Company officials said it will not be able to complete and submit Form 10-K to the SEC until it has obtained “adequate external financing” to properly complete the form, according to the news report. In late 2010, the FDA rescinded approval of ReGen’s Menaflex Collagen Meniscus implant, which gained 510(k) clearance in 2008 after three years of review. The company has since declined the FDA’s offer of a hearing before the agency formalizes its decision to rescind clearance of the Menaflex Collagen Meniscus implant.
Read the news report about ReGen Biologic’s inability to file Form 10-K.
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