Aroa Biosurgery Registry Shows Minimal Safety Issues Across 474 Defects

MASTRR interim analysis: Myriad safety data across 474 defects

In its investor presentation, Aroa Biosurgery outlined interim safety results from the MASTRR registry (Short et al., Adv Ther, 3 September 2026), which recorded zero definitively device-related adverse events and 1 probable device-related adverse event across 474 defects in 411 subjects.

Management highlighted a median follow-up period of 27.1 weeks. The presentation described the registry as the “largest prospective evidence base in this category.”

The presentation framed the data against a sector backdrop of a “dearth of high quality large scale data” for bioscaffolds, alongside limited clinical evidence for specific product use across a wide range of procedures and patients.

What MASTRR is

The Myriad Augmented Soft Tissue Reconstruction Registry (MASTRR) is a prospective, single-arm, decentralised registry using relatively broad inclusion and exclusion criteria, described as “real-world”. It covers Myriad Matrix and Myriad Morcells.

Current registry metrics stand at 12 of 15 sites and 550 of 800 subjects. Site focus areas are Trauma/Burn, Colorectal and Lower Extremity.

How a registry study works

A registry collects data on how a product is used in routine clinical practice, rather than testing it against another treatment under tightly controlled conditions. A randomised controlled trial (RCT) assigns patients to different treatments by chance to compare them directly.

The presentation set out the distinction through the questions each design answers. A registry addresses “How does this technology perform in the real world?”, while an RCT addresses “Does treatment A perform better than treatment B under controlled conditions?”

Key contrasts listed in the presentation include:

• Eligibility: registries typically use broad criteria, while RCTs typically use narrower criteria to reduce variability.
• Sample size: registries are often large, while RCTs are usually smaller because of cost and complexity.
• Subgroup learning: registries are described as strong for exploring different indications, surgeons and patient types, while RCTs are limited if subgroup sizes are small.
• Generalisability: registries are designed to reflect real-world practice, while RCTs are often lower because of selective enrolment and controlled conditions.

Because the criteria are broad, registry results reflect a heterogeneous population that is reflective of routine clinical practice.

Safety and clinical outcomes

Patient complexity and safety results

The interim analysis population was clinically complex, according to the presentation:

• 35.8% of subjects were diabetic
• 30.4% had vascular disease
• 91.5% were ASA Grade II or higher
• 88.6% of defects were CDC Grade II or higher
• 15.0% of defects involved osteomyelitis

Index defect related adverse events (AEs) totalled 8.0%, including 0.7% deep tissue infection, 2.9% superficial infection and 0.0% graft loss. Non-index defect related AEs were 11.9%, and incidental AEs were 32.1%.

The table below reproduces the presentation’s adverse event data by severity and causality. Total AEs were 59, with percentages shown per row and per causality column as presented.

Deep tissue infection comparison

The presentation compared the 0.7% deep tissue infection rate for Myriad with rates reported for other bioscaffold types. The comparators are systematic reviews and meta-analyses, not head-to-head trials, while the Myriad figure comes from a prospective registry.

Early outcome data from the registry

The presentation also detailed early outcomes from registry subsets:

1. Limb salvage (n=130, complex lower extremity reconstruction): median 30.0 days to tissue coverage/fill and 127.0 days to closure.
2. Burns (n=32, deep partial thickness): median 18 days to healing.
3. Trauma (n=61, trauma and ACS defects): median 22.5 days to tissue coverage/fill and 70 days to closure.
4. Flap closure (n=46 versus n=48 controls): the OFM implant, used beneath local tissue flaps for pilonidal sinus reconstruction, significantly reduced dehiscence.

A median of 1 product application was reported across the limb salvage, burns and trauma groups.

Why the MASTRR registry matters commercially

Management stated that, as the largest prospective evidence base in this category, the registry “is becoming a commercial asset.” The presentation listed the following expected benefits:

• Surgeon confidence in contaminated and complex cases
• Unlocking the conservative/sceptical early majority
• Competitive differentiation
• Support for the case for hospital value-analysis approvals
• Potential health-economic impact
• Shorter sales cycles

These are management’s stated expectations rather than delivered results, and the presentation did not disclose revenue figures.

Aroa Biosurgery investor presentation

“As the largest prospective evidence base in this category, the MASTRR registry is becoming a commercial asset.”

Enrolment stands at 550 of 800 subjects across 12 of 15 sites. The registry has generated seven research outputs, including the interim safety analysis by Short et al. No timelines for completing enrolment were disclosed.

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