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Second MiMedx EpiFix® Randomized Comparative Study Published In International Wound Journal Shows 92.5% Healing Rate Over 12 Weeks
37 Of 40 Hard To Heal Wounds Closed In 12 Weeks
|By PR Newswire
|February 25, 2014 07:07 PM EST
MARIETTA, Ga., Feb. 25, 2014 /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 "A prospective, randomized comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers" has been published electronically in the International Wound Journal. The study manuscript was authored by Charles M. Zelen, DPM, FACFAS; Thomas E. Serena MD, FACS; and Robert J. Snyder, DPM, MSc.
This study was an institutional review board-approved, registered, prospective, randomized, comparative clinical trial involving patients with diabetic foot ulcers (DFUs). In this study, the patients with non-infected ulcers of greater than 4 weeks duration were evaluated during a 2 week run-in period. If a wound area reduced by 20% or more at the end of the run-in period, the subject was excluded. Those patients whose wounds did not exhibit rapid closure under conservative care totaled 40 in number, and were included in the study and randomized to receive either weekly or biweekly application of EpiFix®. In addition, all weekly and biweekly application study subjects received a non-adherent, moist dressing with compressive wrapping, and all wounds were off loaded. The primary study outcome was mean time to healing.
Overall, in the 12 week study period, 37 out of 40 patients, or 92.5%, of the DFUs healed completely. Of these 37 patients, the mean time to complete healing was 2.4 weeks for those patients receiving weekly applications and 4.1 weeks for those receiving biweekly applications. These findings show that wounds treated with weekly applications heal more rapidly, and that even the wounds treated with biweekly applications had rapid healing rates.
Parker H. "Pete" Petit, Chairman and CEO said, "We are proud to present yet another clinical trial that shows superior healing rates of over 92% with our EpiFix® allograft. This study clearly reiterates the results of other clinical studies that our EpiFix® allograft is a clinically and cost effective therapy. The additional significance of this clinical trial is that it confirms that patients receiving weekly applications of EpiFix® achieved complete healing in nearly half the time as those receiving biweekly applications. This study provides physicians with the clinical evidence that applying EpiFix® at more frequent intervals will accelerate complete healing."
Bill Taylor, President and COO, stated, "While the overall healing rates at the end of the 12 week study period were equally as impressive with greater than 92% complete healing, the weekly group healed 41.5% faster than those in the biweekly group. More rapid healing is essential in improving the patient's return to normal function and mobility, as well as, decreasing clinical costs and preventing the complications inherent in long-term medical treatments."
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 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®. 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 the potential 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 most recent Form 10-Q. 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.
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