MiMedx Group (NASDAQ:MDXG), announced Monday that results from a randomized controlled trial for its EpiFix wound-care allograft have been published in the International Wound Journal.
The clinical trial included patients with diabetic foot ulcers of at least four weeks' duration without infection, having adequate blood supply. Patients were broken into two groups, one receiving standard care alone, the other standard care plus EpiFix. After four and six weeks of treatment, the overall healing rate of patients treated with EpiFix was 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds, respectively. The rate of healing with EpiFix exceeded that of standard treatment as well.
According to the World Health Organization, diabetes will affect 366 million people worldwide -- up from 171 million in 2000. Approximately 25% of diabetics will develop a chronic non-healing ulcer over their lifetime. Diabetic foot ulcers occur in 15% of all patients with diabetes and precede 84% of all lower leg amputations.
EpiFix makes use of dehydrated human amniotic membrane to heal these ulcers. At room temperature, EpiFix can have a shelf life of five years and retains the properties of the natural membrane. Although there are similar, competing products on the market, the superior performance of EpiFix compared with rival products (not yet proven by published studies) could help to make the company a market leader in the treatment of diabetic foot ulcers.
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