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Cool Cardioversion’s Feasibility Shown in both

Pre-Clinical and FIH Work

Pre-Clinical

We developed a simple prototype therapeutic device that uses chilled fluid delivered through a compact stainless steel square applicator. In pre-clinical studies, atrial fibrillation (A-fib) was successfully terminated in under 30 seconds using a 1” × 1” device. Subsequent research confirmed the feasibility and optimal placement of the approach, while demonstrating non-inferiority with a smaller-form device—supporting scalability without compromising performance.  Our results were published in The Journal of the American College of Cardiology.

First in Human

In a first-in-human study, targeted cooling of the oblique sinus successfully terminated intraoperative atrial fibrillation in patients with cardiovascular disease undergoing cardiac surgery. A-Fib termination was shown to be temperature-dependent and typically occurred in under 30 seconds. No complications were observed in association with the cooling procedure, supporting the safety and clinical potential of this approach.  Our results were published in Heart Rhythm O2 in 2025.