MiMedx Epifix® Crossover Study is published in the Journal of Wound Care
MARIETTA, Ga., July 30, 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 its study "An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs" has been published in the July 2013 edition of the Journal of Wound Care (Vol. 22, Issue 7, 11 Jul 2013, pp 347 – 351). The electronic publication of the study is available at:
"This clinical study adds to our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed allografts," said Parker H. "Pete" Petit, Chairman and CEO. "This study is the 'crossover' of the standard of care patients from the randomized controlled trial (RCT) of the diabetic foot ulcer (DFU) patients entitled 'A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers,' which was electronically published recently in the International Wound Journal."
The paper, authored by Dr. Charles Zelen, also was the subject of an award-winning poster presentation at the recent American Podiatry Medical Association (APMA) National Meeting, in which the compelling findings of the "crossover" study were presented.
Patients enrolled in this "crossover" study had been randomized to receive standard care in the DFU clinical trial that compared treatment with EpiFix® to the standard of care. In that RCT, the overall healing rate with application of EpiFix® was shown to be 77% and 92% after 4 and 6 weeks of treatment, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. At completion of the RCT, patients that did not heal with standard care were then offered treatment with EpiFix®. Wounds had been present for an average of over 21 weeks when treatment with EpiFix® was initiated. When reporting outcomes at the predetermined study intervals of 4, 6 and 12 weeks, 55% of the patients achieved complete healing within 4 weeks, 64% within 6 weeks, and 91% within 12 weeks. Although 12 weeks was the predetermined study interval, the 91% complete healing outcome was actually achieved in 9 weeks.
"The study conclusion is that the use of the MiMedx PURION® processed dehydrated human amnion/chorion membrane tissue allografts (dHACM) provides superior rates of healing compared to the standard of care in patients with chronic diabetic foot ulcers," added Petit. "These results provide additional evidence that using EpiFix® in addition to standard care effectively promotes wound healing."
"The average healing time in the "crossover" study was 4.2 weeks and almost half of the patients healed completely after one EpiFix® application. These results clearly support that EpiFix® promotes rapid healing. The "crossover" study article and other articles that are soon to be published not only demonstrate the compelling and efficacious clinical results of our allografts, they also signify the full acceptance and support of these studies in peer-reviewed international journals," commented Bill Taylor, President and COO.
The peer-reviewed publication by Zelen, et al. of the initial RCT, "A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers" can be viewed at: http://onlinelibrary.wiley.com/doi/10.1111/iwj.12097/pdf.
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 160,000 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 results to be achieved from the Company's allografts and the prospect publication of additional articles in peer-reviewed international journals in the near term. 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 clinical results achieved may not be as anticipated, that anticipated publications in peer-reviewed international journals will not be published or will be delayed, 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.