Stem Cell Clinic

Osiris Therapeutics Announces First Quarter 2013 Financial Results

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), 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

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.

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Osiris Therapeutics Announces First Quarter 2013 Financial Results

The Alliance for the Advancement of Adult Stem Cell Therapy and Research Recently Has Proven Stem Cells To Be …

Bonita Springs, Florida (PRWEB) May 07, 2013

The Alliance for the Advancement of Stem Cell Therapy and Research monetarily supports some of the treatments provided by Intercellular Sciences. The Alliance is a non-profit organization dedicated to promoting research and treatment of life altering diseases with adult stem cells.

Howie Linderman, founding board member of The Alliance, says, The Alliance is very proud to be a part of helping people obtain this breakthrough treatment. When I had my stem cell treatment in 2008, the process was much more complex. This new protocol will change the way the world views cardiac problems and we are excited to participate.

To become a supporting member, please visit http://www.thestemcellalliance.org

John C. and Eddie W. have had Dilated Cardiomyopathy for many years and as time has gone on their heart muscle has continued to weaken. The deterioration of their hearts function deteriorated to the point that walking across the room was impossible without shortness of breath. Eddie had become so bad that he was restricted to a wheelchair. Modern science has not been able to stop the progression of this devastating disease. All the medications and defibrillators can do is treat the symptoms. Both men were facing a very grim prognosis. In March they each underwent a treatment using their own stem cells to regenerate the heart muscle. Within several weeks they were both feeling better and able to do much more activity than before. Eddie was out of his wheel chair. John went back to bowling.

John C. (age 62, Dickson, TN), has had Cardiomyopathy since he was a young man. First diagnosed while in college he has had to adjust his life style to adapt to his weak heart function. His doctors recommended a defibrillator a few years ago and he has been dependent on it since. His symptoms became rapidly progressive in the last couple of months. He had to stop many of his activities including cardiac rehab. It had become just too difficult for him. Johns ejection fraction (the percent of pumping of the heart) had dropped to under 10%. His doctors were not optimistic. He and his wife Karen refused to accept such a grim fate and searched for alternative treatment. They soon found an option: adult stem cell therapy. I have much more energy now, said John after his treatment. Im back to walking the perimeter of my 6 acre property and Im back at cardiac rehab. I have even started bowling again which I had stopped. Karen says that the change has been Amazing! An echocardiogram done 3 weeks after his treatment showed an increase in his ejection fraction of 50%. It is expected that his heart function will continue to improve for up to 6 months.

Eddie W. (age 41, Americus, GA) has battled heart disease for the last 14 years. He went through several years with just mild symptoms but, the last year has been devastating. His heart function deteriorated to such a degree that he has been hospitalized twice recently for severe swelling and shortness of breath. The doctors told his wife Leslie to get his affairs in order. While he was in the hospital this last time his family searched for other options. Coming across adult stem cell treatment for heart disease they took a leap of faith and made arrangements for treatment that has to be done outside the United States. Eddie was so weak that he could only get around being pushed in a wheelchair. He also had a pump attached that delivered a medication called Primacor to help his heart. Leslie had to fill the pump once a day with this life sustaining medicine. Eddie was treated in March. The treatment was a success. Within one week the pump was discontinued. Within two weeks he was getting around without the wheelchair. We hosted a church function and Eddie was able to keep up the whole time. Leslie says He could barely get out of his wheelchair before and now to be hosting a party, I cant believe it. Im so grateful. My boys have their father back. Eddies treatment was in part supported by The Alliance for The Advancement of Stem Cell Therapy and Research.

Zannos G. Grekos, MD, MAAC, FACC, chief science officer of Intercellular Sciences and a Florida-based pioneer in the field of adult stem cell therapy explains how, in this groundbreaking treatment, cardiologists insert a catheter into the patients heart similar to a heart cath. In 20 minutes, about 30 separate injections of Regenocytes (activated stem cells) are introduced into the damaged part of the heart. The process of tissue repair begins almost immediately.

The activation provides a key step in the process, Dr. Zannos Grekos explains. The lab extracts the stem cells, concentrates and activates them into over a billion of regenerative adult stem cells while educating them to assist the specific organ that needs regeneration. These cells we call Regenocytes.

Patients remain in the hospital overnight for observation, and are typically discharged the next day. Patients are scheduled for regular subsequent visits after the stem cell treatment to monitor their progress and measure their results.

