First Patient Enrolled in Restrata® Randomized Controlled Trial

Acera Surgical, Inc. (Acera), a leading bioscience company developing and commercializing a portfolio of fully synthetic materials for regenerative medical applications, today announced its first patient enrollment in a clinical study evaluating Restrata, Acera’s leading wound care product, for the treatment of non-healing diabetic foot ulcers (DFUs). The study will generate level 1 clinical evidence to support coverage and reimbursement from US health insurers for Restrata’s use in outpatient wound clinics and physician office settings … Non-healing foot ulcers are among the most debilitating outcomes affecting people with diabetes in the United States. Roughly 1 out of 3 people with diabetes will develop a foot ulcer over the course of their lifetime1. More than 50% of diabetic foot ulcers become infected, and roughly 20% of diabetic foot infections result in amputation. That means that almost every 20 seconds, a lower limb is amputated due to complications associated with diabetes2. In the United States, an estimated $237 billion is spent annually on direct costs for diabetes, and as much as one third of that will be spent to treat lower extremity complications3 … read more