Stereotaxis Achieves CE Mark in Europe and Submits 510(k) in the US for Next Generation Robotic System GenesisX
Stereotaxis (NYSE: STXS), a leader in surgical robotics for minimally invasive endovascular intervention, has achieved significant milestones for its next-generation robotic system, GenesisX. The company has obtained CE mark in Europe and submitted a 510(k) application to the FDA in the US. GenesisX builds upon the established benefits of Robotic Magnetic Navigation (RMN) systems while reducing adoption barriers for hospitals.
Key improvements include smaller magnets, integrated magnetic shielding, no need for structural anchoring, standard power requirements, and an 80% smaller system cabinet. These advancements significantly reduce installation complexities and costs. Stereotaxis plans to launch GenesisX in 2025, focusing on regulatory approvals for compatible catheters, real-world demonstrations, and preparing supply chain and commercial processes.
Stereotaxis (NYSE: STXS), leader nella robotica chirurgica per interventi endovascolari minimamente invasivi, ha raggiunto traguardi significativi per il suo sistema robotico di nuova generazione, GenesisX. L'azienda ha ottenuto il marchio CE in Europa e ha presentato una domanda 510(k) alla FDA negli Stati Uniti. GenesisX si basa sui vantaggi consolidati dei sistemi di Navigazione Magnetica Robotica (RMN) riducendo le barriere all'adozione per gli ospedali.
I miglioramenti principali includono magneti più piccoli, schermatura magnetica integrata, assenza di necessità di ancoraggio strutturale, requisiti energetici standard e un cabinet di sistema ridotto dell'80%. Questi progressi riducono significativamente le complessità e i costi di installazione. Stereotaxis prevede di lanciare GenesisX nel 2025, concentrandosi sulle approvazioni regolatorie per cateteri compatibili, dimostrazioni nel mondo reale e preparazione della catena di approvvigionamento e dei processi commerciali.
Stereotaxis (NYSE: STXS), líder en robótica quirúrgica para intervenciones endovasculares mínimamente invasivas, ha logrado hitos significativos para su sistema robótico de nueva generación, GenesisX. La compañía ha obtenido el marco CE en Europa y ha presentado una solicitud 510(k) a la FDA en EE. UU. GenesisX se basa en los beneficios establecidos de los sistemas de Navegación Magnética Robótica (RMN) mientras reduce las barreras de adopción para los hospitales.
Las mejoras clave incluyen imanes más pequeños, blindaje magnético integrado, sin necesidad de anclaje estructural, requisitos de energía estándar y un gabinete del sistema un 80% más pequeño. Estos avances reducen significativamente las complejidades y los costos de instalación. Stereotaxis planea lanzar GenesisX en 2025, centrándose en las aprobaciones regulatorias para catéteres compatibles, demostraciones en el mundo real y preparando la cadena de suministro y los procesos comerciales.
스테레오택시스(Stereotaxis, NYSE: STXS)는 최소 침습적 혈관 내외과 치료를 위한 외과 로봇 분야의 선두주자로, 차세대 로봇 시스템인 GenesisX에 대한 중요한 이정표를 세웠습니다. 이 회사는 유럽에서 CE 마크를 획득했으며, 미국 FDA에 510(k) 신청서를 제출했습니다. GenesisX는 로봇 자력 네비게이션(RMN) 시스템의 기존 이점을 기반으로 하면서 병원의 도입 장벽을 완화합니다.
주요 개선 사항으로는 더 작은 자석, 통합 자력 차폐, 구조적 고정이 필요 없는 점, 표준 전력 요구 사항 및 시스템 캐비닛 80% 축소 등이 있습니다. 이러한 발전은 설치의 복잡성과 비용을 크게 줄입니다. 스테레오택시스는 2025년에 GenesisX를 출시할 계획이며, 호환 가능한 카테터에 대한 규제 승인, 실제 시연 및 공급망과 상업 프로세스 준비에 집중하고 있습니다.
Stereotaxis (NYSE: STXS), un leader en robotique chirurgicale pour les interventions endovasculaires peu invasives, a atteint des jalons significatifs pour son système robotique de nouvelle génération, GenesisX. L'entreprise a obtenu le marquage CE en Europe et a soumis une demande 510(k) à la FDA aux États-Unis. GenesisX s'appuie sur les avantages établis des systèmes de Navigation Magnétique Robotique (RMN), tout en réduisant les barrières à l'adoption pour les hôpitaux.
Les améliorations clés incluent des aimants plus petits, un blindage magnétique intégré, l'absence de nécessité d'ancrage structurel, des exigences énergétiques standard et un cabinet du système 80% plus petit. Ces avancées réduisent considérablement les complexités et les coûts d'installation. Stereotaxis prévoit de lancer GenesisX en 2025, en se concentrant sur les approbations réglementaires pour les cathéters compatibles, des démonstrations dans le monde réel et la préparation de la chaîne d'approvisionnement et des processus commerciaux.
Stereotaxis (NYSE: STXS), ein führendes Unternehmen im Bereich der chirurgischen Robotik für minimalinvasive endovaskuläre Eingriffe, hat bedeutende Fortschritte mit seinem roboterbasierten System der nächsten Generation, GenesisX, erzielt. Das Unternehmen hat das CE-Zeichen in Europa erhalten und einen 510(k)-Antrag bei der FDA in den USA eingereicht. GenesisX baut auf den bewährten Vorteilen der Robotic Magnetic Navigation (RMN) Systeme auf, während die Hürden für die Einführung in Krankenhäuser verringert werden.
