STEMEDICA ENTERS INTO A GLOBAL DISTRIBUTION AGREEMENT WITH LIFE TECHNOLOGIES

Life Technologies To Distribute Stem Cell Products For Research Use
(Source: June 13 2013; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and clinical development, announced today they have entered into a Global Distribution Agreement with Life Technologies Corporation. Under the terms of this agreement, Life Technologies will exclusively offer Stemedica’s ischemic tolerant allogeneic adult mesenchymal stem cells (itMSCs) and neural stem cells (itNSCs) for sale worldwide to research, academic institutions and corporations both in the United States and internationally. Stemedica stem cell lines will be sold under the brand name Gibco® and will be available to purchase for research initiatives beginning Q2, 2013. The label will also carry the name of Stemedica as the manufacturer of the cell lines.

Life Technologies is a global biotechnology company with customers in more than 180 countries, providing more than 50,000 end-to-end solutions for customers in the fields of scientific research, genetic analysis and applied sciences. The Company’s systems, reagents and consumables represent some of the most cited brands in scientific research. Life Technologies employs approximately 10,000 people and upholds its ongoing commitment to innovation with more than 5,000 patents and exclusive licenses. The Company had sales of $3.8 billion in 2012.

“We are honored to be associated with a company of the caliber of Life Technologies.” stated Maynard Howe, PhD, CEO and Vice Chairman of Stemedica. “The goal of our collaboration is to serve the worldwide market of corporate research and academic institutions. Providing multiple stem cell products using a patented large-scale Reduced Oxygen Tension manufacturing process (Patent #8,420,394) to scientists who are conducting or plan to conduct stem cell research will accelerate new discoveries and ultimately enable physicians to treat medical conditions and diseases for which there are no effective treatments.”

According to Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica, “This collaboration between Stemedica and Life Technologies creates a unique opportunity for all researchers and scientists around the world to advance their discoveries. This acceleration is possible because Stemedica’s stem cell products are manufactured under controlled cGMP conditions allowing for uniform reproducibly manufactured cells to support controlled research. essor of Medicine. He joined the faculty of the University of Pennsylvania in 1996.

About Stemedica Cell Technologies, Inc.  
http://www.stemedica.com
 
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke, acute myocardial infarct, and cutaneous photoaging. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

ROBERT SULLIVAN, PhD, DEAN OF RADY SCHOOL OF MANAGEMENT, TO JOIN STEMEDICA BOARD OF BUSINESS ADVISORS

(San Diego, California – May 2, 2013)
Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that Robert Sullivan, PhD, dean of the Rady School of Management at the University of California, San Diego (UC San Diego) has agreed to join the Company’s Business Advisory Board. Dr. Sullivan is an expert on entrepreneurship, knowledge management and operations management.

As an Advisor, Dean Sullivan’s specific focus will be Stemedica’s newly formed Cardiology Division which aims to advance Stemedica’s national and international clinical trials in chronic heart failure, acute myocardial infarct and other cardiac conditions.  Within this Division, Dr. Sullivan will assist the Company as a liaison between not only the San Diego biotech and business communities, but with organizations worldwide.

As the founding dean of the Rady School of Management, Dr. Sullivan has increased the school’s brand in San Diego and throughout the world. He has successfully recruited top-tier faculty from universities such as the University of Chicago, Massachusetts Institute of Technology (MIT), New York University, Northwestern, Princeton, Stanford, the Wharton School and Yale. In 2011, Dr. Sullivan was elected vice chair-chair elect of the Association to Advance Collegiate Schools of Business (AACSB International), the premier accrediting body for business education.

Dr. Sullivan has held a variety of posts prior to joining the Rady School of Management at UC San Diego. Before coming to San Diego, he was dean of the Kenan-Flagler Business School of The University of North Carolina, Chapel Hill. From 1995 to 1997, he served as director of the University of Texas at Austin’s IC2 Institute, a nontraditional international center for research and education on innovation, creativity, capital and commercialization. Dr. Sullivan served as dean of the Graduate School of Industrial Administration at Carnegie Mellon University from 1991 to 1995. During his tenure, the school’s rankings rose dramatically. He led a reengineering of the school’s educational programs, including integrating advanced technology into the field of finance and creating experiential and international distance-learning opportunities for students. Earlier in his career, he served in a variety of posts at the University of Texas.

