Under the current per-treatment reimbursement system, MiMedx (MDXG) has been a "powerhouse in wound care," taking share with its EpiFix product line, and current structure of the market naturally benefits MiMedx's business model, First Analysis analyst Joseph Munda tells investors. However, the FDA is reviewing the use and regulatory status of amniotic tissues in wound care and FDA action would raise their cost or limit their use, which is a risk for MiMedx that would likely benefit other advanced tissues, including Novadaq's (NVDQ) Dermacell, he contends. Munda keeps an Equal-Weight rating on MiMedx, citing regulatory uncertainties, and has an rate Overweight rating on Novadaq.

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.