Zu den wichtigsten Verbesserungen gehören kleinere Magneten, integrierter Magnetschutz, kein Bedarf an struktureller Verankerung, standardisierte Stromanforderungen und ein 80% kleineres Systemgehäuse. Diese Fortschritte reduzieren erheblich die Installationskomplexität und -kosten. Stereotaxis plant, GenesisX im 2025 auf den Markt zu bringen, wobei der Fokus auf Genehmigungen für kompatible Katheter, realen Demonstrationen sowie der Vorbereitung von Lieferketten und kommerziellen Prozessen liegt.
- Obtained CE mark in Europe for GenesisX robotic system
- Submitted 510(k) application to FDA for US clearance
- GenesisX reduces hospital adoption barriers with smaller size and simplified installation
- New system operates on standard power outlets, reducing infrastructure requirements
- 80% smaller system cabinet improves space efficiency in operating rooms
- Full launch of GenesisX not expected until 2025, potentially delaying revenue growth
- Additional regulatory approvals needed for compatible catheters before full launch
Insights
The CE Mark approval and FDA 510(k) submission for GenesisX are significant regulatory milestones for Stereotaxis. CE Mark allows immediate commercialization in Europe, while the FDA submission initiates the review process for U.S. market access. These steps typically indicate a product is nearing commercial readiness.
The reduced infrastructure requirements of GenesisX, including built-in shielding and standard power needs, could substantially lower barriers to adoption in hospitals. This may accelerate market penetration and expand the addressable market for robotic magnetic navigation systems.
However, investors should note that full commercialization is slated for 2025, suggesting a measured rollout strategy. The company's focus on regulatory approvals for compatible catheters and real-world demonstrations indicates a thorough, risk-mitigating approach to market introduction.
GenesisX represents a significant leap in robotic surgical technology. Its compact design and reduced infrastructure requirements address key adoption barriers in the robotic surgery market. The system's ability to operate without extensive room modifications could dramatically reduce installation costs and time, potentially accelerating market penetration.
The platform's versatility for various endovascular interventions beyond electrophysiology suggests a broader market opportunity. This could position Stereotaxis to compete more effectively in the rapidly growing
However, the delayed full launch until 2025 may give competitors time to respond. Investors should monitor the company's progress in securing regulatory approvals for compatible catheters and demonstrating real-world efficacy, as these will be important for successful commercialization.
While Stereotaxis doesn't provide specific financial projections for GenesisX, the product's potential to expand market reach is significant. The reduced infrastructure requirements could lower the total cost of ownership for hospitals, potentially driving adoption rates and revenue growth.
Investors should note that Stereotaxis reported
The company's cash position (
- Latest innovation in Robotic Magnetic Navigation technology supports broad accessibility of robotics for minimally-invasive endovascular surgery
- GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States
ST. LOUIS, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Europe and submitted a 510(k) application to the FDA in the US for a next generation robotic system, GenesisX.
“We are excited to introduce GenesisX and share the achievement of these significant milestones,” said David Fischel, Chairman and CEO. “Medical innovation only realizes its full potential to advance and improve patient care if it is designed to be broadly accessible. The clinical value of Stereotaxis’ robotic technology has been extensively demonstrated yet difficult to access for the vast majority of interested physicians and hospitals. GenesisX is strategically transformative as it supports broad adoption of robotics in electrophysiology and across endovascular interventions.”
GenesisX builds upon the established benefits and performance of Robotic Magnetic Navigation (RMN) systems, while reducing the complexities and barriers to hospital adoption of the technology. Preparing an operating room to accommodate a RMN system has typically required significant structural modification, including the installation of thousands of pounds of magnetic shielding in the walls, reinforcement of the floor, high electrical power, and extensive cabling through conduits between the operating room and a dedicated cabinet room. This entailed months of planning and coordination between site planners, architects, and contractors. GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure in place of the shielding otherwise installed in the walls of the operating room. It requires no structural anchoring through the floor and operates using standard 120/230V power outlets. A single fiber is routed from each robot to the system cabinet, which is
GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States. Stereotaxis plans to use the coming months to gain regulatory approval for compatible catheters, demonstrate real-world use of the system, enhance compatibility with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch and significant adoption of GenesisX in 2025.
GenesisX Robotic Magnetic Navigation System
Magnetic shielding built into the structure of the GenesisX Robotic Navigation System
About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com.
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe”, "estimate”, "project”, "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled.
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer
Kimberly Peery
Chief Financial Officer
314-678-6100
Investors@Stereotaxis.com
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/b2a52dbd-2ea2-4a04-a6b3-28f48b832d8c
https://www.globenewswire.com/NewsRoom/AttachmentNg/739addac-9797-49cf-b274-3c1eae48bda2
FAQ
What regulatory milestones has Stereotaxis (STXS) achieved for its GenesisX robotic system?
How does the GenesisX system improve upon previous Stereotaxis (STXS) robotic navigation systems?
When is Stereotaxis (STXS) planning to fully launch the GenesisX robotic system?
What are the power requirements for the new GenesisX system from Stereotaxis (STXS)?
