On Tuesday, an Irish startup named FIRE1 raised $120 million for a system that manages one of the leading causes of death worldwide: heart failure.
FIRE1 — which was founded in Dublin in 2016 — is developing a heart failure monitor implant that aims to help patients manage their condition at home, reducing the need for hospital visits. The startup has raised $210 million to date.
The new funding round was led by Polaris Partners and Elevage Medical Technologies. Other participants included Medtronic, Novo Holdings, Sands Capital and Longitude Capital.
FIRE1 CEO Conor Hanley noted that his company’s name stands for “Foundry Innovation and Research 1”, as the company originated at The Foundry, a Silicon Valley-based medical device incubator. Some other companies spun out of The Foundry include Ardian, which Medtronic acquired for $850 million, and Evavle, which Abbott bought for $410 million.
To Hanley, the main goal of FIRE1’s implant is to protect patients from the stress and financial burdens associated with avoidable hospital visits. Not only does the company’s system help reduce hospital visits — which can cost up to $30,000 per occurrence — but it also enables patients to embrace their hobbies and spend time with their loved ones, he explained.
“Through this innovation, we’re redefining what it means to live with heart failure, turning a daunting diagnosis into a manageable condition,” Hanley declared. “FIRE1 believes that the future of chronic care lies in empowering patients with their own data. This is key to engaging them in the management of their diseases — leading to better outcomes and unburdening their care teams that do not have the resources to manage patients in their home over long periods of time.”
FIRE1’s device, called the Norm system, is a minimally invasive implantable sensor designed to identify fluid buildup earlier. This way, the buildup is easier for the patient to manage with their physician — without a hospital visit, Hanley noted.
The Norm system has three components. The first is a sensor, which is placed in the inferior vena cava (a large vein near the heart) to monitor fluid levels.
The next element is a belt, which users wear for a few minutes per day to capture data. The final component is an app, which allows both patients and their care teams to access the data being collected by the Norm system.
While there are other players in the implantable hemodynamic monitoring space, such as Abbott and Endotronix, Hanley thinks the FIRE1’s technology stands out.
“Norm offers a unique approach to heart failure by more directly measuring volume instead of relying on proxies. It does this by measuring the dynamics of the inferior vena cava. The IVC is a highly compliant vessel that is very sensitive to small changes in volume that over time can cause worsening heart failure,” he explained.
By sharing this IVC data directly with patients and their care teams, they can better monitor and manage their volume status over time, Hanley stated.
FIRE1 will use its new capital to complete a pivotal clinical trial for the Norm system, bringing the startup one step closer to delivering its technology to heart failure patients, he added.
He said the trial will focus on quantifying the Norm system’s effect on cardiovascular mortality, hospitalizations and quality of life.
“Our current timeline aims to complete clinical trials and submit for FDA approval by 2029. While regulatory processes always involve some uncertainties, we’re confident in the progress and data we’ve seen so far, which supports this timeline,” Hanley remarked.
Photo: FIRE1
