About Stereotaxis

Stereotaxis, Inc. (Stereotaxis) designs, manufactures, and markets robotic systems, instruments, and information systems for the interventional laboratory. The company’s proprietary robotic technology, Robotic Magnetic Navigation, fundamentally transforms endovascular interventions using precise computer-controlled magnetic fields to directly control the tip of flexible interventional catheters or devices. Direct control of the tip of an interventional device, in contrast to all manual hand-held devices that are controlled from their handle, can improve the precision, stability, reach and safety of these devices during procedures. The company’s primary clinical focus has been electrophysiology, specifically cardiac ablation procedures for the treatment of arrhythmias. The company has shared its aspiration and a product strategy to expand the clinical focus of its technology to several additional endovascular indications, including coronary, neuro, and peripheral interventions. The company’s primary products include the Genesis RMN System, the Odyssey Solution, and other related devices. The company also offers to its customers the Stereotaxis Imaging Model S x-ray System and other accessory devices. The Genesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites. The Odyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the key information in the operating room. This is designed to improve lab layout and procedure efficiency. The system also features a remote viewing and recording capability called Odyssey Cinema, which is an innovative solution that delivers synchronized content for optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store and replay entire procedures or segments of procedures. The Stereotaxis Imaging Model S provides an integrated complete solution for a robotic interventional operating room. It is a single-plane, full-power x-ray system and includes the c-arm, powered table, motorized boom, and large high-definition monitors. Stereotaxis Imaging Model S incorporates modern fluoroscopy technology to support high quality imaging while minimizing radiation exposure for patients and physicians. The company promotes its full suite of products in a typical hospital implementation, subject to regulatory approvals or clearances. This implementation requires a hospital to agree to an upfront capital payment and recurring payments. The company has received regulatory clearances and registration necessary for it to market the Genesis RMN System in the U.S. and Europe, and it is in the process of obtaining necessary registrations for extending its markets in other countries. The company’s prior generation robotic magnetic navigation system, the Niobe System, and the Odyssey Solution, Cardiodrive, and various disposable interventional devices have received regulatory clearance in the U.S., Europe, Canada, China, Japan and various other countries. The company has received the regulatory clearance, licensing and/or CE Mark approvals that allow it to market the Vdrive and Vdrive Duo Systems with the V-CAS, V-Loop and V-Sono devices in the U.S., Canada and Europe. The Stereotaxis Imaging Model S x-ray System is CE marked and cleared by the FDA. The company has strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships the company provides compatibility between its robotic magnetic navigation system and digital imaging and 3D catheter location sensing technology, as well as disposable interventional devices. The maintenance of these strategic relationships, or the establishment of equivalent alternatives, is critical to its commercialization efforts. There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of integrated systems and devices and/or equivalent alternatives. Products Robotic Magnetic Navigation The company’s proprietary robotic magnetic navigation systems (RMN) include the Genesis RMN and the prior generation Niobe Systems. These systems are designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, efficient procedures and reduced x-ray exposure. The company’s systems provide physicians with precise remote digital instrument control in combination with sophisticated image integration. It can be operated either from an adjacent room and outside the x-ray fluoroscopy field or beside the patient table, as in traditional interventional procedures. The RMN system allows the operator to navigate disposable interventional devices to the treatment site through complex paths in the blood vessels and chambers of the heart to deliver treatment by using computer controlled, externally applied magnetic fields to directly govern the motion of the working tip of these devices, each of which has a magnetically sensitive tip that predictably responds to magnetic fields generated by the company’s system. Through its arrangements with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems, the company provides compatibility between the robotic magnetic navigation system and the visualization and information systems used during electrophysiology and endovascular procedures in order to provide the physician with a comprehensive information and instrument control system. In addition, the company has integrated the robotic magnetic navigation system with 3D catheter location sensing technology to provide accurate real-time information as to the 3D location of the working tip of the instrument. The components of the robotic magnetic navigation system are identified and described below: Robotic Magnetic Navigation System: The company’s robotic magnetic navigation systems utilize two permanent magnets mounted on articulating and pivoting arms with one magnet on either side of the patient table. These magnets generate magnetic navigation fields that are less than the strength of fields typically generated by MRI equipment and therefore require significantly less shielding, and cause significantly less interference, than MRI equipment. The robotic magnetic navigation system is indicated for use in cardiac, peripheral and neurovascular applications. Cardiodrive Automated Catheter Advancement System: As the physician conducts the procedure from the adjacent control room, the Cardiodrive Automated Catheter Advancement System (Cardiodrive) in conjunction with the QuikCAS automated catheter advancement system is used to remotely advance and