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Press Release: MiMedx® Group Announces Positive Results From Diabetic Foot Ulcer Randomized Controlled Trial
MiMedx Group, Inc., 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.