MiMedx Group Announces Positive Results From Diabetic Foot Ulcer Randomized Controlled Trial
Published: Aug 07, 2012
KENNESAW, Ga., Aug. 7, 2012 /PRNewswire/ -- MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has closed a clinical trial involving its EpiFix® dehydrated human amniotic membrane allograft for the treatment of diabetic neurovascular foot ulcers.
This prospective trial design initially targeted 80 patients. Those patients selected for the randomized, controlled trial were treated with either a well accepted standard of care program for diabetic foot ulcers or standard of care plus an application of EpiFix®, a MiMedx allograft processed from human amniotic membrane.
Results from the Institutional Review Board ("IRB") approved randomized controlled trial indicated a statistically significant improvement in the healing of wounds treated with EpiFix® compared with patients receiving the standard of care treatment alone. The trial results indicated a significant healing rate, with 92% of the patients in the EpiFix® study arm healed completely at six weeks, contrasted with only 8% of the standard of care control arm patients healed in the same time frame. After reviewing and validating the results with two additional independent wound researchers, the principal investigator recommended termination of the trial earlier than initially expected, and the IRB and MiMedx accepted the early closure of the study. These findings are expected to be submitted for peer reviewed journal publication within the month.
"The intent of the trial was to generate clinical data in treating diabetic foot ulcers with EpiFix®, which has shown strong clinical and cost effectiveness. EpiFix® currently has product specific coding from CMS to permit billing for Medicare patients. This newly generated data will further support continued and expanded Medicare coverage of EpiFix®," said Bill Taylor, President and COO of MiMedx Group.
MiMedx continues characterization of the EpiFix® allografts with several scientific and clinical studies, including frequency of application and cost effectiveness in various wound types. In addition, the Company has similar active clinical studies for its AmnioFix® allograft, which is used for surgical procedures, and its AmnioFix® Injectable, which is used for the enhancement of soft tissue healing.
Human amniotic membrane has been used in the treatment of various wounds for over 100 years, including diabetic neurovascular ulcers, venous stasis ulcers and burns. More recently, MiMedx Group and its Surgical Biologics subsidiary have developed the Purion® Process for both preserving and sterilizing these allografts for commercial use. These allografts are stable at room temperature for years, are easier to handle and apply than current competing products, and to date over 90,000 grafts have been distributed.
About the Company
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "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 include the device technologies HydroFix® and CollaFix, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies, processed from the human amniotic membrane, utilize our proprietary Purion® Process that was developed by our wholly-owned subsidiary, Surgical Biologics, to produce a safe, effective and minimally manipulated implant for homologous use. Surgical Biologics is the leading supplier of amniotic tissue, having supplied over 90,000 implants to date to distributors and OEMs for application in the Ophthalmic, Orthopedics, Spine, Wound Care and Dental sectors of healthcare.
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 the results of the Company's research studies will support continued and expanded Medicare coverage of EpiFix®. 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 the study results may not have the anticipated effect on Medicare coverage for EpiFix® 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, 2011. 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.