RHYTHM AI Ltd Announces publication of Human Clinical Outcome Study for STAR Mapping System for Treatment of Persistent Atrial Fibrillation

Oxford, UK- 14 May 2019:  RHYTHM AI Ltd ("RHYTHM AI" or "the company), a UK company focused on the treatment of Atrial Fibrillation (AF) today announces publication of the first-in-man proof-of-concept study results for its STAR (Stochastic Trajectory Analysis of Ranked signals) mapping method designed to improve outcomes in patients receiving ablation treatment for persistent Atrial Fibrillation (AF).

This new mapping method, developed by cardiologists at St Bartholomew’s Hospital London, used novel computer algorithms to identify the sources or drivers of AF from data acquired from the standard procedure equipment. Key outcome study findings:

• Thirty-five patients with persistent AF (80% with duration of >12months) were prospectively included in the trial
• Commercially available catheters and equipment were used to gather the data for STAR mapping
• AF drivers were identified in 100% of patients with STAR mapping.
• A positive response (AF termination or Cycle Lengths slowing of ≥30ms) was achieved with ablation at 88% of the sites targeted.
• 75% of patients reverted to normal sinus rhythm using ablation alone.
• Over an average follow-up of 18 months, 80% of the patients treated using the STAR method remained free of any abnormal heart rhythm after only a single catheter ablation procedure and without the need for antiarrhythmic drugs.
• The 7 patients who had a recurrence underwent a second procedure and are now arrhythmia-free for 12 months.
• The full paper is published to coincide with the 40^th Annual Heart Rhythm Society Scientific Sessions held in San Francisco, CA, USA

Simon Hubbert, Executive Chairman of RHYTHM AI said: "We are very excited by the positive results from the clinical outcomes study. Other landmark studies in the treatment of persistent AF have shown much lower single procedure success rates and we remain very positive in our belief that STAR Mapping can significantly improve outcomes for the >400,000 patients that undergo ablation treatment for persistent AF every year.

Commenting on the publication, lead author Professor Richard Schilling, said: “Identifying the sources of AF has been a focus for the heart rhythm community for the last 2 decades. These early results are very promising, particularly given they are from a cohort of patients in whom success rates with standard treatments are generally lower. If these results are replicated in a multicentre clinical trial, this will be the first technology to have been able to guide the ablation of persistent AF, a major and growing healthcare burden around the world.”

AF Association found and CEO Trudie Lobban added:  We welcome this news as all too often people with AF do not have access to appropriate treatment. The initial results from the STAR Mapping study will give hope to many and lead to improved outcomes for patients with persistent AF.

RHYTHM AI Ltd is currently raising financing to bring this promising treatment to patients across the world. The company plans to start recruitment into a multi-centre clinical study of STAR Mapping in mid-2020.