Dr. Sullivan holds a doctorate in operations management from Pennsylvania State University, a master’s degree in production management and quantitative methods from Cornell University and a bachelor’s degree in mathematics from Boston College.

Dr. Sullivan commented, “We are fortunate to have such a vibrant biopharmaceutical environment in the San Diego area. Stemedica represents the type of dynamic, emergent company that–with the right blend of strategy, leadership and resources–can become a great success story. The stem cell and regenerative space is growing rapidly and I look forward to contributing my experience and skills to help Stemedica take advantage of this opportunity.”

Maynard Howe, PhD, Chief Executive Officer and Vice Chairman added, “One of the traits of a knowledge-based company is knowing when to reach out to the best external resources to provide a most welcome leadership perspective. We are so very fortunate to have a leading international resource—in the presence of Dean Sullivan—right here in our San Diego community. We look forward to working with him.”

Sergey Sikora, PhD, President of Stemedica’s Cardiology Division added, “We are all very excited about Dean Robert Sullivan joining our Business Advisory Board. It is a true honor to have a business leader of his caliber join our board and assist in the development of our Cardiology Division. He has a track record of bringing business schools from the virtually unknown to world-known premier business education institutions. His experience in rapidly growing organizations will have a huge impact on our organization as well.”

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for clinical trials in ischemic stroke, cutaneous photoaging and acute myocardial infarction. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult allogeneic stem cells. The company is headquartered in San Diego, California.

For more information regarding Stemedica Cell Technologies, Inc., contact Dave McGuigan at dmcguigan@stemedica.com.

STEMEDICA ISSUED U.S. PATENT FOR ECTODERMAL STEM CELLS

(Source: April 30; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leading manufacturer of adult allogeneic stem cells and stem cell factors announced that the Company has been issued “keystone” Patent No. 8,420,394 titled “Culturing Ectodermal Cells Under Reduced Oxygen Tension” by the United States Patent and Trademark Office (USPTO). This patent broadly covers Stemedica’s proprietary manufacturing process for enhancing the proliferation and differentiation potential of ectodermal cells of any origin. The ectodermal layer gives rise to the cells of the skin and nervous system. The patented process provides Stemedica exclusivity for expanding and manufacturing ischemia tolerant ectodermal cells under reduced oxygen tension.

Nikolai Tankovich, MD, PhD, FASLMS, President and Chief Medical Officer of Stemedica noted, “We are pleased that the USPTO recognizes the uniqueness of the technology and processes to manufacture ectodermal cell of any origin. This includes, but is not limited to: allogeneic and autologous adult, embryonic, parthenogenic and iPS sources of stem cells. When compared to stem cells expanded in normal oxygen, Stemedica cells exhibit superior migratory and engraftment properties, enhanced gap junction formation and a unique gene profile. These critical cell characteristics are the direct result of Stemedica’s proprietary technology and expansion methodology.”

Alex Kharazi, MD, PhD, Chief Technology Officer at Stemedica noted that, “We recently published data from the spinal cord injury study in rats done by Ivan Cheng, MD, at Stanford University showing significant efficacy of Stemedica’s neural stem cells injected intrathecally both distally and at the site of injury. We also anticipate publishing extremely promising data in the application of our neural stem cells, mesenchymal stem cells and combined treatment in a mouse model of Alzheimer’s disease. This large scale animal study was funded by the Swiss government and examines both young and older mice for anatomical and biomarker changes in beta amyloid and tau proteins and brain re-perfusion.”

Maynard Howe, PhD, Vice Chairman and Chief Executive Officer of Stemedica commented, “While we are pleased to have added another patent to our growing portfolio of intellectual property, we are extremely excited to be issued this “keystone” patent. It represents the culmination of our research and development, coupled with our cGMP manufacturing processes and our license to make these cells broadly available.”

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke, acute myocardial infarction, and cutaneous photoaging. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

STEMEDICA ENTERS INTO STEM CELL LICENSING AGREEMENT WITH KALBE FARMA

Multi-Stem Cell Products Address Disease Conditions in Southeast Asia
(Source: April 25 2013; Stemedica Cell Technologies, Inc.)

