MARIETTA, Ga., Nov. 19, 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 its study "Dehydrated Human Amnion/Chorion Membrane Allografts in Patients with Chronic Diabetic Foot Ulcers: A Long-term Follow-up Study" has been accepted for publication in Wound Medicine. The study manuscript was authored by Charles M. Zelen, DPM, FACFAS, FACFAOM, FAPWCA; Thomas E. Serena MD, FACS; and Donald E. Fetterolf, MD, MBA, FACP.
This study is the long term follow-up from a previously completed randomized controlled trial (RCT) involving patients with diabetic foot ulcers (DFU). In this follow up study, the patients whose DFU wounds healed after treatment with EpiFix® in the initial RCT and the subsequent crossover study were examined.
Eighteen of 22 eligible patients returned for follow-up examination, which was conducted 9 to 12 months after primary wound closure with EpiFix®. Clinical record review was conducted with IRB approval and patient consent. Of the eighteen patients studied, only one patient had recurrent DFU during the follow-up period, while 17, or 94.4%, remained fully healed. These findings support the long-term effectiveness of dehydrated human amnion/chorion membrane ("dHACM") for treatment of DFU. The study concluded that dHACM is a clinically viable and economically feasible treatment option that should be considered by clinicians who treat diabetic pedal ulcers.
Parker H. "Pete" Petit, Chairman and CEO said, "The identification and implementation of an ideal treatment regimen for DFUs is an increasingly common issue faced by clinicians. Therapies that promote rapid and complete healing, thus reducing the risk for infection and amputation, can substantially improve quality of life while decreasing financial burdens. A competitor recently announced that the clinical study of their products showed that only 52% of their patients both healed in 12 weeks and remained healed at the subsequent 12 week follow-up. An optimal treatment for DFU would be one that supports both rapid and long-term healing. With 94.4% of DFUs remaining healed approximately one year after treatment, we believe our EpiFix® allograft is a clinically effective and economic solution to these needs."
Bill Taylor, President and COO, stated, "Human amniotic membrane has been used as an allograft to treat wounds for over a century. However, our proprietary PURION® process has led to the development of our EpiFix® dHACM allograft. Studies have shown strong clinical and cost effectiveness of EpiFix® for healing of DFUs, Venus leg ulcers, and wounds that have failed to heal with other treatment modalities with minimal, if any, waste. Use of competitive skin substitutes routinely result in waste of over 80% of their graft because they come in only one very large size, which is generally at least 15 times greater than the median DFU. EpiFix® has size appropriate grafts and consequently, there is very little waste."
"This clinical study is one of many in our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed EpiFix® allografts," concluded Petit.
The follow-up study is expected to be e-published during the last week of November in Wound Medicine (http://www.elsevier.com/journals/wound-medicine/2213-9095). The initial RCT entitled "A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers," was published in the International Wound Journal, and the electronic publication can be found at http://onlinelibrary.wiley.com/doi/10.1111/iwj.12097/full. The subsequent "crossover" study, "An evaluation of healing with the use of dehydrated human amniotic membrane allografts in patients with chronic diabetic foot ulcers," was published in Journal of Wound Care, and the electronic publication can be found at http://mimedx.com/r-and-d/clinical-publications.
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 190,000 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 long-term 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.
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- amniotic membrane