Swedish heart failure start-up Acorai has enroled the first patient for a global clinical trial of its heart monitor in London, UK, aimed at securing regulatory approval.
Acorai’s heart monitor is said to be a first-of-its-kind, handheld, scalable medical device for non-invasive intracardiac pressure monitoring (ICPM).
It is designed to enhance heart failure management by using a proprietary machine learning technology and patented SAVE Sensor System that potentially lowers cost and time.
According to the medical device maker, its heart monitor showed accuracy levels that are comparable to the invasive gold standard in a feasibility study of 400 patients.
The first patient in the Acorai Machine Learning Generalisation (MLG) Study was registered at Royal Brompton and Harefield Hospitals by Owais Dar and his team.
In the upcoming months, the Swedish start-up will extend its clinical investigations to additional US and European locations, with a goal to enrol 1,200 patients.
The MLG study will be conducted in two phases. The initial phase will conclude after enroling 920 patients and will serve to refine its machine learning algorithms before the final testing phase.
Beginning in 2024, the second phase will support the validation of the final software as well as the regulatory application for clearance and approval for use in the US and Europe.
Acorai CEO Filip Peters said: “Our focus from day one has been to generate robust clinical data with world-leading clinical partners.
“The shared vision of our investors and clinical partners in bringing transformative products to heart failure patients has allowed us to develop a medical device built on robust scientific evidence and which is able to address deep unmet clinical needs.”
The US Food and Drug Administration (FDA) designated Acorai’s heart monitor as a breakthrough device in August this year. The company aims to submit the device for FDA approval and CE-marking in 2024.
Acorai is currently planning to raise its Series A financing to obtain FDA clearance, with a complete commercial launch anticipated in 2025.
