Irish medtech startup Fire1 has raised $120 million (€116 million) in funding to accelerate the development of its heart failure monitoring system.
This investment comes at a crucial moment for heart failure care, as the company also announces its U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for the Norm system, a pioneering technology designed to empower patients to self-manage their condition at home, reducing the need for frequent hospital visits.
The $120 million funding round was led by Polaris Partners and Elevage Medical Technologies, with participation from prominent investors including Sands Capital, Longitude Capital, and Medtronic.
“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.
The capital will help FIRE1 complete the final stages of clinical trials for the Norm system, with the company aiming for FDA approval by 2029. Fire1 has raised a total of $210 million to date and is rapidly gaining attention from major players in the medtech industry.
Key Highlights
- Fire1 aims to empower millions of people with heart failure to regain their normal lives by transforming chronic disease management through data-driven, patient-centered solutions.
- Fire1 successfully raised $120 million to complete clinical trials for its heart failure management system.
- The company’s medical device Norm has received FDA recognition as a breakthrough device, accelerating its path to market.
- The Norm system enables heart failure patients to monitor fluid levels at home, reducing hospital visits and improving quality of life.
Transforming Heart Failure management
At its core, Fire1 is reimagining how chronic diseases are managed. The Norm system works in collaboration with patients and their care teams to create a more efficient, scalable model of healthcare. It reduces the burden on overworked healthcare providers by offering a solution that allows for consistent monitoring without the need for constant hospital visits.
“Through this innovation, we’re redefining what it means to live with heart failure, turning a daunting diagnosis into a manageable condition,” Hanley remarked. By empowering patients with their own data, Fire1 is not just improving outcomes but giving people the tools to live normal lives again.
The company’s name, FIRE1, stands for “Foundry Innovation and Research 1,” as it originated at The Foundry, a Silicon Valley-based medical device incubator. Based in Dublin, the company is led by CEO and President Conor Hanley, 56, who brings extensive experience in the healthcare sector, having previously held senior roles at ResMed and co-founded BiancaMed. Hanley holds a PhD in Chemical Engineering from the University of Pennsylvania and an MBA from INSEAD.
How Norm device works
The Norm system consists of three simple components, designed to seamlessly integrate into patients’ daily lives:
- Sensor: A small, implantable device placed in the inferior vena cava (IVC), the large vein near the heart, that continuously measures the amount of fluid in the body.
- Belt: Patients wear a belt for just a few minutes a day, which receives data from the sensor and transmits it to the cloud for analysis.
- App: The collected data is sent to a corresponding app on the patient’s phone and to the physician’s system, allowing for immediate monitoring and intervention if necessary.
This three-step process ensures that heart failure patients can easily track their condition at home, with minimal disruption to their daily routine.
The NORM system is designed to empower individuals with heart failure to manage their condition at home, reducing the need for frequent hospital visits. Developed in collaboration with leading cardiologists, the system is currently undergoing clinical trials with top research institutions.
What is Heart Failure?
Heart Failure is a serious condition that affects more than 64 million people worldwide and has become a major global public health priority, according to the latest studies.
Heart failure doesn’t mean your heart has stopped working. It means the heart needs additional support to function more effectively. Heart failure occurs when the heart is unable to pump blood effectively, leading to a reduced supply of oxygen and nutrients to the body’s organs and tissues. As a result, blood can back up, causing fluid to accumulate in the lungs, which often leads to shortness of breath. Although heart failure is a serious and potentially life-threatening condition, proper treatment can help manage symptoms, improve quality of life, and, in some cases, extend survival.
Clinical trials and Future impact
So, what’s next? The funding round will support a pivotal clinical trial with 800 patients, primarily in the US, over 18 months to prove the technology’s effectiveness.
As Fire1 moves forward with its clinical trials for its Norm system, the technology has the potential to dramatically improve heart failure management. The device could help millions of people around the world better monitor and manage fluid buildup—a leading cause of hospitalization for heart failure patients—allowing them to remain healthier and more independent at home.
The first patient in Ireland has already been successfully implanted with the system. Professor Faisal Sharif, Professor of Interventional Cardiology and Translational Medicine at University Hospital Galway, performed the first implant. “The procedure was straightforward and minimally invasive, and the patient was confident using the Fire1 system and taking the readings,” he said. The data gathered from this device will give a new window into heart failure management and could lead to more personalized, proactive treatments, he added.
“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,” said Ellie McGuire, Partner at Polaris Partners. “The Norm heart failure self-management system is a first-of-its-kind innovation that empowers patients to take greater control of their health.”