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The Alliance for the Advancement of Adult Stem Cell Therapy and Research Recently Has Proven Stem Cells To Be ...

NYSCF scientists create personalized bone substitutes from skin cells

Public release date: 6-May-2013 [ | E-mail | Share ]

Contact: David McKeon dmckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (May 6, 2013) A team of New York Stem Cell Foundation (NYSCF) Research Institute scientists report today the generation of patient-specific bone substitutes from skin cells for repair of large bone defects. The study, led by Darja Marolt, PhD, a NYSCF-Helmsley Investigator and Giuseppe Maria de Peppo, PhD, a NYSCF Research Fellow, and published in the Proceedings of the National Academy of Sciences of the USA, represents a major advance in personalized reconstructive treatments for patients with bone defects resulting from disease or trauma.

This advance will facilitate the development of customizable, three-dimensional bone grafts on-demand, matched to fit the exact needs and immune profile of a patient. Taking skin cells, the NYSCF scientists utilized an advanced technique called "reprogramming" to revert adult cells into an embryonic-like state. These induced pluripotent stem (iPS) cells carry the same genetic information as the patient and they can become any of the body's cell types.

The NYSCF team guided these iPS cells to become bone-forming progenitors and seeded the cells onto a scaffold for three-dimensional bone formation. They then placed the constructs into a device called a bioreactor, which provides nutrients, removes waste, and stimulates maturation, mimicking a natural developmental environment.

"Bone is more than a hard mineral composite, it is an active organ that constantly remodels. Blood vessels shuttle important nutrients to healthy cells and remove waste; nerves provide connection to the brain; and, bone marrow cells form new blood and immune cells," said Marolt.

Previous studies have demonstrated the bone-forming potential from other cell sources, yet serious caveats for clinical translation remain. A patient's own bone marrow stem cells can form bone and cartilaginous tissue, not the underlying vasculature and nerve compartments; and, embryonic stem cell derived bone may prompt an immune rejection. The NYSCF scientists chose to work with iPS cells to overcome these limitations, comparing iPS sources with embryonic stem cells and bone marrow derived cells.

"No other research group has published work on creating fully-viable, functional, three-dimensional bone substitutes from human iPS cells. These results bring us closer to achieving our ultimate goal, to develop the most promising treatments for patients," said de Peppo.

While severity varies, bone defects and injuries are currently treated with bone grafts, taken either from another part of the patient's body or a donor bone bank, or with synthetic substitutes. None of these permit complex reconstruction, and they may elicit immune rejection or fail to integrate with surrounding connective tissues. For trauma patients, suffering from shrapnel wounds or vehicular injury, these traditional treatments provide limited functional and cosmetic improvement.

After a comprehensive in vitro analysis of the generated bone, the NYSCF team assessed stability when transplanted in an animal model to address a major concern for iPS-based cell therapies. Undifferentiated iPS cells can form teratomas, a type of tumor. The iPS cell-derived bone substitutes were implanted under the skin of immunocompromised mice. After 12 weeks, the explanted constructs matured and showed no malignancies but complete maturation of bone tissue, while blood vessel cells began to integrate along the grafts. These results indicate the stability of the bone substitutes.

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NYSCF scientists create personalized bone substitutes from skin cells

VistaGen Therapeutics and Duke University Publish Results on Production of Functional 3D Human Heart Tissue

SOUTH SAN FRANCISCO, CA--(Marketwired - May 7, 2013) - VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, announced that its high-quality, human pluripotent stem cell-derived cardiomyocytes (heart cells) were used by collaboration partner Duke University to grow a revolutionary three-dimensional (3D) human heart muscle. An abstract of the original research article published in Biomaterials, an international journal covering the science and clinical application of biomaterials, can be found online at: http://www.sciencedirect.com/science/article/pii/S0142961213004705.

Researchers at Duke University combined VistaGen's human stem cell-derived heart cells with innovative tissue engineering and cardiac electrophysiology technologies to grow what is being called a "heart patch," which mimics the natural functions of native human heart tissue. This heart patch technology is being developed to aid in a better understanding of the biology critical to cardiac tissue engineering, for applications in regenerative cell therapy for heart disease, and as predictive in vitro assays for drug rescue and development.

H. Ralph Snodgrass, PhD, VistaGen's President and Chief Scientific Officer, stated, "The developed contractile forces and other functional properties of these cardiac tissues are remarkable and are significantly higher than any previous reports. The achievement of successfully growing a human heart muscle from cardiomyocytes derived from human pluripotent stem cells not only expands the scope of our drug rescue capabilities, but also reflects the advanced nature and potential of our collaboration with the skilled biomedical engineers at Duke Medical Center."

