Minneapolis-based Melodi — founded in 2021 — began its ARIA FDA investigational device exemption (IDE) trial. It aims to improve clinical outcomes for women undergoing breast reconstruction after mastectomy. Investigators enrolled the first patient at University of Utah Health.
The company, which touts $15 million raised to date, plans to use its proceeds to fund clinical activities and additional product development. Series A investors include HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund and Three Bridges Private Capital.
Melodi develops the Matrix, an absorbable mesh that supports soft tissue. It also provides a controlled release of antibiotic agents as the body absorbs it. The company licensed the implantable medical device from proprietary technology out of Medtronic.
According to a news release, no FDA-approved soft tissue support products exist for use in breast surgery. None contain antibiotics as well.
“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.”
