Magbot Robotic Magnetic Navigation Ablation Catheter Approved by China’s NMPA

STXS 12.09.2024

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ST. LOUISandSHANGHAI,Dec. 09, 2024(GLOBE NEWSWIRE) --Stereotaxis(NYSE: STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, “MicroPort EP”), today announced that the MagbotTM Magnetic Navigation Ablation Catheter has received regulatory approval from China’sNational Medical Products Administration(NMPA).

The MagbotTM Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration withStereotaxis. The catheter works exclusively and in tight conjunction with Stereotaxis’ robotic systems, including the recently NMPA-approved Genesis RMNTM, and MicroPort EP’s ColumbusTM 3D EP Mapping System.

MagbotTM incorporates advanced design features that substantially enhance the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. Robotically navigated using low-intensity magnetic fields, the MagbotTM catheter is able to reach areas of the heart otherwise difficult to access with traditional methods and to maintain precise positioning and stability on cardiac anatomy with millimeter-level accuracy. Full integration with ColumbusTM enables real-time location tracking and 3D cardiac modeling, allowing physicians to accurately record electrocardiographic data and pinpoint lesions for precise diagnosis and treatment of arrhythmias. A unique six-electrode design enhances safety during procedures by offering visibility of the catheter shaft without the need for fluoroscopy. MagbotTM has been approved by NMPA for the ablation of drug-resistant persistent atrial fibrillation, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.

“The approval of the MagbotTM Catheter signifies a major breakthrough for MicroPort EP in cardiac electrophysiology and a significant milestone for robotic navigation technology in China,” emphasized Dr.Yiyong Sun, President of MicroPort EP. “Our recent technological advances withStereotaxisoffer a safer and more precise minimally-invasive treatment solution for complex arrhythmia patients. We are excited about its potential to benefit physicians and patients alike and to strengthen our partnership withStereotaxisto drive innovation in electrophysiology.”

“We are delighted by MagbotTM approval in China,” addedDavid Fischel, Chairman and CEO ofStereotaxis. “This milestone reflects our commitment to improving global cardiovascular care. MagbotTM represents a key innovation in robotic navigation, and we look forward to continuing our collaboration with MicroPort EP to pioneer innovative technologies that advance electrophysiology and benefit patients worldwide.”

MicroPort EP will initiate commercial launch of MagbotTM inChinathrough its existing sales team focused on the electrophysiology community.Stereotaxisshares in the proceeds from MagbotTM adoption. MicroPort EP is one of China’s leading medical device companies with a portfolio of cardiovascular medical devices designed to diagnose and treat arrythmias.Stereotaxisand MicroPort EP previously announced their collaboration inAugust 2021.

AboutStereotaxisStereotaxis(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.Stereotaxistechnology has been used to treat over 150,000 patients acrossthe United States,Europe,Asia, and elsewhere. For more information, please visitwww.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, and 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 theSecurities 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. FischelChairman and Chief Executive Officer

Kimberly PeeryChief Financial Officer

314-678-6100Investors@Stereotaxis.com

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Source: Stereotaxis, Inc.

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