ReGen declines FDA offer for Menaflex hearing

ReGen Biologics Inc. (Pink:RGBO) said it declined FDA's offer to conduct a hearing before formalizing a decision to rescind marketing clearance of ReGen's Menaflex collagen meniscus implant. ReGen said its experience with FDA "makes it clear that any such hearing would be futile." The company also said it will pursue other legal options to continue marketing Menaflex in the U.S. and will seek an "unbiased review" of the product's approval status under U.S. law. ReGen would not specify what legal avenues it would pursue.

Last year, FDA said it would rescind marketing clearance of the resorbable collagen scaffold to re-grow meniscus cartilage after a advisory committee said there was insufficient evidence that the device reinforces and repairs soft tissue injuries. In 2009, an FDA report recommended a reevaluation of the approval of a 510(k) application for Menaflex because the review process had been influenced by outside pressures (see BioCentury Extra, Oct. 14, 2010). ...