AUCKLAND, New Zealand, March 29, 2026 /PRNewswire/ -- Aroa Biosurgery Limited today announced completion of its randomised controlled trial (RCT) evaluating Symphony, with a preliminary study read-out indicating the trial achieved its primary endpoint.
Symphony is AROA's Cellular, Acellular and Matrix-like Product (CAMP), or skin substitute, designed for the treatment of hard-to-heal wounds, including diabetic foot ulcers (DFUs) and venous leg ulcers. The product combines multiple layers of AROA ECM with high molecular weight hyaluronic acid.
The prospective, multi-centre, randomised trial evaluated the safety and performance of Symphony in the treatment of chronic Wagner grade 1 and 2 non-healing diabetic foot ulcers. Patients were randomised to receive either Symphony or standard of care (SOC) dressings on a weekly basis until wound healing or for up to 12 weeks.
The study design provided for recruitment of up to 150 patients across multiple sites in the United States. The primary endpoint assessed whether more diabetic foot ulcers healed within the 12-week treatment period with Symphony compared with SOC.
Based on the preliminary read-out, the Company believes the trial met its primary endpoint. AROA expects that, once confirmed through final analysis and publication, the results will further support Symphony's clinical efficacy in the management of diabetic foot ulcers.
The Company also believes publication of the full study results will help meet the high standard of clinical evidence likely to be required under future reimbursement policies.
"This is a crucial step in building the clinical evidence base for Symphony and supporting clinical adoption in chronic, complex wounds," said Brian Ward, Chief Executive Officer of AROA Biosurgery. "Randomised controlled trials are regarded as the most robust form of clinical evidence, and these results further validate Symphony's clinical value. We are encouraged by the preliminary study read-out and look forward to publication of the full study results in the coming months."
SOURCE Aroa Biosurgery
