In This Article:
Stereotaxis STXS recently submitted an application seeking FDA regulatory clearance for its EMAGIN 5F catheter, marking a major step in expanding its Robotic Magnetic Navigation (RMN) technology into endovascular procedures.
With this submission, Stereotaxis aims to revolutionize the endovascular field by bringing robotics into neurointerventional, cardiology, and radiology procedures. The company expects regulatory approval in the second half of 2025, positioning itself as a multi-specialty robotics leader while addressing critical challenges in complex interventions.
Likely Trend of STXS Stock Following the News
Following the announcement, shares of the company plunged 5.8% and closed at $1.94 on Monday. In the past six months, STXS shares have lost 11.4% compared with the industry’s 1.9% decline. The S&P 500 increased 8.6% in the same time frame.
However, if approved, the EMAGIN 5F catheter could expand Stereotaxis' market reach, boosting revenue potential. Rising demand for minimally invasive robotic surgeries strengthens the long-term outlook, while successful adoption could enhance the company's competitive edge and attract strategic partnerships, driving investor confidence.
Meanwhile, STXS currently has a market capitalization of $174.5 million.
Image Source: Zacks Investment Research
More on the News
The EMAGIN 5F is the first robotically navigated endovascular device under the EMAGIN brand (Endovascular Magnetic Intervention). The catheter features a 5-French diameter and uses magnetic fields to navigate tortuous venous and arterial vasculature, enabling precise access to hard-to-reach anatomy.
The EMAGIN brand by Stereotaxis represents a new generation of robotically navigated endovascular devices designed to enhance precision and safety in minimally invasive procedures. The name EMAGIN stands for Endovascular Magnetic Intervention, highlighting its core technology of RMN. This platform is likely to include a comprehensive portfolio of robotic catheters and wires aimed at addressing various clinical applications across neurointervention, cardiology, and oncology. The EMAGIN devices are engineered to navigate through tortuous vascular anatomy with high precision by leveraging magnetic fields that directly steer the catheter tip. This technology could open new treatment possibilities for complex conditions such as stroke, cancer, and cardiovascular diseases.
Stereotaxis has already submitted a 510(k) application to the FDA and expects to file a European CE Mark application this month. The catheter is designed and manufactured by its subsidiary, Access Point Technologies. If regulatory approvals come through, the EMAGIN 5F is expected to be launched in the second half of 2025. The device could open new revenue streams for Stereotaxis by expanding its robotics platform into multiple medical specialties, positioning the company as a multi-specialty robotics leader in interventional cardiology, radiology, and neurology.