Once-scorned biomaterials maker FzioMed is getting another day with the FDA to discuss its Oxiplex spinal surgery gel, which was rejected by U.S. healthcare officials in 2008.
FzioMed will meet June 10, 2014, with the FDA’s Medical Device Dispute Resolution Panel to discuss the "approvability" of the Oxiplex gel, which has been on the European market since 2012 and is approved for sale in 70 countries. The product has already been used in more than 350,000 surgeries, FzioMed said.
"For more than a decade, FzioMed has been seeking approval of Oxiplex in the U.S.," president & CEO John Krelle said in prepared remarks. "Over the course of its review, the FDA’s Center for Devices and Radiological Health (CDRH) has reviewed data on approximately 500 patients from 4 peer-reviewed published clinical studies spanning 3 continents. The totality of data from the various studies submitted to FDA on Oxiplex, combined with extensive clinical success achieved around the world, demonstrate that Oxiplex can offer increased clinical benefit compared to discectomy surgery alone, while presenting no significant safety risk."
The panel provides guidance to top FDA regulators regarding complex or contested issues between regulators and industry. The panel isn’t convened very often, FzioMed noted, but they have the authority to overturn CDRH’s denial of the Oxiplex product.
San Luis Obispo, Calif.-based FzioMed originally filed its PMA application for Oxiplex in October 2007. The FDA responded with a "not approvable letter" back in July 2008 after determining that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
In December 2012 the medical device company filed a citizen’s petition asking for a reconsideration of the PMA application.