Stereotaxis and CardioFocus Announce Strategic Collaboration to Advance Robotic Pulsed Field Ablation for Cardiac Arrhythmias

 StereotaxisAndCardioFocusJointly announced that they have signed a cooperation agreement to jointly promote the commercialization process of robotic pulsed field ablation technology.

Executive Evaluation

"We are thrilled to partner with CardioFocus to accelerate the introduction of robotic PFA technology to the electrophysiology community. The precision, stability, and safety offered by robotics, combined with the high efficiency of the PFA ablation system Centauri and the attractive lesions it creates, make for a winning combination. We look forward to transitioning to first-in-human applications in the coming months and advancing through the regulatory approval process."

---David Fischel   Chairman and Chief Executive Officer of Stereotaxis

"The combination of our patented PFA waveform with the MAGiC catheter has the potential to improve patient lives. Through rigorous scientific development, we have customized the proven PFA waveform for Stereotaxis’ surgical robot RMN, and we anticipate that this collaboration will advance patient care in the field of electrophysiology."

---Stephan Ogilvie  CardioFocus CEO

StereotaxisAndCardioFocusHave unique technologies in various fields.StereotaxisWith the world's only one-of-a-kind cardiacMagnetic Navigation RobotRMN, andCardioFocuswhich has the world's only universally applicable PFA energy platform.Centauri. However, neither of the two has achieved quantitative and qualitative changes in various niche fields. LikeCardioFocusCentauri Second Product ApprovedPFA Energy Platform, but due to the lack of配套 ablation catheters, it took more than three years after its market launch for the number of surgeries to exceed 9,000 (still less than...FARAPULSE Two-Week Surgical Volume). SimilarlyStereotaxisThere is also this issue, within its heartMagnetic Navigation RobotRMN has been on the market for many years, but its global commercialization progress has not been very smooth, with only 150,000 units completed so far.Cardiac Ablation Surgery.

Although these two companies have weak commercialization capabilities, their products are highly unique. If they can complement each other's strengths, there is a good chance for a breakthrough. Currently, PFA has become the future of electrophysiological ablation and the fastest-growing segment in cardiovascular surgeries. For instance, Boston Scientific completed 300,000 surgeries in less than 8 months this year.StereotaxisAndCardioFocusComplementing advantages is highly promising to make their products available in more...Applied in electrophysiological ablation.

CurrentlyStereotaxisAndCardioFocusThe cooperation has been initiated.CardioFocusPFA Energy PlatformCentauri is paired with Stereotaxis' MAGiC robotic cardiac ablation catheter and has successfully completed a significant number of laboratory and preclinical tests, including recent pivotal preclinical studies. The preclinical studies demonstrated that this combination can deliver impressive lesions safely and efficiently, including creating deep and durable lesions in ventricular tissue.

Therefore, the cooperation agreement signed by both parties aims to advance this joint solution into the clinical trial stage and promote the progress of MAGiC ablation catheter and Centauri energy platform in terms of regulatory compliance and commercial availability.