth units are structured to enable a smooth transition from dislodgement of the functional, mature tooth to replacement with the new tooth. Identifying three developmental phases for each tooth unit, the researchers conclude that the alligator dental laminae contain what appear to be stem cells from which new replacement teeth develop.

“Stem cells divide more slowly than other cells,” said co-author Randall B. Widelitz, Ph.D., associate professor of pathology at the Keck School of Medicine. “The cells in the alligator’s dental lamina behaved like we would expect stem cells to behave. In the future, we hope to isolate those cells from the dental lamina to see whether we can use them to regenerate teeth in the lab.”

The researchers also intend to learn what molecular networks are involved in repetitive renewal and hope to apply the principles to regenerative medicine in the future.

The authors also report novel cellular mechanisms by which the tooth unit develops in the embryo and molecular signaling that speeds growth of replacement teeth when functional teeth are lost prematurely. Co-authors include colleagues from the Louisiana Department of Wildlife and Fisheries, University of Georgia, National Cheng Kung University, National Taiwan University, and Xiangya Hospital in China.

The research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grants 5R01AR042177-19, 5R01AR060306-03 and 2R01AR047364-11A1.

$325,000 stem cell hamburger to be eaten soon

A proof-of-concept lab-grown hamburger is slated to be eaten soon, after many delays and $325,000 in research and development.

by Amanda Kooser

A lab-grown meat strip. Doesn’t it look appetizing?
(Credit: Mark Post)
The race for a lab-grown meat alternative has been on for years. Modern Meadow, for example, has gone after a type of 3D-printed meat using bioprinting techniques. Dutch tissue engineer Mark Post is using stem cells to make a lab-grown hamburger, one that may be actually going down someone’s gullet very soon.

Post’s Cultured Beef Project has been in development at Maastricht University in the Netherlands for some time thanks to $325,000 in funding from an anonymous donor. Cow muscle stem cells are grown into miniscule strips of tissue. Each strip can take several weeks to grow. It takes 20,000 of these to make a single hamburger. It’s a time-consuming and expensive product at this stage of the project.

The resulting burger will probably have more in common taste-wise with a patty from McDonald’s than a gourmet burger from a fancy restaurant. At this point, it’s not about the flavor so much as the proof that it could be created at all. Making it delicious will come later. Post has said he plans to add only salt and pepper before cooking it.

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Originally, the engineered patty was scheduled to be cooked up last year, but the New York Times reports it could now happen within a few weeks.

The burger isn’t exactly vegetarian-friendly just yet. The cells are grown in fetal calf serum. A non-animal-source alternative will need to be found before the lab beef could be considered kill-free. It could be years before research and funding make cultured beef a viable alternative, and that’s not considering potential issues of consumer resistance to buying lab-grown meat.

Despite the time, effort, and money that has gone into creating Post’s burger-of-science, I imagine people are still going to want to know first and foremost, “How does it taste? Is it better than a veggie burger?”

Strips of meat grow in a lab.

Beware of stem cell therapy claims: Column

Alex Berezow, USATODAY3:44 p.m. EDT May 15, 2013

Fortunately, the FDA is starting to crack down.
While it can’t control some companies that move outside the country to operate.
In the U.S., every medical treatment should be required to pass a ‘truth in advertising’ test.

Angelina Jolie courageously announced Tuesday that she underwent a preventative double mastectomy after genetic testing showed she had a high probability of developing breast and ovarian cancer, which she followed up with reconstructive surgery of her breasts. Not only does this highlight the promise of medical research and biotechnology, undoubtedly, Jolie’s willingness to publicize her decision will encourage other women who find themselves in similar circumstances.

But there is another aspect of biotechnology and cosmetic surgery that should not be readily promoted. Imagine hearing a crunching sound every time you opened your eye. Then, imagine how you would react if a doctor said that bone fragments had grown around it because of a botched procedure. This isn’t just a hypothetical scenario; it actually happened to a California woman.

