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ST. LOUIS - Stereotaxis (NYSE:STXS), a $207 million medical technology company with annual revenues of $27.5 million, announced Monday it has received FDA 510(k) clearance for its MAGiC Sweep catheter, the first robotically navigated high-density electrophysiology mapping catheter. According to InvestingPro data, the company maintains a healthy gross margin of 53%, though it is not yet profitable.
The device features 20 electrodes designed to create detailed electroanatomical maps of heart chambers for diagnosing and treating complex arrhythmias. According to the company’s press release, the catheter integrates with Stereotaxis’ robotic systems to navigate difficult-to-reach areas of the heart.
Dr. Roderick Tung, Chief of Cardiology at The University of Arizona College of Medicine - Phoenix, called the development "a major milestone for the EP field," noting that point-by-point mapping limitations had previously restricted robotic navigation adoption.
The catheter is designed to create more anatomically accurate maps by avoiding distension caused by rigid catheters, while its atraumatic shaft prioritizes patient safety, the company stated.
"FDA clearance of MAGiC Sweep marks a pivotal moment for Stereotaxis as we advance a broad portfolio of differentiated robotically-navigated catheters," said David Fischel, Stereotaxis Chairman and CEO. "This catheter is Stereotaxis’ first FDA clearance for an interventional catheter in nearly 20 years." Wall Street appears optimistic about the company’s prospects, with analysts setting price targets between $4 and $5 per share, according to InvestingPro data.
The company, which describes itself as a pioneer in surgical robotics for minimally invasive endovascular intervention, reports its technology has been used to treat over 150,000 patients globally. For detailed analysis of Stereotaxis’s financial health, growth prospects, and comprehensive valuation metrics, investors can access the full Pro Research Report available on InvestingPro, which covers over 1,400 US stocks with expert insights and actionable intelligence.
This article is based on a press release statement from Stereotaxis.
In other recent news, Stereotaxis, Inc. announced its expectations for the second quarter of 2025, projecting revenue between $8.5 million and $8.8 million. This represents a significant 90% increase compared to the same period in 2024, driven by growth in both recurring and system revenues. The company also anticipates gross margins for the quarter to be at or slightly above those reported in the first quarter of 2025. Additionally, Stereotaxis has raised approximately $12.5 million through a registered direct offering of common stock, with the transaction set to close in two stages.
At the company’s Annual Meeting of Shareholders, two Class III directors were elected, with Dr. Nathan Fischel and Mr. Ross B. Levin securing positions until the 2028 Annual Meeting. In the first quarter of 2025, Stereotaxis reported stable earnings per share (EPS) of -0.07, meeting Wall Street expectations. Revenue for the quarter reached $7.5 million, surpassing the anticipated $6.83 million. These developments indicate a period of growth and strategic financial moves for Stereotaxis.
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