Acorai is a Swedish medical device startup developing a first-of-its-kind, scalable device for non-invasive intracardiac pressure monitoring to improve heart failure management for over 64 million patients worldwide. The company's heart monitor uses a patented SAVE Sensor System that integrates seismic, acoustic, visual, and electrical sensors to collect data, which is then analyzed by proprietary machine learning models to estimate diastolic, systolic, and mean pulmonary artery pressures.
Acorai's heart monitor has demonstrated accuracies comparable to invasive gold-standard measurements in a 400-patient feasibility study conducted in June 2023. The non-invasive, handheld device allows healthcare professionals to quickly obtain intracardiac pressure readings by simply holding it against the patient's chest, without requiring specialized training or dedicated equipment.
In August 2023, the company received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its heart monitor. Acorai aims to submit the device for FDA clearance and CE-marking in 2024, with full commercial launch expected in 2025. The company has initiated the CAPTURE-HF global clinical trial across 11 sites in several countries to validate the device's performance on 1,200 patients undergoing catheterization procedures.
In November 2023, Acorai secured a EUR 2.3 million grant and a follow-on EUR 10 million investment offer from the European Innovation Council to support clinical validation and regulatory submissions. The company also raised USD 4.5 million in an oversubscribed seed equity round led by Solardis Health Ventures in January 2024 to finance the CAPTURE-HF study.
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