First Patients Treated with Galaxy Medical’s CENTAURI Pulsed Electric Field Cardiac Ablation System

MENLO PARK, California, October 9, 2020 — Galaxy Medical, (Galaxy), a developer of Pulsed Electric Field (PEF) technology for the treatment of cardiac arrhythmias, today announced that the first patients were successfully treated with the proprietary CENTAURI™ System by Dr. Ante Ani in Split, Croatia as part of the ECLIPSE-AF study. This multicenter trial is designed to assess the safety, efficacy, and interoperability of the Centauri System and is intended to support CE-Mark.

The Centauri System is uniquely designed as an open energy platform utilizing a proprietary wave control algorithm enabling electrophysiologists to continue with the established point-by-point clinical workflow used in the majority of cardiac ablation procedures to deploy PEF energy to treat the widest array of patients with any lesion set. Thus eliminating the learning curve associated with other systems under development.

Key features of the CENTAURI System include:

• Plug and play with all cardiac mapping and navigation systems
• Compatible with all market released contact force catheters
• Programable dosing to address variable tissue thickness
• Proprietary wave control algorithm for complete elimination of micro-bubbles during PEF delivery
• Automatic impedance monitoring

Ante Ani , EP Lab Director at University Hospital Split and the Primary Investigator of the ECLIPSE-AF study, said: “The innovative Galaxy Medical Centauri System, based on extensive research, development and preclinical validation, operated seamlessly within my clinical atrial fibrillation ablation workflow. I was able to perform a standard focal ablation without compromising the ablation catheter, contact force feedback, or cardiac mapping system.”

Jonathan Waldstreicher, MD, CEO of Galaxy Medical commented: “In developing the Centauri System, our three main priorities are safety, interoperability, and efficacy. With the complete elimination of micro-bubbles which may cause cerebral or coronary air emboli, we believe we have addressed the primary safety concern of PEF technology in the heart. Further by enabling physicians to continue to use the ablation catheters they know we believe we have eliminated the learning curve paving the way for rapid uptake of this technology for delivering safe and effective ablation procedures. We are confident that staying with the standard of care focal approach yields predictable and transmural lesions rather than intermittent electrical stunning. We look forward to completing enrollment of the ECLIPSE-AF study and sharing the clinical experience in the near future.”

As part of the ECLIPSE-AF study, patients will be assessed and followed with standard safety and efficacy procedures including acute demonstration of entrance and exit block, three-month electrophysiologic remapping to confirm pulmonary vein isolation, cerebral MRI and upper GI endoscopy.

PEF technology utilizes high voltage, high frequency bursts of electrosurgical energy to ablate tissue. In comparison to radio frequency ablation procedures, PEF has the potential to improve the safety of cardiac ablation by reducing the unintentional conductive heating or cooling of extracardiac structures including the esophagus, phrenic nerve and airway. By limiting the therapeutic dose of PEF energy to the heart, full thickness transmural ablations are readily achieved.

CENTAURI is an investigational device and not commercially available.