According to a British Heart Foundation document last year, it is estimated that some 64 million people worldwide are affected by heart failure, with the figure increasing each year.
This is the target market for Fire1, an Irish company that has developed a device that it believes will result in a major breakthrough in how patients can manage the condition, improve their quality of life and, for the most part, stay out of hospital.
It is also the reason why a group of 13 respected investors (including the Ireland Strategic Investment Fund) have to date stumped up €213 million between them to back Fire1.
Heart failure occurs when the heart muscle doesn’t pump blood as well as it should, according to the respected Mayo Clinic in the United States. When this happens, blood often backs up and fluid can build up in the lungs, causing shortness of breath. Heart failure can be life-threatening.
Fire1 claims its technology enables patients to monitor and control their fluid volume themselves with a device at home. Its sensor is implanted into the body’s largest vein, located in the abdomen, known as the inferior vena cava (IVC) and works by continuously measuring the size of the IVC, giving a marker of the amount of fluid in the body.
High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs, which lead to an emergency hospital admission.
The patient wears a belt reader around the abdomen for about a minute a day to take a reading from the sensor. The system is designed to alert a clinical team at the hospital whenever the patient’s condition deteriorates.
Originally founded in 2014 in Menlo Park, California, Fire1 moved its headquarters to Ireland in 2016, in part to feed off the medtech ecosystem here. Based in Dublin, it employs about 60 staff, with plans to put boots on the ground in the US.
The company is led by chief executive and president Conor Hanley, 56, who is also a non-executive director of Enterprise Ireland and was a finalist last year in the EY Entrepreneur of the Year awards.
He was co-founder of BiancaMed Ltd in 2005, a venture capital-backed company involved in medical and consumer products focused on sleep and home health. It was spun out of UCD and later acquired by ResMed.
What’s in store for 2025?
This latest (Series B) funding round of €120 million will allow it to conduct clinical trials, predominantly in the US, among 800 patients to demonstrate that the technology is providing effective outcomes.
Fire1 is pre-revenue and burning through cash. Its latest set of accounts, for the year to the end of December 2023, show it made a loss of €15 million and had accumulated losses of €65 million. These losses will have since grown and the €120 million is designed to help the company bridge the period between now and when revenue begins to flow.
It will need to go to the investor well again if, and when, it gets past the clinical trials stage and secures regulatory approval to take the device to market.
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