SAN LUIS OBISPO, California – February 29, 2008 – FzioMed, Inc. today announced that Health Canada has approved the company’s Oxiplex® gel for use in lumbar spine surgery.
Oxiplex is an absorbable gel that is applied to spinal nerve roots during lumbar laminectomy, laminotomy and discectomy procedures. Oxiplex creates a temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain. Oxiplex has been shown to improve spine surgery outcomes by significantly reducing postoperative leg pain, back pain and neurological symptoms.
“We are very pleased to add Canada to the growing list of countries where Oxiplex is approved,” said John Krelle, FzioMed President and Chief Executive Officer.
Oxiplex is now approved in 49 countries and has been used in nearly 100,000 surgeries. Health Canada’s approval of Oxiplex for spine surgery was based on final data from a U.S. multi-center, randomized, blinded, controlled study involving 352 patients. The company has filed a Pre-Market Approval Application with the FDA seeking approval to market Oxiplex in the U.S.
About Oxiplex Gel for Spine Surgery
Despite the success of spine surgical procedures, many patients later experience persistent or recurrent pain that is attributed to postoperative irritation of the nerve root. Oxiplex is an absorbable gel that is applied during lumbar spine surgery to provide a protective environment around the nerve root and physical separation of tissues during the healing process. Oxiplex does not interfere with normal healing and clears naturally from the body.
FzioMed is a privately held medical device company developing and manufacturing absorbable, surgical biomaterials based on the company’s patented polymer science. FzioMed’s technology has uses in a variety of medical fields including spine surgery, orthopedics, gynecology, general surgery and aesthetic surgery. FzioMed products include Oxiplex/SP, the leading adhesion barrier for spine surgery, and Intercoat Adhesion Barrier Gel for peritoneal surgery, both marketed outside the U.S. FzioMed products are for investigational use only in the U.S.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.