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Medical device company Fire1 received $120 million in an unlabeled financing round, CEO Conor Hanley tells Axios.

Why it matters: The financing will be used to complete a pivotal clinical trial for its heart device.

How it works: Fire1's Norm device is placed inside the inferior vena cava in an outpatient procedure.

No battery is needed and it takes a daily reading lasting 60 seconds.

The patient wears an external belt that takes the data from the reading and uploads it to the patient's phone and the clinical center.

The pivotal trial that will start early 2026 consists of 800 patients using the device for a year.

"This device allows people to take action, so it's not remote monitoring but rather remote management," says Hanley.

Catch up quick: The Dublin-based company had raised $93 million prior to this round.

By the numbers: The heart failure market is expected to grow at a 9.6% compound annual growth rate from $13.5 billion in 2022 to $33.7 billion in 2032.

By 2030, U.S. heart failure costs are expected to be at least $70 billion per year.

The big picture: Hanley believes this device can be similar to how continuous glucose monitoring devices have changed the lives of those with type 1 diabetes.

"Diabetes was transformed by continuous glucose monitoring, where the sensor actually empowers the patient under physician guidance, and we're doing a very similar analogy in heart failure."

Dexcom went public in 2005 at an earlier stage than Fire1 is, and now its market cap is close to $30 billion.

Zoom in: The round was co-led by Polaris Partners and Elevage Medical Technologies, joined by new investors Sands Capital and Longitude Capital.

Insiders Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA (New Enterprise Associates), Novo Holdings and Seventure Partners were also in the mix.

The Norm device received Breakthrough Device Designation from the U.S. Food and Drug Administration and has also been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP).

❤️ Fun fact: Norm was chosen as the name when patients kept saying, "I just want to get my normal life back" during interviews, he says.

Fire1 funnels $120M for heart failure device

The financing will be used to complete a pivotal clinical trial.

Illustration of a one-hundred-dollar bill with a portrait of a heart.

Medical device company Fire1 received $120 million in an unlabeled financing round, CEO Conor Hanley tells Axios.Why it matters: The financing will be used to complete a pivotal clinical trial for its heart device.

Fire1 funnels $120M for heart failure device

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