Stereotaxis and CardioFocus Announce Collaboration to Advance Robotic Pulsed Field Ablation Technology Toward Commercialization

Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, and CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac arrhythmias, today announced they have entered into a Collaboration Agreement to advance robotic Pulsed Field Ablation (PFA) technology towards commercialization.

The collaboration combines the proprietary technologies of both companies to accelerate commercial availability of the first-ever robotic PFA solution for the treatment of cardiac arrhythmias. CardioFocus’ Centauri Pulsed Field Ablation (PFA) System is a next generation PFA system. The Centauri System is CE-marked and has been used to treat over 9,000 patients across Europe, with clinical experience reported in over 40 publications demonstrating high levels of procedural efficiency, durable cardiac lesions, and low rates of complications. Stereotaxis’ Robotic Magnetic Navigation (RMN) systems introduce the precision and safety of advanced robotic technology in cardiac ablation procedures, with clinical value demonstrated in over 150,000 cardiac ablation patients treated globally and over 500 publications.

CardioFocus and Stereotaxis have collaboratively worked to pair the Centauri PFA system with Stereotaxis’ MAGiC robotic cardiac ablation catheter. The two companies successfully completed extensive bench and preclinical testing of Centauri with MAGiC, including recent pivotal preclinical studies which demonstrated safe, efficient and impressive lesion delivery, including deep durable lesions in ventricular tissue. The Collaboration Agreement entered into by the companies supports advancing this joint solution to a clinical trial, facilitating regulatory compatibility and commercial availability of MAGiC and Centauri.

“We are excited to collaborate with CardioFocus to accelerate bringing robotic PFA to the Electrophysiology community,” said David Fischel, Stereotaxis Chairman and CEO. “The precision, stability and safety profile of robotics with the efficiency and attractive lesions created by Centauri is a winning combination. We look forward to transitioning to first human use and advancing the regulatory process in the coming few months.”

“The combination of our patented PFA waveform and the MAGiC catheter has the potential to improve patient lives,” said Stephan Ogilvie, CEO of CardioFocus. “Through rigorous scientific development, we have customized our proven PFA waveform for Stereotaxis’ RMN systems and anticipate the collaboration will advance patient care in electrophysiology.”