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December 3, 2024
September 26, 2024

Published Clinical Results Show Non-Invasive Monitoring Technology Predicts Heart Failure Events at Twice the Rate of Conventional Care

The Journal of Cardiac Failure has published data from the SCALE-HF 1 study on Bodyport Inc.’s, non-invasive biomarker guided technology, showing it predicts heart failure events at twice the rate of weight-based monitoring, with an average lead time of 14 days and with 38% fewer false alerts. The results highlight the technology’s potential to reduce hospitalization risks for heart failure patients.

Participants in the study took measurements at home by standing barefoot for approximately 30 seconds a day on the Bodyport Cardiac Scale, a non-invasive device in the form factor of a weight scale but capturing multiple validated biomarker measures that directly reflect a patient’s fluid levels, the primary measure healthcare teams monitor to detect worsening heart failure.

“This is really exciting technology that I think has the potential to improve care for patients living with heart failure. This technology took a common tool that we have used in clinical care for decades, a bathroom scale, and improved it to the point that we can better predict worsening heart events,” said Adam DeVore, MD, MHS, cardiologist and associate professor of medicine at Duke University School of Medicine. “The data from this SCALE-HF 1 study suggest that we may be able to use this technology to prevent hospitalizations related to volume overload.”

Key Study Results

Details

Study Type

Prospective, observational (SCALE-HF 1)

Congestion-related biomarkers analyzed by the Congestion Index

Participants

329 enrolled at 8 sites

56% of Patients LVEF ≤40% (reduced  ejection fraction)

36% Patients LVEF ≥50% (preserved  ejection fraction)

Follow up duration of 238 patient years

Heart Failure Event (HFE) Prediction

Congestion Index

Correctly predicted 48 of 69 (70%) of heart failure events (HFEs)

Weight-scale standard

Detected 24 of 69 HFEs (35%)

Sensitivity

Congestion Index demonstrated significantly higher sensitivity (p<0.01) than weight-scale care

Congestion Index Alert Rate

Generated 2.58 alerts per patient-year

Weight-scale Alert Rate

Produced 4.18 alerts per patient-year

"With twice the sensitivity of traditional weight-scale monitoring in Heart Failure, the Bodyport Congestion Index significantly outperforms the current noninvasive standard of care, yet captures hemodynamic data in a familiar scale form which is easy to adopt for patients," said Corey Centen, founder, president, and chief technical officer at Bodyport.

The FDA-cleared Bodyport fluid management platform is currently being implemented in a variety of commercial settings to enhance heart failure care. By leveraging the Bodyport Cardiac Scale and Clinical Dashboard, healthcare organizations are developing fluid-guided care pathways aimed at improving patient outcomes and preventive care.

To access the SCALE-HF 1 data presented in the Journal of Cardiac Failure article, visit Surveillance and Alert-Based Multiparameter Monitoring to reduce Worsening Heart Failure Events: Results from SCALE-HF 1 - Journal of Cardiac Failure (onlinejcf.com).

To learn more about the Congestion Index and the FDA-cleared Cardiac Scale and commercial availability, visit www.bodyport.com.

Bodyport develops remote monitoring technologies for patients with fluid management-related health conditions. The FDA-cleared Bodyport Cardiac Scale measures weight, peripheral impedance, pulse rate, and balance through a simple daily measurement. Bodyport’s clinician-facing software combines longitudinal data into the Congestion Index, a clinical decision support tool that helps healthcare professionals identify and evaluate changes associated with worsening congestion.Based in San Francisco, the company is backed by top-tier investors including Boehringer Ingelheim Venture Fund, Terumo Medical, Initialized Capital, Playground Global, Rock Health, and Y Combinator. For more information, visit bodyport.com and follow the company on LinkedIn and Twitter.