SAN LUIS OBISPO, California – February 5, 2001 – FzioMed, Inc. announced today that it has initiated a clinical trial of the company’s Oxiplex™/SP spine surgery product. The U.S. Food and Drug Administration (FDA) recently approved FzioMed’s Investigational Device Exemption (IDE) application to conduct a multi-center clinical pilot study of the new product. Oxiplex™/SP is a bioresorbable material that is applied within the surgical site during lumbar surgery and designed to reduce post-operative peridural scarring, also known as post-surgical adhesions. Post-surgical adhesions are a leading complication of many surgical procedures. Over 400,000 patients undergo lumbar surgery in the United States each year.
Ronald Haynes, President and CEO of FzioMed, Inc. said, “The start of this, our second Oxiplex™ clinical trial, is a key milestone in expanding the market potential for FzioMed technology. There is a great unmet need for an effective anti-adhesion product in spine surgery and we believe that Oxiplex™/SP can be an important tool for surgeons.”
FzioMed is a privately-held biomedical company engaged in the development and manufacture of bioresorbable products based on the company’s patented Oxiplex™ technology. Oxiplex™ is a unique polymer technology that is formulated for a variety of targeted medical indications and markets. Products in development using Oxiplex™ include those for the prevention of post-surgical adhesions, hemostasis during surgery, osteoarthritis and drug delivery. FzioMed products are at various stages of clinical and pre-clinical development, and are directed towards high growth markets in the rapidly growing field of biosurgery products.
Oxiplex™ is a registered trademark of FzioMed, Inc.