FIRE1 has announced a $120 million funding round to accelerate the development and deployment of its innovative Norm heart failure monitoring system. This Dublin-based medtech company also disclosed that the U.S. Food and Drug Administration (FDA) has granted the Norm system breakthrough device designation, as well as inclusion in the agency’s Total Product Life Cycle Advisory Program (TAP).

The Norm system features a minimally invasive sensor implanted in the inferior vena cava—the largest vein in the body—to monitor and detect dangerous fluid imbalances in patients with heart failure. By providing direct, precise measurements of vein size and pressure changes, the device offers a more reliable method of assessing fluid retention compared to traditional proxies like left ventricular mass index (LVMI).

This funding round, significantly larger than the $25 million raised earlier in 2023, was led by Polaris Partners and Elevage Medical Technologies, with additional support from Sands Capital, Longitude Capital, and returning investors including Andera Partners, Gilde Healthcare, Gimv, ISIF, Lightstone Ventures, Medtronic, NEA Partners, Novo Holdings, and Seventure Partners.

“FIRE1 has developed a groundbreaking solution to one of healthcare’s most pressing challenges,” said Ellie McGuire of Polaris Partners, who will join FIRE1’s board of directors. “The Norm system empowers heart failure patients with a unique self-management tool, marking a significant shift in the management of chronic diseases.” Michael Wasserman, COO of Elevage Medical Technologies, will also join the board.

The Norm sensor continuously measures pressure changes and adjusts its dimensions in response to fluid accumulation in the body. Data is transmitted using a wearable belt, which collects readings in minutes, at least once daily. The real-time insights enable earlier detection and intervention, helping patients avoid repeated hospitalizations.

FIRE1’s innovative approach has drawn significant interest from the clinical community, particularly because it measures fluid volume directly rather than relying on indirect markers. Wasserman noted, “This differentiated strategy positions FIRE1 to capitalize on significant market opportunities, and we are excited to support the company on this journey.”

The Norm system has already achieved milestones in clinical research. In 2022, the first patient in Ireland received the implant during a clinical investigation at University Hospital Galway. Additionally, an earlier feasibility study demonstrated the system’s safety and efficacy at the three-month mark.

FIRE1’s progress highlights its potential to revolutionize heart failure management, offering patients and clinicians a practical and effective tool to improve outcomes and reduce the burden of chronic disease.

Leave a Reply