AROA BIOSURGERY LIMITED (ASX: ARX) has announced compelling positive results from a prospective multicenter randomised controlled trial (RCT) for its Symphony™ product. AROA Biosurgery is a soft-tissue regeneration company committed to unlocking regenerative healing for everybody, developing and manufacturing medical and surgical products from a proprietary extracellular matrix bioscaffold. The findings, recently published in the International Wound Journal, indicate that the addition of Symphony™ to standard of care substantially improved healing outcomes for diabetic foot ulcers (DFUs).
The trial enrolled 143 patients across ten US sites, focusing on challenging DFUs classified as Wagner grade 1 or 2. Results showed that 55% of DFUs in the Symphony™ arm achieved complete wound closure within 12 weeks, a significant improvement compared to 35% in the standard of care-only arm. Furthermore, the mean time to complete wound closure was reduced by 7.8 days for patients receiving Symphony™ plus standard of care, averaging 65.4 days compared to 73.2 days for those on standard of care alone.
Dr David Armstrong, Lead Investigator, highlighted the importance of high-quality randomised clinical evidence in improving patient outcomes, stating that the Symphony™ trial demonstrates the product’s ability to significantly improve wound healing when combined with good standard of care. AROA CEO Brian Ward remarked that this represents a major milestone for Symphony™. He noted the statistically significant results, which included a 55% increase in the incidence of complete wound closure at 12 weeks and a 7.8-day reduction in mean healing time. Symphony™, AROA’s Cellular, Acellular and Matrix-like Product (CAMP), combines AROA ECM™ with high molecular weight hyaluronic acid, designed to treat hard-to-heal wounds like DFUs. These findings are expected to support product differentiation, clinical adoption, and evolving US reimbursement requirements, positioning Symphony™ with Level I effectiveness data.