In Scientific American, Ferris Jabr reports that a woman’s adult stem cells were removed during a liposuction procedure and re-injected around her eye. Because of the particular cocktail of chemicals the cosmeticians used, the stem cells turned into bones. Thus, instead of rejuvenation, her face became an example of a medical procedure gone wrong.

Unfortunately, this probably will not be the only time something tragic occurs. A stem cell transplant can help cure patients with acute myeloid leukemia, and research has shown incredible potential, from growing teeth to mending “unhealable” bone fractures. Still, stem cells are poorly understood. Despite this, as Jabr writes, many cosmeticians continue to claim that stem cells are a cure-all for “everything from wrinkles to joint pain to autism.”

Need better understanding

Until we understand them better, stem cells are the new snake oil peddled by 21st century charlatans. Thankfully, the Food and Drug Administration is cracking down.

Celltex Therapeutics Corp. was thrust into the limelight when Texas Gov. Rick Perry revealed that he was a client. The company collected and re-injected Perry’s own stem cells into his back as a therapy for pain. The Houston Chroniclereported that the FDA investigated Celltex and discovered it was unable to verify whether the banked stem cells were alive and uncontaminated — serious violations that could result in the company being shut down. So Celltex decided to move its operations to Mexico.

A company moving abroad to perform unproven, and sometimes dangerous, therapies is contributing to another problem: medical tourism. Americans who cannot legally receive treatment in the U.S. go to foreign countries where medical procedures are far less regulated.

Plethora of possibilities?

For instance, the Harvard Gazettereports: “Internet sites offer help for people suffering from a dizzying array of serious conditions, including: Alzheimer’s, Amyotrophic lateral sclerosis, atherosclerosis, autism, brain damage, cancer, cerebellar ataxia, cerebral palsy, chronic obstructive pulmonary disease, Crohn’s, diabetes, diseases of the eye, genetic disorders, Huntington’s, kidney disease, lupus, muscular sclerosis, muscular dystrophy, Parkinson’s, rheumatoid arthritis, spinal cord injury, spinal muscular atrophy, stroke and Tay-Sachs disease.” But the only FDA-approved stem cell therapy on that list is for leukemia (cancer).

Yet, a pesky bioethical issue remains, one that the non-profit Genetic Literacy Project recently hit upon: Even if the treatments don’t work, do people have a right to use their own stem cells? There are two main objections. First, the FDA claims that manipulating stem cells allows them to be classified as a “drug” and subject to its jurisdiction. Second, there is a “truth in advertising” problem: Cosmeticians and other purveyors of stem cell therapies promise rejuvenation and good health, yet they don’t have the scientific evidence to back up those claims.

Is there a solution? Banning medical tourism is nearly impossible, but the U.S. can make things more difficult for charlatans at home. Every medical treatment should be required to pass a “truth in advertising” test. An independent laboratory should verify claims made about medical products and procedures before they are allowed to go to market. But this wouldn’t just ensnare cosmetic and stem cell companies; it would also certainly shut down many alternative medicine practitioners. And it could even catch some conventional antidepressant medications, some of which might not be better than placebo.

Certainly, more regulation has its drawbacks. The FDA is notoriously slow, and some critics believe that it stifles innovation. Despite its flaws, on balance the FDA probably does more good than harm.

Modern technology has outpaced regulators and laws. The Internet is causing us to re-think intellectual property rights, ‘Net neutrality and cyberwarfare. Similarly, as biotechnology advances, it will continue to present society with increasingly complex legal and moral gray areas. We would be wise to reignite a serious debate over these issues now.

Alex B. Berezow is editor of RealClearScience and a member of USA TODAY’s Board of Contributors. He holds a Ph.D. in microbiology and is co-author of Science Left Behind.

In addition to its own editorials, USA TODAY publishes diverse opinions from outside writers, including our Board of Contributors.

