SAN LUIS OBISPO, California – June 30, 2004 – FzioMed, Inc. today announced the presentation of preclinical data showing that Oxiplex/SP Adhesion Barrier Gel for Spine Surgery does not inhibit healing in non-critical bone defects. The poster presentation is being made at the 11th International Meeting on Advanced Spine Techniques (IMAST) held in Bermuda from July 1 to July 3, 2004.
Oxiplex/SP Gel is a synthetic, bioabsorbable gel developed by FzioMed to reduce epidural post-surgical adhesions following discectomy, laminectomy, and laminotomy procedures in spine surgery. Oxiplex/SP Gel is approved for sale in the European Union and in certain countries outside the United States. The product is supplied to these markets through FzioMed’s distribution partners. A pivotal clinical trial of Oxiplex/SP Gel is underway in the United States.
The study compares healing of a non-critical bone defect filled with Oxiplex/SP Gel to that of a control group where the defect is not filled with the gel. Results demonstrate that the presence of Oxiplex/SP Gel at the site of a bone defect does not inhibit healing at any time point. The results suggest further study of Oxiplex/SP Gel for use in preventing epidural adhesions in spine surgeries where bone fusion is desired. “This preclinical study, and previous comprehensive work with Oxiplex/SP Gel, support our goal to expand applications for FzioMed’s technology in orthopedic surgery,” said Ronald Haynes, President and CEO of FzioMed.
FzioMed is a privately held medical company engaged in the development and commercialization of synthetic, absorbable biomaterials based on the company’s patented Oxiplex technology. FzioMed is developing products for the prevention of post-surgical adhesions, for tissue healing and augmentation, and for the delivery of drugs. Oxiplex is an innovative polymer technology with potential uses across a wide variety of specialties including orthopedics, gynecology, general surgery, cardiac, neurosurgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery, currently marketed outside of the United States. Other FzioMed products are in various stages of development and commercialization, and are directed towards high growth markets in the rapidly growing field of biosurgery materials.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.