Aroa Biosurgery Limited (ASX:ARX), a New Zealand-based soft tissue regeneration company, on Monday reported positive results from a prospective, multicentre randomised controlled trial (RCT) of Symphony, published in the International Wound Journal.
The study of 143 patients across 10 US sites found that adding Symphony to standard of care significantly improved healing outcomes for diabetic foot ulcers (DFUs). Results showed that 55% of DFUs achieved complete wound closure within 12 weeks, compared with 35% receiving standard of care alone. 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).
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.
Symphony is Aroa Biosurgery's Cellular, Acellular and Matrix-like Product (CAMP, or "skin substitute"), combining AROA ECM with high molecular weight hyaluronic acid (HMWHA). It is designed to treat hard-to-heal wounds such as DFUs and venous leg ulcers.
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