The trial is expected to support Melodi Health’s efforts to seek FDA approval. Credit: Chinnapong / Shutterstock.

Medical device company Melodi Health has closed an oversubscribed $10.75m Series A financing round, which will be directed towards clinical activities and further product development of its absorbable mesh, Melodi Matrix.

Since its inception in February 2021, Melodi Health has raised a total of $15m.

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The Series A round saw contributions from Engage Venture Partners, HM Venture Partners, Southeast Minnesota Capital Fund, and Three Bridges Private Capital.

These funds will support the company’s Melodi Matrix for breast reconstruction and positively impact women’s lives affected by breast cancer.

Concurrently, the company has commenced the first subject enrolment in its pivotal Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction with Infection Outcomes Assessment (ARIA) investigational device exemption (IDE) trial at the University of Utah Health.

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The study aims to enhance clinical outcomes for women undergoing breast reconstruction post-mastectomy.

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The multi-centre, nationwide, randomised and controlled study will evaluate the efficacy and safety of the Melodi Matrix, which is designed to support soft tissue and provide a controlled release of antibiotic agents as it is absorbed by the body.

This implantable medical device is based on technology licensed by Melodi Health from Medtronic.

Melodi Health co-founder and CEO Sarah Worrell said: “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.

“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 ARIA clinical trial is expected to support Melodi Health’s efforts to seek approval from the US Food and Drug Administration for the Melodi Matrix in breast reconstruction.

Melodi Health chief medical officer Hunter Moyer said: “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.”