The company also reached a major FDA milestone with breakthrough device designation. The agency also accepted its technology into its Total Product Lifecycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices.
Dublin, Ireland–based Fire1 develops the Norm heart failure management system that enables patients to engage in physician-directed self-management. Norm aims to reduce the burden on healthcare staff and make it easier to keep patients healthier and at home.
Fire1 said the funding — led by Polaris Partners and Elevage Medical Technologies — enables the completion of a pivotal clinical trial. New investors Sands Capital and Longitude Capital participated as well. Existing investors Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, NEA (New Enterprise Associates), Novo Holdings, and Seventure Partners, all joined in.
“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,” said Conor Hanley, CEO and President of FIRE1. “I am thrilled to welcome four more world-class investors to our exceptional syndicate.”
