SAN LUIS OBISPO, California—May 28th, 2014— FzioMed, Inc. today announced it has agreed with the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) to postpone the Dispute Resolution Panel for its Oxiplex PMA; the meeting was previously scheduled for June 10. The postponement was agreed between the parties to allow Office of Device Evaluation (ODE) to review additional clinical information. The postponement remains subject to final approval by the FDA appeal authority. That approval is expected shortly.
The additional information, which the company expects to submit in June, will consist of analyses of additional data obtained in a clinical investigation of Oxiplex outside the United States. ODE has committed to an expeditious review of this information within 90 days of receipt. If the additional clinical information is determined to be sufficient to support approval, together with previously submitted data, the company would proceed with submission of a PMA amendment. The company intends to renew the DRP process in the fourth quarter if the postponement fails to result in a resolution.
Commenting on this development, John Krelle, President and Chief Executive Officer of FzioMed, stated, “We appreciate the continuing cooperation of ODE staff, the Center Ombudsman’s Office, the Center Director’s Office, and the Commissioner’s Team throughout this process. We look forward to working collaboratively with FDA to analyze and evaluate the additional data.”
FzioMed is a privately held medical device company founded in 1996. The Company develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. FzioMed adhesion barriers are used in many surgical applications including spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is the number one barrier gel for spine surgery worldwide and is distributed by Medtronic, DePuy (a division of Johnson & Johnson) and other independent distributors. For more information please visit www.fziomed.com
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc.