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 latest peer-reviewed clinical study on MiMedx allografts, "Dehydrated Human Amnion/Chorion Membrane Treatment of Venous Leg Ulcers: Correlation Between 4-week and 24-week Outcomes," was published in print in the Journal of Wound Care, Vol 24. No 11. November 2015.
The paper was authored by Thomas E. Serena, MD; Raphael Yaakof; Daniel T. DiMarco, DO; Lam T. Le, MD; Elisa Taffe, MD; Magruder Donaldson, MD; and Michael Miller, MD. The paper is a retrospective long-term follow-up study of patients with prior enrollment in the peer-reviewed study previously published "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," the first ever peer-reviewed venous leg ulcer (VLU) study evaluating processed amniotic tissue and the first paper using a surrogate marker of greater than 40% wound area reduction at 4 weeks in VLUs as primary endpoint in a clinical evaluation of an advanced bioactive allograft arena.
The original study concluded that 62% of EpiFix® patients achieved the surrogate marker endpoint of greater than 40% wound area reduction at 4-weeks vs. 32% of Control patients. The purpose of the follow-up study was to evaluate if the rate of wound healing at 4-weeks correctly correlates with rates of complete healing within 24 weeks in patients with VLUs. Patients who did not heal completely during the RCT 4-week study period and who continued to receive treatment at the study center were eligible for long term follow-up. The objective of the follow-up study was to evaluate the correct correlation between an intermediate rate of wound reduction (40% wound area reduction after 4 weeks treatment) and complete healing at 24 weeks in patients with a VLU. A correct correlation occurs when the surrogate marker or intermediate outcome correctly predicted the ultimate outcome. Example: patients with less than 40% healing at 4 weeks that did not heal completely within 24 weeks, and patients with greater than or equal to 40% healing at 4 weeks that went on to heal completely both had correct correlation of their 4 week and 24 week outcome.
Study Highlights include:
- The study validated the intermediate outcome used in the initial RCT which showed that VLU treated with dHACM had greater reduction in wound size within the first 4 weeks of treatment than VLU treated with compression alone.
- The study found that 80% of patients with a healing rate of greater than or equal to 40% after 4 weeks of treatment went on to heal completely within 24 weeks, while only one-third of patients healing at a rate of less than 40% after 4 weeks went on to heal completely, p=0.0023.
- In the overall study population (n=44), the healing status at 4 weeks (at least 40% healed, yes or no) correctly correlated with the healed status (completely healed, yes or no) after 24 weeks 73% of the time.
- These results validate the use of the intermediate endpoint in the initial RCT.
- Surrogate endpoints/intermediate study outcomes, such as status at 4 weeks, that can predict the complete healing over a longer period are beneficial for research in new wound healing products, allowing for more rapid evaluation of potentially promising innovations.
Parker H. "Pete" Petit, Chairman and CEO, said, "The purpose of the follow-up study was to provide more support for the short 4-week study period and the 40% cut-off in the original RCT. The study clearly evidenced that surrogate endpoints and/or intermediate study outcomes can effectively predict complete healing over a longer period. This finding should be very beneficial in the evaluation of wound care treatment innovations."
Bill Taylor, President and COO, added, "MiMedx is committed to the scientific and clinical rigor necessary to be the leading processor of amniotic membrane allografts for multiple therapeutic uses, and this study is just another demonstration of our commitment".
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, that surrogate endpoints and/or intermediate study outcomes can effectively predict complete healing over a longer period, and that the study's findings will be beneficial in the evaluation of would care treatment options. 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 additional studies (if any) may not also evidence that surrogate endpoints and/or intermediate study outcomes can effectively predict complete healing over a longer period, that medical professionals may not adopt the study's findings in their evaluation of would care treatment options, 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 its most recent Form 10Q filing. 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.