Fed’s Powell opens door to potential rate cuts at Jackson Hole
ST. LOUIS - Stereotaxis , Inc. (NYSE:STXS), a leader in robotic technologies for endovascular surgery, has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its novel EMAGIN™ 5F catheter. This device represents the company’s first foray into robotically navigated catheters designed for broader endovascular use. The announcement comes as the company’s stock, currently trading at $2.06, has experienced a challenging period, down nearly 10% in the past week according to InvestingPro data.
The EMAGIN 5F catheter, with a 5-French diameter, is engineered to navigate complex venous and arterial systems. It employs precise magnetic fields to steer the catheter tip, aiming to enhance both the safety and efficiency of accessing challenging vascular anatomy. This technology is anticipated to benefit minimally invasive treatments for conditions such as stroke, cancer, and cardiovascular diseases. With a market capitalization of $174.5 million and operating with a moderate debt level, Stereotaxis maintains a current ratio of 1.39, indicating adequate liquidity to support its innovative developments.
Prominent medical professionals have expressed optimism about the catheter’s potential. Prof. Timo Krings of Beth Israel Lahey Health in Boston highlighted the promise of robotic navigation in tackling neurointerventional challenges. Similarly, Dr. Kalpa De Silva from St Thomas’ Hospital in London sees the technology as a significant advancement for complex interventions, including renal denervation and intricate coronary procedures.
Manufactured by Stereotaxis’ subsidiary Access Point Technologies in Minnesota, the EMAGIN 5F is the first in a planned portfolio of robotic endovascular devices. Following anticipated regulatory approvals, Stereotaxis expects to launch the product in the second half of the year, with a focus on demonstrating its clinical value in various endovascular applications. Despite reporting revenue of $25.14 million in the last twelve months, InvestingPro analysis reveals the company faces profitability challenges, with analysts not anticipating profitability this year. For deeper insights into Stereotaxis’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
David Fischel, Chairman and CEO of Stereotaxis, emphasized the company’s commitment to becoming a multi-specialty robotics leader and advancing clinical care in cardiology, radiology, and neurology. The firm also plans to seek European CE Mark clearance for the EMAGIN 5F within the month.
Stereotaxis’ mission encompasses the development and delivery of robotic systems and instruments for the interventional lab, aiming to enhance patient care, expand access to minimally invasive therapies, and improve operating room productivity and intelligence. The company’s technology has been utilized in over 150,000 patient procedures globally.
This news is based on a press release statement from Stereotaxis, Inc. and does not constitute an endorsement of the company’s claims. The success of the EMAGIN 5F catheter and its impact on the endovascular surgery field will be subject to the outcomes of regulatory reviews and the product’s performance in clinical settings. With analyst price targets ranging from $4 to $5, significantly above current trading levels, investors seeking detailed analysis can explore additional insights and 7 more exclusive ProTips available on InvestingPro.
In other recent news, Stereotaxis Inc. has submitted a regulatory application to the U.S. Food and Drug Administration (FDA) for its new MAGiC Sweep™ catheter. This device is the first high-density electrophysiology mapping catheter designed for robotic navigation, aiming to enhance the precision of cardiac ablation procedures. The catheter can collect detailed electroanatomical mapping data from 20 electrodes simultaneously, potentially improving both the safety and accuracy of these procedures. Stereotaxis has also sought European CE Mark clearance, with plans for a commercial launch in the latter half of the year, contingent on regulatory approvals. The MAGiC Sweep is part of Stereotaxis’ strategic move toward expanding its portfolio of proprietary catheters, including the EMAGIN 5F vascular guidance catheter. The company emphasizes its commitment to robotic precision and safety, with over 150,000 patients treated globally using its technologies. These developments represent significant milestones in Stereotaxis’ evolution, as stated by CEO David Fischel. The company acknowledges that forward-looking statements carry risks and uncertainties, particularly concerning regulatory approvals and market acceptance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.