FIRE1 Secures Funding to Advance its Heart Failure Management Tech

FIRE1 has completed a $120 million financing round that included an investment from Medtronic. The company intends to use the money to conduct a clinical trial of its heart failure management technology.

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.

“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,” FIRE1 President/CEO Conor Hanley said. “I am thrilled to welcome four more investors to our syndicate.”

FIRE1’s Norm heart failure management system offers an unconventional approach for managing the condition. By enabling patients to engage in physician directed self-management, Norm reduces the burden on healthcare staff, making it easier to keep patients healthier and at home. The funding will enable the company to complete a pivotal clinical trial of the Norm system.

Related: Enrollment Complete in Study of FIRE1’s Remote Heart Failure Monitoring System

In addition to the financing, FIRE1 announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP).

The company also welcomed Ellie McGuire, partner at Polaris Partners, and Michael Wasserman, chief operating officer at Elevage Medical Technologies, to its Board of Directors.

“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,” McGuire stated. “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.”

NORM has three components: The first is a sensor that is placed in the large vein near the heart called the IVC, which monitors fluid levels. The second is a belt that is worn for a few minutes a day. The third is an app on the patient’s phone and a corresponding app/portal on the medical team’s system.

After the sensor is implanted, patients wear the belt for a few minutes every day. The belt receives the sensor measurements and sends them to the cloud where they are analyzed.

“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. This differentiated approach positions FIRE1 to unlock substantial market opportunities, and we are proud to support the company on this journey,” Wasserman added.

Headquartered in Dublin, Ireland, FIRE1 is a connected medical device solutions company dedicated to improving outcomes for individuals suffering from chronic diseases. The experienced FIRE1 team collaborates with world-leading researchers, clinicians, patients, and payers to alleviate the burden of heart failure.

Polaris Partners has a 25-plus-year history of partnering with repeat entrepreneurs and innovators who are improving the people live and work. The multibillion-dollar firm manages specialty and diversified funds in healthcare and healthcare-adjacent technology with investments across all stages. Polaris has offices in Boston, San Francisco, New York, and Singapore.

Elevage Medical Technologies is a platform established by Patient Square Capital and is dedicated to supporting medical technology companies that can improve health outcomes and quality of life for patients. Elevage provides capital along with deep technical, regulatory, and operational expertise to companies ranging from advanced clinical development to commercial acceleration stage. Elevage supports rapidly growing, highly differentiated companies with paradigm shifting technologies and strives to help build medical technologies.