Stemedica Asia PTE, LTD, a wholly owned subsidiary of Stemedica Cell Technologies, Inc., a leading manufacturer of adult allogeneic stem cells and stem cell factors, announced that the Company has entered into a definitive licensing agreement with the Stem Cell and Cancer Institute, a division of PT Kalbe Farma Tbk. (Kalbe). Under the terms of the Agreement Kalbe shall be the exclusive licensor of Stemedica’s ischemic tolerant adult allogeneic mesenchymal and neural stem cells for use in clinical trials in Indonesia, Philippines and Thailand. The Agreement also provides Kalbe with first rights of refusal for additional countries including Singapore, Malaysia, Vietnam, Brunei, Cambodia, Laos and Myanmar. Kalbe’s Stem Cell and Cancer Institute shall be responsible for organizing and funding clinical trials in Southeast Asia.

Headquartered in Central Jakarta, Indonesia, Kalbe is the largest publicly listed pharmaceutical company in Southeast Asia with close to US $6 billion in market capitalization as of Q1 2013. Established in 1966, Kalbe has expanded by strategic acquisitions of companies involved in prescription and over-the-counter pharmaceuticals, energy drinks and nutritional products. Kalbe’s Prescription Pharmaceutical Division features a complete product range including the manufacture of generics and licensed drugs. Pharma Metric Labs, a Kalbe company, is an independent Contract Research Organization (CRO) providing global studies in oncology, monoclonal antibodies and stem cells. Kalbe’s packaging and distribution capabilities allow the company to reach over one million outlets with their brands.

Kalbe’s Stem Cell and Cancer Institute was established in 2006 as part of Kalbe’s founder Dr. Boenjamin Setiawan’s belief that stem cells and regenerative medicine represent the future of medicine. According to Dr. Setiawan, “Our scientists and researchers have thoroughly evaluated worldwide stem cell manufacturers. We have chosen to license Stemedica products based upon the quality of their cGMP manufacturing and the unique attributes of their ischemia tolerant stem cells. Their ability to scale production to treat hundreds of thousands of patients from a single tissue donation is in keeping with our objective as a pharmaceutical company is to bring a safe, effective, off-the-shelf solution to millions of people in Southeast Asia suffering from disease.”

Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica noted, “We are honored to be associated with a company of Kalbe’s caliber; a company that strictly adheres to the ethical and regulatory guidelines in medicine.”

Addressing the significance of the collaboration, Maynard Howe, PhD, Stemedica’s Vice-Chairman and Chief Executive Officer noted, “Our agreement with Kalbe is in keeping with our corporate strategy of partnering with global and regional pharmaceutical companies that are committed to licensing our multiple stem cell products for use in approved clinical trials. We are extremely pleased to have a strong partner such as Kalbe for Southeast Asia.”

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for clinical trials in ischemic stroke, cutaneous photoaging and myocardial infarct. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult allogeneic stem cells. The company is headquartered in San Diego, California.

About PT. Kalbe Farma Tbk.
PT Kalbe Farma Tbk. (“Kalbe”) is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has a broad and strong portfolio of brands in prescription pharmaceuticals (Cefspan, Brainact, Broadced, etc), OTC pharmaceuticals (Woods, Promag, Mixagrip, Komix, etc), ready-to-drink products (Hydro Coco, Extra Joss, Nitros) and nutritional products (Milna, Prenagen, Diabetasol, etc), complemented with a robust distribution arm covering much of the Indonesian archipelago. Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

EMORY CARDIOLOGISTS ARSHED QUYYUMI AND JAVED BUTLER JOIN STEMEDICA CARDIOLOGY DIVISION SCIENTIFIC ADVISORY BOARD

(Source: April 22 2013; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that Professors Arshed Quyyumi, MD, FRCP, FACC and Javed Butler, MD, MPH, FACC, FAHA of the Emory Clinical Cardiovascular Research Institute have agreed to join the Scientific Advisory Board for Stemedica’s Cardiology Division.

