What You Should Know:
– FIRE1, a connected medical device company, announced it has secured $120M in funding to advance its mission to transform the lives of millions of people living with heart failure. The round was led by Polaris Partners and Elevage Medical Technologies, joined by new investors Sands Capital and Longitude Capital, and existing investors Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA (New Enterprise Associates), Novo Holdings, and Seventure Partners.
– The investment will fuel the development and clinical trials of FIRE1’s innovative Norm™ heart failure management system.
Monitor Your Heart at Home
Headquartered in Dublin, Ireland, FIRE1 is dedicated to improving outcomes for individuals with chronic diseases. The company’s experienced team collaborates with world-leading researchers, clinicians, patients, and payors to develop innovative solutions that empower patients and alleviate the burden of chronic conditions like heart failure.
FIRE1’s innovative Norm™ heart failure management system offers a groundbreaking approach to heart failure management by empowering patients to engage in physician-directed self-management. This reduces the burden on healthcare staff and improves patient outcomes by making it easier for individuals to manage their condition and stay healthier at home.
Breakthrough Device Designation and FDA Collaboration
In addition to the funding, FIRE1 announced that its Norm™ system has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation recognizes the potential of Norm™ to provide more effective treatment for life-threatening or irreversibly debilitating diseases. FIRE1 has also been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP), which provides proactive guidance and support throughout the development process.
“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. “I am thrilled to welcome four more world-class investors to our exceptional syndicate.”
