SAN LUIS OBISPO, California – December 12, 2005 – FzioMed, Inc. announced today that it has submitted its third Pre-Market Approval (PMA) application module to the U.S. Food and Drug Administration for the company’s Oxiplex/SP Adhesion Barrier Gel.
Four modules are required to complete FzioMed’s PMA application for approval to market Oxiplex/SP Gel in the United States. The three modules filed thus far contained documentation and data related to the design, development, pre-clinical testing, quality assurance and manufacturing of Oxiplex/SP Gel. The fourth, and final, module will include the clinical results from the Oxiplex/SP Gel pivotal clinical trial currently in progress in the U.S. FDA previously granted expedited review status to FzioMed for its Oxiplex/SP PMA application.
“This is a significant milestone and I want to recognize the diligent efforts of FzioMed’s team in completing three of the four modules required in the U.S. approval process for Oxiplex/SP Gel,” said John Krelle, President and Chief Operating Officer. “We continue to work closely with the FDA to conclude our PMA application on schedule and submit the final PMA module with sufficient data to support the safety and efficacy of Oxiplex/SP Gel.”
Oxiplex/SP Gel is a patented synthetic, bioabsorbable gel developed by FzioMed to reduce post-surgical epidural adhesions in discectomy, laminectomy, and laminotomy procedures in spine surgery. Post-surgical epidural adhesions can compress or tether the nerve root, often causing recurrent pain and radiculopathy following lumbar disc surgery. Previously published results from the company’s pilot clinical trial demonstrated that Oxiplex/SP Gel was easy to use and safe for patients undergoing unilateral lumbar disc surgery. The benefits of using Oxiplex/SP Gel during surgery included reduced leg pain and reduced lower extremity weakness, especially for patients with severe leg pain and weakness at baseline. Follow-up data demonstrated that the benefits of using Oxiplex/SP Gel continued 12 months after surgery.
Oxiplex/SP Gel is being evaluated in a multi-center, pivotal clinical trial in the U.S. Oxiplex/SP Gel is approved for sale in more than 45 countries outside of the U.S. including the European Union. The product is supplied to these OUS markets through FzioMed’s distribution partners.
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 adhesion prevention, tissue augmentation and regeneration, and the delivery of drugs. Oxiplex is an innovative polymer technology with uses in a variety of specialties including orthopedics, gynecology, general surgery, neurosurgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery currently marketed outside of the United States, Oxiplex/AP adhesion barrier for gynecologic and general surgery, and a cosmetic dermal filler.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.