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MiMedx Group, Inc. announced today that a randomized controlled trial (RCT) for the Company's EpiFix® wound care allograft has been published in the International Wound Journal.
Pete Petit, Chairman and CEO, said, "The results of this clinical trial were compelling. The allografts were so clinically effective that extremely high statistical significance was reached quickly, and the study was concluded early. This adds to our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed allografts. We expect the results of several additional clinical and scientific studies to be released in the next few months."
The patients receiving "standard of care" treatment were given the chance to have EpiFix® applied in a "crossover study." Bill Taylor, President and COO, commented, "The results of that crossover study have been accepted for publication as well, and they should also be available shortly. When our study data is compared to a published RCT of a major competitor's product, EpiFix® brought wound closure to approximately three times more patients in half the time. EpiFix® also has size appropriate grafts to fit the wound area with very little waste, making EpiFix® much more cost-effective overall."
Included in the IRB-approved, prospective, randomized, single-center clinical trial were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomized to receive standard care alone or standard care with the addition of EpiFix®. Wound size reduction and rates of complete healing after 4 and 6weeks were evaluated. After 4 and 6weeks of treatment, the overall healing rate with application of EpiFix® was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. Patients treated with EpiFix® achieved superior healing rates over standard treatment alone. These results show that using EpiFix® in addition to standard care is efficacious for wound healing.
The peer-reviewed publication by Zelen, et al. can be viewed here:
http://onlinelibrary.wiley.com/doi/10.1111/iwj.12097/full