Stereotaxis, Inc.

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Good afternoon. Thank you for joining us for StereoTax's second quarter 2025 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 to date. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report of 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, Mr. David Fishel, Chairman and CEO of Astera Texas.

Thank you, operator, and good afternoon, everyone. We've described this year as a pivotal, milestone-rich year in which we advance a broad portfolio of strategic innovations to market and demonstrate their initial commercial impact. We're intelligently executing on multiple fronts, and I'm pleased with our results. From both the regulatory and commercial perspective, our results are in line with the guidance provided at the start of this year. I'll keep our prepared remarks brief, providing updates on our key innovation and commercial efforts. As a reminder, our innovation strategy rests on four primary pillars. First, making our robot widely available by innovating it such that it doesn't require construction and can be rapidly installed in the majority of labs. Second, building an ecosystem of catheters and integrations in our core EP ablation market so physicians have greater choice in technologies while we reduce our dependencies and build an attractive razor blade business. Third, developing the right interventional devices so that our robots become a platform for endovascular surgery more broadly, providing value in several new clinical indications. And fourth, establishing a digital backbone that introduces connectivity and AI to our robot and the broader cath lab environment. Genesis X is the key technological innovation enabling robotics to be more broadly accessible. We received CE mark in Europe and have been working through the regulatory process for FDA clearance in the U.S. On our last call, we described having addressed the vast majority of FDA's questions and that we received additional questions on a few final topics. We addressed these topics in a submission to the FDA late in the second quarter and view regulatory approval of Genesis X as likely still this summer. Concurrent with the regulatory effort, we are working to enhance compatibility of the robot with various x-rays and preparing our supply chain, manufacturing, installation, and commercial processes for a full launch. We successfully completed transfer to manufacturing of Genesis X in the second quarter, manufacturing the first commercial Genesis X system. That system is expected to be installed at our first customer in Europe as soon as they complete installation of an x-ray in their lab, as they are placing Genesis X in a newly built cath lab. We expect to demonstrate Genesis X working in daily clinical use in one or two hospitals still this year, upon which we should be ready for full launch in Europe and the U.S. We continue to see steady demand for Genesis, but expect Genesis X orders to outpace the tempo of Genesis orders following full launch. Our effort to build an ecosystem of proprietary EP catheters in our core EP ablation market has seen two significant regulatory milestones so far this year. CE mark of the MAGIC ablation catheter during the first quarter and FDA clearance of the MAGIC sweep high-density mapping catheter just a couple weeks ago. We've talked about the importance and impact of MAGIC on previous calls. In line with our guidance, MAGIC contributed approximately a couple hundred thousand dollars in revenue from initial European customers during the second quarter. Initial procedures have now taken place at approximately 30% of our EU accounts, and administrative efforts at others are ongoing. We continue to work on FDA approval for MAGIC and maintain a continuous dialogue with FDA. FDA received formal clinical results from our ongoing MAGIC study in the second quarter, and we are working with FDA through a body of questions on sterility, biocompatibility, and manufacturing practices. We continue to expect U.S.