NeoStem’s Subsidiary, Progenitor Cell Therapy, to Provide Cellular Therapy Services to Georgetown University Hospital

05/13 07:30 AM

ALLENDALE, N.J. and WASHINGTON, May 13, 2013 (GLOBE NEWSWIRE) — NeoStem, Inc. (NBS:$0.56,00$0.0278,5.22%) , a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC (“PCT”), an internationally recognized contract development and manufacturing organization, announced today that PCT has entered into a Cell Therapy Processing Customer Agreement with MedStar Georgetown University Hospital in Washington, D.C. to provide autologous and allogeneic cellular therapy services for cellular products provided by MedStar Georgetown University Hospital (“MGUH”) and deliver resulting cellular therapy products to MGUH for patient care.
In April, Georgetown’sLombardi Comprehensive Cancer Center, part of MedStar Georgetown University Hospital, and the John Theurer Cancer Center, part of Hackensack University Medical Center (“HackensackUMC”) in Hackensack, N.J., announced the establishment of an oncology affiliation arrangement between them to enhance patient access to innovative clinical trials, and is a significant step towards developing a clinical, translational and basic science cancer research consortium.
In its agreement with PCT, MedStar Georgetown University Hospital will use the services of PCT for processing and storage of peripheral blood progenitor cells, donor leukocytes, bone marrow and cord blood, as well as requested assaying and storage of cellular therapy product, and retrieval and transportation logistics.
“Akin to our relationship with HackensackUMC, whose engagement of PCT began over thirteen years ago, we look forward to developing a strong association with Georgetown,” said Robert A. Preti, Ph.D., President and Chief Scientific Officer of PCT. “Our agreements with HackensackUMC and MedStar Georgetown University Hospital enable us to continue to play a vital part in patient care for cancers and other hematologic disorders, and to continue to provide cell products to our entire client base. Since its founding, PCT has provided cell therapy products for infusion into over 6,000 patients.”
Dr. Robin L. Smith, NeoStem’s (NBS:$0.56,00$0.0278,5.22%) Chairman and Chief Executive Officer, stated that, “NeoStem (NBS:$0.56,00$0.0278,5.22%) is committed to supporting and enabling the development of emerging cell therapy products. We, as well as our clients, are developing innovative therapies using the cells of our body to treat chronic diseases such as cancers, autoimmune conditions and cardiovascular disease. We are thrilled to be working with prestigious institutions such as MedStar Georgetown University Hospital and HackensackUMC to support their bone marrow transplant programs. PCT’s exceptional client retention rate validates the management’s commitment to Quality and Service as we look forward to future growth with our clients outside of the United States.”
The Georgetown Lombardi Comprehensive Cancer Center at MedStar Georgetown University Hospital is the Washington, D.C. metropolitan region’s only comprehensive cancer center, a designation from the National Cancer Institute (NCI) demonstrating its scientific excellence and the capability to integrate multi-disciplinary, collaborative research approaches to focus on the problem of cancer.
The John Theurer Cancer Center at HackensackUMC is a nationally renowned, award-winning cancer center with a strong clinical program of excellence. HackensackUMC is ranked among the 50 best hospitals in the United States and the John Theurer Cancer Center is the highest ranked cancer center in New Jersey in the 2012-13 U.S. News & World Report Best Hospitals ranking.
About John Theurer Cancer Center at Hackensack University Medical Center
John Theurer Cancer Center at HackensackUMC is New Jersey’s largest and most comprehensive cancer center dedicated to the diagnosis, treatment, management, research, screenings, preventive care, as well as survivorship of patients with all types of cancer.
Each year, more people in the New Jersey/New York metropolitan area turn to the John Theurer Cancer Center for cancer care than to any other facility in New Jersey. The 14 specialized divisions feature a team of medical, research, nursing and support staff with specialized expertise that translates into more advanced and focused care for all patients. The John Theurer Cancer Center provides comprehensive multidisciplinary care, state of the art technology, access to clinical trials, compassionate care and medical expertise—all under one roof. Physicians at the John Theurer Cancer Center are members of Regional Cancer Care Associates, one of the nation’s largest professional hematology/oncology groups. For more information please visit jtcancercenter.org.
About NeoStem (NBS:$0.56,00$0.0278,5.22%)
NeoStem, Inc. (NBS:$0.56,00$0.0278,5.22%) (“NeoStem” or the “Company”) is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization (“CDMO”) providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue generating service provider business provides the Company with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
Forward-Looking Statements for NeoStem, Inc. (NBS:$0.56,00$0.0278,5.22%)
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy, including with respect to the Company’s research and development and clinical evaluation efforts for cellular therapies, including with respect to AMR-001, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the Company’s ability to successfully grow its contract development and manufacturing business. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2013 and in the Company’s periodic filings with the Securities and Exchange Commission. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
CONTACT: NeoStem (NBS:$0.56,00$0.0278,5.22%)
Dr. Robin L. Smith
Chairman and CEO
Phone: +1-212-584-4174
Email: rsmith@neostem.com
Image: NeoStem Inc. (NBS:$0.56,00$0.0278,5.22%) Logo