retract the electrophysiology catheter in the patient’s heart while the robotic magnetic navigation system magnets precisely steer the working tip of the device. Odyssey Solution The Odyssey Solution offers a fully integrated, real-time information solution to manage, control, record and share procedures across networks or around the world. The Odyssey Solution enhances the physician workflow in interventional labs through a consolidated user interface of multiple systems on a single display to enable greater focus on the case and improve the efficiency of the lab. Through the use of a single mouse and keyboard, the Odyssey Solution allows the user to command multiple systems in the lab from a single point of control. In addition, the Odyssey Solution acquires a real-time, remote view of the lab, capturing synchronized procedure data for review of important events during cases. The Odyssey Solution enables physicians to access recorded cases and create snapshots following procedures for enhanced clinical reporting, auditing and presentation. The Odyssey Solution enables physicians to establish a comprehensive master archive of procedures performed in the lab providing an excellent tool for training new staff on the standard practices. The Odyssey Solution further enables procedures to be observed remotely around the world with high speed Internet access over a hospital VPN, even wirelessly using a standard laptop or Windows tablet computer. Stereotaxis Imaging Model S X-ray System Developed in collaboration with Omega Medical Imaging, and designed to be specifically available with RMN Systems, the Stereotaxis Imaging Model S provides an integrated complete solution for a robotic interventional operating room. It is a single-plane, full-power x-ray system and includes the c-arm, powered table, motorized boom, and large high-definition monitors. Stereotaxis Imaging Model S incorporates modern fluoroscopy technology to support high quality imaging while minimizing radiation exposure for patients and physicians. Disposables and Other Accessories The company’s robotic magnetic navigation systems are designed to use a toolkit of associated disposable interventional devices. The toolkit consists of: the company’s QuikCAS automated catheter advancement disposables designed to provide precise remote advancement of proprietary electrophysiology catheters; an Biosense Webster’s CARTO RMT navigation and ablation system, CELSIUS RMT, NAVISTAR RMT, NAVISTAR RMT DS, NAVISTAR RMT THERMOCOOL and CELSIUS RMT THERMOCOOL Irrigated Tip Diagnostic/Ablation Steerable Tip Catheters co-developed by Biosense Webster and Stereotaxis, as described below. The company also manufactures and markets various disposable (the V-Loop, V-Sono, and V-CAS) components, which can be manipulated by its Vdrive Robotic Navigation System a complimentary product that provides navigation and stability for diagnostic and therapeutic devices designed to improve interventional procedures. In addition, the company markets and distributes other disposable and related devices that can be use with its robotic magnetic navigation systems. Other Recurring Revenue Other recurring revenue includes revenue from product maintenance plans, other post warranty maintenance, and the implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation of its systems. Revenue from services and software enhancements is deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed on a time-and-materials basis is recognized when performed. Regulatory Approval The company has received regulatory clearance, licensing and/or CE Mark approvals necessary for it to market the Genesis RMN System in the U.S. and Europe, and it is in the process of obtaining necessary registrations for extending its markets in other countries. The company has received regulatory clearance, licensing and/or CE Mark approvals necessary for it to market the Niobe System, Cardiodrive, and various disposable devices in the U.S., Canada, Europe, China, Japan, and various other countries. The Stereotaxis Imaging Model S x-ray System is CE marked and cleared by the FDA. The company has received regulatory clearance, licensing and/or CE Mark approvals necessary for it to market the Vdrive and Vdrive Duo Systems with the V-CAS, V-Loop and V-Sono devices in the U.S., Canada and Europe. Biosense Webster has received FDA approval, and CE Mark for the CARTO RMT navigation system for use with the Niobe System, the 4mm CELSIUS RMT Diagnostic/Ablation Steerable Tip Catheter, the 4mm NAVISTAR RMT Diagnostic/Ablation Steerable Tip Catheter, the 8mm Navistar RMT DS Diagnostic/Ablation Steerable Tip Catheter, and the 3.5mm NAVISTAR RMT THERMOCOOL Irrigated Tip Catheter. In addition, Biosense Webster has received FDA approval and CE Mark for the 3.5mm CELSIUS RMT THERMOCOOL Irrigated Tip Catheter. Biosense Webster also received China CFDA approval and Japan PMDA approval for the CARTO RMT navigation system for use with the Niobe System, and the 3.5mm NAVISTAR RMT THERMOCOOL Irrigated Tip Catheter. The company’s strategic relationship with Biosense Webster provided for co-development of catheters that can be navigated with its system, both with and without Biosense Webster’s 3D catheter location sensing technology. In addition, the company can utilize technology which allows its system to recognize specific disposable interventional devices in order to prevent unauthorized use of its system. Clinical Applications The company has focused its clinical and commercial efforts on applications of its products primarily in electrophysiology procedures for the treatment of arrhythmias and secondarily in complex interventional cardiology procedures for the treatment of coronary artery disease. The company’s system potentially has broad applicability in other areas, such as structural heart repair, interventional neurosurgery, interventional neuroradiology, peripheral vascular, renal denervation, pulmonology, urology, gynecology and gastrointestinal medicine, and some of its patents may be applicable in these areas as well. Customer Service and Support The company provides worldwide maintenance and support services to its customers for its integrated products directly or with the assistance of outsourced product and service representatives. By utilizing these relationships, the company provides