Privately held medical device maker FzioMed won Australian regulatory approval for its Dynavisc post-surgical gel, an absorbable gel applied to tendons and nerves to reduce adverse events after surgery.
Dynavisc has European CE Mark approval and FzioMed CEO John Krelle said in prepared remarks that the FDA is reviewing a citizen petition for product approval in the U.S.
"Australia has proven to be a strong market for our products and adding a product for use in tendon and peripheral nerve surgery to our already successful spine and gynecology products, provides more protection for patients who suffer the debilitating effect of adhesions after surgery," said Krelle. "Oxiplex is not yet approved in the United States despite having demonstrated safety and effectiveness in clinical studies involving more than 500 patients."
In 2012, FzioMed filed a citizen’s petition with the commissioner of the FDA, asking the agency to re-open a rejected premarket approval application for its Oxiplex spinal surgery gel.