Aroa Biosurgery Limited (ARX.AX) announced the completion of its randomized controlled trial (RCT) evaluating Symphony, with preliminary results indicating that the study achieved its primary endpoint. Symphony is AROA's Cellular, Acellular and Matrix-like Product (CAMP), a skin substitute designed to treat hard-to-heal wounds such as 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-center trial assessed the safety and performance of Symphony in treating chronic Wagner grade 1 and 2 non-healing diabetic foot ulcers. Patients were randomized to receive either Symphony or standard of care (SOC) dressings weekly until wound healing or for up to 12 weeks. The study design allowed for recruitment of up to 150 patients across multiple sites in the United States.
The primary endpoint measured whether more diabetic foot ulcers healed within the 12-week treatment period with Symphony compared to SOC. Based on the preliminary read-out, Aroa believes the trial met this endpoint. Once confirmed through final analysis and publication, the company expects the results will further support Symphony's clinical efficacy in managing diabetic foot ulcers.
ARX.AX was trading at A$0.5600, down A$0.0100 or 1.75%.
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