FIRE1, the Dublin-based connected medical device company, has secured $120 million in its latest financing round to advance innovative heart failure treatment solutions. Polaris Partners and Elevage Medical Technologies led the round, with new investors Sands Capital and Longitude Capital joining existing backers Medtronic, NEA, and Novo Holdings.
This investment will primarily fund FIRE1’s pivotal clinical trial of its Norm
system, designed to transform heart failure management for an estimated 64 million people worldwide. The funding will also support exploring additional applications of its technology, advancing the company’s mission to transform chronic disease care through patient-centred, data-driven solutions.
Behind FIRE1’s Technology for Patient-Centered Care
In 2013, Dr. Conor Hanley founded FIRE1, the first European venture from The Foundry, a California-based medical device incubator. The company tackles one of healthcare’s most pressing challenges: traditional heart failure management, which burdens patients and healthcare systems with complex medication schedules and frequent hospital visits.
The company’s flagship Norm system marks a significant advance in patient care. The device continuously monitors body fluid levels by placing a sensor in the inferior vena cava, enabling early detection of complications. This proactive approach allows timely interventions while enabling patients to manage their condition from home.
“From the beginning, our team has been driven by two core goals: creating a better way to manage heart failure by monitoring fluid volume more directly and empowering patients with actionable data to improve their lives,” said Conor Hanley, CEO and President of FIRE1.
FDA Recognition Accelerates Development
The Norm system has gained significant regulatory recognition, earning the FDA’s Breakthrough Device Designation and acceptance into the agency’s Total Product Lifecycle Advisory Program (TAP). These designations speed up development and validate the technology’s potential impact on heart failure management.
The Norm system stands out for its holistic approach to patient care. The platform combines real-time monitoring capabilities with user-friendly interfaces for patients and healthcare providers, creating a comprehensive heart failure management ecosystem.
As the digital health solutions market grows, FIRE1 is well-positioned to lead innovation in chronic disease management. The company’s technology platform shows promise beyond heart failure, potentially transforming healthcare delivery in the digital age.
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