Heart failure start-up Acorai has announced the initiation of a global clinical trial with the enrolment of its first patient in London, UK.
The Acorai heart monitor was designated as a breakthrough device by the US Food and Drug Administration (FDA) in August 2023 and the company aims to submit the device for regulatory approval to the FDA and CE-marking in 2024.
Acorai is developing a scalable device for non-invasive intracardiac pressure monitoring to improve heart failure management. According to a company press release, the device has demonstrated accuracies comparable to the invasive gold standard in a 400-patient feasibility study and consists of a patented hardware technology and proprietary machine learning system.
The first of the patients in the Acorai MLG Study was enrolled at Royal Brompton and Harefield Hospitals by Owais Dar, is a cardiologist specialising in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research programme at Harefield Hospital
Dar said: “This is a fantastic achievement after over a year of planning to get to the stage of final testing of the Acorai device in a clinical setting. If the same accuracy is shown within this global study as previously shown in their 400-patient study, then I have no doubt that Acorai will transform how we identify and manage patients with heart failure.”
Acorai will expand its clinical studies to other European and US sites over the coming months, with an overall recruitment target of 1,200 patients. This expansion will start with Dar’s colleague Colm McCabe, a specialist in pulmonary vascular disease at the Royal Brompton, followed by Rigshospitalet (Copenhagen, Demark) and Cardiovascular Center, OLV Hospital (Aalst, Belgium).
Amongst the clinical collaborators is Duke Clinical Research Institute DCRI (Duke University, USA), operating as the core lab for the study to ensure the highest study quality and independence.
Acorai’s foremost US clinical collaborator is Saint Luke’s Mid America Heart Institute (Kansas City, USA), led by principal investigator Tim Fendler. Saint Luke’s is anticipated to be the first US enrolling site on 11 September 2023.