MARIETTA, Ga., June 28, 2013 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company's wound care allograft, EpiFix®, received reimbursement coverage by Medicare Contractor Wisconsin Physician Services (WPS), effective July 1, 2013.
Parker H. "Pete" Petit, Chairman and CEO, said, "We are pleased to receive approval from another of the Medicare Contractors. The approval by WPS brings the total Medicare Contractors agreeing to reimburse for our EpiFix® wound care tissue grafts to six of the nine. As we have stated previously, we have aggressively pursued this critical aspect of our reimbursement strategy, and we are very happy to see the results from that initiative continue to expand the geography in which EpiFix® is approved for coverage."
Bill Taylor, President and COO, commented, "The documented efficacy and cost-effectiveness of EpiFix® is driving the rapid pace at which we are securing approvals from the Medicare Contractors. We expect that a number of our publications will have a significant influence on the reimbursement approval from the remaining Medicare Contractors. Most recent was the peer-reviewed publication of the compelling results from our randomized controlled clinical trial of patients with diabetic foot ulcers. In addition, the results of the crossover study from that clinical trial have been accepted for publication, and over the next few months, we expect several additional clinical studies to be published. These publications should further support the efficacy and cost-effectiveness of EpiFix®."
WPS has approved EpiFix® and has indicated its use for neuropathic diabetic foot ulcers and venous stasis ulcers that have failed to respond to conservative measures. Payment is approved for up to 5 applications per ulcer.
About the Company
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 the device technologies HydroFix® and CollaFix™, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies are processed from human amniotic membrane that is derived from the 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, effective and minimally manipulated implant for homologous use. MiMedx® is the leading supplier of amniotic tissue, having supplied over 150,000 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 prospect of additional approvals from the remaining Medicare Contractors, the results of in-process clinical studies and the publication of additional clinical studies in the next few months. 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 results of the clinical studies will not be as anticipated, that the studies will not be accepted for publication or that publication will be delayed, that the Medicare Contractors will not approve EpiFix® for reimbursement, that Medicare reimbursement will be less than anticipated, 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. 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.
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