SAN LUIS OBISPO, Calif. – Feb. 11, 2003 – FzioMed, Inc. announced today that it has received approval in Europe to expand the label claims for its Oxiplex®/SP Gel for use in spine surgery to include the reduction of pain and radiculopathy.
Oxiplex®/SP Gel is a bioabsorbable gel that is applied during spine surgery as a barrier to reduce the formation of post-surgical adhesions, a leading complication of many surgical procedures. The product, currently sold throughout Europe, is indicated for use in laminectomy, laminotomy and discectomy surgeries. The expanded labeling, based on results from the company’s clinical trial, now includes indications for the reduction of pain and radiculopathy.
“The use of Oxiplex®/SP Gel in spine surgeries offers the potential for improved patient outcomes,” said Ronald Haynes, President and CEO of FzioMed. “We are very pleased to report this expansion of label claims. The patient benefits of reducing pain and radiculopathy will be the subject of an article in an upcoming issue of Spine.”
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 that is formulated for a variety of medical indications and markets. Products in development 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 are directed towards high growth markets in the rapidly growing field of biosurgery.
Oxiplex® is a registered trademark of FzioMed, Inc.