Melodi Health, a Minneapolis-based medical device company, has announced two major milestones: the successful closing of an oversubscribed $10.75 million Series A financing round and the launch of the “ARIA” investigational device exemption (IDE) trial. The trial aims to improve clinical outcomes for women undergoing breast reconstruction after mastectomy. The company, founded in February 2021, is dedicated to developing transformative medical products for breast reconstruction, especially for women undergoing breast cancer treatment.
The Series A funding, which brings the total amount raised by Melodi Health to $15 million, will support clinical activities and further product development. The round was led by investors including HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital.
“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.”
Melodi Health’s ARIA Pivotal IDE Trial is a nationwide, multicenter, randomized controlled study evaluating the safety and efficacy of the Melodi Matrix™, an absorbable mesh designed to support soft tissue while releasing antibiotics to reduce post-surgical infections. Currently, there are no FDA-approved soft tissue support products for use in breast surgery, making the Melodi Matrix a groundbreaking innovation.
Dr. Hunter Moyer, Chief Medical Officer of Melodi Health, emphasized the significance of this new device: “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.”
The first patient was enrolled in the ARIA trial at University of Utah Health, where Dr. Alvin Kwok, the principal investigator, expressed optimism about the device’s potential impact on reducing the national average infection rate in breast reconstruction, which currently stands at 10-14%.
