Stereotaxis Achieves CE Mark in Europe and Submits 510(k) in the US for Next Generation Robotic System GenesisX

Rhea-AI Summary

Stereotaxis (NYSE: STXS), a leader in surgical robotics for minimally invasive endovascular intervention, has achieved significant milestones for its next-generation robotic system, GenesisX. The company has obtained CE mark in Europe and submitted a 510(k) application to the FDA in the US. GenesisX builds upon the established benefits of Robotic Magnetic Navigation (RMN) systems while reducing adoption barriers for hospitals.

Key improvements include smaller magnets, integrated magnetic shielding, no need for structural anchoring, standard power requirements, and an 80% smaller system cabinet. These advancements significantly reduce installation complexities and costs. Stereotaxis plans to launch GenesisX in 2025, focusing on regulatory approvals for compatible catheters, real-world demonstrations, and preparing supply chain and commercial processes.

Positive

• Obtained CE mark in Europe for GenesisX robotic system
• Submitted 510(k) application to FDA for US clearance
• GenesisX reduces hospital adoption barriers with smaller size and simplified installation
• New system operates on standard power outlets, reducing infrastructure requirements
• 80% smaller system cabinet improves space efficiency in operating rooms

Negative

• Full launch of GenesisX not expected until 2025, potentially delaying revenue growth
• Additional regulatory approvals needed for compatible catheters before full launch

Insights

Medical Device Regulatory Expert

The CE Mark approval and FDA 510(k) submission for GenesisX are significant regulatory milestones for Stereotaxis. CE Mark allows immediate commercialization in Europe, while the FDA submission initiates the review process for U.S. market access. These steps typically indicate a product is nearing commercial readiness.

The reduced infrastructure requirements of GenesisX, including built-in shielding and standard power needs, could substantially lower barriers to adoption in hospitals. This may accelerate market penetration and expand the addressable market for robotic magnetic navigation systems.

However, investors should note that full commercialization is slated for 2025, suggesting a measured rollout strategy. The company's focus on regulatory approvals for compatible catheters and real-world demonstrations indicates a thorough, risk-mitigating approach to market introduction.

Medical Technology Analyst

GenesisX represents a significant leap in robotic surgical technology. Its compact design and reduced infrastructure requirements address key adoption barriers in the robotic surgery market. The system's ability to operate without extensive room modifications could dramatically reduce installation costs and time, potentially accelerating market penetration.

The platform's versatility for various endovascular interventions beyond electrophysiology suggests a broader market opportunity. This could position Stereotaxis to compete more effectively in the rapidly growing $16.5 billion surgical robotics market.

However, the delayed full launch until 2025 may give competitors time to respond. Investors should monitor the company's progress in securing regulatory approvals for compatible catheters and demonstrating real-world efficacy, as these will be important for successful commercialization.

Financial Analyst

While Stereotaxis doesn't provide specific financial projections for GenesisX, the product's potential to expand market reach is significant. The reduced infrastructure requirements could lower the total cost of ownership for hospitals, potentially driving adoption rates and revenue growth.

Investors should note that Stereotaxis reported $30.3 million in revenue for 2023, with a net loss of $21.9 million. The success of GenesisX will be important for improving the company's financial position. However, the planned 2025 full launch means any substantial revenue impact is likely 1-2 years away.

The company's cash position ($30.5 million as of Q4 2023) and ongoing losses underscore the importance of efficient commercialization. Monitoring pre-orders, initial installations and operating expenses in the coming quarters will be key for assessing GenesisX's potential financial impact.

• Latest innovation in Robotic Magnetic Navigation technology supports broad accessibility of robotics for minimally-invasive endovascular surgery
• GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States

ST. LOUIS, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Europe and submitted a 510(k) application to the FDA in the US for a next generation robotic system, GenesisX.

“We are excited to introduce GenesisX and share the achievement of these significant milestones,” said David Fischel, Chairman and CEO. “Medical innovation only realizes its full potential to advance and improve patient care if it is designed to be broadly accessible. The clinical value of Stereotaxis’ robotic technology has been extensively demonstrated yet difficult to access for the vast majority of interested physicians and hospitals. GenesisX is strategically transformative as it supports broad adoption of robotics in electrophysiology and across endovascular interventions.”

GenesisX builds upon the established benefits and performance of Robotic Magnetic Navigation (RMN) systems, while reducing the complexities and barriers to hospital adoption of the technology. Preparing an operating room to accommodate a RMN system has typically required significant structural modification, including the installation of thousands of pounds of magnetic shielding in the walls, reinforcement of the floor, high electrical power, and extensive cabling through conduits between the operating room and a dedicated cabinet room. This entailed months of planning and coordination between site planners, architects, and contractors. 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 80% smaller than the cabinet of Genesis and can fit under a table in the operating room. GenesisX is smaller and lighter than any previous generation system, and maintains the speed, responsiveness, and efficient workflow of Genesis. GenesisX will serve as a platform for additional innovations in the future.

GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States. Stereotaxis plans to use the coming months to gain regulatory approval for compatible catheters, demonstrate real-world use of the system, enhance compatibility with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch and significant adoption of GenesisX in 2025.

GenesisX Robotic Magnetic Navigation System

Magnetic shielding built into the structure of the GenesisX Robotic Navigation System

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 100,000 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, 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 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

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/b2a52dbd-2ea2-4a04-a6b3-28f48b832d8c

https://www.globenewswire.com/NewsRoom/AttachmentNg/739addac-9797-49cf-b274-3c1eae48bda2

FAQ

What regulatory milestones has Stereotaxis (STXS) achieved for its GenesisX robotic system?

Stereotaxis has obtained CE mark in Europe and submitted a 510(k) application to the FDA in the United States for its GenesisX robotic system.

How does the GenesisX system improve upon previous Stereotaxis (STXS) robotic navigation systems?

GenesisX features smaller magnets, integrated magnetic shielding, no need for structural anchoring, standard power requirements, and an 80% smaller system cabinet, significantly reducing installation complexities and costs for hospitals.

When is Stereotaxis (STXS) planning to fully launch the GenesisX robotic system?

Stereotaxis plans to fully launch and drive significant adoption of the GenesisX robotic system in 2025, following regulatory approvals and preparation of supply chain and commercial processes.

What are the power requirements for the new GenesisX system from Stereotaxis (STXS)?

The GenesisX system operates using standard 120/230V power outlets, eliminating the need for high electrical power installations in operating rooms.