FIRE1, an Irish startup developing an implantable heart failure monitor, announced Tuesday it has raised $120 million in funding to revolutionize heart failure monitoring.
The Dublin-based company, founded in 2016, aims to reduce hospital visits for heart failure patients by enabling at-home management of the condition.
The funding round was led by Polaris Partners and Elevage Medical Technologies, with participation from Medtronic, Novo Holdings, Sands Capital, Longitude Capital and existing partners. This brings FIRE1’s total funding to $210 million.
CEO Conor Hanley said the company’s name stands for “Foundry Innovation and Research 1,” originating from The Foundry, a Silicon Valley medical device incubator. The Foundry has also produced companies such as Ardian, acquired by Medtronic for $850 million, and Evavle, bought by Abbott for $410 million.
Hanley emphasized the goal of FIRE1’s implant, the Norm system, is to alleviate the stress and financial burdens associated with avoidable hospitalizations, which can cost up to $30,000 per occurrence.
According to Henley, the company is leveraging innovation to redefine what it means to live with heart failure by turning once a daunting diagnosis into a manageable condition.
The Norm System
The Norm system consists of three components: an implantable sensor placed in the inferior vena cava (IVC), a large vein near the heart, to monitor fluid levels; a belt worn by users for a few minutes daily to capture data; and a mobile app for patients and care teams to access the collected data.
Hanley also explained that the Norm system differs from other hemodynamic monitoring devices available on the market due to its ability to directly measure fluid volume in the IVC instead of relying on proxy measurements used by similar devices.
While other companies such as Abbott and Endotronix operate in the implantable hemodynamic monitoring space, Hanley asserted that FIRE1’s technology offers a unique and more direct approach that allows for direct volume measurement as opposed to relying on proxies.
FIRE1 will use the new funding to complete a pivotal clinical trial for the Norm system, bringing it closer to market availability. The trial will focus on quantifying the system’s impact on cardiovascular mortality, hospitalizations and quality of life.
Hanley said the company aims to complete clinical trials and submit for FDA approval by 2029.
