In a 143-patient randomized controlled trial published in the International Wound Journal, Symphony plus standard of care closed diabetic foot ulcers completely in 55% of patients within 12 weeks, against 35% for standard of care alone. That 20-percentage-point gap (p=0.039) also came with a concrete speed advantage: wounds healed roughly 7.8 days faster on average, reaching closure in 65.4 days versus 73.2 days. For a wound category notorious for treatment failures and amputation risk, those numbers carry real weight in payer conversations.
The trial design adds credibility that single-arm studies cannot. Ten U.S. sites enrolled patients with Wagner Grade 1 or 2 ulcers, meaning the population included wounds extending through the full skin thickness and into deeper structures like tendons and joint capsules. Weekly Symphony applications continued for up to 12 weeks, and the primary endpoint was complete wound closure. Both the closure rate and time-to-closure differences crossed statistical significance, giving Aroa Biosurgery something the CAMP category frequently lacks: Level I effectiveness data.
That matters because Medicare reclassified most CAMPs effective January 1, 2026, tightening reimbursement criteria and intensifying pressure on manufacturers to show controlled clinical evidence rather than retrospective or registry data. Symphony received FDA 510(k) clearance in June 2020, so it is already commercially available in the U.S. market; the RCT publication now gives sales teams and hospital formulary committees the evidence tier that payers are increasingly requiring before covering advanced wound products. Aroa describes Symphony as combining its proprietary extracellular matrix with high molecular weight hyaluronic acid, a polymer that retains moisture and carries anti-inflammatory properties relevant to the chronic inflammation typical in DFUs.
The commercial question is how quickly that evidence converts to formulary wins. With the 2026 Medicare reimbursement changes already live, any CAMP without RCT data faces a harder coverage argument at each contract cycle. Symphony’s published 55% closure rate in a prospective multicenter trial is the specific number that will either open or close those negotiations.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
