SAN LUIS OBISPO, California – August 11, 2003 – FzioMed, Inc. is presenting additional follow-up data from the company’s Oxiplex/SP Adhesion Barrier Gel clinical trial this week at the Council of Spine Societies’ World Spine II conference in Chicago, Illinois. The results demonstrated that the benefits of using Oxiplex/SP Adhesion Barrier Gel in laminectomy, laminotomy and discectomy surgery continued twelve (12) months after surgery.
Post-surgical epidural adhesions can compress or tether the nerve root, often causing recurrent pain and radiculopathy following lumbar disc surgery. Oxiplex/SP Adhesion Barrier Gel is an absorbable synthetic material shown in pre-clinical studies to be effective in reducing adhesion formation.
The objectives of FzioMed’s pilot clinical trial were to evaluate safety and assess the efficacy of Oxiplex/SP Adhesion Barrier Gel in reducing leg pain and lower extremity weakness in patients undergoing lumbar disc surgery. Oxiplex/SP Gel was safe and well-tolerated in all patients. In patients with moderate to severe leg pain and lower extremity weakness, those patients that received Oxiplex/SP Gel continued to experience a greater improvement twelve months after surgery compared to patients that did not receive the gel.
“A positive twelve month result is a significant milestone,” said Ronald Haynes, President and CEO of FzioMed, Inc. “Discectomy patients treated with Oxiplex/SP Adhesion Barrier Gel experience less pain and radiculopathy twelve months after surgery compared to patients who did not receive the gel. The literature shows that discectomy patients stabilize at twelve months post-surgery, suggesting that the benefits of Oxiplex/SP Adhesion Barrier Gel will persist over the long term.”
A pivotal clinical trial of Oxiplex/SP Adhesion Barrier Gel is underway in the United States. The product has received CE Mark approval in the European Union and is being sold outside of the United States.
FzioMed is a privately held biomedical company engaged in the development and commercialization of advanced, absorbable biosurgery products based on the company’s patented Oxiplex® platform technology. Oxiplex® is an innovative polymer material that is formulated for a variety of surgical indications and markets. Products include those for the prevention of post-surgical adhesions, drug delivery and hemostasis. FzioMed products are at various stages of clinical and pre-clinical development, and commercialization, and are directed towards high growth markets in the rapidly growing field of biosurgery.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.