Acorai, founded in 2019, builds a handheld Heart Monitor that uses seismic, acoustic, visual and ECG sensors plus proprietary machine learning to estimate intracardiac pressures non-invasively. The device presents direct pressure estimates (not risk indices) that clinicians can incorporate into patient assessments. In pilot work in Sweden the company reported correlation above 0.8 versus right heart catheterization and high‑80s accuracy for specific pressure cutoffs; an initial pilot covered over 300 patients and 1,000+ measurements. Acorai is now running a larger global study of 1,500 patients across 14 hospitals in six countries to support validation. The company received FDA Breakthrough Device Designation for non-invasive estimation of pulmonary artery pressures and is planning to seek U.S. clearance and commercialize primarily in the U.S. in H2 2025 pending regulatory approval. The recently closed seed funding will mainly be used to finance these clinical studies and regulatory work. Acorai is building a non-invasive intracardiac pressure monitoring device intended to improve heart failure management. The company demonstrated promising results in a Swedish 350-patient pilot study and is now enrolling a global clinical validation study of 1,200 patients across 11 sites in Sweden, Denmark, Belgium, Great Britain, the US, and Canada. This global study is planned to end in 2024 and to support an FDA submission and clearance by 2025. Acorai received FDA Breakthrough Device Designation in August 2023 and was selected for the pilot FDA Total Product Life Cycle (TPLC) advisory program (TAP), enabling expedited interactions with regulators. Led by CEO Filip Peters and based in Helsingborg, Sweden, the company plans to use recent funds to accelerate clinical validation and regulatory submissions to enable commercialization. Financially, the company secured €2.3M in grant funding and has a €10M follow-on investment offer from the European Innovation Council.

Total raised

$18M

Funding rounds

3

Latest round

Seed

Latest activity

Jan 2024