August 16, 2023—Acorai AB, a Sweden-based start-up medical device manufacturer, announced the initiation of the Acorai MLG—Machine Learning Generalization—study, a global clinical trial of the company’s device for noninvasive intracardiac pressure monitoring to improve heart failure management.

The device is designed for the noninvasive estimation of diastolic pulmonary artery pressure, systolic pulmonary artery pressure, and mean pulmonary artery pressure in patients with stage C heart failure who have been referred for hemodynamic monitoring.

On August 12, the company announced that the FDA granted Breakthrough Device designation for the Acorai heart monitor. The company aims to submit the heart monitor for regulatory approval in the United States and European Union in 2024. Acorai is raising Series A round of financing to secure FDA clearance by the end of 2024, with full commercial launch expected in 2025.

In the clinical trial, the first patient was enrolled by Owais Dar, MRCP, and his team at Royal Brompton and Harefield Hospitals in London, United Kingdom. Dr. Dar is a cardiologist specializing in heart failure and leads the advanced heart failure, heart transplant, and mechanical circulatory support research program at Harefield Hospital.

Dr. Dar commented in the press release, “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.”

In addition to Royal Brompton, enrollment in the company’s clinical study will be expanded to sites in Europe and the United States sites during the coming months. The next sites will be Rigshospitalet in Copenhagen, Demark, and the Cardiovascular Center, OLV Hospital in Aalst, Belgium.

In the United States, the first patient is expected to be enrolled by principal investigator Tim Fendler, MD, at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, on September 11, 2023.

Duke Clinical Research Institute at Duke University in Durham, North Carolina is the core lab for the study.

According to the company, the study builds upon the success of a similar protocol of a feasibility study of the Acorai device conducted by Niklas Bergh, MD, of Sahlgrenska University Hospital in Gothenburg, Sweden, and Göran Rådegran, MD, of Skåne University Hospital in Lund, Sweden. The study concluded in June 2023 with a total enrollment of 400 patients.

In the feasibility study, which supported the FDA Breakthrough Device designation, preliminary data from 281 patients demonstrated accuracies with a strong correlation to the invasive gold-standard measurements of pulmonary pressure, noted the company.