Aroa Biosurgery (ASX:ARX) has achieved a clinical milestone following the completion of its randomised controlled trial for Symphony, a sophisticated cellular, acellular, and matrix-like product designed for complex wound care.
The prospective, multi-centre study focused on the treatment of chronic Wagner grade 1 and 2 non-healing diabetic foot ulcers, a notoriously difficult-to-treat condition that places a heavy burden on healthcare systems.
The trial, which recruited 150 patients across various sites in the United States, compared the efficacy of Symphony dressings against the current standard of care over a 12-week period.
Preliminary findings released by the company indicate that the study met its primary endpoint, demonstrating that a higher proportion of diabetic foot ulcers healed within the 12-week window when treated with Symphony compared to those receiving traditional SOC treatments.
"This is a crucial step in building the clinical evidence base for Symphony," stated Aroa CEO Brian Ward.
He emphasised that the robust nature of an RCT provides the validation necessary for widespread clinical adoption.
Beyond immediate patient benefits, the company anticipates that these results will satisfy the increasingly rigorous evidence thresholds required for future US reimbursement policies.
At the time of reporting, Aroa Biosurgery's share price was $0.60.