direct, on-site technical support activities, including call center, customer support engineers and service parts logistics and delivery. In certain situations, the company uses these third parties as a single point of contact for the customer, allowing it to focus on providing installation, training, and back-up technical support. The company’s back-up technical support includes a combination of on-line, telephone and on-site technical assistance services 24 hours a day, seven days a week. The company employs service and support engineers with networking and medical equipment expertise and outsource a portion of its installation and support services. The company offers different levels of support to its customers, including basic hardware and software maintenance, extended product maintenance, and rapid response capability for both parts and service. Sales and Marketing The company markets its products in the U.S and internationally through a direct sales force of senior sales specialists, distributors and sales agents, supported by account managers and clinical specialists who provide training, clinical support, and other services to its customers. The company’s sales and marketing efforts include two important elements: selling robotic magnetic systems, Odyssey Solutions, and Stereotaxis Imaging Model S x-ray Systems directly and through distributors; and leveraging its installed base of systems to drive recurring sales of disposable interventional devices, software and service. Intellectual Property As of December 31, 2022, the company had 50 issued U.S. patents and 2 pending U.S. patent applications. In addition, the company had 15 issued foreign patents and 2 pending foreign patent applications. The key patents that protect the company’s technology and systems extend until 2028 and beyond. The company has also developed substantial expertise in magnet design, magnet physics and magnetic instrument control that was developed in connection with the development of the robotic magnetic navigation system, which it maintains as trade secrets. The company’s Odyssey Solution contains numerous complex algorithms and proprietary software and hardware configurations, and requires substantial knowledge to design and assemble, which it maintains as trade secrets. This proprietary software and hardware, some of which is owned by Stereotaxis, and some of which is licensed to Stereotaxis, is a material aspect of the ability to design, manufacture and install an information integration, storage, and delivery platform. Trademarks Genesis RMN, Niobe, Navigant, Odyssey, Odyssey Cinema, Vdrive, Vdrive Duo, V-CAS, V-Loop, V-Sono, QuikCAS and Cardiodrive are trademarks of the company. Research and Development The company’s research and development expenses were $10.6 million for the year ended December 31, 2022. Government Regulation In many foreign countries in which the company markets its products, it is subject to regulations affecting, among other things, product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. Many of these regulations are similar to those of the FDA or other U.S. regulations. In addition, the company’s products must meet the requirements of a large and growing body of international standards, which govern the design, manufacture, materials content and sourcing, testing, certification, packaging, installation, use and disposal of its products. The majority of the company’s products are Class II devices requiring 510(k) clearances. When all approvals are obtained, the company initiates a clinical study to evaluate the device. Following completion of the study, the company collects, analyzes, and presents the data in an appropriate submission to the FDA (i.e., in the support of a 510(k), de novo, or PMA). When a 510(k) clearance is required, the company must submit a pre-market notification demonstrating that its proposed device is substantially equivalent to a previously cleared and legally marketed 510(k) device, de novo approved device, or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of pre-market approval applications. The company is subject to unannounced inspections by the FDA to determine its compliance with the Quality System Regulation and other regulations. The company is subject to annual surveillance audits and periodic re-certification audits in order to maintain its CE Mark permissions. The company is subject to various federal and state laws relating to healthcare fraud and abuse, including anti-kickback and false claims laws. Under the Physician Payments Sunshine Act, or the Sunshine Act, which was enacted by Congress as part of the Patient Protection and Affordable Care Act, the company is required to track and report to the federal government on an annual basis, subject to certain exceptions, all payments and other transfers of value to the U.S. physicians and teaching hospitals, as well as ownership interests held by physicians. The company is subject to laws and regulations protecting the privacy and integrity of patient medical information, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information, and the applicable Privacy and Security Standards of HITECH, the Health Information Technology for Economic and Clinical Health Act. In addition to federal regulations issued under HIPAA, some states and foreign countries have enacted privacy and security statutes or regulations that, in some cases, are more stringent than those issued under HIPAA. For example, the General Data Protection Regulation (the ‘GDPR’), which is in effect across the European Economic Area (the ‘EEA’), imposes several stringent requirements for controllers and processors of personal data and increased the company’s obligations, for example, by imposing higher standards when obtaining consent from individuals to process their personal data, requiring more robust disclosures to individuals, strengthening individual data rights, shortening timelines for data breach notifications, limiting retention periods and secondary use of information, increasing requirements pertaining to health data, as well as pseudonymised data, and imposing additional obligations when the company contracts third-party processors in connection with the processing of personal data. History Stereotaxis, Inc. was founded in 1990. The company was incorporated in Delaware in 1990.