Stereotaxis seeks FDA nod for robotic catheter system

Published 03/03/2025, 13:42
Stereotaxis seeks FDA nod for robotic catheter system

ST. LOUIS - Stereotaxis Inc. (NYSE: NYSE:STXS), a leader in robotic technologies for minimally invasive endovascular procedures trading at $2.06 per share, has announced the submission of a regulatory application to the U.S. Food and Drug Administration (FDA) for its new MAGiC Sweep™ catheter. The company, which has seen its stock decline nearly 10% in the past week according to InvestingPro data, continues to pursue innovation despite market challenges. This device represents the first high-density electrophysiology (EP) mapping catheter designed to be robotically navigated using the company’s Robotic Magnetic Navigation systems.

The MAGiC Sweep catheter aims to revolutionize the EP field by allowing for more efficient and precise identification of arrhythmia origins during cardiac ablation procedures. It features the capability to collect detailed electroanatomical mapping data simultaneously from 20 electrodes, enhancing the procedure’s safety and accuracy. The robotic technology enables automated mapping, which is expected to be improved with the integration of MAGiC Sweep.

Dr. Roderick Tung, Chief of Cardiology at The University of Arizona College of Medicine - Phoenix, highlighted the significance of this innovation, stating that the ability to map with multi-electrode catheters has greatly advanced the understanding and treatment of arrhythmias. While the company maintains a solid gross profit margin of 56%, InvestingPro analysis reveals ongoing profitability challenges, with analysts not expecting positive earnings this year. The MAGiC Sweep is anticipated to overcome limitations of current point-by-point mapping and foster the adoption of robotic navigation.

Stereotaxis has also filed for European CE Mark clearance and plans a broad commercial launch of MAGiC Sweep in the second half of the year, pending regulatory approvals. The device was developed and is manufactured by Stereotaxis’ subsidiary Access Point Technologies in Minnesota.

David Fischel, Chairman and CEO of Stereotaxis, emphasized the strategic transformation of the company toward a broader portfolio of proprietary differentiated catheters. The submission of MAGiC Sweep, along with the EMAGIN 5F vascular guidance catheter, marks the first milestones in this evolution.

Stereotaxis, with a history of over 150,000 patients treated globally, continues to focus on delivering robotic precision and safety in the interventional lab, enhancing minimally invasive therapy access, and improving operating room productivity and intelligence.

The company’s forward-looking statements involve risks and uncertainties that could affect actual results, including the timing of regulatory approvals and market acceptance of its products. With analyst price targets ranging from $4 to $5, significantly above current trading levels, market watchers remain optimistic about the company’s potential. For deeper insights into Stereotaxis’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro, which offers exclusive metrics and expert research reports covering over 1,400 US stocks.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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