ProChon Biotech Selects Averion International for the BioCart Cartilage Regeneration System Study
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WOBURN, Mass.--(Business Wire)-- ProChon Biotech, Ltd., an innovator of tissue regenerative technologies that are being developed to relieve pain and restore the mobility and quality of life for sufferers of articular cartilage injuries, today announced that it has selected Averion International Corp. (OTC BB: AVRO), a leading international clinical research organization, to support and manage the clinical development of ProChon`s BioCart Autologous Cartilage Regeneration System. Averion brings a 20 year history working with living cell therapies and will support ProChon`s FDA Phase II multicenter clinical study by managing additional site selection and patient recruitment, site monitoring, data management, data analysis, report writing, quality assurance and regulatory services. The first clinical study site, the Mount Sinai School of Medicine in New York, is currently recruiting patients. "Averion`s working knowledge of global regulations concerning cell therapy in the United States and around the world, coupled with their orthopedic expertise, makes Averion an ideal partner for us as we embark upon this critical FDA approval process," said Patrick O`Donnell, chief executive officer of ProChon. "We believe that the BioCartTM System has the potential to be a first line of treatment option for the hundreds of thousands of people with articular cartilage damage. The ProChon/Averion team is focused on accelerating all clinical trial activities, further underscoring our commitment to accelerating the rehabilitation process and quality of life for patients with knee pain associated with cartilage injury." "We are pleased to work with ProChon, a company that is redefining the focus of clinical orthopedics, and provide them with clinical trial management support in the U.S. and abroad," said Philip T. Lavin, Ph.D., founder and vice chairman of the board of Averion International. "For more than 25 years we have been a trusted partner in clinical research and are committed to working with ProChon to ensure that its clinical trials are executed to the highest possible standard." About Averion International Corp. Averion International Corp. (Averion) is a leading international clinical research organization (CRO) with proven expertise in supporting global clinical trials for pharmaceutical, biotechnology and medical device companies. Our well-designed trials span the product development lifecycle from first-in-man through regulatory approval and post-marketing surveillance studies. Major therapeutic categories including medical devices (including orthopedics), oncology, cardiology, and critical care are primary therapeutic areas for Averion since its` founding in 1983. About The BioCart Cartilage Regeneration System The BioCart™ Cartilage Regeneration System is an autologous chondrocyte implant system that is a safe, minimally invasive, high-quality implant for long-term articular cartilage regeneration stemming from joint cartilage defects and injuries. The system is commercially available in Italy, Greece and Israel and is undergoing an FDA Phase II multicenter clinical study in the United States. To date, over 70 patients have received the BioCartTM implant with some patients over five years post-implantation. About ProChon Biotech, Ltd. Founded by world leaders in the field of regenerative medicine, ProChon is a privately-held biotechnology company focused on modulating the fibroblast growth factor (FGF) system to enable it to create more effective solutions for tissue regeneration. ProChon`s products combine cell regeneration technologies with proprietary growth factors and biocompatible scaffolds to restore injured or chronically damaged tissues to normal. ProChon has filed patent applications, licensed patents for core technologies and products, and has been granted patents in the United States, Europe, Israel and Australia. ProChon`s R&D facility resides in Ness Ziona, Israel and the executive management team is based in Woburn, Massachusetts. Schwartz Communications Jon Siegal, 781-684-0770 prochon@schwartz-pr.com or ProChon Biotech, Ltd. Thomas C. May, 508-735-5524 tmay@prochon.co.il Copyright Business Wire 2009
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