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The dawn of regenerative medicine

By Tom Bulford May 08, 2013

Last summer, a Swedish ten-year old was given a lifesaving transplant. The little girl had a blockage in the vein that connects her intestines and spleen with her liver. This is a rare condition that can stunt development or can even be fatal. And her parents were presented with some very worrying options for their daughter.

First off: a vein implant to replace the blocked one. Doctors usually cut deep into patient’s leg or neck to remove a vein that can replace the defective one, putting the patient at risk of additional traumatic surgery. Another option is to use man-made replacement veins, but these are prone to dangerous clots and blockages and virtually guarantee that the patient will need a lifelong course of drugs to keep their immune system from attacking it. Hope was wavering.

There was a third option, but it would be the first time such an operation had taken place. After lengthy discussions, the parents opted for this pioneering technique. The surgeons undertook an incredibly tricky procedure. They implanted the girl with a vein that had been grown in the lab using her own cells.

Her parents had an agonising wait. First, doctors took about 3.5 inches of vein from the groin of a 30-year-old deceased donor and removed all of the donor’s cells, leaving just the protein scaffolding of the vein. They then took cells from the bone marrow of the girl and seeded the vein scaffolding with them. For two weeks they watched the cells grow before implanting it to replace the faulty vein.

Thankfully, a year after the transplant, the girl had grown nearly 2.5 inches taller, gained 11 pounds in weight and was throwing somersaults. Her body was showing no signs of rejecting the vein. According to Dr Adam Katz, a director of plastic surgery at the University of Florida, this was, “a validation of what we believe will be a revolution in medicine”.

Regenerative medicine can help heart disease, stroke and cancer

This remarkable transplant will soon become routine. By creating a vein made of the girl’s own cells, this procedure overcame the biggest problem with transplants – rejection by the immune system. Another major problem in transplants is the huge waiting lists. Some patients die before they ever reach the operation theatre.

This ten-year-old is only one example of the remarkable feats happening across the globe. In Baltimore, a team has managed to rebuild an ear for a cancer patient using her own tissue inside her own forearm.

Regenerative medicine will be able to help cure heart disease by successfully growing heart valves from human cells. This means heart valves will be repaired without the need to perform surgery. Researchers are also looking into helping stroke patients in the rehabilitation period, aiming to help patients regain motor and neural functions by using cells to rescue brain tissue at or near the site of the stroke.

During cancer treatments to rid the body of cancerous cells, the healthy cells must also be killed off. This leaves the body weak and in need of new cells. These cells must come from a compatible donor, and this is no easy task. What if you had your own stash of cells? Regenerative medicine can be used to try and help tissues lost to trauma, disease and wear and tear.

