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MiMedx Follow Up Study of Diabetic Foot Ulcer Patients Show 94% Remain Healed After Nine To Twelve Months

MiMedx Group, Inc. (NASDAQ: MDXG) announced 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.

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.

18 of 22 eligible patients returned for follow-up examination, which was conducted 9 - 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.

Mr. Pete Petit, Chairman and CEO of MiMedx 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 of MiMedx, 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 Mr. Petit.

The follow-up study is expected to be e-published in Wound Medicine.

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, in this electronic publication.

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 in this electronic publication.