ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the ...

ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the ...

Stereotaxis (STXS) a pioneer in surgical robotics for minimally invasive endovascular intervention, recently announced its successful recertification under the European Union's Medical Device Regulation (MDR). This significant milestone, which covers all Stereotaxis devices currently available in Europe, marks a crucial advancement in the company's pursuit of excellence in the surgical robotics market. The News in Detail The MDR (Regulation (EU) 2017/745) replaces the previous European Medical Device Direct ...

Stereotaxis (STXS) recently announced that the first robotic cardiac heart program in Southern Italy had been developed at Hospital Santa Maria della Pietà, Nola. With the help of this cutting-edge technology, patients with heart rhythm abnormalities can now be effectively treated with robotic ablation treatments. Hospital Santa Maria della Pietà is the first hospital in Italy to use the latest generation of Genesis Robotic Magnetic Navigation (RMN) system. Price Performance For the past six months, STXS's ...

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union's new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed ...

MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certific ...

Stereotaxis Reports Solid Results We must contextualize Stereotaxis' (NYSE:STXS) reported results until their new products get approved. The company will have limited sales growth and a modest cash burn in the meantime. This doesn't mean we shouldn't analyze the current business. It just shouldn't be where the majority of our focus lies. I have fairly low expectations for the existing business, but very high expectations for the medium term (next ~2 years). With that in mind, let's briefly look at the Q1 re ...

ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. DELAWARE 94-3120386 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Iden ...

Financial Data and Key Metrics Changes - Revenue for Q1 2024 totaled $6.9 million, a growth of 5% from $6.5 million in Q1 2023 [17] - Operating loss for Q1 2024 was $4.7 million, compared to $5.6 million in the previous year [18] - Adjusted operating loss for the quarter was $2.2 million, down from $3 million in the prior year [18] - Gross margin for Q1 2024 was 58% of revenue, with recurring revenue gross margin at 76% and system gross margin at 27% [37] Business Line Data and Key Metrics Changes - System revenue for Q1 2024 was $2.6 million, while recurring revenue was $4.3 million, compared to $1.8 million and $4.7 million in the prior year [17][61] - The company experienced a backlog increase to $16 million due to two additional orders for Genesis robots from existing customers in Europe [23] Market Data and Key Metrics Changes - Recurring revenue remains impacted by Johnson & Johnson catheter shortages, affecting procedure volumes [24] - In Europe, the company received a completeness check shortly after submitting its CE application, indicating progress in regulatory processes [25] Company Strategy and Development Direction - The company aims to maintain sales momentum and financial strength while preparing for a breakout through a comprehensive innovation strategy [4] - The acquisition of APT is seen as strategic, enhancing in-house capabilities for catheter development and manufacturing [14][16] - The company plans to demonstrate the new robot's real-world use and enhance compatibility with various X-ray systems in 2024, with a full launch expected in 2025 [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing regulatory processes and the potential for significant growth in 2025 and beyond [13][39] - The company anticipates modest double-digit revenue growth for the full year, driven by system backlog and new orders [39] Other Important Information - The company has a healthy active pipeline of customers across key geographies, despite challenges from the existing product ecosystem [5] - The digital surgery platform, Sync, is in limited release, with additional features being incorporated [12] Q&A Session Summary Question: Synergies from APT acquisition - Management indicated that the acquisition is not expected to impact current catheter developments but will focus on future innovations [42] Question: PMA conversion impact - The conversion from PMA supplement to traditional PMA is not expected to significantly alter timelines, with ongoing collaborative discussions with the FDA [43] Question: Capital equipment environment - Management noted ongoing challenges in the macro environment but highlighted interest in their technology and innovation strategy [44] Question: APT's catheter integration - APT's catheters are compatible with existing mapping systems, and there are plans to develop robotically steered versions [90] Question: Pipeline development - The company is pleased with the progress of its robot development and anticipates regulatory submissions in the near future [91]