The Irish medtech said the funding would allow it to complete a clinical trial for its heart failure management system.

Dublin-based medtech Fire1 has raised $120m in a financing round, marching towards innovations in heart failure management. Led by Polaris Partners and Elevage Medical Technologies, the funding round saw participation from new investors Sands Capital and Longitude Capital, and existing investors including Andera Partners, Medtronic and the Ireland Strategic Investment Fund.

In a statement released today (7 January), the company also announced that it has received the ‘Breakthrough Device Designation’ from the US Food and Drugs Administration (FDA) for its Norm heart failure management system.

According to Fire1, Norm has three components: a sensor placed in the inferior vena cava vein to monitor fluid levels; a belt to be worn for a few minutes daily; and a corresponding app on the wearer’s device, as well as a platform for the medical team to monitor progress.

The monitoring system aims to enable patients to engage in physician-directed self-management of heart failure, reducing the burden on healthcare staff while making it easier for at-home care.

Fire1 said that the funding raised will help the company complete a clinical trial of the system.

“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, the CEO and president of Fire1.

While Ellie McGuire, a partner at Polaris Partners said: “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 hospitalisations.

“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.”

Last year, Fire1 implanted the first-ever Norm device into an Irish patient in a procedure at the University Hospital Galway as part of the company’s first in-human clinical investigation.

At the time, Hanley said that the device, developed, manufactured and trialled in Ireland marked a “true clinical research success” for the country.

“It showcases Ireland’s capability for groundbreaking medical innovation with the potential to change healthcare delivery globally.”

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