5/12/2026

speaker
Operator
Conference Operator

Good afternoon. Thank you for joining us to Stereo Taxi's first quarter 2026 earnings conference call. Certain statements during the conference call and question and answer period to follow may relate to future events, expectations, and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the company in the future to be materially different from the statements that the company's executives may make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments following the presentation. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to your host, David Fishel, Chairman and CEO of Stereo Taxis.

speaker
David Fischel
Chairman and CEO

Thank you, Operator, and good afternoon, everyone. Stereo Taxis has had an amazing start to this year. While our reported quarterly numbers don't yet reflect it, we're going through one of the most exciting periods in Stereotaxis' history, given the amount of progress, the initial commercial green shoots of success, and the clarity on the opportunity ahead of us. These give us confidence in our overall vision, reaching a new level of maturity in our near-term and long-term growth. In my prepared remarks, I'll touch upon the key areas of progress, the commercial green shoots, and the opportunities ahead of us. Kim will then review our first quarter results, and we will open the line to questions. The most notable achievement of the past year has been a string of regulatory approvals in the US and Europe for an entirely new foundational ecosystem of products. While Stereo Taxes has a long history, Our clinical and commercial experience is nearly all with first-generation technology from 20 years ago. After spending the past eight years and over $75 million rebuilding an R&D pipeline, we brought to market an entirely new foundation of products. In just the past few months, we received four U.S. FDA regulatory approvals for a complex surgical robot, robotically-steered therapeutic and diagnostic catheters, and a digital surgery cockpit. Outside of the U.S., we received multiple approvals in Europe and China. These product approvals are not just incremental innovations, but rather we structurally change our opportunity. We essentially developed a fresh new startup company on the shoulders of our legacy technology and funded by our legacy business. The streak of regulatory success that began last year continued in the first part of this year with two essential FDA approvals. First, in January, we received PMA approval for the MAGIC cardiac ablation catheter. Then just last month, we received FDA clearance for Synchrony, our digital surgery cockpit that introduces connectivity and intelligence to the operating room. MAGIC is Stereotaxis' first proprietary therapeutic catheter. and is the first ablation catheter ever to be approved by FDA specifically for arrhythmia patients with complex congenital heart disease. The catheter strategically allows us to overcome our historical dependency on Johnson & Johnson and to participate robustly in the recurring revenue of each procedure. Following regulatory approval, we recently announced that we began first MAGIC procedures at multiple US hospitals. Those procedures have gone well, The first patient treated with the catheter had complex congenital heart disease, was being cardioverted weekly, failed multiple attempts to be treated with manual catheters, and was now successfully treated using magic. The most beautiful example for why our innovations are critical and improve lives. The physician who did that procedure later commented, and I quote, that was the most gratifying case I've ever done. I could have never done this without robotics. Demand for Magic is much higher than supply and we are rolling out the catheter in both Europe and the US in line with the manufacturing ramp. While the ramp is gradual, we're seeing meaningful progress and our contract manufacturer still expects production to top 500 catheters a month by the end of this year. In addition, to mitigate catheter shortages, we began selling an additional catheter in Europe that we have exclusive rights to through our collaboration with Microport and we are making meaningful progress on other efforts that expand production capacity and redundancy. For now, the still small contribution from our new catheters is being countered by the headwind of winding down our relationship with Johnson & Johnson. This transition is messy and makes it difficult in reported quarterly financials to observe the underlying ramp of our new disposable business. The green shoots of this new business model are very evident to us, though, and are very attractive. In our initial U.S. MAGIC procedures, we are seeing disposable revenue often above $8,000 per procedure and always above $5,000. This robust razor blade business model benefits from our strategy to build a synergistic portfolio of catheters, including MAGIC, MAGIC Sweep, and MAPIT. In Europe, just this month, we received an order for $100,000 in disposables from a single hospital for what it expects to be a month worth of procedures. These amounts are in line with the EP market, but are unprecedented for us. They demonstrate the transformation that is just starting to take shape in our business model. Still at low numbers, but increasingly very material as we advance through this year, and transition our installed base of robotic accounts over to this new ecosystem. By the end of this year, we expect to have substantially transitioned customers as they use up remaining inventory of JMJ catheters, work through hospital approvals and tender processes, and gain experience with Magic.

speaker
N/A
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The structural transformation to our disposable business model

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