Breakthrough Technology Gains Funding and FDA Recognition
FIRE1, a Dublin-based medtech company, has secured $120 million in funding to advance its Norm heart failure monitoring system, a minimally invasive implant designed to detect hidden signs of heart failure. The round was led by Polaris Partners and Patient Square Capital’s Elevage Medical Technologies, with participation from Sands Capital, Longitude Capital, and other existing investors like Medtronic and Novo Holdings.
Norm System: A Paradigm Shift in Heart Failure Management
The Norm system includes a sensor implanted within the inferior vena cava (IVC), which monitors changes in the vein’s size as fluid levels fluctuate due to heart failure. Key features include:
- Daily Monitoring: Activated by a wearable belt, the sensor provides daily fluid level readings in minutes.
- Accurate Detection: Offers a direct measure of fluid buildup, improving accuracy compared to traditional pressure-based methods.
FDA Breakthrough Designation and TAP Inclusion
The U.S. FDA granted Breakthrough Device Designation for Norm and accepted it into the Total Product Life Cycle Advisory Program (TAP). These acknowledgments underscore the system’s potential to address critical gaps in heart failure management.
Investor and Clinical Community Excitement
Ellie McGuire of Polaris Partners stated, “The Norm system empowers patients with chronic heart failure to manage their health, representing a significant step forward in chronic disease management.” Michael Wasserman of Elevage Medical Technologies highlighted the system’s ability to unlock substantial market opportunities through its unique approach.
Clinical Milestones
- Irish Clinical Trial Success: The first Irish patient was successfully implanted at University Hospital Galway.
- Positive Feasibility Study: Preliminary results demonstrated safety and effectiveness over three months.
Future Outlook
With this new funding, FIRE1 aims to scale the development and deployment of the Norm system, offering heart failure patients a revolutionary tool for managing their condition and reducing hospitalizations.
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