Melodi Health, a medical device company based in Minneapolis, announced two significant milestones last week. The company successfully closed a $10.75 million oversubscribed Series A funding round and launched the “ARIA” investigational device exemption (IDE) trial, designed to improve outcomes for women undergoing breast reconstruction following mastectomy. The funds raised will support ongoing clinical activities and further product development.
Melodi Health, founded in February 2021, has now raised a total of $15 million. The Series A round saw participation from HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital. The company is focused on developing innovative medical products that aim to transform breast reconstruction and provide better outcomes for women undergoing breast cancer treatment.
“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,” said Sarah Worrell, co-founder and CEO of Melodi Health. “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.”
The investigational device at the center of Melodi Health’s efforts, the Melodi Matrix, is an absorbable mesh designed to support soft tissue while releasing antibiotics in a controlled manner as the device is absorbed into the body. This novel technology, licensed from Medtronic, aims to address a significant unmet need in breast reconstruction surgery. Currently, there are no FDA-approved soft tissue support products specifically designed for breast surgery that incorporate antibiotics.
“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,” said Dr. Hunter Moyer, chief medical officer of Melodi Health.
The ARIA trial, formally known as the Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction with Infection Outcomes Assessment, is a multicenter, nationwide, randomized, controlled study. It aims to evaluate the safety and efficacy of the Melodi Matrix to support an FDA approval for use in breast reconstruction. The first patient was enrolled at University of Utah Health, marking the beginning of this pivotal clinical study.
“A 10-14% national average infection rate in breast reconstruction is not acceptable,” said Dr. Alvin Kwok, 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 is dedicated to advancing surgical innovation in breast reconstruction, with the ultimate goal of improving outcomes for women facing complex treatment regimens. The company’s flagship product, the Melodi Matrix, represents a promising advancement in this field, combining proven Medtronic technology with a focus on patient safety and efficacy.
