MiMedx Receives Additional Medicare Reimbursement Coverage for EpiFix®
"We have been persistent in executing our strategy to gain MAC coverage throughout the country," said
CGS approved EpiFix® for both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that fail to respond to standard of care treatments. The approval was retroactively effective to
Currently, two of the largest categories of chronic wounds are DFUs and VLUs. A clinical study of over 300,000 wounds reported the median size of a DFU to be 1.35 cm2 and the median size of a VLU to be 2.32 cm2. Widely used legacy skin substitute products are only offered in fixed sheet sizes of approximately 40 cm2, which leads to tremendous wastage in treating both DFUs and VLUs.
"We look forward to continuing to provide our clinically and cost effective allograft, EpiFix®, for advanced wound healing. By offering providers various sized product to more closely match actual wound sizes, EpiFix® allografts can eliminate unnecessary wastage of product compared to many other available skin substitute products," added Petit.
About
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies processed from human amniotic membrane that is derived from donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® process, to produce a safe and effective implant. MiMedx® is the leading supplier of amniotic tissue, having supplied over 200,000 allografts to date to distributors and OEMs for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the clinical and cost effectiveness of EpiFix®, the prospect of additional approvals from the remaining two Medicare Administrative Contractors and the opportunities presented by the CGS coverage determination. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the remaining two Medicare Administrative Contractors will not approve EpiFix® for reimbursement, that we will be unable to capitalize on the opportunity for expanded sales of our EpiFix® allografts, that EpiFix® will not perform as expected or will not gain acceptance in the medical community, and the risk factors detailed from time to time in the Company's periodic
SOURCE
Michael Senken, (770) 651-9100