Melodi Health, a medical device company, announced two milestones: the close of a $10.75 million oversubscribed Series A financing; and the launch of the “ARIA” investigational device exemption (IDE) trial aimed at improving clinical outcomes for women undergoing breast reconstruction after mastectomy. The Minneapolis-based company is committed to developing medical products that transform breast reconstruction and impact women undergoing treatment for breast cancer.
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The Series A proceeds will be used to fund clinical activities and additional product development activities. Melodi Health has raised $15 million since its founding in February 2021. Series A investors include 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.”
“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 Hunter Moyer, MD, chief medical officer of Melodi Health.
Today, there are no 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 an indication in breast reconstruction. 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.
Melodi’s first patient was enrolled at University of Utah Health. “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.”