Dr. Arshed A. Quyyumi has been involved in clinical translational research in cardiovascular diseases for over 25 years. His research focuses on vascular biology, angiogenesis, progenitor cell biology, mechanisms of myocardial ischemia, and the role of genetic and environmental risks on vascular disease. In 2001 he was appointed Professor of Medicine in the Division of Cardiology at the Emory University School of Medicine. In 2010, he was named Co-Director of the Emory Clinical Cardiovascular Research Institute (ECCRI). Dr. Quyyumi serves on the editorial boards of several national journals and is a reviewer for the National Institute of Health’s (NIH) National Heart, Lung and Blood Institute Study Sections. Dr. Quyyumi has authored more than 220 peer-reviewed publications and has been an invited speaker and session chair at many scientific meetings and conferences. During his academic career, Dr. Quyyumi has managed more than 50 NIH, industry-funded, or investigator-initiated projects, including numerous clinical trials.

Dr. Javed Butler’s research focuses on the disease progression, outcomes, and prognosis determination in patients with heart failure, with special emphasis on patients undergoing cardiac transplantation and left ventricular assist device placement. Before moving to Emory University where he is a professor of cardiology, he was Director for the Heart and Heart-Lung Transplant programs at Vanderbilt University. He also serves as the Deputy Chief Science Advisor for the American Heart Association. Additionally, he serves various editorial responsibilities for the Journal of the American College of Cardiology, Journal of Cardiac Failure, American Heart Journal, Journal of the American College of Cardiology – Heart Failure, Heart Failure Clinics, Current Heart Failure Report, and Congestive Heart Failure. He is board certified in Cardiology, Internal Medicine, Advanced Heart Failure and Transplantation Medicine, and Nuclear Cardiology. Dr. Butler also serves on the Executive Council of the Heart Failure Society of America. He has published over 175 peer reviewed papers and has participated in over 50 federally funded and non-federally funded clinical trials. He has served on several steering committees, events committees and data safety monitoring committees for multi-center clinical trials.

Stephen Epstein, M.D., Chairman of the Medical & Scientific Advisory Board for Stemedica’s Cardiology Division, commented, “I am delighted to welcome Drs. Quyyumi and Butler to the cardiology team. I believe our collective breadth of experience will provide Stemedica with both perspective and direction as the company expands its efforts in cardiovascular medicine.”

Stemedica recently formed its Cardiology Division due to the considerable progress in the translational application of its ischemia tolerant adult allogeneic stem cells for cardiovascular diseases. The Company gained FDA approval for a multi-center Phase II clinical trial for intravenous treatment of AMI with its Stemedyne™-MSC product. Regulatory approval has also been granted to the National Medical Research Center in Astana, Kazakhstan for a Phase III trial with Stemedyne™-MSC. A Phase II clinical trial for chronic heart failure has begun at Hospital Angeles in Mexico. The Cardiology Division Scientific Advisory Board was organized to support these and future efforts.

Sergey Sikora, Ph.D., M.D., President of Stemedica’s Cardiovascular Division noted, “Emory has been one of the leaders in cardiology and we are honored to have physicians of Drs. Quyyumi and Butler’s statures participate with us in cardiovascular translational medicine.”

Nikolai Tankovich, MD, PhD, FASLMS, President and Chief Medical Officer of Stemedica commented, “We are pleased by the impressive and promising outcomes that Stemedica’s adult stem cells are experiencing in cardiology. We view this area as critical for the success of Stemedica and have worked diligently to get the best experts to advise us in this field.”

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for clinical trials in ischemic stroke, cutaneous photoaging and myocardial infarct. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult allogeneic stem cells. The company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

STEMEDICA AND THE SCRIPPS RESEARCH INSTITUTE TO JOINTLY INVESTIGATE THE THERAPEUTIC EFFECT OF ISCHEMIA TOLERANT MESENCHYMAL STEM CELLS (itMSC) AND STEM CELL FACTORS IN LUNG INJURY AND SEPSIS

(San Diego, CA, December 19, 2012)
Stemedica Cell Technologies, Inc., a leading manufacturer of adult ischemia tolerant allogeneic stem cells and stem cell factors announced that the Company has signed an agreement with The Scripps Research Institute to investigate the role of Stemedica’s ischemia tolerant human mesenchymal stem cells and stem cell factors as a therapy for severe lung injury and sepsis.

Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) are the most common causes of respiratory failure among critically ill patients. The mortality for this syndrome remains high at 30-40% and accounts for approximately 75,000 deaths per year. Severe bacterial pneumonia is the most common cause of ALI/ARDS and is frequently associated with septic shock. The only intervention for ALI/ARDS that has resulted in a mortality benefit is low tidal volume ventilation. Despite several attempts, there have been no pharmacological agents that have reduced the morbidity or mortality from ALI/ARDS. Furthermore, treatment of bacterial pneumonia is increasingly hampered by the rapid spread of multi-drug resistant bacteria and the lack of new antimicrobial agents to treat them. Therefore, given the large public health impact of severe bacterial pneumonia and ALI/ARDS, novel therapies are needed to address this common and growing clinical problem.

Bone marrow derived mesenchymal stem cells (MSCs) are an emerging form of cell-based therapy that have been increasingly studied in experimental models of lung injury and sepsis. Experimental studies have shown that murine MSCs can improve survival, reduce lung injury, and enhance bacterial clearance in clinically relevant models of bacterial pneumonia in mice. These beneficial effects have also been achieved using human MSCs in an ex-vivo human lung model of ALI.

Naveen Gupta, MD, Assistant Professor of Molecular and Experimental Medicine and Principal Investigator at The Scripps Research Institute, has authored and co-authored a number of publications in peer-reviewed journals in this field. He commented that, “This project will investigate the therapeutic effects of Stemedica’s ischemia tolerant MSCs in experimental lung injury and sepsis. Specifically, it will determine the optimal route, dose and timing of cell delivery in an E. coli pneumonia model. In addition, studies will be done using purified soluble factors secreted by the stem cells to determine whether a therapeutic effect comparable to using live MSCs can be achieved.” Dr. Gupta continued: “Given Stemedica’s expertise in the field of developing MSC-based clinical therapies and the scientific and clinical expertise in Pulmonary and Critical Care Medicine present at Scripps, I believe that this will be a mutually beneficial and productive collaboration that may have important implications in how cell based therapy is applied to critically ill patients.”

Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica noted, “One of the great advantages of using Stemedica’s cGMP produced, FDB licensed (Food & Drug Branch of the California Department of Public Health) stem cells is that they have already been approved by the Food and Drug Administration for use in a variety of clinical trials. The same cGMP manufactured cell can be used in all phases of the approval process from preclinical through clinical trials and ultimately to commercialization. This will contribute significantly to accelerating the process from benchtop to bedside.”

Maynard Howe, Ph.D., Vice Chairman and Chief Executive Officer of Stemedica commented, “We are pleased to be working with a renowned organization like Scripps to advance treatment for this critical condition. The goals of our organizations are aligned–we strive to save lives–and one of the most meaningful ways we can do this is to stem mortality from ARDS.”

About The Scripps Research Institute
The Scripps Research Institute is one of the world’s largest independent, not-for-profit organizations focusing on research in the biomedical sciences. Over the past decades, TSRI has developed a lengthy track record of major contributions to science and health, including laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. The institute employs about 3,000 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists (including three Nobel laureates) work toward their next discoveries. The institute’s graduate program, which awards Ph.D. degrees in biology and chemistry, ranks among the top ten of its kind in the nation. For more information, see www.scripps.edu.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke, acute myocardial infarction, and cutaneous photoaging. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

For more information please contact Dave McGuigan at dmcguigan@stemedica.com

Noted Neurosurgeon Joseph Maroon, MD, FACS To Head Stemedica Medical & Scientific Advisory Board

(Source: November 19 2012; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, announced today that Joseph C. Maroon, MD, FACS Neurosurgeon, Vice Chairman and Professor of the Department of Neurological Surgery at the University of Pittsburgh Medical Center (UPMC) has agreed to serve as Chairman of the Company’s Medical and Scientific Advisory Board. Dr. Maroon is also the Heindl Scholar in Neuroscience at UPMC.

Dr. Maroon is widely regarded as a premiere specialist in the surgical treatment of injuries and diseases of the brain and spine. His research into brain tumors, concussions and diseases of the spine have led to many innovative techniques for diagnosing and treating these disorders. He is the author of more than 250 peer-reviewed papers and 55 books or book chapters.

