Fire1, a Dublin-based medical device company, has raised $120 million in a Series B funding round to advance its Norm heart failure management system. The funding was led by Polaris Partners and Elevage Medical Technologies, with participation from new investors Sands Capital and Longitude Capital, as well as existing investors such as Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA, Novo Holdings, and Seventure Partners. This brings the total funding for the company to $213 million from 13 investors since its inception a decade ago.
The Norm system is designed to empower heart failure patients by enabling physician-directed self-management, which aims to reduce the burden on healthcare staff and keep patients healthier at home. The system consists of three components: a sensor placed in the inferior vena cava to monitor fluid levels, a belt worn by users for a few minutes per day to capture data, and an app that allows patients and their care teams to access the collected data. Fire1 CEO Conor Hanley stated, “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.”
The new funding will enable Fire1 to complete a pivotal clinical trial for Norm, involving 800 patients primarily in the US over an 18-month period, followed by at least 12 months of follow-up to seek regulatory approval for commercialization.
Funding advances heart failure management
The trial will focus on quantifying the Norm system’s effect on cardiovascular mortality, hospitalizations, and quality of life. The FDA has recognized Norm as a transformative technology and has accepted it into its Total Product Lifecycle Advisory Program, offering a smoother regulatory pathway.
Hanley highlighted the importance of the trial, noting that heart failure affects one in five people during their lifetime, with 100,000 patients in Ireland and eight million in the US. The economic impact is substantial, costing approximately $70 billion annually in the US alone. Ellie McGuire, a partner at Polaris, and Michael Wasserman, COO at Elevage, have joined Fire1’s board to bolster the company’s strategic direction.
McGuire asserted Norm’s potential in addressing one of healthcare’s most pressing challenges by managing chronically ill patients and reducing hospitalizations, while Wasserman emphasized the significant excitement and market opportunities generated by Fire1’s differentiated approach.
