FIRE1’s Norm System Congestion Score Featured as Late-Breaking Science at HFSA 2025

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DUBLIN--(BUSINESS WIRE)--Sep 29, 2025--

FIRE1, a connected medical device solutions company, announced that its program of trials (FUTURE-HF and FUTURE-HF2) were selected for presentation in the Late-Breaking Science program at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025. The plenary session took place place on Sunday, September 28, from 9:00 – 10:30 a.m. CT. A companion manuscript, “Derivation of a Personalized Congestion Score Using a Chronic Implantable Inferior Vena Cava Management System in Heart Failure: An Analysis from the FUTURE-HF Trial Portfolio,” was published simultaneously in the Journal of Cardiac Failure.

FIRE1’s Norm™ investigational heart failure management system offers a potentially groundbreaking approach for patients to manage heart failure. By enabling patients to engage in physician directed self-management, Norm has a potential to reduce the burden on healthcare staff, making it easier to keep patients healthier and at home.

The presentation, titled “FUTURE-HF: Development of an Individualized Congestion Score using a Novel Implantable Inferior Vena Cava Sensor – the FUTURE-HF Trial Portfolio,” was delivered by Marat Fudim, MD, MHS, Advanced Heart Failure Cardiologist at Duke Health, Durham, NC.

The NORM Score, a novel, individualized congestion index derived from daily ambulatory measurements of the inferior vena cava (IVC) using an implantable FIRE1 sensor, was developed retrospectively using data captured during FUTURE-HF and FUTURE-HF2 studies. Because the IVC is highly compliant, it provides an early signal of congestion before filling pressures rise. Elevated Norm Score was significantly associated with increased NT-proBNP levels (β=5.64;95% CI: 3.23–8.05; p<0.001) and predicted worsening heart failure events with high sensitivity (detecting 92.6% of HF events, C-statistic: 0.83) and low unexplained alert rate (0.57 per patient-year). Odds ratio for hospitalization was 18.0 (95% CI: 3.5–93.8) for 5 out of 7 days out of range.

FIRE1 intends to initiate a larger confirmatory study to demonstrate how use of the Norm System coupled with the Norm Score could transform how clinicians detect decompensation earlier, streamline clinical response, and enable personalized patient self-management.

“We are honored Norm System Congestion Score was chosen for Late-Breaking Science at HFSA 2025,” said Marat Fudim, MD, MHS, Advanced Heart Failure Cardiologist at Duke Health, Durham, NC. “This recognition highlights the importance of advancing research into new ways of managing congestion in heart failure.”

About FIRE1

Headquartered in Dublin, Ireland, FIRE1 is a connected medical device solutions company dedicated to improving outcomes for individuals suffering from chronic diseases. Its mission is to empower millions of people with heart failure to regain their normal lives. The experienced FIRE1 team collaborates with world-leading researchers, clinicians, patients, and payors to alleviate the burden of heart failure.

For more information, visit www.fire1foundry.com.

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PUB: 09/29/2025 05:29 PM/DISC: 09/29/2025 05:29 PM

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