Stereotaxis announces its first order for the GenesisX robotic system, enhancing accessibility in endovascular surgery.
Quiver AI Summary
Stereotaxis has announced the receipt of the first order for its new robotic system, GenesisX™, which aims to enhance the field of minimally invasive endovascular surgery. This first order comes from a notable European hospital and marks a significant step towards the full commercial launch of the GenesisX system. CEO David Fischel expressed excitement about demonstrating the system's performance in clinical settings. GenesisX features advancements such as smaller magnets and a compact design that eliminates the need for extensive structural modifications in operating rooms. It has received CE Mark approval in Europe and is awaiting FDA clearance in the US. Stereotaxis plans to expand its product line, showcase real-world usage, and prepare for a comprehensive launch throughout 2025.
Potential Positives
- First order received for the GenesisX™ robotic system from a pioneering European hospital, indicating strong initial market interest.
- GenesisX represents a critical milestone towards full commercial launch, showcasing the company's commitment to advancing surgical robotics.
- Innovative design of GenesisX improves accessibility and operational efficiency, potentially leading to broader adoption in endovascular surgery.
- Regulatory approvals planned for 2025, indicating proactive steps towards commercialization and expansion of product offerings in both Europe and the US.
Potential Negatives
- The reliance on forward-looking statements indicates potential volatility and uncertainty regarding future performance, which may undermine investor confidence.
- The warning about the potential for purchase orders to be canceled or modified raises concerns about the stability of demand for the company's products.
- The mention of dependency on regulatory approvals suggests possible delays or complications that could hinder the company's planned launch and financial performance.
FAQ
What is the GenesisX robotic system?
GenesisX is Stereotaxis's latest generation robotic system designed for minimally invasive endovascular surgeries.
When was GenesisX first ordered?
The first order for GenesisX was received on January 30, 2025, from a pioneering European hospital.
What makes GenesisX different from previous systems?
GenesisX is smaller, lighter, and requires no structural anchoring, enhancing accessibility for healthcare providers.
What regulatory approvals are expected for GenesisX?
GenesisX has obtained CE Mark in Europe and has been submitted for FDA 510(k) clearance in the United States.
How has Stereotaxis technology impacted patient care?
Stereotaxis technology has been used to treat over 150,000 patients globally, enhancing care with robotic precision and safety.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$STXS Insider Trading Activity
$STXS insiders have traded $STXS stock on the open market 3 times in the past 6 months. Of those trades, 3 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $STXS stock by insiders over the last 6 months:
- PAUL J ISAAC has made 3 purchases buying 9,349 shares for an estimated $17,707 and 0 sales.
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$STXS Hedge Fund Activity
We have seen 43 institutional investors add shares of $STXS stock to their portfolio, and 26 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARCHON CAPITAL MANAGEMENT LLC removed 314,183 shares (-19.7%) from their portfolio in Q3 2024, for an estimated $640,933
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- TRAYNOR CAPITAL MANAGEMENT, INC. added 160,509 shares (+inf%) to their portfolio in Q4 2024, for an estimated $365,960
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Full Release
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 80% smaller than previous cabinets and can fit under a table in the operating room. GenesisX is smaller and lighter than any previous generation system, while maintaining the highest standards in speed, responsiveness, and efficient workflow.
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
[email protected]