Aroa Biosurgery (ARX) Study result summary

Product and study design

• Symphony (OFM-HA) combines layered ovine forestomach matrix/AROA ECM with high-molecular-weight hyaluronic acid; preclinical work showed increased keratinocyte proliferation and migration.

• Prospective, multicenter RCT enrolled adults with chronic Wagner Grade 1–2 diabetic foot ulcers, comparing Symphony plus standard care (SOC) with SOC alone; control care included collagen and calcium alginate dressing, debridement and off-loading.

• Of 197 screened, 143 were randomized; mITT populations were 68 with Symphony plus SOC and 72 with SOC alone, while per-protocol populations were 57 and 52. Groups were broadly comparable, though Symphony patients had longer diabetes duration and higher A1C.

• Protocol included a two-week SOC run-in, weekly treatment visits, debridement and off-loading; primary endpoint was wound closure at 12 weeks, with time to heal and adverse events as secondary endpoints and a two-week healing confirmation period.

Clinical findings

• At 12 weeks, mITT closure was 46% (31/68) with Symphony plus SOC vs 24% (17/72) with SOC alone (p=.008); per-protocol rates were 54% vs 33% (p=.033).

• Time to closure favored Symphony: 67.4 vs 75.2 days in mITT (p=.023) and 65.4 vs 73.2 days per protocol (p=.041).

• Results support efficacy across Wagner Grades 1 and 2; no prespecified grade-specific subgroup analysis was reported.

Safety and interpretation

• Overall adverse-event rates were 50% with Symphony plus SOC vs 51% with SOC alone; index-ulcer infections were 13% vs 17%, osteomyelitis/gangrene cases 1 vs 7, and minor amputations 1 vs 3.

• No unexpected device-related adverse events or major amputations occurred; interpretation was limited by post-randomization exclusions, differential withdrawal and an adjusted comparison near the significance threshold (p=.045).