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Acorai Advances to Key Phase in Pursuit of Regulatory Approval for Heart Failure Solution

Thursday, August 17, 2023

Swedish startup Acorai has taken a significant leap forward in the field of medical devices, launching a global clinical trial with its first patient enrolled in London, UK. This milestone follows Acorai's attainment of breakthrough device status from the US FDA in August 2023. The company is now aiming for regulatory approvals, including FDA approval and CE marking in 2024, for its innovative heart monitoring device.

Acorai is dedicated to developing a scalable medical device for non-invasive intracardiac pressure monitoring. Their primary objective is to enhance the management of the 64 million individuals worldwide who suffer from heart failure. Through a feasibility study involving 400 patients, Acorai's heart monitor has demonstrated accuracy levels comparable to established invasive methods. The device incorporates patented hardware technology and a proprietary machine learning system.

The first participant in the Acorai MLG Study (Machine Learning Generalisation) [NCT05835024] was enrolled at the Royal Brompton and Harefield Hospitals in London, led by Dr. Owais Dar and his team. Dr. Dar specializes in heart failure and leads a research program focused on advanced heart failure, heart transplant, and mechanical circulatory support at Harefield Hospital. He praised the achievement, highlighting the potential transformation of heart failure patient identification and management, contingent upon the device's sustained accuracy in the global study.

Acorai's plans extend to expanding their clinical trials to other esteemed medical institutions in Europe and the US, with a target of enrolling 1200 patients. Collaborative partners include Dr. Colm McCabe at Royal Brompton, Rigshospitalet in Copenhagen, Denmark, and the Cardiovascular Center at OLV Hospital in Aalst, Belgium. Ensuring the highest standards of quality and impartiality, the renowned Duke Clinical Research Institute (DCRI) at Duke University serves as the study's core lab.

Dr. Tim Fendler of Saint Luke's Mid America Heart Institute, a key clinical collaborator in the US, expects enrollment initiation on September 11th, 2023. Dr. Fendler expressed enthusiasm for this pivotal moment and the potential of Acorai's heart monitor to revolutionize diagnostic, monitoring, and treatment approaches for heart failure patients, aligning with the institution's dedication to advancing cardiovascular research and innovation.

https://www.prnewswire.com/news-releases/heart-failure-start-up-acorai-embarks-on-the-next-vital-stage-towards-regulatory-approval-301902821.html


 

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