StemCells, Inc. Announces Webcast to Discuss First Quarter 2013 Financial Results and Business Update

05/07 09:00 AM

NEWARK, Calif., May 7, 2013 (GLOBE NEWSWIRE) — StemCells, Inc. (STEM:$1.78,00$0.01,000.56%) , a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, announced today that it will release financial results for the first quarter ended March 31, 2013 after the market close on Thursday, May 9. In connection with this announcement, StemCells (STEM:$1.78,00$0.01,000.56%) will host a conference call and webcast to discuss its results and an update on its business at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) the same day.
Interested parties are invited to listen to the call over the Internet by accessing the Investors section of the Company’s website at www.stemcellsinc.com. Webcast participants should allot extra time before the webcast begins to register and, if necessary, download and install audio software.
Event:Q1 2013 Financial Results Conference Call / Webcast
Date: Thursday, May 9, 2013
Time: 1:30 PM PT (4:30 PM ET)
Live webcast: http://investor.stemcellsinc.com/phoenix.zhtml?c=86230&p=irol-calendar

An archived version of the webcast will also be available for replay on the Company’s website beginning approximately two hours following the conclusion of the live call and continuing for a period of 30 days.
About StemCells, Inc. (STEM:$1.78,00$0.01,000.56%)
StemCells, Inc. (STEM:$1.78,00$0.01,000.56%) is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and recently reported positive interim data for the first patient cohort. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in Alzheimer’s disease. StemCells (STEM:$1.78,00$0.01,000.56%) also markets stem cell research products, including media and reagents, under the SC Proven® brand. Further information about StemCells (STEM:$1.78,00$0.01,000.56%) is available at http://www.stemcellsinc.com.
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including those described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012 and in its subsequent reports on Forms 10-Q and 8-K.
CONTACT: Rodney YoungStemCells, Inc. (STEM:$1.78,00$0.01,000.56%)
Chief Financial Officer
(510) 456-4128

Ian StoneRusso Partners
(619) 308-6541
Image: company logo

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BioTime and Subsidiary LifeMap Sciences Announce Release of Enhanced LifeMap BioReagents™ Portal

BioTime and Subsidiary LifeMap Sciences Announce Release of Enhanced LifeMap BioReagents™ Portal Offering Additional PureStem™ Human Progenitor Cells Including Those for Diabetes Research 05/07 09:00 AM

