Melodi Health has announced the first enrollment in its pivotal ARIA (Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction with Infection Outcomes Assessment) clinical trial. This multicenter, nationwide, randomized, controlled study will evaluate the safety and efficacy of the Melodi Matrix™ in women undergoing breast reconstruction after mastectomy. The company also announced the close of a $10.75 million oversubscribed Series A financing round to support these clinical and product development activities.
The ARIA trial is designed to support an FDA approval for the Melodi Matrix in breast reconstruction. The Melodi Matrix is an absorbable mesh designed to provide soft tissue support while providing controlled release of antibiotic agents as it is absorbed into the body. It represents a novel approach to reducing post-surgical infections, which occur in as many as 14% of women undergoing mastectomy followed by reconstruction.
Addressing Post-Surgical Infections in Breast Reconstruction
Post-surgical infections remain a significant challenge in breast reconstruction, leading to complications, increased healthcare costs, and patient distress. Current options for soft tissue support lack antibacterial properties, leaving an unmet need for solutions that can both support tissue and prevent infection.
"Breast cancer patients come to me at a terrible time. My purpose is to help them, and I know I need the best available options for infection prevention and cosmetic results," said Hunter Moyer, MD, chief medical officer of Melodi Health. "Reconstructive surgeons have been looking for the next generation of soft tissue support, and we now have that with the investigational Melodi Matrix, which is designed to give both soft tissue support and infection reduction."
The ARIA Trial: Design and Objectives
The ARIA trial is a randomized, controlled study comparing the Melodi Matrix to standard of care in breast reconstruction. The primary endpoint is the incidence of post-surgical infections. Secondary endpoints include measures of soft tissue support, cosmetic outcomes, and patient-reported outcomes.
"A 10-14% national average infection rate in breast reconstruction is not acceptable," said Alvin Kwok, MD, associate professor of surgery and principal investigator at University of Utah Health. "I look forward to offering the Melodi Matrix to patients in this trial and observing the impact of this device on patient outcomes, including infections."
Melodi Matrix: Technology and Mechanism of Action
The Melodi Matrix is based on technology licensed from Medtronic. It is a bioabsorbable mesh that elutes antibiotic agents and is fully absorbed by the body. This dual-action approach aims to provide immediate soft tissue support while reducing the risk of infection during the critical post-operative period.