Dr. Maroon commented, “Stem cells are taking on an increasingly important role in the treatment of multiple neurological conditions. I have been impressed with Stemedica’s credentials as a cGMP manufacturer of its proprietary lines of ischemic tolerant neural and mesenchymal stem cells that are licensed for use in clinical trials. These cells possess the important safety, potency, purity and immune-privileged characteristics that are needed in translational medicine. I look forward to helping to guide the Company’s scientific and medical efforts as they move forward in the clinical trial process toward commercialization.”

David G. Armstrong, DPM, MD, PhD, professor of surgery and director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona Department of Surgery, and a current member of Stemedica’s Scientific Advisory Board, commented, “I join my colleagues in welcoming Dr. Maroon. Many of the conditions targeted by Stemedica involve ischemia and nerve damage. Addressing these complicated disease mechanisms requires integrative, synergistic approaches among multiple specialists. Dr. Maroon brings a depth and breadth of experience that will be helpful in our efforts to help patients.”

William Maloney, MD, Professor and Chair, Stanford University School of Medicine Orthopaedic Surgery, and a Board member of Stemedica commented, “Strategically, Stemedica is strengthening affiliations with respected researchers and clinicians at the major medical institutions in the United States and abroad. The University of Pittsburgh is well-recognized as one of the leading centers for the evaluation and treatment of neurological trauma and is also one of the top institutions in stem cell research. Dr. Maroon has been a major contributor to the field of neurological trauma. I am personally delighted to welcome another strong academically-oriented physician to the Stemedica team.”

Nikolai Tankovich, MD, PhD, FASLMS, President and Chief Medical Officer of Stemedica commented, “Stemedica is honored to have a physician of Dr. Maroon’s stature join our team. We look forward to working closely with him as we continue to grow our preclinical and clinical initiatives.”

Stemedica currently has three FDA-approved clinical trials for ischemic stroke, myocardial infarct and cutaneous photoaging. The Company anticipates additional FDA filings in the near term for clinical trials in diabetic foot ulcers, osteoarthritis, vascular dementia and spinal cord injury. Stemedica’s Advisory Board currently includes clinical experts in these and other indications. Under Dr. Maroon’s leadership, Stemedica will be expanding its Medical and Scientific Advisory Board.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company that is committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for clinical trials in ischemic stroke, cutaneous photoaging and myocardial infarct. Stemedica is currently developing regulatory pathways for a number of other medical indications using adult allogeneic stem cells. The company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com

Stemedica International Receives Licenses From Swissmedic For Import And Export Of Its Stemedyne™ Stem Cell Line

Epalinges, Switzerland (August 14, 2012)

Stemedica International, SA (Epalinges, Switzerland), a wholly owned subsidiary of Stemedica Cell Technologies, Inc. (“Stemedica”), a leader in adult stem cell research and manufacturing, announced today that it has been granted a series of licenses by Swissmedic (the Swiss equivalent of the United States Food and Drug Administration).  These licenses specifically authorize the Company to import and export its Stemedyne™ stem cell products worldwide for human use in approved clinical trials.

Granting of the license by Swissmedic marks the culmination of a two-year inspection process of Stemedica’s United States and Swiss operations. The Swiss government’s rigorous inspection and approval process has included: (1) a comprehensive, in-depth audit of Stemedica’s processes and procedures; (2) the examination of Stemedica’s quality systems; and (3) interviews with facility management and onsite inspections of the facilities.

Stemedica currently produces two lines of ischemia-tolerant adult allogeneic stem cell products. These include Stemedyne™-MSC, bone marrow derived mesenchymal stem cells and Stemedyne™-NSC, neural stem cells. A third product, Stemedyne™ Retinal Pigment Epithelium (RPE) stem cells is currently in development. Stemedica now has full regulatory approval from the Swiss government to provide these cells to countries that can legally import them for the purpose of conducting clinical trials. Stemedica’s immune-privileged stem cells have been approved and are being used in clinical trials in the United States and in multiple countries.

