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.

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, the company states. 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,” says 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.”