FDA Throws ReGen Biologics Another Curveball
BY DAVID KRESSEL, SEPTEMBER 25, 2007
ReGen Biologics today announced it received a "Not Substantially Equivalent" (NSE) letter from the FDA in response to the 510(k) premarket notification the company submitted for its meniscal repair implant. In a press release and conference call, a clearly frustrated Dr. Gerald Bisbee, ReGen's CEO, explained the FDA did not feel their product was substantially similar to previously approved or cleared products. Without a 510(k), ReGen would need to submit a PMA, which would mean it would take years to get the product approved.
This is the second 510(k) ReGen has had denied. In November 2006 they successfully appealed an earlier NSE and submitted an updated 510(k) in December 2006. They plan to appeal this NSE as well and expect that process to take another 9 months. At which point, assuming a positive judgment, ReGen could resubmit their 510(k).
This is clearly bad news for ReGen. The stock was off 60% today, down to $0.12 per share. Bisbee explained the company is currently restructuring and will be able to use its $7m of cash on hand to offset negative cash flow for the next 12 months.