Dr. Nikolai Tankovich, M.D., Ph.D., Chairman of Stemedica International, noted the significance of the Swiss approval, “Swiss safety regulations are among the most stringent in the world. We are pleased to be recognized for the relentless attention we place on creating cells with the highest standards for safety, purity, potency and scalability.”

According to Maynard A. Howe, PhD, CEO and Vice Chairman of Stemedica USA, “The Swiss government’s approval positions Stemedica International as one of only a few companies worldwide with broad-based regulatory compliance.  Our Swissmedic licenses, coupled with the US Food and Drug Administration (FDA) investigational new drug approval for our mesenchymal stem cells, provides assurance to regulators, hospitals, physicians, and patients, that Stemedica products meet the most rigid specifications. ”

Stemedica’s manufacturing process is in full compliance with current good manufacturing processes (cGMP) requirements in that there is full traceability for every batch lot released by the company.

Earlier this year, Stemedica International, along with its academic partner, The École Polytechnique Fédérale de Lausanne (EPFL) was awarded a $620,000 grant by the Swiss Commission for Technology and Innovation to study the use of optical coherence microscopy for functional label free imaging of brain perfusion and size/number of beta-amyloid plaques with Stemedyne™ neural and mesenchymal stem cells in an animal model for Alzheimer’s.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials.  The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke.  Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells.  The Company is headquartered in San Diego, California.  www.stemedica.com

For more information about Stemedica please contact Dave McGuigan at dmcguigan@stemedica.com

Stemedica Stem Cells Approved For Clinical Trials In Mexico For Chronic Heart Failure

(Source: May 29 2012; Stemedica Cell Technologies, Inc.)
Stemedica Cell Technologies, Inc. announced today that its strategic partner in Mexico, Grupo Angeles Health Services, has received approval from Mexico’s regulatory agency, COFEPRIS, for a Phase I/II single-blind randomized clinical trial for chronic heart failure. COFEPRIS is the Mexican equivalent of the United States FDA. The clinical trial, to be conducted at multiple hospital sites throughout Mexico, will utilize Stemedica’s adult allogeneic ischemia tolerant mesenchymal stem cells (itMSC) delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage. The COFEPRIS approval is the second approval for the use of Stemedica’s itMSCs. COFEPRIS approved Stemedica’s itMSCs in 2010 for a clinical trial for ischemic stroke. These two trials are the only allogeneic stem cell studies approved by COFEPRIS.

Grupo Angeles is a Mexican company that is 100% integrated into the national healthcare development effort. The company is comprised of 24 state-of-the-art hospitals totaling more than 2,000 beds and 200 operating rooms. Eleven thousand Groupo Angeles physicians annually treat nearly five million patients a year. Of these, more than two million are seen as in-patients. In just over two decades, Groupo Angeles has radically transformed the practice of private medicine in Mexico and contributed decisively to reform in the country’s health system. Grupo Angeles hospitals conduct an estimated 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.

“We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedica’s product for this indication. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition,” said Maynard Howe, PhD, CEO of Stemedica Cell Technologies, Inc.

Roberto Simón, MD, CEO of Grupo Angeles Health Services, noted, “We are proud to be the first organization to bring regulatory-approved allogeneic stem cell treatment to the people of Mexico. We envision that this type of treatment may well become a standard for improving cardiac status for chronic heart failure patients and are pleased to be partnering with Stemedica, one of the leading companies in the field of regenerative medicine.”

Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica commented, “For the more than five million North Americans who suffer from chronic heart failure, this is an important trial. Our ischemia tolerant mesenchymal stem cells hold the potential to improve ejection fraction—the amount of blood pumped with each heart beat—and therefore, dramatically improve quality of life.”

About Stemedica Cell Technologies, Inc. 
http://www.stemedica.com

Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com
For more information about Grupo Angeles and the chronic heart failure trial please contact Paulo Yberri at pyberri@angelesehealth.com.

