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MiMedx Multi-Center Randomized, Controlled VLU Clinical Study Published In Peer-Reviewed Journal

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 the publication of another peer-reviewed clinical study.

The study article, A Multi-center Randomized Controlled Clinical Trial Evaluating the Use of Dehydrated Human Amnion/Chorion Membrane Allografts and Multi-layer Compression Therapy vs. Multi-layer Compression Therapy Alone in the Treatment of Venous Leg Ulcers" has been published in the peer-reviewed journal, Wound Repair & Regeneration. The paper was authored by Thomas E. Serena, MD, FACS; Marissa J. Carter, PhD MA; Lam T. Le, MD; Matthew J. Sabo, DPM; and Daniel T. DiMarco, DO. The electronic publication of the study is now available in the Wiley Online Library at http://onlinelibrary.wiley.com/doi/10.1111/wrr.12227/pdf. The hard copy publication is expected to follow in a future issue of Wound Repair & Regeneration.

Venous leg ulcers ("VLU"s) produce significant clinical and economic burdens on society and often require advanced wound therapy. Up to 2 million people annually in the United States are affected with chronic VLUs. The therapeutic mainstay in management of VLUs has been graduated compression bandaging, referred to as multi-layer compression therapy ("MLCT"). This multi-center, randomized, controlled study was established to evaluate the application of dehydrated human amnion/chorion membrane ("dHACM") allograft along with MLCT, versus MLCT alone in the treatment of VLUs. The study was conducted under the direction of a primary investigator, Dr. Thomas Serena.

Study Highlights include:

  • The primary study outcome was the proportion of patients achieving 40% wound closure at 4 weeks.
  • Of the 84 participants enrolled from 8 centers, 53 were randomized to receive MiMedx PURION® Processed dHACM allograft (EpiFix®) plus MLCT, and 31 were randomized to the control group of MLCT alone.
  • At 4 weeks, 62% in the allograft group and 32% in the control group demonstrated a greater than 40% wound closure (p=0.005) thus demonstrating a significant difference between the MiMedx dHACM allograft-treated groups and the MLCT alone group at the 4-week surrogate endpoint.
  • After 4 weeks, wounds treated with MiMedx dHACM allograft had reduced in size a mean of 48.1% compared to 19.0% for controls.
  • VLUs treated with MiMedx dHACM allograft had a significant improvement in healing at 4 weeks compared to MLCT alone.

Mr. Pete Petit, Chairman and CEO, said, "Previous clinical studies have established that the application of MiMedx PURION® Processed dHACM is an effective treatment for chronic diabetic foot ulcers. This current study is unique as it is the first randomized controlled trial to evaluate the efficacy of amniotic allograft as a treatment for VLUs. Our results show that VLUs treated with MiMedx PURION® Processed dHACM, in addition to MLCT, heal in a significantly more rapid fashion than those treated with MLCT alone."

The natural history of chronic VLUs is a continuous and frustrating cycle of slow and painful healing, recurrent breakdown, considerable morbidity and impaired quality of life. Not uncommonly, wound care specialists see patients who have suffered for years or face amputation of the limb as their only option due to complications of the disease.

Bill Taylor, President and COO, stated, "Given the long healing period for VLUs, intermediate endpoints such as percent change in wound area by the fourth week of treatment have been proven to be important surrogate markers of complete wound healing by 12 or 24 weeks. Use of a surrogate endpoint allowed us to identify that VLUs treated with MiMedx PURION® Processed dHACM, in addition to MLCT, had substantially reduced wound size within 4 weeks compared to MLCT therapy alone."