Melodi Health Gains $10.75 Million in Funding for Product Development

Melodi Health has closed $10.75 million in oversubscribed Series A financing from various investors, including HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital.

The money will be used to fund clinical activities and additional product development activities. Melodi Health has raised $15 million since its founding in February 2021. 

The company also has launched the “ARIA” investigational device exemption (IDE) trial, aimed at improving clinical outcomes for women undergoing breast reconstruction after mastectomy. “We are thrilled to achieve these important financial and clinical milestones, namely the first implant of a device being evaluated for safety and efficacy that is designed to provide soft-tissue support and reduce post-surgical infections associated with breast cancer surgery,” Melodi Health Co-Founder/CEO Sarah Worrell said. “This device is unlike anything surgeons currently have in their toolbox to mitigate a situation that occurs in as many as 14% of women undergoing mastectomy followed by reconstruction.”
 
There currently are no U.S. Food and Drug Administration (FDA)-approved soft tissue support products for use in breast surgery, and none that contain antibiotics. The Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction with Infection Outcomes Assessment (ARIA) clinical trial is a multicenter, nationwide, randomized, controlled study evaluating the safety and efficacy of the Melodi Matrix to support an FDA approval for breast reconstruction indication. The Melodi Matrix, an absorbable mesh that is designed to support soft tissue while providing controlled release of antibiotic agents as it is absorbed into the body, is an implantable medical device comprised of proprietary technology licensed from Medtronic by Melodi Health.

“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. As a reconstructive surgeon, I want to restore what cancer took from my patients. I can’t do that if infections and complications intercede. 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,” Melodi Health Chief Medical Officer Hunter Moyer, M.D., stated.
 
Melodi’s first patient was enrolled at University of Utah Health. “A 10% to 14% national average infection rate in breast reconstruction is not acceptable,” said Alvin Kwok, M.D., 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 Health aims to transform breast reconstruction through surgical innovation to meaningfully improve outcomes in patients undergoing complicated treatment regimens. Melodi’s flagship offering, the Melodi Matrix, is based on proven technology from Medtronic. The Melodi Matrix is a bioabsorbable mesh that elutes antibiotic agents and is fully absorbed by the body. Melodi has licensed Medtronic technology for the breast surgery field of use.