ALAMEDA, Calif.–(BUSINESS WIRE)– BioTime, Inc. (BTX:$3.97,00$0.12,003.12%) and subsidiary, LifeMap Sciences, today announced the release of the enhanced LifeMap BioReagents™ portal (http://bioreagents.lifemapsc.com/) featuring an improved user interface, product descriptions, and customer support options, as well as the addition of new PureStem™ progenitor cells to the site. These novel progenitors provide new and unique tools for researchers to study developmental biology, tissue genesis and regenerative medicine, demonstrating purity in culture and unique gene expression. Among the new product offerings are novel PureStem™ progenitor cells such as the E72 cells capable of differentiating into betatrophin-expressing adipocytes, which may be useful in diabetes research.
Via LifeMap BioReagents™, researchers in academia, research hospitals, and biotech and pharma companies can access and purchase BioTime’s research products, including PureStem™ human progenitor cells, PureStem™ packages, clinical and research grade human embryonic stem cell (hES) lines, culture media, and cell differentiation kits. As of April, the portal also offers select recombinant proteins, including growth factors, signaling molecules, differentiation factors, cytokines and chemokines that complement BioTime research product lines.
LifeMap BioReagents™ is integrated with LifeMap’s integrated database suite products LifeMap Discovery™, GeneCards® and MalaCards, thereby providing all biomedical researchers accessing these databases a means of identifying stem cell reagents that can enhance research and discovery efforts in a variety of fields, including stem cell research, developmental biology, mechanisms of various human diseases, drug discovery and therapeutic discovery and development. According to Google Analytics, the sites have generated more than 2,000,000 unique visitors with more than 13,000,000 page views in the past 12 months. LifeMap holds an exclusive, worldwide license from Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science, to market GeneCards® (www.genecards.org), the human gene compendium, and MalaCards (www.malacards.org), a database with nearly 17,000 human disease entries.
“The diversity, purity, and scalability of PureStem™ cells combined with the continued discovery process underway at BioTime (BTX:$3.97,00$0.12,003.12%) , where novel differentiation pathways are being defined, gives us a growing opportunity to market these products in the research sector,” said Jeffrey Janus, Vice President of Sales and Marketing at BioTime (BTX:$3.97,00$0.12,003.12%) . “This is an exciting beginning to a new era in stem cell research. In combination with the LifeMap integrated database suite, our embryonic progenitors will provide researchers a unique new set of products to make novel clinical discoveries and advance the field of regenerative medicine.”
“We are pleased to continue the expansion and enhancement of our e-Commerce portal,” stated Yaron Guan-Golan, Head of Marketing at LifeMap Sciences. “Our growing user base will have improved access to our product portfolio via LifeMap BioReagents™. The addition of PureStem™ human progenitor lines, including cell types targeting the hottest new research in diabetes, will increase LifeMap BioReagents™ brand awareness and the quality of our offering to the global biomedical research community.”
About LifeMap Sciences, Inc.
LifeMap Sciences’ (www.lifemapsc.com) core technology and business is based on its integrated database suite, the discovery platform for biomedical and stem cell research. This platform includes GeneCards®, the leading human gene database; LifeMap Discovery™, the database of embryonic development, stem cell research and regenerative medicine; and MalaCards, the human disease database. According to Google Analytics, the sites have generated more than 2,000,000 unique visitors with more than 13,000,000 page views in the past 12 months. LifeMap Sciences also markets PanDaTox, an innovative, recently developed, searchable database that can aid in the discovery of new antibiotics and biotechnologically beneficial products.
In addition to database offerings, LifeMap Sciences is BioTime’s principal marketing subsidiary for research products, including PureStem™ human progenitor cell lines, GMP human embryonic stem (hES) cell lines, ESpan™ growth media for progenitor cell lines, and cell differentiation media for non-therapeutic uses, via its LifeMap BioReagents™ portal. LifeMap Sciences utilizes its databases as part of its online marketing strategy to reach life sciences researchers at biotech and pharmaceutical companies and at academic institutions and research hospitals worldwide.
In a therapeutic discovery collaboration with BioTime (BTX:$3.97,00$0.12,003.12%) , LifeMap’s scientists utilize LifeMap’s proprietary platform, including LifeMap Discovery™, its stem cell database along with the GeneCards® and MalaCards integrated database suite, to aid in the development of BioTime’s proprietary PureStem™ human progenitor cell lines into products for the treatment of human diseases, especially degenerative diseases that might be treatable with cell replacement therapies. The LifeMap Discovery™ platform will be used to select the progenitor cell lines that are most likely to be useful in developing cell-based regenerative medicine therapies for a wide range of diseases.
About BioTime, Inc. (BTX:$3.97,00$0.12,003.12%)
BioTime (BTX:$3.97,00$0.12,003.12%) , headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime (BTX:$3.97,00$0.12,003.12%) develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary PureStem™ cell lines, HyStem® hydrogels, culture media, and differentiation kits. BioTime (BTX:$3.97,00$0.12,003.12%) is developing Renevia™ (formerly known as HyStem®-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime’s (BTX:$3.97,00$0.12,003.12%) therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime’s (BTX:$3.97,00$0.12,003.12%) majority owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime’s (BTX:$3.97,00$0.12,003.12%) subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx™ currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime’s (BTX:$3.97,00$0.12,003.12%) proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime’s (BTX:$3.97,00$0.12,003.12%) subsidiary LifeMap Sciences, Inc. markets GeneCards®, the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery™ database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap Sciences also markets BioTime (BTX:$3.97,00$0.12,003.12%) research products and PanDaTox, an innovative, recently developed, searchable database that can aid in the discovery of new antibiotics and biotechnologically beneficial products. Asterias Biotherapeutics, Inc. is a new subsidiary being used to acquire the stem cell assets of Geron Corporation, including patents and other intellectual property, biological materials, reagents and equipment for the development of new therapeutic products for regenerative medicine. BioTime’s (BTX:$3.97,00$0.12,003.12%) lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime (BTX:$3.97,00$0.12,003.12%) can be found on the web at www.biotimeinc.com.
Forward-Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime (BTX:$3.97,00$0.12,003.12%) 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, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, 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 business of BioTime (BTX:$3.97,00$0.12,003.12%) and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime’s (BTX:$3.97,00$0.12,003.12%) Securities and Exchange Commission filings. BioTime (BTX:$3.97,00$0.12,003.12%) disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime (BTX:$3.97,00$0.12,003.12%) corporate communications, please click on the following link to join our email alert list: http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts
Source: BioTime, Inc. (BTX:$3.97,00$0.12,003.12%)

