- MiMedx Group (MDXG) updates investors on discussions with the FDA regarding the regulatory classification of its micronized products.
- Despite disagreeing with the regulator's position (that these products don't fall solely under Section 361 of the PHSA) MDXG says it will "propose to the FDA that it will pursue the IND and BLA process for certain micronized products.
- Meanwhile, MDXG reiterates 2013 and 2014 guidance, noting that "the [FDA's] review and its regulatory pathway decision [are] relevant only to micronized tissue products and [have] no applicability to sheet tissue products."
- Also notable is the company's commentary on CMS final payment rules: "...we believe the recent CMS final rule on packaging skin substitutes will provide even greater opportunity for MDXG than previously anticipated, due to the tiered pricing ... and the pass-through status of EpiFix." (PR)
- More on CMS pricing is here
- More on the FDA discussions is here
MiMedx provides update on FDA discussions
Dec 5 2013, 07:45 ET