SAN LUIS OBISPO, California – July 6, 2005 – FzioMed, Inc. announced today the presentation of preclinical studies demonstrating Oxiplex Gel as an injectable drug delivery system for a novel, synthetic peptide bone growth factor. The poster presentation is being made at the 12th International Meeting on Advanced Spine Techniques (IMAST) held in Banff, Alberta, Canada from July 7 through July 9, 2005.
Oxiplex is a synthetic, bioabsorbable, injectable gel formulated by FzioMed for the percutaneous delivery of therapeutics. FzioMed is developing Oxiplex gels for use in a variety of surgical applications including the prevention of post-surgical adhesions in spine, gynecologic and general surgeries.
The first study tested Oxiplex for its utility as a drug delivery system. The results demonstrated that Oxiplex loaded with the antibiotic ampicillin was easily injected into a site and did not impact the activity or diffusion of the ampicillin.
The second study evaluated Oxiplex as a vehicle for the delivery of a novel peptide bone growth factor being developed by FzioMed. The study compared healing in a bone defect filled with Oxiplex containing the growth factor to controls where the defect was filled with either Oxiplex alone or left unfilled. The results showed that Oxiplex alone had a positive stimulatory effect on bone healing. However, when Oxiplex was combined with the bone growth factor, there was an additional acceleration of bone healing.
“The promising results of this new bone growth peptide will support our expansion in orthopedic surgery,” said Richard Berg, PhD, Vice President of Research and Development at FzioMed. “We continue to build compelling evidence for the use of FzioMed’s Oxiplex technology as a drug vehicle with broad application.”
FzioMed’s Oxiplex/SP is a bioabsorbable gel for use in reducing epidural post-surgical adhesions following discectomy, laminectomy, and laminotomy procedures in spine surgery. Oxiplex/SP is approved for sale in the EU and in certain countries outside the United States. FzioMed’s Oxiplex/AP product, designed for use in abdominal and pelvic surgeries, is also approved for sale in the EU. Both of these products are investigational devices in the United States, where pivotal clinical trials are in progress.
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 postsurgical adhesions, tissue augmentation and regeneration, and the delivery of drugs. Oxiplex is an innovative polymer technology with potential uses in a variety of specialties including orthopedics, gynecology, general surgery, neurosurgery and aesthetic surgery. FzioMed products include the leading adhesion barrier for spine surgery, currently marketed outside of the United States, and a cosmetic dermal filler. Other FzioMed products are in various stages of development and commercialization, and are directed towards high growth markets in the field of biosurgery materials.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.