Melodi Health, a Minneapolis-based medical device company, has achieved two major milestones in its mission to improve breast reconstruction outcomes for women undergoing mastectomies. The company recently announced the successful closure of a $10.75 million Series A funding round, which was oversubscribed, alongside the launch of the “ARIA” investigational device exemption (IDE) trial.
Series A Funding to Drive Innovation
Founded in February 2021, Melodi Health has now raised a total of $15 million, with the latest Series A round attracting significant interest from investors. The round included participation from HM Venture Partners, Engage Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital. These funds are earmarked to support ongoing clinical trials and further the development of innovative medical products designed to transform breast reconstruction surgery.
Focus on Improving Breast Reconstruction Outcomes
Melodi Health is at the forefront of developing cutting-edge medical products aimed at enhancing breast reconstruction outcomes for women recovering from breast cancer. The company’s flagship product, the Melodi Matrix, is an absorbable mesh designed to provide soft tissue support while releasing antibiotics in a controlled manner as it is absorbed by the body.
“We are thrilled to achieve these important financial and clinical milestones,” said Sarah Worrell, co-founder and CEO of Melodi Health. “The first implant of this device marks a significant step in evaluating its safety and efficacy. It’s designed to provide soft-tissue support and reduce post-surgical infections, a complication faced by up to 14% of women undergoing mastectomy followed by reconstruction.”
Pioneering Technology Licensed from Medtronic
The Melodi Matrix stands out as a novel solution in the field of breast reconstruction surgery, where there are currently no FDA-approved soft tissue support products specifically designed for breast surgery that incorporate antibiotics. Licensed from Medtronic, this technology addresses a critical unmet need by combining soft tissue support with infection prevention, a key concern for surgeons and patients alike.
“As a reconstructive surgeon, my goal is to restore what cancer took from my patients,” said Dr. Hunter Moyer, chief medical officer of Melodi Health. “Infections and complications can hinder this process, which is why the investigational Melodi Matrix is so promising. It’s designed to provide both soft tissue support and reduce the risk of infections.”
Launch of the ARIA Trial
Melodi Health’s ARIA trial, officially known as the Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction with Infection Outcomes Assessment, is a nationwide, multicenter, randomized, controlled study. This pivotal trial aims to assess the safety and efficacy of the Melodi Matrix, with the ultimate goal of securing FDA approval for its use in breast reconstruction.
The trial’s first patient was recently enrolled at University of Utah Health, signaling the beginning of this crucial clinical study.
“A national infection rate of 10-14% in breast reconstruction is not acceptable,” remarked Dr. Alvin Kwok, associate professor of surgery and principal investigator at University of Utah Health. “I am eager to observe the impact of the Melodi Matrix on patient outcomes, particularly in reducing infections.”
Commitment to Surgical Innovation
Melodi Health remains dedicated to advancing surgical innovation in breast reconstruction, with the overarching goal of improving outcomes for women facing complex treatment regimens. The company’s innovative approach, exemplified by the Melodi Matrix, represents a significant advancement in the field, combining proven technology with a strong focus on patient safety and efficacy.
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