ACORAI Presents Positive Results in 1,600-Patient CAPTURE-HF Study for its AI-Powered Non-Invasive Multi-Sensor Platform for Improved Heart Failure Patient Management

MINNEAPOLIS, Oct. 6, 2025 /PRNewswire/ -- Acorai, a clinical-stage company pioneering non-invasive hemodynamic monitoring for heart failure management, this week announced topline results from the 1,600-patient CAPTURE-HF study (Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-Invasive Multi-sensor Device). Results were presented during a Late-Breaking Clinical Science session by Principal Investigator Andrew J. Sauer, M.D., Professor of Medicine at Saint Luke's Kansas City, at the Heart Failure Society of America (HFSA) 2025 Annual Scientific Meeting in Minneapolis, Minnesota.

The prospective, two-phase study enrolled patients across 20 global sites to evaluate the accuracy, safety, and usability of Acorai's device compared to the invasive right heart catheterization gold standard.

In patients with heart failure, Acorai's non-invasive multi-sensor device demonstrated:

• Pulmonary Capillary Wedge Pressure (PCWP >15 mmHg): AUC 0.821, Sensitivity 86%, Specificity 53%, Negative Predictive Value (NPV) 90%
• Right Atrial Pressure (RAP >10 mmHg): AUC 0.852, Sensitivity 87%, Specificity 70%, NPV 97%

"Based on CAPTURE-HF data presented as late-breaking science at HFSA, Acorai's multi-sensor platform showed high sensitivity and strong negative predictive value for ruling out elevated PCWP and RAP," said Dr. Sauer. "In practice, that 'rule-out' performance is exactly what clinicians need for rapid ED triage, day-to-day fluid management, and confident discharge readiness decisions at the point of care."

The results reinforce Acorai's potential to serve as an easy-to-use and accurate point-of-care tool that enables clinicians to assess both left- and right-sided pressures. Importantly, subgroup analyses demonstrated stability of performance across patient populations and ejection fraction, supporting broad applicability in real-world care.

"CAPTURE-HF study data compares favorably to bedside clinician assessments alone and can provide more stable and repeatable measurements for improved detection of hemodynamic congestion and personalization of heart failure therapy ," said Filip Peters, Chief Executive Officer of Acorai. "These results pave the way for our CAPTURE-HF 2 and HOSP-HF studies, designed to confirm both clinical and economic value, as we advance toward planned FDA submission in 2026."

About CAPTURE-HF

CAPTURE-HF enrolled 1,600 patients across 20 clinical sites in six countries. Phase 1 (n=1,300) focused on machine learning training; Phase 2 was a prespecified, prospective patient cohort (n=300) which validated performance against right heart catheterization. 50% of patients were enrolled at U.S. sites.

About Acorai

Acorai is dedicated to advancing non-invasive heart failure care by equipping clinicians with next-generation tools to improve patient outcomes. The company's patented SAVE Sensor System is a pioneering multi-sensor platform designed to non-invasively estimate cardiac filling pressures, enabling more confident decision-making across the care continuum. Acorai has received FDA Breakthrough Device Designation and has studied its platform in over 2,000 patients. Supported by leading medtech investors and strategic partners, Acorai is committed to shaping the future of cardiac care through innovation in non-invasive monitoring.

For the latest updates, follow Acorai on LinkedIn or visit acorai.com

Contact: Filip Peters, CEO & Co-Founder, [email protected]

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SOURCE Acorai