Aroa Biosurgery Limited (ASX: ARX), a soft tissue regeneration company, announced positive results from a prospective, multicenter randomized controlled trial (RCT) of Symphony™, published in the International Wound Journal.

The study enrolled 143 patients across 10 U.S. sites and found that adding Symphony to standard of care significantly improved healing outcomes for diabetic foot ulcers (DFUs):

• 55% of DFUs achieved complete wound closure within 12 weeks, compared with 35% receiving standard of care alone (p=0.039).
• Mean time to complete wound closure was reduced by 7.8 days: 65.4 days with Symphony plus standard of care, compared with 73.2 days with standard of care alone (p=0.041).

The trial enrolled patients with challenging Wagner Grade 1 or 2 DFUs, ranging from ulcers involving the full thickness of the skin to deeper ulcers extending into ligaments, tendons, joint capsules or deep fascia. Patients were randomly assigned to receive weekly Symphony plus standard of care or standard of care alone, for up to 12 weeks or until complete wound closure.

The findings provide high-quality clinical evidence supporting Symphony's effectiveness and are expected to support product differentiation, clinical adoption and evolving U.S. reimbursement requirements.

"New technologies and high-quality randomised clinical evidence are essential if we are to continue improving outcomes for patients with diabetic foot ulcers," said lead investigator Dr David Armstrong. "The Symphony trial demonstrates that combining a novel extracellular matrix bioscaffold with high molecular weight hyaluronic acid can significantly improve wound healing when added to good standard of care. Studies like this help clinicians make informed treatment decisions based on robust evidence."

"This is a major milestone for Symphony. The study delivered clear, statistically significant results: adding Symphony to standard of care for DFUs increased complete wound closure at 12 weeks to 55%, compared with 35% for standard of care alone, and reduced mean healing time by 7.8 days," said AROA CEO Brian Ward.

"The multicentre design and involvement of recognised key opinion leaders strengthen the evidence's credibility and clinical relevance. Amid growing demand from clinicians, payors and reimbursement authorities for robust RCT data, this publication places Symphony among a small group of CAMPs with Level I effectiveness data, strengthening its differentiation and commercial value proposition."