RHYTHM AI Announces Clinical Trial Collaboration With Biosense Webster

Companies to collaborate on multi-centre study of STAR Mapping™ to improve outcomes of persistent Atrial Fibrillation treatment

London, UK– 4th February 2020: RHYTHM AI Ltd (“RHYTHM AI” or “the company), a UK company focused on the treatment of Atrial Fibrillation (AF) today announces the signing of a research collaboration agreement with Biosense Webster (Israel), Ltd.

The agreement grants the company access to certain data from the Biosense Webster CARTO®3, System to support a multi-centre clinical trial of their STAR Mapping™ system.

STAR Mapping is a new, AI driven mapping system developed using novel computer algorithms to identify the sources or drivers of AF from data acquired from the 3D Mapping equipment, Outcomes in a single centre study published in May 2019 demonstrated that 80% of patients treated in a single procedure using STAR Mapping were free of AF without the use of anti-arrhythmia drugs at an average of 18.5 months follow-up. This compares very favourably to a study published in 2015, which demonstrated 48% of patients free form AF at 18 months follow-up using the standard mapping treatment. *

Simon Hubbert, Chief Executive Officer of RHYTHM AI said: “We are delighted to have reached agreement with Biosense Webster to collaborate on our forthcoming multi-centre trial. STAR Mapping has demonstrated a significant improvement in outcomes in a single centre study and we look forward to further demonstrating the value of STAR in a UK multicentre trial with recruitment starting later this year.

* N Engl J Med 2015; 372:1812-1822 DOI: 10.1056/NEJMoa1408288

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About Atrial Fibrillation
Atrial Fibrillation (AF) is the commonest abnormal heart rhythm seen in clinical practice in which irregular electrical signals wander chaotically throughout the upper chambers (Atria) of the heart. AF affects an estimated 1.5 million in the UK and 4 to 6 million in the USA alone and the prevalence of AF has been projected to increase to 15.9 million by the year 2050, Atrial fibrillation is associated with significant clinical morbidity, and is also an independent risk factor for mortality. Thromboembolic stroke is the most serious and debilitating of all the complications of AF and AF is also known to precipitate and worsen the outcomes of congestive heart failure.

Treatment of AF and its associated complications increases the use of healthcare resources and contributes to the ever-growing costs of healthcare, particularly costs associated with hospitalizations.

Catheter ablation is the commonest and most effective treatment for AF but has limited success in patients in whom the AF is present all the time because of the seemingly random and chaotic nature of the AF. This makes it highly challenging to identify the cause or sources of the AF. This means that even in the best hands the first time success rate is usually only around 50%.