MARIETTA, Ga., Nov. 12, 2015 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and the Dental sectors of healthcare, announced today that the Comparative clinical study "A Prospective, Randomized, Controlled, Multi-Centre Comparative Effectiveness Study of Healing Using Dehydrated Human Amnion/Chorion Membrane Allograft, Bioengineered Skin Substitute, or Standard of Care for Treatment of Chronic Diabetic Lower Extremity Ulcers," has been published in the December print issue of the International Wound Journal (Int Wound J. 2015 Dec;12(6):724-32. doi: 10.1111/iwj.12395).
The prospective multi-center randomized controlled trial (RCT) was conducted at three sites to compare the healing effectiveness of chronic lower extremity diabetic ulcers treated with either weekly applications of Apligraf®, EpiFix®, or standard wound care with collagen-alginate dressing. The paper was authored by Charles M. Zelen, DPM FACFAS; Lisa Gould, MD PhD; Thomas E. Serena, MD FACS; Marissa J. Carter, PhD MA; Jennifer Keller, DPM; and William W. Li, MD. The hard copy publication is expected to follow in a future issue of the International Wound Journal.
The highlights of the study include:
- After 4 weeks, 85% of EpiFix® patients achieved complete healing compared to only 35% of Apligraf® patients.
- After 6 weeks, 95% of EpiFix® patients achieved complete healing compared to only 45% of Apligraf® patients.
- Median time to healing with EpiFix® was 13 days compared to 49 days with Apligraf®.
- Mean number of EpiFix® grafts used was 2.51 at an average cost of $1,669, compared to 6.2 Apligraf® grafts used at a cost of $9,216.
- For every square centimeter of EpiFix® wasted, approximately 61.5 centimeters of Apligraf® was wasted.
- EpiFix® had a superior rate of wound healing and significantly faster rate of wound closure while utilizing 65% fewer grafts and 97.1% fewer square centimeters of graft material.
- EpiFix® dramatically reduces wastage and costs while achieving superior clinical results.
The comparative study established that EpiFix®, MiMedx's PURION® Processed dehydrated human amnion/chorion membrane (dHACM) allograft, is superior to Apligraf® in both the rate of wound healing and the speed at which wounds are completely healed. Not only did EpiFix® achieve superior clinical results, but the study also clearly demonstrated the dramatic cost savings of EpiFix® over Apligraf®. This study confirms the wastage and excessive expense that are caused when size appropriate grafts are not made available to the practicing physicians.
The RCT evidenced a number of dramatic examples of Apligraf® wastage. For every square centimeter of EpiFix® wasted, approximately 61.5 square centimeters of Apligraf® were wasted. Patients treated with EpiFix® utilized 65% fewer grafts and 97% fewer square centimeters of graft material. For the patients treated with EpiFix®, the mean number of grafts used and graft cost per patient were 2.15 grafts at a cost of $1,669, as compared to 6.2 grafts at a cost of $9,216 for patients treated with Apligraf®. The comparative savings based on the average sales price of the products was determined in the study to be 81.9% for those patients treated with EpiFix® compared to Apligraf®.
This study is the first multi-center randomized comparative effectiveness study examining side by side the performance, outcomes, wastage and cost of two generally available advanced wound care products as a treatment for chronic lower extremity diabetic ulcers.
Apligraf® is a registered trademark of Organogenesis, Inc.
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies are AmnioFix®, EpiFix®, CollaFix™ and OrthoFlo. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Through our donor program, a mother delivering via scheduled full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 500,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. The Company has recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by consenting mothers delivering healthy babies by scheduled full-term Caesarean section births. CollaFix™, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the continuing clinical and cost benefits of EpiFix® over Apligraf®. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that changes to the Apligraf® product will close or eliminate the gap in clinical and cost effectiveness, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2014, and the most recent Form 10-Q. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.
SOURCE MiMedx Group, Inc.