Aroa Biosurgery (ASX:ARX) has announced the completion of a significant clinical trial that it says could shape the future of chronic wound care.
The Auckland-based regenerative medicine company has finished its Symphony randomised controlled trial, a multi-centre study focused on treating diabetic foot ulcers, one of the most persistent and costly complications of diabetes. Early findings suggest that the trial has achieved its primary goal. More wounds heal within 12 weeks when treated with Symphony than with standard care.
Symphony represents a new class of treatment often described as a skin substitute, designed specifically for wounds that resist conventional healing approaches. It combines multiple layers of AROA’s extracellular matrix technology with high-molecular-weight hyaluronic acid, forming a structure intended to support tissue regeneration in complex cases such as diabetic foot ulcers and venous leg ulcers.
The trial enrolled patients across multiple sites in the United States, targeting individuals with chronic non-healing diabetic foot ulcers classified as Wagner grades 1 and 2. Participants received either Symphony or standard dressings weekly until healing occurred or the 12-week study period concluded.
Chief executive Brian Ward described the outcome as an important step in strengthening the clinical evidence behind Symphony, noting that randomised controlled trials are widely considered the most reliable standard in medical research.
The implications extend into market access and reimbursement. Aroa expects that publishing the full results will help meet increasingly stringent evidence requirements in the United States healthcare system, potentially smoothing the path for broader adoption of Symphony in clinical practice.