Stereotaxis Announces First GenesisX Robotic System Order
Rhea-AI Summary
Stereotaxis (NYSE: STXS) has received its first order for the GenesisX™ robotic system from a European hospital. GenesisX represents the latest advancement in endovascular surgical robotics, featuring smaller magnets and built-in magnetic shielding, eliminating the need for wall shielding installation.
The system operates on standard power outlets without requiring structural floor anchoring. It includes a cabinet 80% smaller than previous versions and can be stored under an operating room table. The system maintains high performance standards while being more compact and lighter than previous generations.
GenesisX received CE Mark in Europe in 2024 and is pending FDA 510(k) clearance in the US. Throughout 2025, Stereotaxis plans to obtain regulatory approvals for compatible catheters, demonstrate real-world usage, enhance x-ray compatibility, and prepare for full commercial launch.
Positive
- First commercial order received for GenesisX system
- CE Mark approval already obtained in Europe
- System requires no structural modifications and uses standard power
- 80% smaller cabinet size compared to previous versions
- Built-in magnetic shielding eliminates need for room modifications
Negative
- FDA approval still pending in the United States
- Full commercial launch not yet ready, pending multiple preparatory steps
- Compatible catheter portfolio still requires regulatory approvals
Insights
The first GenesisX order marks a pivotal moment for Stereotaxis, signaling market validation for their next-generation surgical robotics platform. The system's innovative design addresses key adoption barriers in the $4.5 billion endovascular surgical robotics market.
Several technical advancements make GenesisX particularly compelling for hospitals:
- Elimination of specialized room shielding and structural requirements, significantly reducing installation costs
- Standard power supply compatibility and 80% smaller system cabinet, enabling flexible deployment
- Integrated magnetic shielding and streamlined connectivity, simplifying installation logistics
The regulatory pathway appears well-structured, with CE Mark already secured and FDA 510(k) submission in progress. The company's 2025 strategic roadmap encompasses critical elements for successful commercialization:
- Expanding compatible catheter portfolio across EP and vascular applications
- Establishing real-world clinical validation
- Developing x-ray system compatibility
- Optimizing supply chain and installation processes
While this first order is promising, several factors will influence commercial success:
- Pricing strategy and hospital ROI metrics
- Competition from established surgical robotics players
- Clinical data generation and publication timeline
- Manufacturing scalability and margin profile
ST. LOUIS, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it has received the first order for its latest generation robotic system, GenesisX™.
“We are thrilled to announce the first firm order for GenesisX from a pioneering European hospital,” said David Fischel, Stereotaxis Chairman and CEO. “Establishing the first GenesisX robotic lab is a critical milestone for us as we advance towards full commercial launch. We look forward to demonstrating the performance and reliability of GenesisX in the demanding clinical environment. GenesisX promises to transform the accessibility of Robotic Magnetic Navigation and is central to our mission of driving broad robotic adoption throughout endovascular surgery.”
GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic Navigation while significantly enhancing the accessibility of the technology for healthcare providers. GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure in place of the shielding otherwise installed in the walls of the operating room. It requires no structural anchoring through the floor and operates using standard 120/230V power outlets. A single fiber is routed from each robot to the system cabinet, which is
GenesisX obtained CE Mark in Europe in 2024 and has been submitted to the FDA for 510(k) clearance in the United States. During 2025, Stereotaxis plans to gain regulatory approvals in Europe and the US for a portfolio of compatible EP and vascular catheters, demonstrate real-world use of GenesisX, enhance compatibility of GenesisX with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch.
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
FAQ
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