Irish medical technology company Fire1 secured $120 million in funding to launch a clinical trial of its new remote heart failure monitoring device.
The clinical trial, part of the Food and Drug Administration approval process, will include about 800 patients in the U.S.
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“Getting pivotal trial data is critical to make sure that you're actually ready to commercialize, but I think it's more holistic,” said Conor Hamlet, CEO and president. “We're going to continue to evolve the technology, and we want to make sure it's linked into what the insurance people need.”
The funding round was led by Polaris Partners and Elevage Medical Technologies. Other investors included Medtronic, Sands Capital, Longitude Capital, Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, New Enterprise Associates, Novo Holdings and Seventure Partners.
The Norm heart failure management system requires patients to undergo a procedure to install a sensor in their inferior vena cava, which is the largest vein in the body and where most excess fluid accumulates. Patients also wear a belt for a few minutes each day that collects data from the sensor.
The sensor continuously measures the size of the vein, which is an indicator of the amount of fluid in the body. High levels of fluid put patients at risk of breathing difficulties and if the fluid accumulates in the lungs, they must be admitted to the hospital.
The data is sent to both the physician and the patient, and can be accessed on a mobile phone. The physician can prescribe a patient’s medication in advance and if the sensor detects an increase in volume, the medication can automatically be adjusted.
“Without a device like this, the patient wouldn’t know if their fluid levels are increasing until very later on when they experience symptoms,” Hamlet said. “They might call an ambulance, but at that stage it’s harder to correct and you need to give a bigger dose of medication.”
Fire1 was granted breakthrough device designation from the FDA to speed the development, assessment and review for regulatory approval. The company also has been accepted into the agency's Total Product Life Cycle Advisory Program, which provides guidance on the path to market and patient access.
