ReGen takes exception to FDA CDRH's plan to rescind Menaflex knee implant 510(k) clearance

ReGen Biologics Inc. is taking exception to the FDA's Center for Devices and Radiological Health's (CDRH) Thursday announcement of a plan to rescind the 510(k) clearance of the company's Menaflex knee implant. "For CDRH to arrive at the decision that the device has a new intended use four years after two senior CDRH officials informed the company that the device could be reviewed through the 510 (k) program is totally unbelievable," said Gerald E. Bisbee, Jr., Ph.D., Chairman and CEO of ReGen. "Even more incredible is that they arrived at that conclusion after the second Orthopedic Advisory Panel of independent experts chosen by FDA was specifically asked about the intended use of the device and confirmed that it functioned like predicates. When they received that answer from the Panel, CDRH repeated the same question three additional times in order to try to get the answer that they apparently wanted, but they did not."

"The agency's Center for Devices and Radiological Health rigorously reviewed and cleared the Menaflex collagen scaffold for use in the U.S. after the first independent Advisory Panel Meeting in November 2008," said Dr. Bisbee. "Since then the FDA has created storylines about the review process to discredit this clearance, as well as taken numerous actions that are illegal or well outside its existing statutory authority."

CDRH's announcement of a planned rescission of the Menaflex 510(k) clearance came nearly five years after the start of the device's review process, which is targeted to be completed in 90 days. In November 2006 and again in June 2008, two senior CDRH officials informed ReGen that the device qualified for 510(k) review. The company subsequently filed two additional 510(k)s, including adding specific product labeling that CDRH recommended. This is the same labeling that Dr. Shuren has now said indicates that the Menaflex device has a different intended use.

"ReGen has invested 58 months and more than $30 million to meet the CDRH's requirements, 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," said Dr. Bisbee. "To further obfuscate the agency's political agenda, the FDA continues to trot out patently false allegations that our company employed undue political influence to secure Menaflex's clearance. As the chronology of this matter shows, nothing could be further from the truth."

The FDA's determination that Menaflex could be reviewed under 510(k) criteria as a surgical mesh was made in November 2006 by the director of the agency's Office of Device Evaluation. Contrary to the story that FDA is telling, that determination could not have been affected by any political influence because ReGen did not seek the assistance of New Jersey legislators until almost a year later, in late 2007. Even then, it was only after receiving a rejection of its submission based on an illegal review standard, following nearly two years of review.  These members of Congress asked the FDA to examine the ReGen matter and insure that the review was treated fairly and consistent with existing agency regulations.

"There is absolutely no substance to the FDA's assertion that ReGen used undue political influence to secure Menaflex's 510(k) review or its clearance," said Dr. Bisbee. "The politics surrounding changes suggested in the 510(k) program appear to underlie FDA actions, for example, a group of dissident FDA reviewers has sought legislative intervention because of their dissatisfaction with the current regulations and agency management.  The agency's clearance of Menaflex has become a political football and the FDA is not playing by the rules.

According to Dr. Bisbee, "The Menaflex device has the potential to provide U.S. surgeons the same safe and effective treatment for patients with meniscus injury as European surgeons have experienced with thousands of patients over the last nine years. This sets the stage for an increased regulatory burden imposed by the FDA which will slow down or stall medical device innovation in the U.S. -- traditionally a world leader. Already, we are seeing more and more medical device companies leave the U.S. to conduct clinical trials and market their products. Smaller companies with innovative products are not pursuing FDA clearance because of the unpredictability in regulation and increased regulatory burden."

The company is investigating alternatives for financing its European subsidiary, ReGen Biologics AG in order to continue marketing the Menaflex product in markets outside the United States where it has been well received. The company is evaluating its options in response to the FDA's intention to rescind its U.S. clearance.