Irish medical device company Fire1 has raised $120 million (€116 million) from investors to fund clinical trials in the United States for a device that seeks to provide a remote monitoring solution to improve outcomes for heart failure patients.
Called Norm, the Irish company’s management system is being designed to “empower heart failure patients to manage their data” from home, in a way that should improve their quality of life and reduce the burden on healthcare systems, the company said.
Fire1 was founded a decade ago in California before later moving its headquarters to Ireland. It is pre-revenue and raised the finance via a Series B round. The valuation placed on the business as a result of this funding has not been disclosed.
Speaking to The Irish Times, Conor Hanley, chief executive and president of Fire1, said the money would be used for a “pivotal trial” (designed to prove the technology works) of 800 patients, which will be recruited primarily in the US over an 18-month period. It will then take a minimum of 12 months of “follow up” before, subject to regulatory approval, it could begin to commercialise Norm.
According to Mr Hanley, one in five people will get heart failure during their lifetime. Some 100,000 people in Ireland suffer from the condition and there are eight million sufferers in the US, with more than one million hospital admissions there per year, he said.
About $70 billion is spent each year treating heart failure in the United States, added Mr Hanley.
The funding round was led by Polaris Partners and Elevage Medical Technologies, joined by new investors Sands Capital and Longitude Capital, and existing investors Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA (New Enterprise Associates), Novo Holdings and Seventure Partners.
This latest round of funding brings to $213 million the sum raised by the company to date from 13 investors. The State’s Ireland Strategic Investment Fund (Isif) has provided $22 million to the company.
Isif investment director for life sciences Georgina Murphy said the fund was “delighted” to invest in the next stage of the company’s development. “Fire1 is one of Ireland’s most innovative scaling companies and has the ambition to meet significant medical needs that aren’t being met. This Series B financing will power Fire1 as it brings its new technology to market.”
What’s in store for 2025?
In addition to the financing, Fire1 said it had received breakthrough device designation from the US Food and Drug Administration (FDA) and has been accepted into the FDA’s Total Product Lifecycle Advisory Program. This is the FDA recognising that Norm is a “transformative technology” for patients and provides a smoother regulatory pathway, said Mr Hanley.
The company also added Ellie McGuire, a partner at Polaris, and Michael Wasserman, chief operating officer at Elevage, to its board.
“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 hospitalisation,” said Ms McGuire, describing Norm as a “first-of-its-kind innovation” that “represents a paradigm shift in chronic disease management”.
Mr Wasserman said Norm had “generated significant excitement in the clinical community”, adding that the company’s “differentiated approach positions Fire1 to unlock substantial market opportunities”.
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