Stereotaxis Receives CE Mark Approval for the MAGiC Ablation Catheter

ST. LOUIS, Jan. 27, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received European CE Mark approval for the MAGiC™ ablation catheter. This approval is a significant milestone for Stereotaxis and for the community of physicians pioneering robotics in electrophysiology. It is reflective of the company’s commitment to advancing significant innovations that make robotics increasingly impactful across interventional medicine.

Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The MAGiC catheter was developed based on insights collected over the course of nearly 20 years and 150,000 robotic ablation procedures performed using predecessor catheters. The MAGiC catheter is designed to enhance treatment precision and control during cardiac ablation, while maintaining the intrinsic safety advantage of a soft flexible catheter. It builds upon existing benefits of robotic cardiac ablation with design enhancements that include:

• Optimized Navigation, Force & Stability – The unique placement of magnets and design of the distal section of the catheter supports intuitive navigation, consistent contact forces, and enhanced stability.
• Improved Data & Information – MAGiC is available with iConnect and the eContact module, offering catheter tissue contact information as well as clear electrogram and responsive temperature data to support physician decision making.
• Efficient Low-Flow Uniform Cooling – Cooling of the tip is accomplished with low-flow irrigation that substantially reduces overall fluid load on patients while protecting against char and coagulation.

The MAGiC catheter has been approved in Europe with a broad label that includes the delivery of “local lesions in cardiac tissue for the treatment of cardiac arrhythmias.” Obtaining the CE Mark follows years of effort and substantial investments in catheter development, testing, manufacturing, and preclinical and clinical research. Clinical experience with MAGiC in an ongoing clinical study in Europe supports expectations for broad adoption of MAGiC across robotic users.

“We are thrilled to announce this significant milestone and introduce the MAGiC catheter to European physicians and patients,” said David Fischel, Stereotaxis Chairman and CEO. “We want to thank and recognize the significant contributions from clinicians who guided us throughout the development efforts and team members of Stereotaxis and Osypka that made this possible. We look forward to seeing MAGiC serve as one of the key pillars in our effort to make robotics broadly impactful and beneficial in electrophysiology and endovascular surgery.”

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.

This press release includes statements that may constitute “forward-looking” statements, 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, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its 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