First-in-Human Coronary Intervention Study Results of Robocath’s Next-Generation Robotic System Highlighted at TCT
The pilot reported 95% technical success, with all but one procedure completed entirely robotically without conversion to manual.
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Rhea-AI Summary
Stereotaxis (STXS) announced first-in-human study results showing 100% clinical success for subsidiary Robocath’s next-generation robotic system in coronary interventions.
The prospective pilot enrolled 20 patients undergoing percutaneous coronary intervention, a procedure to open narrowed coronary arteries. Technical success was 95%, with all but one procedure completed entirely robotically without conversion to manual. No device-related adverse events were reported through 30-day follow-up. The study included several levels of lesion complexity, and operating physicians had no fluoroscopy radiation exposure. Findings were presented at TCT on November 1, 2026; a manuscript is under review. Stereotaxis plans to progress the technology toward regulatory submissions.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointClinical success reached 100% across 20 patients in the first-in-human coronary intervention pilot.
- Minor pointSafety findings included no device-related adverse events through 30-day follow-up and no intra-procedural vascular complications.
- Minor pointOperating physicians had no fluoroscopy radiation exposure during the procedures.
- Minor point. Forward-looking: it has not happened yet and may not happen.Stereotaxis plans to advance Robocath’s technology toward regulatory submissions.
Negative
- Minor pointTechnical success was 95%; one procedure was not completed entirely robotically without conversion to manual.
Details
Market move: STXS +5.73% vs previous close. First-in-human clinical data
On Nov 2, the day this news came out, the latest delayed price for STXS is 5.73% above the previous close. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $0.91. Relative volume is very high at 3.5x what this stock usually trades by this time of day.
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Key Figures
- Clinical success
- 100%
- First-in-human PCI study
- Technical success
- 95%
- First-in-human PCI study
- Patients enrolled
- 20 patients
- Prospective pilot study
- Device-related adverse events
- 0
- Through 30-day follow-up
Key Terms
first-in-human medical
stenosis medical
fluoroscopy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
100% clinical success and no device-related adverse events in 20 First-in-Human Percutaneous Coronary Intervention procedures with next-generation robotic system- Robocath system demonstrates ability to efficiently and effectively support the full range of coronary interventions including in complex coronary artery disease patients
- Principal investigator, Dr. Nejjari, shared the findings during the “Innovations in Robotics for Transcatheter Heart Interventions” session at TCT on November 1, 2026
ST. LOUIS and ROUEN, France, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the findings from the first-in-human clinical results for Robocath’s next-generation robotic system during the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. The findings support a favorable performance profile for the system, with
The study was conducted by Dr. Mohammed Nejjari and Dr. Franck Digne, Interventional Cardiologists at Centre Cardiologique du Nord (CCN) in Saint-Denis, France. This prospective pilot clinical study enrolled twenty patients undergoing PCI for coronary artery disease. Key findings from the study include:
100% clinical success and95% technical success: All 20 patients met the study’s clinical success criteria of minimal residual stenosis post PCI. In all but one procedure the physician was able to complete the procedure entirely robotically without conversion to manual.- No device-related adverse events: Clean safety profile with no intra-procedural vascular complications, major adverse events, or device related adverse events through 30-day follow-up
- No physician radiation exposure: Operating physicians performed the procedures entirely protected from fluoroscopy radiation, supporting the system’s potential to reduce occupational risk in interventional cardiology.
- Performance across lesion complexity: The study included A/B1, B2, and C-type lesions, representing three levels of procedural complexity, including in complex coronary disease in tortuous distal vasculature.
Dr. Nejjari discussed these findings during the November 1, 2026 scientific session “Innovations in Robotics for Transcatheter Heart Interventions” that took place at TCT. A manuscript documenting these findings has been submitted for publication and is under review.
“These initial findings mark an important milestone in the advance of robotic technology in interventional cardiology,” said Dr. Nejjari. “The results are very encouraging, particularly the clinical success and safety observed across the patient cohort including in complex PCI. We are excited for the potential of this robotic innovation to improve care for patients and benefit physician safety and workflow.
Robocath, a subsidiary of Stereotaxis, is a technology leader in pioneering advanced robotic innovations for interventional cardiology and neurointerventions. Robocath’s next-generation system builds on the clinical and technological experience of the first-generation R-One system, now used in centers worldwide. It adds advanced capabilities such as multi-device handling of up to five interventional devices simultaneously to support increasingly complex interventional procedures.
“These first-in-human results support our confidence in our innovation strategy and reflect our commitment to advancing differentiated robotic technologies across endovascular interventions,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to building on these initial findings, progressing Robocath’s technology towards regulatory submissions, and delivering this promising technology to interventional physicians and patients suffering from coronary disease and stroke.”
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.
Cautionary Note Regarding Forward-Looking Statements
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, our overall liquidity and our ability to fund operations, 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, our ability to manage and integrate recent acquisitions, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company's periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release.
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer
Kimberly Peery
Chief Financial Officer
314-678-6100
Investors@Stereotaxis.com
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