Aroa Biosurgery (ARX) Status update summary

Registry overview

• MASTRR is a prospective, decentralized real-world registry of Myriad Matrix and Myriad Morcells across soft-tissue reconstruction; tracking reached 12 of 15 sites and 550 of 800 planned subjects.

• The interim analysis covered 411 patients and 474 defects across 10 sites, with median follow-up of 27.1 weeks.

• Interim cohort characteristics included 28.3% with diabetes, 30.4% with vascular disease, 91.5% ASA Grade II or higher, and 88.6% of defects CDC Grade II or higher.

• Nearly 60% of defects were over 30 days old; 11% had exposed structures and 15% had osteomyelitis.

• Use included dermal reconstruction (65%), implantation (25%) and fistula augmentation (9.7%); diabetic foot ulcers accounted for 22.6% of defects. Registry outputs span multiple specialties and applications.

Interim safety findings

• No definitively device-related adverse events were reported; 47 events (79.7%) were assessed as unrelated, 11 (18.6%) as unlikely related and one (1.7%) as probable.

• Index-defect outcomes included deep tissue infection at 0.7%, superficial infection at 2.9% and graft loss at 0.0%.

• Index-defect adverse events were each below 5%; dehiscence occurred in 3.2% of subjects. The single probable device-related event was categorized as an allergic reaction.

• In the diabetic foot ulcer subgroup, including 75 Wagner Grade III or IV wounds, no associated index adverse events were reported.

• The 0.7% deep tissue infection rate was compared with 16.9%–26.24% rates in cited bioscaffold reviews and meta-analyses across varied defect types and burns.

Clinical and economic relevance

• Dr. Short said the real-world registry includes patients often excluded from RCTs, informing decisions for complex wounds with exposed tendon or bone, infection, or osteomyelitis.

• Clinician commentary highlighted typically low reapplication needs; Myriad can be used in non-pristine wound beds with standard dressings or negative-pressure therapy.

• For diabetic foot ulcers, Dr. Short contrasted single-application use with traditional care that may involve repeated weekly applications and procedures, citing potential to avoid a month of procedures.

• Potential system benefits included fewer procedures, shorter hospital stays, outpatient management and lower infection-related costs.

• Economic evidence-building includes published analyses and hospital examples comparing costs before and after switching to Myriad.