ReGen Biologics Inc. (PINK:RGBO) rebuffed an offer from the FDA for one last go-around about the revocation of clearance for its Menaflex knee implant, saying it will try other ways of getting the device to the U.S. market.
The ever-feisty company, in an unusually long press release, said the six-year imbroglio with the federal watchdog agency “makes it clear that any such hearing would be futile.”
Read more about ReGen Biologics’ FDA drama
“The safety and effectiveness issues surrounding the clearance of our device were settled years ago, at a Nov. 14, 2008, advisory panel meeting. The independent experts on that panel were completely in Menaflex’s favor,” chairman and CEO Gerald Bisbee Jr. said. “The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren’t on the table in a Part 16 review. Enough is enough.”
Last October, the Food & Drug Administration said it would rescind the 510(k) clearance it granted the Menaflex device, a bio-absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage, in late 2008.
That means Hackensack, N.J.-based ReGen has to keep the device off the U.S. market until it can prove its safety and effectiveness to the FDA’s satisfaction.
ReGen wasn’t shy about voicing its displeasure over the rescission, with Bisbee calling it “totally unbelievable.”
The FDA said it wants ReGen to "discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness," five years after the company began the 510(k) application process.
ReGen has sunk $30 million into meeting requirements set by the FDA’s Center for Devices & Radiological Health, according to Bisbee, "only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true.”
The Menaflex 510(k) clearance in December 2008 came despite the fact that the device often failed and required second operations — and over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.
In March, the agency’s Orthopaedic & Rehabilitation Devices Panel at the decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market.
“It’s unbelievable that after more than five years of 510(k) review of this product — and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh — [CDRH head Dr. Jeffrey] Shuren now says that they were wrong,” Bisbee said today in prepared remarks. “This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval.”
And that wasn’t the only shot Bisbee fired across the FDA’s bow.
“We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage,” he said. “After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA’s administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients.”