Stereotaxis Inc.
Recent innovations in robotic magnetic navigation technology support the widespread use of robots in minimally invasive endovascular procedures.
GenesisX has received CE Mark in Europe and is currently undergoing 510(k) clearance with the FDA in the United States.
ST. LOUIS, Aug. 12, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), the pioneer and global leader in surgical robotics for minimally invasive endovascular interventions, today announced it has received CE Mark in Europe and submitted a 510(k) application to the U.S. FDA for its next-generation robotic system, GenesisX.
“We are excited to announce GenesisX and share the achievement of these important milestones,” said David Fischel, Chairman and CEO. “Medical innovations only realize their full potential to advance and improve patient care when they are designed for broad access. The clinical value of Stereotaxis' robotic technology has been widely demonstrated, but it remains difficult to access for the majority of interested physicians and hospitals. GenesisX is strategically transformative as it supports the broad adoption of robotics across electrophysiology and endovascular interventions.”
GenesisX builds on the established benefits and performance of Robotic Magnetic Navigation (RMN) systems while reducing the complexity and barriers to hospital adoption of this technology. Preparing an OR for an RMN system typically required significant structural changes, including thousands of pounds of magnetic shielding in the walls, reinforcing the floors, high power, and extensive cabling through conduits connecting the OR to dedicated cabinet rooms. This required months of planning and coordination between site planners, architects, and contractors. GenesisX uses smaller magnets and incorporates magnetic shielding into its structure instead of shielding installed in the OR walls. It does not require structural anchors that penetrate the floor and runs on a standard 120/230V power outlet. A single fiber runs from each robot to the system cabinet, which is 80% smaller than the Genesis cabinet and fits under the OR table. GenesisX is smaller and lighter than previous generation systems while maintaining the speed, responsiveness, and efficient workflow of Genesis. GenesisX will serve as a platform for further innovation in the future.
GenesisX has received CE Mark in Europe and is seeking 510(k) clearance from the FDA in the U.S. Over the coming months, Stereotaxis plans to obtain regulatory approval for compatible catheters, demonstrate real-world use of the system, enhance compatibility with a range of x-rays, and prepare the supply chain, manufacturing, installation and commercial processes for the full launch and significant adoption of GenesisX in 2025.
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Stereotaxic fixation
GenesisX Robotic Magnetic Navigation System
Stereotaxic fixation
Magnetic shielding built into the structure of the GenesisX robotic navigation system
About stereotaxy
Stereotaxis (NYSE: STXS) is the pioneer and global leader in innovative surgical robotics for minimally invasive endovascular interventions. The company's mission is to discover, develop and deliver robotic systems, instruments and information solutions for the interventional laboratory. These innovations enable physicians to deliver exceptional patient care with robotic precision and safety, expand access to minimally invasive procedures, and increase productivity, connectivity and intelligence in the operating room. Stereotaxis technology has been used to treat more than 100,000 patients in the United States, Europe, Asia and other regions. For more information, visit www.stereotaxis.com.
This press release contains statements that may qualify as “forward-looking” statements, which generally include words such as “believes,” “estimates,” “plans,” and “expects.” Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that may cause or contribute to such differences include, but are not limited to, our ability to manage expenses at a sustainable level, market acceptance of our products, the impact of global economic conditions on customers' ability and willingness to purchase our technology, competitive factors, changes resulting from healthcare policies, our reliance on third-party vendors, the timing of regulatory approvals, the impact of pandemics and other disasters, and statements regarding our recent acquisition of APT (including the expected benefits from the acquisition), as well as other risks discussed in our periodic reports and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company assumes no obligation to update to revise or amend these statements after the date of this release. There can be no assurance that the Company will recognize any revenues associated with its purchase orders and other contracts, as some of these purchase orders and other contracts are subject to contingencies outside the Company's control and may be amended, modified, delayed or canceled.
Fixed Contacts:
David L. Fishel
Chairman and Chief Executive Officer
Kimberly Peary
CFO
314-678-6100
[email protected]
Photos accompanying this announcement can be found at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/b2a52dbd-2ea2-4a04-a6b3-28f48b832d8c
https://www.globenewswire.com/NewsRoom/AttachmentNg/739addac-9797-49cf-b274-3c1eae48bda2