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Osiris Therapeutics Announces First Quarter 2013 Financial Results

05/07 08:00 AM

COLUMBIA, Md.–(BUSINESS WIRE)– Osiris Therapeutics, Inc. (OSIR:$10.60,00$0.49,004.85%) , the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the first quarter of 2013.
Highlights and Recent Developments
Launched CartiformTM, viable cartilage mesh for the treatment of articular cartilage injury.
Established and deployed a direct sales force for Grafix®, a premium cellular repair matrix for serious wounds including diabetic foot ulcers.
Received title of Orphan Drug designation from European Medicines Agency (EMA) for Prochymal®.
Defended a key patent, against an Australian opponent, covering the administration of mesenchymal stem cells for the treatment of inflammatory conditions involving the gastrointestinal tract.
Quarterly product revenue rose to $4.1 million– representing a 38% increase over the prior quarter.
Improved gross margin to 72% of revenue, with gross profit of $2.9M for the quarter.
Ended the quarter with a strong cash, receivables and short-term investment position of $34.9 million.
“Our team’s execution during the first quarter has given us a very strong start to 2013,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “While we are pleased with our accomplishments, we are focused solely on the future.”
First Quarter Financial Results
Product revenues during the first quarter of 2013 were $4.1 million, compared to $1.1 million during the first quarter of 2012, an increase of 257%. Gross margin during the first quarter was 72% compared to 66% during the first quarter of 2012. Gross profit was $2.9 million during the first quarter of 2013 and $0.75 million during the same period of 2012. We reported a loss of $2.7 million in the first quarter of 2013. As of March 31, 2013, Osiris had $34.9 million in cash, receivables and short-term investments.
Research and development expenses for the first quarter of 2013 were $3.0 million, compared to $4.0 million incurred in the first quarter of 2012. Selling, general and administrative expenses were $2.9 million for the first quarter of 2013, compared to $1.5 million for the same period of the prior year, reflecting our increased commercial activity.
Webcast and Conference Call
A webcast and conference call to discuss the financial results is scheduled for today, May 7, 2013, at 9:00 a.m. ET. To access the webcast, visit the Investor Relations section of the company’s website at http://investor.osiris.com/events.cfm. Alternatively, callers may participate in the conference call by dialing (877) 303-6133 (U.S. participants) or (970) 315-0493 (international participants). Note that a presentation will accompany the webcast.
An archive of the webcast will be available approximately two hours after the completion of the call. To access the archived webcast, visit the Investor Relations section of the company’s website at http://investor.osiris.com/events.cfm.
About Osiris Therapeutics (OSIR:$10.60,00$0.49,004.85%)
Osiris Therapeutics, Inc. (OSIR:$10.60,00$0.49,004.85%) , is the leading stem cell company, having developed the world’s first approved stem cell drug, Prochymal. Osiris currently markets Grafix and Ovation® for wound and tissue repair, and Cartiform for cartilage repair. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of cell therapy products. Osiris has developed an extensive intellectual property portfolio to protect the company’s technology, including 50 U.S. and 156 foreign patents.
Osiris, Prochymal, Chondrogen, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. (OSIR:$10.60,00$0.49,004.85%) More information can be found on the company’s website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal, Chondrogen®, Grafix, Ovation and Cartiform); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

