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FzioMed Inc. Receives CE Mark for DYNAVISC® Gel


1/23/2012 7:38:38 AM

SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC® adhesion barrier gel in Europe for tendon and peripheral nerve surgery.

DYNAVISC is a clear, absorbable gel supplied ready-to-use in a 1mL syringe. It is designed to coat tissues during tendon and peripheral nerve surgery. DYNAVISC gel acts as a temporary, protective barrier that separates tissues and reduces fibrosis and the formation of post-surgical adhesions.

DYNAVISC was developed by FzioMed and is based on the Company’s world-leading anti-adhesion biomaterial technology.

Adhesions are internal bands of scar tissue that can develop following surgery as the body attempts to heal. Adhesions tether tissues and surfaces that are normally not connected, later causing pain, nerve compression and impaired motion. Adhesions are a significant complication of many surgical procedures and a prevalent cause of post-surgical morbidity.

“Well over a million procedures to repair tendons are performed in the EU each year and one-third of traumatic injuries involve damage to tendons and nerves,” said John Krelle, President & CEO of FzioMed. “Adhesions can impact an otherwise successful procedure, leaving a patient with pain and diminished quality of life.”

Adhesions in Tendon and Peripheral Nerve Surgery

Adhesions can form following tendon and peripheral nerve surgeries such as in the hand (for nerve repair, carpal tunnel syndrome and Dupuytren’s contracture), foot, shoulder and knee. Adhesions bind tendons to each other and to surrounding structures, inhibiting their normal gliding function.

Adhesions following flexor tendon surgery in the hand cause diminished function and pain. Adhesions that tether nerves produce tension which can lead to ischemia and further nerve injury. Despite surgical and rehabilitation techniques to maximize function, postoperative adhesions remain a serious problem. Use of an adhesion barrier gel such as DYNAVISC can reduce adhesion formation and improve the outcome of tendon and peripheral nerve procedures.

About DYNAVISC

DYNAVISC gel is intended to reduce fibrosis and formation of adhesions following tendon and/or peripheral nerve surgery. DYNAVISC is applied to coat tissue surfaces exposed during surgery. The gel remains at the site of application for a period of time, providing a barrier to adhesion formation during the healing process. DYNAVISC is bioabsorbable and supplied in a sterile syringe with a flexible application for easy application.

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, tendon, peripheral nerve, gynecology, aesthetics and general surgery. www.fziomed.com

FzioMed® and Dynavisc® are registered trademarks of FzioMed, Inc.

Contacts

FzioMed, Inc.

805.546.0610

John Krelle, CEO and President



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