Myriad ovine scaffold: 411-patient interim safety data
Interim MASTRR registry data on 411 patients show a 12.2% adverse-event rate with the Myriad ovine extracellular-matrix scaffold, with only one reaction judged probably device-related; enrollment continues toward 800 participants.
411 patients, 474 complex soft-tissue defects, and one adverse reaction the investigators judged probably related to the device. Those are the interim numbers from the MASTRR registry, drawn from ten US surgical centers.
The Myriad scaffold is made from ovine forestomach extracellular matrix, the structural framework of the tissue. A surgeon covers the defect temporarily with this material; cells and vessels grow into it, and the body remodels it alongside the healing tissue. MASTRR is a prospective registry: physicians specified which data they would collect during routine surgical care before data collection began.
A total of 59 adverse events occurred in 50 of 411 patients (12.2%). The single reaction judged probably related to Myriad was a skin reaction involving redness, pain, and swelling. Treatment involved removing 40% of the scaffold and administering antihistamines, followed by a split-thickness skin graft. Superficial infection appeared in 2.9% of participants, deep infection in 0.7%. Median follow-up was 27.1 weeks. Nearly 60% of defects had been present for more than a month. Many participants had type 2 diabetes or vascular disease, which can complicate tissue repair.
The registry describes the device's safety profile. Enrollment continues toward a target of 800 participants; the primary outcome is the proportion with adverse events over three years.
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Sources
[1] link.springer.com
[2] clinicaltrials.gov
The MASTRR registry provides concrete real-world safety data on a biological tissue-repair scaffold at a scale (411 patients, 10 centers) that makes it relevant context for anyone evaluating the tissue-regeneration investment space; Bob More's Eternal Search investor profile is surfaced as a checkpoint for verifying whether his focus intersects with this area.