Medical device company Sonavex has raised $15m in a Series A-2 financing round and plans to use part of the proceeds to support the development of EchoMark and EchoSure.

The funding round attracted a diverse group of new institutional investors, as well as significant participation from existing shareholders and industry veterans in the vascular and dialysis sectors.

Among the new investors include Unorthodox Ventures, GenHenn Capital, JSTAR Capital, Oakwood Circle Ventures, Riptide Ventures, and Partners Investment.

EchoMark and EchoSure technologies enable healthcare providers to gather vital vascular data in dialysis clinics to assist with arteriovenous (AV) fistula maturation assessments.

A portion of the proceeds will support the ongoing evidence development for EchoMark and EchoSure, including the MAFASA [Maturation of Arteriovenous Fistula with Automated Sonography Assessments] randomised trial for which 304 patients are being actively enrolled.

Sonavex CEO David Narrow said: “This fundraise represents the culmination of the extraordinary multidisciplinary team effort over the past several months.

“The team’s ability to secure strong clinical data, a new CPT code, FDA IDE approval for the MAFASA pivotal trial, and grant funding to support FDA clearance of our pipeline product in a short period of time was instrumental in attracting the financing.”

In January 2024, Sonavex completed its initial clinical study that evaluated the effectiveness of EchoMark and EchoSure in improving AV fistula maturation assessments for dialysis patients.

The positive results from this study led to the US Food and Drug Administration granting approval under an investigational device exemption (IDE) for the MAFASA trial.

A study completed in September 2023 demonstrated that users without prior ultrasound experience could accurately measure AV fistula maturation using EchoSure.