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IlluminOss Medical Receives ISO 13485
CertificationCompany with Innovative Technology for the Minimally Invasive Treatment of Bone Fractures Achieves Significant Milestone in CE Mark Approval Pathway East Providence, RI – February 20, 2009 – IlluminOss Medical Inc., a medical device company developing the innovative IlluminOss™ Photodynamic Bone Stabilization System for orthopedic surgery, today announced that it had received an ISO 13485 Certificate of Registration issued by BSI (British Standards Institute). This certification indicates that IlluminOss has implemented a quality system that conforms to the exacting International Organization for Standardization (ISO) standards for medical devices and is one of the key regulatory requirements for a CE Mark in the European Union as well as other international markets. ISO 13485 is an internationally recognized standardization system which defines standards for the design, development, production and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective devices. According to Bob Rabiner, Founder and President of IlluminOss Medical, "ISO 13485 certification represents a major milestone for IlluminOss and patients worldwide. We believe that our minimally invasive technology will fundamentally improve the treatment of hundreds of thousands of bone fractures by driving much earlier restoration of functionality, improving the durability of orthopedic repairs, decreasing pain and reducing scarring." About IlluminOss Medical Inc. IlluminOss Medical is a privately held, early-stage medical device company dedicated to the development of minimally invasive orthopedic systems for the stabilization and treatment of bone fractures. The IlluminOss Photodynamic Bone Stabilization System utilizes a photodynamic (light-curable) polymer system intended to eliminate the need for traditional, inconvenient and painful methods of bone fixation with external pins, plates and screws. The Company is currently developing the IlluminOss Photodynamic Bone Stabilization System for small bones such as fractures of the hands, wrists, clavicle and arms. It is anticipated that the IlluminOss Photodynamic Bone Stabilization System will also have applications in the spine and long bones. Founded in 2007, IlluminOss is headquartered in East Providence, RI. For more information about IlluminOss Medical, please visit www.illuminoss.com. |