EpiFix achieving results

Study published in International Wound Journal reported statistically significant evidence of healing compared to control group

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MARIETTA, Ga.—MiMedx Group, Inc., a developer and marketer of regenerative and therapeutic biologics, announced today that a new study regarding the use of EpiFix in the treatment of diabetic foot ulcers (DFUs) has been published in the peer-reviewed journal, International Wound Journal.

EpiFix is a tissue matrix allograft composed of dehydrated human amnion/chorion membrane (dHACM). MiMedx’s published scientific work indicates that MiMedx dHACM retains a diverse array of regulatory proteins including essential growth factors, cytokines and chemokines, which are regulators in inflammation, wound repair and tissue regeneration.

The paper is entitled “A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics,” and authored by William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M Caporusso, DPM; and Patrick S. Agnew, DPM.
This multi-center randomized and controlled trial was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for InterMountain Healthcare. Tettelbach is now Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.
The objective of the study was to determine the safety and effectiveness of EpiFix as compared to standard of care (SOC) therapy for the treatment of non-healing DFUs. The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 110 patients meeting study inclusion and exclusion criteria were analyzed in the Intent-to-Treat (ITT) cohort. A total of 98 patients completed the study Per Protocol (Per-Protocol cohort).
ITT analysis requires patients to be included even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are counted towards the final results.
In the current study on an ITT basis, 70% of patients who received weekly EpiFix had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (EpiFix 70% vs. SOC 50%, p=0.0338). For patients completing the study per protocol, 81% of those who received weekly EpiFix treatments achieved complete healing by 12 weeks. In comparison, 55% of patients had complete healing in 12 weeks after receiving weekly SOC alone (EpiFix + SOC 81% vs. SOC 55%, p=0.0093).
In the ITT cohort, adjusting for co-variates associated with healing, Cox regression analysis showed patients treated with EpiFix were more than twice as likely to heal completely within 12 weeks as those not receiving EpiFix (HR: 2.15, 95% confidence interval 1.30-3.57, p=0.003).

“In a heterogeneous patient population across the United States, healing rates with the use of dHACM were superior to those achieved with standard dressings alone, even when ITT data analysis, including non‐compliant subjects, was conducted. Reported healing rates within 12 weeks of 70% (ITT analysis) and 81% (per protocol analysis) remain superior to healing rates reported in comparable prospective studies of other advanced wound care products,” the study notes. “The results of this 110 patient, multicentre, randomised controlled study provide additional Level I evidence regarding the efficacy of dHACM and are useful to clinicians who are determining which advanced wound care product to choose when caring for their patients and for health care policymakers in both the United States and globally who are challenged to evaluate the benefits of available advanced wound care products compared with costs.”
MiMedx is a biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The company processes the human placental tissue utilizing its proprietary PURION process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

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