STEMEDICA ISCHEMIC TOLERANT STEM CELLS PRODUCE SIGNIFICANT IMPROVEMENT IN CARDIAC FUNCTION AFTER HEART ATTACK

(Source: April 3 2012; Stemedica Cell Technologies, Inc.)
Transplanted ischemic tolerant mesenchymal stem cells (itMSC) developed by Stemedica Cell Technologies, Inc., a leader in adult allogeneic stem cell manufacturing, research and development, produced significant improvement in the pumping function of the left ventricle in patients who had experienced a heart attack. The study was presented at the 26th American College of Cardiology (ACC) meeting in Chicago, March 26, 2012 by Daniyar Jumaniyazov, MD, PhD and Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica.

Forty five patients who had experienced an acute myocardial infarct underwent reperfusion by stent and after being carefully matched, were divided into a treatment and a control group. The treatment group received intravenous infusion of Stemedica itMSCs on day seven; the control group received normal saline. At the end of three months, those in the treatment group experienced an 11 point improvement in the ejection fraction of the left ventricle (the amount of blood pumped with each heart contraction) in comparison with the control group. This level of improvement restored the treatment group’s ejection fraction to normal levels. In comparison, the control group showed a level of improvement expected with standard of care; however, the ejection fraction remained below normal. In addition, the treatment group had statistically significant improvements in two blood markers of inflammation; levels of C-reactive protein and BNP were lower in the treated group. Patients in the stem cell treatment group also had improvement in quality of life indicators. Magnetic Resonance Imaging (MRI) performed day six and again day 30 in the treatment group showed significant decreases in lesion size. Patients in this study will be followed for one year.

Commenting on the study, Nabil Dib, MD, MSc, FACC, Director, Clinical Cardiovascular Cell Therapy & Associate Professor of Medicine at the University of California, San Diego noted, “Data from this early clinical trial are very promising. If these results continue as patients are followed longer term, and if they can be replicated in a larger clinical trial, then Stemedica’s ischemic tolerant allogeneic mesenchymal stem cells may well play an important role in the treatment of heart disease.”

According to Jackie See, MD, FACC, an interventional cardiologist specializing in stem cell research in Fullerton, California, “These are impressive results and provide a great deal of hope for patients with heart disease. Stents open up the narrowed blood vessels. With the addition of stem cells, we can potentially rescue some of the damaged myocardial cells, promote new blood vessel growth, decrease inflammation, and strengthen the damaged muscle. I can see a day in the near future when intravenous itMSC administration becomes part of the standard of care following an acute myocardial infarct.”

Noting that not all stem cells are created equally, Dr. Tankovich raises a key point about the research, “This study highlights the importance of using allogeneic stem cells specifically manufactured to be effective in the toxic tissue environment following a heart attack. In vitro, we know that our itMSCs secrete more of the important healing factors in response to ischemia. Our cells also retain their ‘steminess,’ remaining undifferentiated and potent throughout the manufacturing process. They also pass the most stringent tests for infectious disease, acute and chronic toxicity and tumorigenecity, and they are immune privileged. These are some of the advantages of using a well characterized, homogeneous population.”

Dr. See notes that the importance of expanding cells from a single, healthy young donor versus using autologous bone marrow cells from the same patient. “Results from a large multi-center study supported by the National Heart, Lung, and Blood Institute, presented at the ACC, showed that bone marrow derived stem cells taken from older, sicker patients were not very effective in improving heart function. This is understandable, because these stem cells no longer have the power to differentiate, migrate, engraft and secrete the factors that are necessary for wound healing. So the patients who most need the treatment do not have potent stem cells to accelerate the cardiac healing process.”

Dr. Tankovich further notes that providing enough stem cells for thousands of patients who could benefit from Stemedica’s itMSC treatment is not an issue. “With our advanced expansion techniques, with only four passages, from a single tissue donation, we can treat half a million patients.”

The placebo controlled blinded Phase II clinical trial was conducted according to ICH guidelines at the National Medical Research Center (NMRC) in Astana, Kazakhstan. The NMRC is Kazakhstan’s premier medical research institute and internationally known for initial assessment and treatment of returning NASA astronauts. Based upon the outcome of this trial, NMRC is planning a Phase III trial using Stemedica’s itMSCs for a larger population.

Stemedica is planning a parallel Phase II clinical trial in the United States and Switzerland. The U.S. based trial will take place under Stemedica’s existing IND for the itMSCs.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

Media Contact for Stemedica: Dave McGuigan at dmcguigan@stemedica.com