MiMedx Group has reported positive results from a study of its EpiFix, a dehydrated human amniotic membrane allograft, designed as a treatment for diabetic neurovascular foot ulcers.
The controlled, randomized trial, which enrolled 80 patients, is designed to compare the effectiveness of EpiFix allograft with the standard of care treatment.
Results from the Institutional Review Board demonstrated statistically significant improvement in the healing of wounds treated with EpiFix compared with patients receiving the standard of care treatment alone.
The trial also demonstrated 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.
MiMedx Group president and COO Bill Taylor said the intent of the trial was to generate clinical data in treating diabetic foot ulcers with EpiFix, which has shown clinical and cost effectiveness.
"EpiFix currently has product specific coding from CMS to permit billing for Medicare patients," Taylor added.
"This newly generated data will further support continued and expanded Medicare coverage of EpiFix®."