Heart Failure Startup Acorai Advances Toward Regulatory Approval

21 August 2023 | Monday | News

Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024.
Dr Owais Dar (middle) and the study team in the Cardiac Catheterization Lab at Harefield Hospital and Acorai’s Chief Scientific Officer Matthew Mace (back right) (PRNewsfoto/Acorai AB)

Dr Owais Dar (middle) and the study team in the Cardiac Catheterization Lab at Harefield Hospital and Acorai’s Chief Scientific Officer Matthew Mace (back right) (PRNewsfoto/Acorai AB)

Acorai is developing a first-of-its-kind, scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide. Their heart monitor has demonstrated accuracies comparable to the invasive gold standard in a 400-patient feasibility study and consists of a unique, patented hardware technology and proprietary machine learning system.

 

The first of the patients in the Acorai MLG Study (Machine Learning Generalisation) [NCT05835024] was enrolled at Royal Brompton and Harefield Hospitals by Dr. Owais Dar and his team. Dr. Dar is a cardiologist specializing in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research programme at Harefield Hospital. Dr. 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 1200 patients. This expansion will start with Dr. Dar's colleague Dr. 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 their internationally renowned 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, MO), led by principal investigator Dr Tim Fendler. Saint Luke's is anticipated to be the first US[1]enrolling site on September 11th, 2023. Dr. Fendler said that the first global enrolment in London was "an exciting step on the journey of Acorai and the development of their heart monitor. At Saint Luke's, we constantly strive to lead in cardiovascular research, as evidenced by our rich history - extending from the pioneering legacy of the first primary coronary angioplasty performed in the early 1980s at our Institution, to ongoing innovation at the forefront of developing and implementing patient reported outcome as tools to guide patient care and optimize quality of life in coronary artery disease, heart failure and other conditions; and our leading role in the latest advances for heart failure therapeutics. We look forward to collaborating with Acorai, whose heart monitor may have the potential to 'change the game' in diagnostics, monitoring, and treatment of patients with heart failure."

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