Multicenter Randomized Controlled VLU Clinical Study Demonstrates Significantly Higher Healing Rates of EpiFix®
Marietta, GA – October 11, 2017 – MiMedx Group, Inc.. (NASDAQ: MDXG), a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the latest peer-reviewed clinical study of MiMedx dehydrated human amnion/chorion membrane ("dHACM") allografts has been published in the International Wound Journal.
The paper entitled "A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers," was authored by Christian Bianchi, MD, FACS; Shawn Cazzell, DPM, FACFAS; Dean Vayser, DPM, FACFAS; Alexander M. Reyzelman, DPM, FACFAS; Hasan Doslouglu, MD, FACS; Gregory Tovmassian, DPM; and the EpiFix VLU Study Group of Delores Farrer, DPM, MBA, CWS; Elisa Taffe, MD; Lacey Loveland, DPM; David O'Connor, MD; Marc D. Baer, DPM, FACFAS; and Sara Dahle, DPM, MPH.
The electronic publication of the article in the International Wound Journal can be found at http://onlinelibrary.wiley.com/doi/10.1111/iwj.12843/epdf.
Venous leg ulcers (VLUs) affect over two million people annually in the United States and cause significant clinical and economic consequences on society. VLUs are often marked by a significant level of chronicity and may require many months of treatment before a satisfactory level of healing is achieved. Even once healed, recurrence of a VLU is common. Slow rates of healing and frequent recurrence result in prolonged disability and the need for repetitive care, which compounds the psychosocial issues and economic burdens associated with the condition. In the United States, the estimated payer burden associated with treatment of VLUs was near $15 billion in 2014, and this number is only expected to rise.
The study was a 16-week randomized, fifteen-center, clinical trial conducted to evaluate the efficacy of EpiFix® as an adjunct to moist wound dressings and multilayer compression bandages for the treatment of non-healing full-thickness VLUs. Subjects (n=109) were randomized to receive EpiFix® in addition to moist dressings and compression (n=52) or moist dressings and compression alone (n=57). The primary endpoint of the study was time to complete wound closure, as assessed over a 12-week period from treatment initiation. Secondary endpoints included the proportion of subjects with complete wound closure by 12 and 16 weeks. Complete healing of the study ulcer was defined as 100% re-epithelialization without drainage.
Parker H. Petit, Chairman and CEO, stated, "This is a significant study that offers the most important data generated for VLU patients and their caregivers in the last 20 years. EpiFix® is the first and only placental-based allograft to show clinical superiority over multilayer compression therapy in a multi-center, randomized, prospective clinical study."
Bill Taylor, President and COO, noted, "The rapid and complete healing is the primary goal when treating a VLU. The longer it takes to heal an ulcer, the greater the financial burdens to the healthcare system. Moreover, the longer length of healing causes significant financial burden on the patient and family as well as encumbrances in quality of life and other personal burdens for the patient. Unfortunately, less than 50% of VLUs heal within three months with standard treatment of debridement, wound dressings and aggressive compression therapy. When first line treatments fail, more advanced therapies should be used."
In the Company's earlier press release of August 31, 2017, MiMedx confirmed the impressive results of this study. The study results indicate that:
- Patients treated with EpiFix® showed VLU healing rates of 60% within 12 weeks and 71% within 16 weeks. Healing rate in this context means the percentage of patients that achieved complete healing.
- EpiFix showed clinical superiority over Standard of Care (SOC) in the treatment of non-healing, full thickness VLUs. Wounds treated with EpiFix® were 2.26 times more likely to heal within 12 weeks than wounds treated with standard care alone.
- Results of this study are vastly superior to VLU healing rates reported in studies of other advanced wound care products.
- In the 1998 randomized study of VLU healing rates with Apligraf® conducted by Falanga, et al., a healing rate of 63% was reported at 24 weeks, which, while a separate study, nevertheless corresponds to the week 12 healing rate of 60% with EpiFix® reported in this study. The healing results observed with EpiFix® within 12 weeks are even more remarkable given that Falanga, et al. reported a mean wound size of 1.33 ± 2.69 cm2 for Apligraf® treated subjects, and excluded patients with uncontrolled diabetes and other clinically significant medical conditions that could impair wound healing. In this EpiFix® study, patients with these types of comorbidities were included and mean wound size was considerably larger at 7.6 ± 6.1 cm2.
"When comparing individual 12-week VLU clinical trial results of Apligraf®, the other biologically active product with next largest market share behind our EpiFix® allograft, EpiFix® shows by far the highest percentage of patients healed in 12 weeks. Compared to the superior 60% healing rate of EpiFix®, it took Apligraf® twice as long to heal 45% of wounds at 24 weeks. Additionally, in the Apligraf study, significantly smaller wounds were treated, and the study excluded patients with difficult medical conditions that were included in the EpiFix® study," said Petit.
Taylor added, "With only about 30% of the commercial plans that cover EpiFix® for diabetic foot ulcers (DFUs) also covering EpiFix® for VLUs, we expect this study will dramatically increase that ratio. We look forward to working with those commercial health plans to gain EpiFix® coverage for VLUs. Conservatively, we expect our incremental annual revenue opportunity based on patients presenting with VLUs not currently covered by our commercial insurance to be between approximately $75 million and $150 million."
Petit commented, "We have demonstrated in several peer-reviewed publications that our PURION® Processed dHACM recruits stem cells, promotes migration, and modulates stem cell activity in vitro and in vivo compared to appropriate controls. Numerous randomized controlled clinical trials have demonstrated that our PURION Processed dHACM is an effective therapy for treatment of chronic wounds and to promote soft tissue healing. In addition, MiMedx's dHACM allografts are now described in an official U.S. Pharmacopeia – National Formulary monograph with the publication of USP 40 - NF 35. We believe no other competitor can come close to this level of accomplishment, nor can their and products compare with the clinical and economic effectiveness of our dHACM allografts."
Apligraf® is federally registered trademark of Organogenesis Inc. Use of this marks in this press release does not imply any affiliation with or endorsement by the trademark holder.
MiMedx is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.
Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding EpiFix® expected healing rates, expected expanded insurance coverage, and the expected incremental revenue opportunity. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that actual healing rates may be less than those obtained in the study, expected favorable insurance coverage decisions are delayed or do not occur, and that the market for EpiFix® is less than expected. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.