Stereotaxis & CardioFocus Collaborate to Advance Robotic Pulsed Field Ablation for Cardiac Arrhythmias

Rhea-AI Summary

Stereotaxis (NYSE: STXS) and CardioFocus announced a Collaboration Agreement on October 13, 2025 to advance a first‑ever robotic Pulsed Field Ablation (PFA) solution toward commercialization.

The collaboration pairs CardioFocus’ CE‑marked Centauri PFA system (used in >9,000 patients and reported in >40 publications) with Stereotaxis’ MAGiC catheter and Robotic Magnetic Navigation (RMN) platform (used in >150,000 patients and reported in >500 publications). Companies completed bench and pivotal preclinical studies showing safe, efficient, deep durable ventricular lesions and plan to move toward first‑human use, clinical trial initiation, regulatory compatibility work, and commercialization in the coming months.

Positive

• Centauri CE‑marked and used in >9,000 patients
• Stereotaxis RMN used in >150,000 patients globally
• Pivotal preclinical studies showed deep, durable ventricular lesions
• Collaboration aims to advance to first human use and clinical trial

Negative

• Timing of regulatory approvals is uncertain and may delay commercialization
• No assurance the company will recognize revenue from customer orders that may be revised or canceled

Insights

Robotic EP Collaboration Analyst

Strategic collaboration aims to pair proven PFA waveform with robotic navigation to enable first-in-human robotic PFA and move toward commercialization.

The partnership combines CardioFocus’s CE-marked Centauri PFA System (used in over 9,000 patients and described in 40+ publications) with Stereotaxis’s MAGiC robotic catheter and RMN platform (used in over 150,000 patients and 500+ publications). This creates a clear business mechanism: integrate a clinically experienced PFA waveform with an established robotic navigation catheter to offer a differentiated robotic PFA therapy for arrhythmia ablation.

Key dependencies and risks are regulatory and clinical. The companies completed bench and preclinical testing, including pivotal preclinical studies reporting safe, efficient, and deep durable ventricular lesions, but human safety and efficacy remain untested; regulatory compatibility and successful first‑in‑human experience are required before commercialization. The announcement explicitly links the Collaboration Agreement to advancing a clinical trial and regulatory steps in the coming months, so near-term milestones will determine value realization.

Concrete items to watch are initiation of first‑in‑human clinical use and the clinical trial start date (coming few months), regulatory submissions and clearances tied to the joint solution, and clinical endpoints on lesion durability and complication rates compared with existing PFA and robotic ablation data; these milestones will materialize on a clinical/regulatory timeline over the next 6–24 months depending on trial design and approvals.

ST. LOUIS and MARLBOROUGH, Mass., Oct. 13, 2025 (GLOBE NEWSWIRE) -- 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.”

About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com.

About CardioFocus
Headquartered in Marlborough, MA, CardioFocus is a medical device innovator and manufacturer dedicated to advancing pulsed field ablation treatment for cardiac disorders such as atrial fibrillation, the most common heart arrhythmia. For more information, visit www.CardioFocus.com.

This press release includes statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, including statements regarding the completion of the Company’s offering and the anticipated use of proceeds therefrom, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company's periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. There can be no assurance that the Company will recognize revenue related to customer purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled.

Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer

Kimberly Peery
Chief Financial Officer

314-678-6100
Investors@Stereotaxis.com

FAQ

What did Stereotaxis (STXS) and CardioFocus announce on October 13, 2025?

They announced a Collaboration Agreement to advance a robotic Pulsed Field Ablation solution pairing CardioFocus’ Centauri PFA with Stereotaxis’ MAGiC catheter and RMN systems.

How many patients have been treated with CardioFocus Centauri PFA and Stereotaxis RMN?

Centauri has been used in >9,000 patients; Stereotaxis RMN technology has been used in >150,000 patients globally.

What preclinical results support the Stereotaxis‑CardioFocus collaboration?

Pivotal preclinical studies demonstrated safe, efficient lesion delivery including deep durable lesions in ventricular tissue.

Will the collaboration move to human clinical trials and when?

The companies said they plan to transition to first human use and advance regulatory processes in the coming months.

Does Centauri PFA have regulatory clearance in Europe?

Yes. Centauri is CE‑marked and has documented clinical use across Europe.

What are the main risks investors should note about the collaboration (STXS)?

Key risks include timing of regulatory approvals, market acceptance, and that customer orders may be revised or canceled affecting revenue recognition.