SAN LUIS OBISPO, California – September 24, 2012 – FzioMed, Inc. (www.fziomed.com) announced that they have shipped the 300,000th unit of Oxiplex®. Oxiplex is approved outside of the United States in 68 countries worldwide and is distributed under the brand names Oxiplex®, Oxiplex®/SP and MediShield™.
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 in numerous clinical studies to improve spine surgery outcomes by significantly reducing postoperative leg pain, back pain and neurological symptoms.
“Worldwide adoption of Oxiplex continues to grow as evidenced by this significant milestone. Sales have been buoyed further this year with the publication of the US pivotal data in Spine, providing surgeons with the evidence they need to add Oxiplex to their everyday clinical regimen. This growing body of real world evidence will add further substance to our discussions with FDA as we strive to make Oxiplex available to patients in the United States,” said John Krelle, FzioMed’s President and Chief Executive Officer.
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 is used in a variety of surgical specialties including orthopedics/spine, peripheral tendons and nerves, gynecology, aesthetics and general surgery. www.fziomed.com
FzioMed® and Oxiplex® are registered trademarks of FzioMed, Inc. MediShield™ is a registered trademark of Medtronic, Inc.