"VistaGen's human cardiomyocytes produced engineered cardiac tissues that exhibited structural and functional properties superior to those previously reported," said Dr. Nenad Bursac, Associate Professor in the Departments of Cardiology and Biomedical Engineering at Duke University. "This is the closest man-made approximation of natural human heart muscle to date."

Achieving this capability represents a significant breakthrough in heart cell-based therapies and in testing new medicines for potential heart toxicity and potential therapeutic benefits impacting heart disease. The following are among several key development points from the study:

The original research article also will be published in print in Biomaterials.

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.

VistaGen's small molecule prodrug candidate, AV-101, has completed Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.

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VistaGen Therapeutics and Duke University Publish Results on Production of Functional 3D Human Heart Tissue

Dr. Ernesto Gutierrez is Named President of World Stem Cells Clinic, a Stem Cell Research and Stem Cell Treatment …

Tampa, FL (PRWEB) May 04, 2013

World Stem Cells Clinic in Cancun is pleased to announce the appointment of Dr. Ernesto Gutierrez to the position of President of their medical lab and treatment center. Dr. Gutierrez brings experience and intensity to his new position at World Stem Cells Clinic and promises he and his team of experts will provide the best medical care available in the world to improve their patients quality of life.

Dr. Ernesto Gutierrez is an extensively educated physician. He is a graduate from the Universidad Anhuac Norte, School of Medicine in Mexico City and additionally holds a Post-Graduate Degree in Aesthetic and Anti-Aging Medicine from the Instituto Mexicano de Medicina Antienvejecimiento y Esttica, Guadalajara, Mexico. He holds active membership of both the Mexican College of Aesthetic and Anti-Aging Medicine and the Age Management Medicine Group. Dr. Gutierrez has spent considerable time in additional training in the US, with rotations in both Florida and Nevada for two specialty organizations and is certified in Age Management Medicine by the Cenegenics Education and Research Foundation part of Cenegenics Medical Institute in Las Vegas, Nevada. His bilingual English and Spanish skills, both in medical and conversational applications, are excellent. Dr. Gutierrez is the perfect addition to the team given his thorough understanding of both the North and South American medical systems.

Dr. Ernesto Gutierrez explains how the clinic and laboratory at World Stem Cells Clinic in Cancun were designed, built and are operated under the stringent guidelines as established by The International Cellular Medical Society (ICMS) and the US Food and Drug Administrations Good Tissue Practice (cGTP) regulations for pharmaceutical, biologics and clinical laboratories. The strict adherence to these established guidelines and policies guarantees the highest quality of clinical care and stem cell treatment safety for the patient. At World Stem Cells Clinic they continually strive to improve the patients outcomes with breakthrough research and by creating new cells and protocols.

Both the US patient management team at World Stem Cells, LLC (http://worldstemcells.com/) and their Cancun patient management team at World Stem Cells Clinic (http://worldstemcellsclinic.com/) offer medical information on the stem cell treatments provided by the doctors, help patients arrange transportation to Cancun and within the city, hotels, medical records procurement, and basically ensure that their every need is met.

Dr. Gutierrez says, "we will treat you like family!"

Working under the guidelines set forth by ICMS, World Stem Cells Clinic (http://worldstemcellsclinic.com/) provides Stem Cell Treatment for Ankylosing Spondylitis, Autism, Cerebral Palsy, Charcot-Marie-Tooth Disease (CMT), Crohns Diseases, COPD, Fuchs disease, Guillain-Barre Syndrome, Hashimotos Thryroiditis, ITP, Kidney Diseases, Macular Degeneration, Lupus (SLE), Multiple Sclerosis, PAD, Parkinsons disease, Rheumatoid Arthritis, Scleroderma, Stroke, Ulcerative Colitis at its contract Clinics, GLP laboratory, doctors and hospitals in the beautiful resort area of Cancun. They endeavor to provide the best care possible at a competitive price while providing documentation of all treatments that can be used to provide better future care and scientific data to the medical industry. World Stem Cells Clinic is participating in ICMS (International Cellular Medical Society) Stem Cell Reimplantation Registry. They provide Stem Cell Treatments to patients in need.

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Dr. Ernesto Gutierrez is Named President of World Stem Cells Clinic, a Stem Cell Research and Stem Cell Treatment ...