The Dublin-based medical device company also announced that the US Food and Drug Administration (FDA) awarded Norm a breakthrough device designation. Image credit: Shutterstock/Denklim.

FIRE1 has raised $120m in a financing round to advance its sensor that monitors important warning signs of heart failure (HF).

The round was led by Polaris Partners and Elevage Medical Technologies, with Sands Capital and Longitude Capital joining as new investors. Existing investors such as Medtronic and Novo Holdings also participated in the round, which represents a large leap from the $25m raised in early 2023.

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The latest funding will enable the company to complete a pivotal clinical trial of its investigational device, Norm.

The Ireland-based medical device company also announced that the US Food and Drug Administration (FDA) awarded Norm a breakthrough device designation, along with acceptance into the Total Product Lifecycle Advisory Program (TAP). Both frameworks are designed to expedite market access to the new technology.

Individuals with HF struggle to pump blood around the body, which causes fluid to build up. The condition is estimated to affect 5.2 million people in the US, with average out-of-pocket expenses per patient reaching around $4,400. Analysis by GlobalData has shown the HF drug market is expected to grow at a 9.6% compound annual growth rate (CAGR) from $13.5bn in 2022 to $33.7bn in 2032.

The cardiovascular device market was estimated to be worth $72.2bn last year and it is forecast to grow to $116.8bn by 2033, as per analysis by GlobalData.

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FIRE1 says its device reduces the burden on healthcare staff by “enabling patients to engage in physician-directed self-management…making it easier to keep patients healthier and at home”.

The sensor measures the amount of fluid in the body, which is a warning sign of congestive heart failure. Via a small catheter, it is inserted in collapsed form and expands to full size upon entering the vena cava. It continuously measures the size of the vessel that changes with fluid buildup, sending data to a belt reader around the abdomen worn once a day.

In July 2023, the first US patient was implanted with the system as part of a feasibility trial called FUTURE-HF2 (NCT05763407). Enrolment was completed in February 2024.

FIRE1’s CEO Conor Hanley said the company’s goals are “[to create] a better way to manage heart failure by monitoring fluid volume more directly, and [to empower] patients with actionable data to improve their lives”.

Ellie McGuire of Polaris Partners said: “The Norm heart failure self-management system is a first-of-its-kind innovation that empowers patients to take greater control of their health. We believe this represents a paradigm shift in chronic disease management.”