FDA Throws FzioMed a Lifeline

Just when you think it’s not safe to wade into FDA waters, the agency throws someone a lifeline.

FzioMed, Inc. boss John Krelle announced on November 4, 2013, that FDA Commissioner Margaret Hamburg, M.D. has approved the company’s petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel. The agency issued a Not Approvable letter in September 2008.

Oxiplex Gel

Oxiplex is an absorbable, clear, viscoelastic gel that is applied during lumbar spine surgery. Oxiplex has been approved for sale in the European Union since 2001 and is now approved in 70 countries. It has been used in more than 340, 000 surgeries worldwide, said Krelle. The company has been working for 12 years to gain FDA approval to market this device in the U.S.

Medical Device Dispute Resolution Panel

Hamburg’s decision means that a special Medical Devices Dispute Resolution Panel (DRP) will be convened. It’s the first time we’ve noted such a panel meeting for a spine or orthopedic device in the past six year. This panel provides advice to the Commissioner on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by the FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to Agency decisions or actions. In this case, FzioMed is seeking to have the DRP recommend a reversal of FDA’s earlier denial of its PMA for Oxiplex.

A Decade of Persistence

Krelle was obviously happy with the Commissioner. He said the totality of data from the various studies submitted to FDA on Oxiplex, representing approximately 500 patients studied over nearly a decade, combined with extensive clinical success achieved outside the U.S., “demonstrate that Oxiplex can offer increased effectiveness compared to spine surgery alone, while presenting no significant safety risk.”

According to the company, no jurisdiction other than the U.S. has ever denied an application for approval of Oxiplex, which has been available outside the U.S. for more than a decade. It is approved in 70 countries including the 28 member states of the European Union, The Russian Federation, Canada, and Mexico, as well as on the continents of Africa, Australia, South America and Asia.

Oxiplex was studied in two U.S. FDA-approved Investigational Device Exemption (IDE) clinical trials, as well as two foreign confirmatory clinical studies in subjects undergoing spine surgery. The company announcement said the IDE pivotal study, which required more than five years to complete, found that subjects having both leg pain and severe preoperative back pain experienced a greater reduction in leg pain when treated with Oxiplex compared to undergoing surgery alone.

“The extensive body of peer-reviewed published literature on Oxiplex, as well as extensive commercial experience outside the U.S. in more than 340, 000 surgeries, provides additional evidence of the safety and effectiveness of the device for use in conjunction with spine surgery, ” continued the company statement.

Potential Jobs Return to San Luis Obispo

The company filed a petition for reconsideration last December. At the time Krelle said that should the FDA reverse its decision, the company would be in a position to add several hundred well-paying jobs to its U.S. operations. When the FDA first issued the Not Approvable letter, FzioMed was forced to downsize its California operations by 50% and to outsource jobs overseas.

San Luis Obispo, California-based FzioMed is a privately held company founded in 1996 and develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. The company says its 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, Inc., DePuySynthes and other independent distributors.