First Patients Enrolled in Prospective Randomized Multi-Center Comparative Clinical Study Evaluating Restrata®

for the Treatment of Venous Leg Ulcers
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 multicenter, head-to-head clinical study evaluating Restrata® for the treatment of non-healing venous leg ulcers (VLUs). William Marston, M.D., the George Johnson Jr. Distinguished Professor of Vascular Surgery at the University of North Carolina School of Medicine is the study’s lead investigator. The study will be the first level 1 clinical comparison between Restrata and a biologic skin substitute.

Venous leg ulcers (VLUs) are a chronic ulcer type which affect 3% of the world population, including over 2 million people annually in the US.1,2 VLUs are a major cause of morbidity and poor quality of life resulting from venous insufficiency in the lower limbs. This type of wound presents clinical challenges as VLUs may require many months of treatment before healing is achieved.3 The US economic burden of VLU treatment was close to $15 billion in 2014 … read more