Brean Capital believes the FDA is at least 1-2 years away from regulating the use of amniotic tissue for wound care despite never seeing any safety issues with the product. The firm believes its ruling could lead to a less onerous 510K requirement over a BLA license. Brean Capital believes MiMedx is oversold, largely due to the FDA concern, and reiterated its Buy rating and $12 price target on the stock.

BTIG notes that seven Medicare Administrative Contractors, or MACs - CGS, WPS, NGS, Palmetto, Novitas, First Coast, and Noridian - this morning published new proposed local coverage determinations, or LCDs, regarding the coverage of skin substitutes grafts and cellular and tissue based products for the treatment of diabetic foot ulcers, or DFUs, and venous leg ulcers, or VLUs. This marks "the second attempt in the past 12 months where MACs have proposed an LCD that would drastically shake up the advanced wound care market," says the analyst, who highlights that the proposed LCD includes non-coverage products from Integra Lifesciences (IART), Organogenesis (ORGO), Smith & Nephew (SNN), MiMedx (MDXG), Anika Therapeutics (ANIK) and numerous smaller, private wound care companies. The firm adds that it thinks Integra and Organogenesis both have meaningful exposure to the LCDs based on their product portfolio and the revenue mix within their Advanced Wound Care businesses.