August 4,2020

Adagio Medical, Inc., a leading innovator for the treatment of atrial fibrillation (AFib) and ventricular tachycardia (VT), and developer of the intelligent Continuous Lesion Ablation System (iCLAS?), today announced successful pre-clinical results demonstrating their existing cryoablation catheter is also capable of ablating the tissue through pulsed field ablation (PFA) delivered via the existing array of electrodes.

"Our goal is to lead the innovation and development of true continuous, transmural lesions anywhere in the heart.  Our primary technologies under development have been ultra-low temperature cryo (ULTC) and electroporation (PFA)," said Olav Bergheim, President and CEO of Adagio Medical.  He further says, "Therefore, our CE marked catheter and the catheter undergoing US IDE trials were designed to incorporate both technologies.  The electrodes and the wiring in the catheters are currently activated for navigation and diagnostic purposes only.  Software and hardware updates will be installed in the Adagio console to enable the PFA functionality once clinical and regulatory approvals are received." 

Dr. Alex Babkin, PhD, CTO of Adagio said, "In recent years, PFA and ULTC have become important alternatives in the field of AFib treatment.  We believe that our ULTC technology, together with PFA, creates a new treatment and delivery option, the pulsed field cryo ablation (PFCA) technology, that combines the best of both worlds."  As outlined below, our PFCA technology may overcome some disadvantages known to exist in each of these modalities. These two very different energy sources can also be used independently during one procedure depending on the treatment region in the heart.

While using our PFA technology, we had to overcome the following issues:

• Creation of bubbles in the atrium of the heart due to significant electrical current generated in the blood during a PFA treatment.

• Lesion depths are normally limited to 3-4 mm due to the nature of the electric field. Creating deeper lesions are more problematic as they would require applied voltage that may not be practical and/or safe to use.

• Musculo-skeletal contractions associated with pulsed field application.

• Ablation of adipose tissue. The most known safety benefit of PFA, tissue selectivity, can potentially become its "Achilles heel" in a situation when a myocardial tissue has inclusion of some other tissue e.g. adipose tissue.    

While using our ULTC technology, we want to overcome the following issue:

• Risk of collateral damage to the esophagus and phrenic nerve

Dr. Babkin stated that "our pre-clinical trials have demonstrated that these issues can be controlled by combining the two platform technologies into one catheter."