FIRE1 heats up with $120M for its heart failure monitor implant

Things are heating up for FIRE1, which posted a $120 million funding round to support its implant for tracking the hidden signs of heart failure.

The Dublin-based company also announced that the FDA has handed down a breakthrough designation to its Norm system, which includes a minimally invasive sensor that sits within the body’s largest vein to help monitor for unsafe buildups in a patient’s internal fluid levels.

In addition, the device was accepted into the agency’s Total Product Life Cycle Advisory Program, or TAP.

The new funding round—a large step up from its previous $25 million raise in early 2023—was led by Polaris Partners and Patient Square Capital’s Elevage Medical Technologies, and was joined by new backers at Sands Capital and Longitude Capital.

Returning investors included Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA, Novo Holdings and Seventure Partners.

“FIRE1 has developed a groundbreaking solution to one of healthcare’s most pressing challenges: providing scalable ways to manage the disease of chronically ill patients and prevent the need for frequent hospitalizations,” Polaris partner Ellie McGuire said in a statement.

“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,” added McGuire, who will join FIRE1’s board of directors alongside Elevage’s chief operations officer, Michael Wasserman.

The Norm sensor sits within the inferior vena cava and expands and contracts with the changing size of the vessel. According to FIRE1—short for Foundry Innovation & Research 1—when fluids begin to build up in the body, the vein swells in a way that’s easier to gauge more accurately compared to other types of pressure measurements. The sensor itself is activated through the skin by a wearable belt to record readings within a few minutes once a day.

“FIRE1’s unique approach to heart failure—a more direct measure of volume instead of relying on proxies—has generated significant excitement in the clinical community,” said Wasserman. “This differentiated approach positions FIRE1 to unlock substantial market opportunities, and we are proud to support the company on this journey.”

Last year, FIRE1 announced that the first Irish patient was successfully implanted with its approach as part of a clinical study at University Hospital Galway. Additionally, a feasibility study previously delivered preliminary results showing that Norm met its device safety and effectiveness endpoints after three months.