FzioMed said today that a dispute resolution panel slated for next month for its Oxiplex spinal surgery gel has been postponed so the FDA can review more clinical data.
The dispute resolution panel is on hold until the watchdog agency’s Center for Devices & Radiological Health deems the submission sufficient to support approval, according to a press release. If the CDRH, which agreed to review the new data within 90 days of receipt, deems the data insufficient FzioMed plans to renew the dispute resolution process during the 4th quarter, according to the release.
"We appreciate the continuing cooperation of [Office of Device Evaluation] staff, the Center Ombudsman’s Office, the Center Director’s Office, and the Commissioner’s Team throughout this process. We look forward to working collaboratively with FDA to analyze and evaluate the additional data," FzioMed president & CEO John Krelle said in prepared remarks.
FzioMed said it plans to submit the new data, which is the result of an overseas clinical investigation, in June. The dispute panel was originally scheduled to convene June 10.
The Oxiplex gel 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, according to the company.
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.