Low Infection Rates Reported for Myriad Bioscaffolds in Complex Soft Tissue Reconstruction

Aroa Biosurgery Limited has announced the publication of interim results from its ongoing MASTRR Registry, a peer-reviewed study that evaluates the safety and performance of the company’s Myriad Matrix and Myriad Morcells in complex soft tissue reconstruction procedures. The study, published in Advances in Therapy, reports low infection rates and no adverse events definitely related to Myriad products.

The analysis included 411 patients and 474 soft tissue defects treated across 10 US centers. To Aroa’s knowledge, it is the largest published prospective analysis of a bioscaffold in in-patient soft tissue reconstruction. Myriad Matrix and Myriad Morcells were evaluated across a broad range of complex soft tissue reconstruction procedures in a highly challenging real-world patient population. Approximately 59% of the patients were ASA Class III or IV, indicating significant underlying systemic disease. Additionally, 35% of the patients had diabetes, 30% had vascular disease, and 23% used nicotine. The defects were similarly complex, with approximately 89% being clean-contaminated or contaminated, 59% chronic, 15% involving confirmed osteomyelitis, and 11% involving exposed structures, including bone, tendon, or viscera.

Despite this complexity, deep tissue infection occurred in only 0.7% of patients, and superficial infection in 2.9%. No infections were attributed to Myriad over a median follow-up period of 27 weeks. Across the 474 defects, the median number of Myriad applications was one.

Aroa CEO Brian Ward stated, "This is an important milestone for Myriad and the MASTRR Registry. AROA is lifting the bar for the quality of clinical evidence in soft tissue reconstruction."

"Despite the challenging patient population, infection rates were exceptionally low, and no adverse events were causally related to Myriad. It is also encouraging to see the infection profile compared very favorably with other commercially available bioscaffolds, as we see this as a key differentiator," Ward added.

The authors of the interim analysis discussed Myriad's low infection rates in the context of infection rates reported for several resorbable synthetic bioscaffold products used in complex soft tissue reconstruction, as reported in separately published meta-analyses. Those reported infection rates ranged from 16% to 25%.

Post-operative infections can delay healing, increase the risk of further complications, and may require additional treatments, surgical interventions, or hospitalization. A large US analysis of patients undergoing open surgical procedures found that a surgical site infection added an average 7.8-9.3 days to a patient's hospital stay and approximately US$18,600, US$21,000 in healthcare costs, with deep tissue infections creating an even greater burden.

While the MASTRR interim analysis assessed safety rather than healthcare utilization or cost savings, Aroa noted that Myriad's favorable infection profile may be relevant to healthcare providers managing complex soft tissue defects.

The MASTRR Registry is an ongoing prospective, multicenter observational study evaluating the real-world safety and performance of Myriad Matrix and Myriad Morcells. More than 550 patients are currently enrolled, and the registry is approved to enroll up to 800 patients across 15 US sites.

The publication adds to previously published procedure-specific analyses from the MASTRR Registry in lower extremity reconstruction, trauma, burns, pilonidal disease, and pressure injuries. Aroa expects the expanding registry dataset to support further analyses across multiple surgical specialties and applications.

The study, "Safety of Ovine Forestomach Matrix Across 474 Soft Tissue Defects: Interim Results from the Prospective Multicenter MASTRR Registry," has been published in Advances in Therapy and is available online.