MARIETTA, Ga., June 10, 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 a randomized controlled trial (RCT) for the Company's EpiFix® wound care allograft has been published in the International Wound Journal.
Parker H. "Pete" Petit, Chairman and CEO, said, "The results of this clinical trial were compelling. The allografts were so clinically effective that extremely high statistical significance was reached quickly, and the study was concluded early. This adds to our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed allografts. We expect the results of several additional clinical and scientific studies to be released in the next few months."
The patients receiving "standard of care" treatment were given the chance to have EpiFix® applied in a "crossover study." Bill Taylor, President and COO, commented, "The results of that crossover study have been accepted for publication as well, and they should also be available shortly. When our study data is compared to a published RCT of a major competitor's product, EpiFix® brought wound closure to approximately three times more patients in half the time. EpiFix® also has size appropriate grafts to fit the wound area with very little waste, making EpiFix® much more cost-effective overall."
Included in the IRB-approved, prospective, randomized, single-center clinical trial were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomized to receive standard care alone or standard care with the addition of EpiFix®. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. After 4 and 6 weeks of treatment, the overall healing rate with application of EpiFix® was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. Patients treated with EpiFix® achieved superior healing rates over standard treatment alone. These results show that using EpiFix® in addition to standard care is efficacious for wound healing.
The peer-reviewed publication by Zelen, et al. can be viewed at: http://onlinelibrary.wiley.com/doi/10.1111/iwj.12097/full
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 anticipated additional publications that will chronicle the clinical and cost effectiveness of the Company's PURION® processed allografts. 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 additional publications will not chronicle, as anticipated, the clinical and cost effectiveness of the Company's PURION® processed allografts, that the additional publications may not be released in the time period 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.
SOURCE MiMedx Group, Inc.