SAN LUIS OBISPO, California – July 17, 2008 – FzioMed, Inc. today said that it strongly disagrees with the recommendation made July 15 by the U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel, that the Company’s Premarket Approval (PMA) application for Oxiplex gel was not approvable. The advisory panel’s action constitutes a recommendation that is not binding on the FDA. The FDA may accept or reject the recommendation, modify it, request additional information, or take no action.
“We are in the process of scheduling a meeting with FDA to discuss the advisory panel’s comments and the steps necessary to resolve the questions that were raised by the panel,” said John Krelle, President and Chief Executive Officer of FzioMed, Inc.
Oxiplex is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. Oxiplex is intended to improve patient outcomes by reducing residual pain and symptoms following lumbar spine surgery. FDA granted expedited review status for Oxiplex because there are no approved alternative products in the U.S. for this debilitating condition.
Outside the U.S., Oxiplex is approved for sale in 49 countries and has been used in more than 100,000 spine surgeries.
FzioMed is a privately held medical device company developing and commercializing absorbable, surgical biomaterials based on the company’s patented science. FzioMed’s polymer technology has uses in a variety of surgical specialties including orthopedics, spine, gynecology and general surgery.
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.