, Dec. 12, 2013
/PRNewswire/ -- MiMedx Group, Inc.
(NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that Medicare contractor, CGS, has confirmed that the Company's wound care allograft, EpiFix®, has received reimbursement coverage from CGS. The coverage by CGS now brings the total Medicare Administrative Contractors (MACs) covering EpiFix® to six of the eight and 86% of Medicare beneficiaries will now be eligible for coverage for EpiFix® products.
"We have been persistent in executing our strategy to gain MAC coverage throughout the country," said Parker H. Petit, Chairman and CEO. "With the additional coverage by CGS encompassing the states of Kentucky and Ohio, we have further expanded the opportunity for Medicare beneficiaries suffering from chronic wounds to have access to our clinically and cost effective allografts."
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 November 1, 2013. Of the six MACs that cover EpiFix®, five cover both DFUs and VLUs.
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.
Bill Taylor, President and COO, stated, "Recently, the Centers for Medicare and Medicaid Services (CMS) announced a change in the way skin substitutes will be reimbursed beginning in 2014. The change bundles reimbursement for the cost of the product with the fee for the related surgical procedure. The change incentivizes physicians to use more cost effective skin substitutes. We supported the change and educated congressional members about the excessive wastage history in the skin substitute product area to encourage them to support the change as well. We are pleased that the payers are embracing this cause and consistently adding our cost effective EpiFix® allografts to their coverage authorizations."
"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.
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 Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2012, and the Company's Forms 10-Q filed in 2013. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.