OSIRIS THERAPEUTICS, INC. (OSIR:$10.60,00$0.49,004.85%)
Condensed Balance Sheets
Amounts in thousands

March 31, 2013 December 31, 2012
(unaudited)

Assets
Current assets:
Cash $ 1,287 $ 1,854
Investments available for sale 28,292 32,238
Accounts receivable, net 5,346 3,063
Inventory 1,611 1,278
Prepaid expenses and other current assets 462 603
Total current assets 36,998 39,036

Property and equipment, net 2,037 2,111
Restricted cash 317 317
Total assets $ 39,352 $ 41,464

Liabilities and Stockholders’ Equity

Current liabilities:
Accounts payable and accrued expenses $ 4,985 $ 4,999
Capital lease obligations, current portion 44 44
Total current liabilities 5,029 5,043

Long-term portion of capital lease obligations 151 162
Other long-term liabilities 350 369
Total liabilities 5,530 5,574

Stockholders’ equity
Common stock, $.001 par value, 90,000 shares
authorized, 32,930 shares outstanding – 2013,
32,881 shares outstanding – 2012 33 33
Additional paid-in-capital 279,911 279,269
Accumulated other comprehensive income (loss) 5 (20 )
Accumulated deficit (246,127 ) (243,392 )
Total stockholders’ equity 33,822 35,890
Total liabilities and stockholders’ equity $ 39,352 $ 41,464

OSIRIS THERAPEUTICS, INC. (OSIR:$10.60,00$0.49,004.85%)
Condensed Statements of Operations
Unaudited
Amounts in thousands, except per share data

Three Months Ended
March 31,
2013 2012

Product revenues$ 4,055 $ 1,137
Cost of product revenues 1,135 387
Gross profit 2,920 750

Revenue from collaborative research agreements and royalties186 3,446

Operating expenses:
Research and development 2,981 3,963
Selling, general and administrative 2,889 1,523
5,870 5,486

Loss from operations (2,764 ) (1,290 )

Other income, net 29 18

Loss before income taxes (2,735 ) (1,272 )

Income tax benefit – –

Net loss$ (2,735 ) $ (1,272 )

Basic and diluted loss per share $ (0.08 ) $ (0.04 )

Weighted average common shares (basic and diluted) 32,912 32,830

OSIRIS THERAPEUTICS, INC. (OSIR:$10.60,00$0.49,004.85%)
Condensed Statements of Cash Flows
Unaudited
Amounts in thousands
Three Months Ended
March 31,
2013 2012
Cash flows from operating activities:
Net loss $ (2,735 ) $ (1,272 )
Adjustments to reconcile net loss to net cash used in operations:
Depreciation and amortization 185 177
Non cash share-based payments 473 385
Provision for bad debts 22 –
Changes in operating assets and liabilities:
Accounts receivable (2,305 ) (269 )
Inventory (333 ) 352
Prepaid expenses, and other current assets 141 (166 )
Accounts payable and accrued expenses (33 ) 101
Deferred revenue – (3,333 )
Net cash used in operating activities (4,585 ) (4,025 )

Cash flows from investing activities:
Purchases of property and equipment (111 ) (20 )
Proceeds from sale of investments available for sale 4,000 3,985
Purchases of investments available for sale (29 ) (15 )
Net cash provided by investing activities 3,860 3,950

Cash flows from financing activities:
Principal payments on capital lease obligations (11 ) –
Proceeds from the issuance of common stock, net 169 –
Net cash provided by financing activities 158 –

Net decrease in cash (567 ) (75 )
Cash at beginning of period 1,854 1,661

Cash at end of period $ 1,287 $ 1,586

Source: Osiris Therapeutics, Inc. (OSIR:$10.60,00$0.49,004.85%)

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