Oxiplex Targets Unmet Need; Application to Receive Expedited Processing
SAN LUIS OBISPO, California – October 4, 2007 – FzioMed, Inc. announced today that the U.S. Food and Drug Administration (FDA) has completed its initial review of the company’s Pre-Market Approval (PMA) application for Oxiplex spine surgery gel and has accepted the PMA for filing.
FDA also confirmed that the Oxiplex PMA will receive expedited processing. Oxiplex is intended to reduce pain and symptoms following lumbar spine surgery. FDA granted expedited review status because there are no approved alternative products in the U.S. for this debilitating condition.
Oxiplex is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. Oxiplex gel is applied around the sensitive spinal nerve root and surrounding neural tissues, creating a protective environment during post-surgical healing. Oxiplex does not interfere with normal healing and clears naturally from the body.
The Oxiplex PMA was based on final data from a multi-center, randomized, blinded, controlled U.S. pivotal study. Outside the U.S., Oxiplex is approved for sale in 47 countries and has been used in more than 80,000 surgeries.
“Over a million people in the U.S. undergo spine surgery each year and lower back pain is a leading cause of disability,” said John Krelle, President and Chief Executive Officer. “Acceptance of the Oxiplex PMA brings us closer to offering U.S. surgeons a new tool, with the potential to improve clinical outcomes for countless patients.”
Founded in 1996, FzioMed is a privately held medical company developing and commercializing absorbable, surgical biomaterials based on the company’s patented science. FzioMed’s innovative polymer technology has uses in a variety of specialties including orthopedics, spine, gynecology, general surgery and aesthetic surgery. FzioMed products include Oxiplex® gel for spine surgery and LaresseT cosmetic dermal filler, both currently marketed outside of the U.S.
FzioMed®, Oxiplex® and Laresse® are registered trademarks of FzioMed, Inc.