FIRE1, an Irish medical device company focused on connected solutions, has announced the completion of a $120 million financing round. The funding will support the advancement of its Norm heart failure management system and the completion of a pivotal clinical trial. The Norm system is designed to enable patients to engage in physician-directed self-management of their condition, with the goal of reducing hospitalizations and improving overall quality of life.
Norm Heart Failure Management System
The Norm system takes a novel approach to heart failure management by directly monitoring fluid volume via a sensor placed in the inferior vena cava. This provides a more accurate and timely assessment of a patient's condition compared to traditional methods that rely on indirect measures. The system also includes a wearable belt for daily monitoring and a corresponding app that allows patients to track their progress and communicate with their medical team. The data is also available on a platform for the medical team to monitor progress.
Conor Hanley, CEO and President of FIRE1, stated that the company's core goals are to improve heart failure management by directly monitoring fluid volume and empowering patients with actionable data. He also expressed enthusiasm for the new investors joining their syndicate.
FDA Breakthrough Device Designation
In addition to the financing, FIRE1 announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Norm system. The FDA also accepted FIRE1 into its Total Product Lifecycle Advisory Program (TAP). This program provides early and frequent strategic engagement from the FDA, patients, providers, and payers, facilitating rapid development and widespread access to medical devices.
Clinical and Market Impact
Heart failure affects millions worldwide and is a leading cause of hospitalization. Current management strategies often involve frequent clinic visits and hospital readmissions, placing a significant burden on both patients and healthcare systems. The Norm system aims to address these challenges by providing a scalable solution for remote monitoring and self-management.
Ellie McGuire, Partner at Polaris Partners, emphasized the potential of the Norm system to transform chronic disease management. Michael Wasserman, COO at Elevage Medical Technologies, highlighted the excitement within the clinical community regarding FIRE1's unique approach to heart failure management.
With the new funding and FDA support, FIRE1 is poised to conduct a pivotal clinical trial to evaluate the safety and efficacy of the Norm system. The results of this trial will be crucial in determining the potential of this innovative technology to improve outcomes for patients with heart failure.
