Stereotaxis Announces First GenesisX Robotic System Order
Stereotaxis (NYSE: STXS) has received its first order for the GenesisX™ robotic system from a European hospital. GenesisX represents the latest advancement in endovascular surgical robotics, featuring smaller magnets and built-in magnetic shielding, eliminating the need for wall shielding installation.
The system operates on standard power outlets without requiring structural floor anchoring. It includes a cabinet 80% smaller than previous versions and can be stored under an operating room table. The system maintains high performance standards while being more compact and lighter than previous generations.
GenesisX received CE Mark in Europe in 2024 and is pending FDA 510(k) clearance in the US. Throughout 2025, Stereotaxis plans to obtain regulatory approvals for compatible catheters, demonstrate real-world usage, enhance x-ray compatibility, and prepare for full commercial launch.
Stereotaxis (NYSE: STXS) ha ricevuto il suo primo ordine per il sistema robotico GenesisX™ da un ospedale europeo. GenesisX rappresenta il più recente avanzamento nella robotica chirurgica endovascolare, con magneti più piccoli e schermatura magnetica integrata, eliminando così la necessità di installazione di schermature a parete.
Il sistema funziona su prese di corrente standard senza richiedere ancoraggi strutturali a terra. È dotato di un armadietto che è l'80% più piccolo delle versioni precedenti e può essere riposto sotto un tavolo operatorio. Il sistema mantiene alti standard di prestazione pur essendo più compatto e leggero rispetto alle generazioni precedenti.
GenesisX ha ricevuto il marchio CE in Europa nel 2024 ed è in attesa di approvazione FDA 510(k) negli Stati Uniti. Durante il 2025, Stereotaxis prevede di ottenere approvazioni normative per cateteri compatibili, dimostrare l'uso nella vita reale, migliorare la compatibilità con i raggi X e prepararsi al lancio commerciale completo.
Stereotaxis (NYSE: STXS) ha recibido su primer pedido para el sistema robótico GenesisX™ de un hospital europeo. GenesisX representa el último avance en la robótica quirúrgica endovascular, con imanes más pequeños y blindaje magnético incorporado, eliminando la necesidad de instalación de blindaje en las paredes.
El sistema funciona con enchufes eléctricos estándar sin requerir anclajes estructurales en el suelo. Incluye un armario que es un 80% más pequeño que las versiones anteriores y puede almacenarse debajo de una mesa de cirugía. El sistema mantiene altos estándares de rendimiento mientras es más compacto y ligero que las generaciones anteriores.
GenesisX recibió la marca CE en Europa en 2024 y está pendiente de la autorización 510(k) de la FDA en EE. UU. A lo largo de 2025, Stereotaxis planea obtener aprobaciones regulatorias para catéteres compatibles, demostrar su uso en la práctica real, mejorar la compatibilidad con rayos X y prepararse para el lanzamiento comercial completo.
스테레오탁시스 (NYSE: STXS)는 유럽 병원으로부터 제네시스X™ 로봇 시스템에 대한 첫 번째 주문을 받았습니다. 제네시스X는 소형 자석과 내장형 자석 차폐가 특징인 최첨단 혈관 내 수술 로봇으로, 벽 차폐 설치 필요성을 없앱니다.
이 시스템은 구조적 바닥 고정 없이 표준 전원 콘센트에서 작동합니다. 이전 버전보다 80% 더 작은 캐비닛이 포함되어 있으며, 수술대 아래에 저장할 수 있습니다. 이 시스템은 이전 세대보다 더 콤팩트하고 가벼우면서도 높은 성능 기준을 유지합니다.
제네시스X는 2024년 유럽에서 CE 마크를 획득했으며, 미국에서는 FDA 510(k) 승인이 대기 중입니다. 스테레오탁시스는 2025년 내에 호환 카테터에 대한 규제 승인을 얻고, 실제 사용을 입증하며, X선 호환성을 향상시키고, 전체 상업적 출시를 준비할 계획입니다.
Stereotaxis (NYSE: STXS) a reçu sa première commande pour le système robotique GenesisX™ d'un hôpital européen. GenesisX représente la dernière avancée en matière de robotique chirurgicale endovasculaire, avec des aimants plus petits et une protection magnétique intégrée, éliminant ainsi le besoin d'installer des protections murales.
Le système fonctionne sur des prises électriques standard sans nécessiter d'ancrage structurel au sol. Il comprend un coffre 80 % plus petit que les versions précédentes et peut être rangé sous une table d'opération. Le système maintient des normes de performance élevées tout en étant plus compact et léger que les générations précédentes.
GenesisX a reçu le marquage CE en Europe en 2024 et attend l'autorisation FDA 510(k) aux États-Unis. Tout au long de l'année 2025, Stereotaxis prévoit d'obtenir des approbations réglementaires pour des cathéters compatibles, de démontrer une utilisation réelle, d'améliorer la compatibilité avec les rayons X et de se préparer au lancement commercial complet.
Stereotaxis (NYSE: STXS) hat seinen ersten Auftrag für das GenesisX™ Robotersystem von einem europäischen Krankenhaus erhalten. GenesisX stellt den neuesten Fortschritt in der endovaskulären Chirurgie dar, mit kleineren Magneten und integrierter magnetischer Abschirmung, wodurch die Installation von Wandabschirmungen überflüssig wird.
Das System arbeitet mit Standardsteckdosen, ohne dass eine strukturelle Bodenverankerung erforderlich ist. Es umfasst einen Schrank, der 80 % kleiner ist als frühere Versionen und unter einem OP-Tisch verstaut werden kann. Das System hält hohe Leistungsstandards ein und ist kompakter und leichter als frühere Generationen.
GenesisX erhielt 2024 die CE-Kennzeichnung in Europa und wartet auf die FDA 510(k) Genehmigung in den USA. Im Jahr 2025 plant Stereotaxis, regulatorische Genehmigungen für kompatible Katheter zu erhalten, den Einsatz in der Praxis nachzuweisen, die Röntgenkompatibilität zu verbessern und sich auf die vollständige Markteinführung vorzubereiten.
- First commercial order received for GenesisX system
- CE Mark approval already obtained in Europe
- System requires no structural modifications and uses standard power
- 80% smaller cabinet size compared to previous versions
- Built-in magnetic shielding eliminates need for room modifications
- FDA approval still pending in the United States
- Full commercial launch not yet ready, pending multiple preparatory steps
- Compatible catheter portfolio still requires regulatory approvals
Insights
The first GenesisX order marks a pivotal moment for Stereotaxis, signaling market validation for their next-generation surgical robotics platform. The system's innovative design addresses key adoption barriers in the $4.5 billion endovascular surgical robotics market.
Several technical advancements make GenesisX particularly compelling for hospitals:
- Elimination of specialized room shielding and structural requirements, significantly reducing installation costs
- Standard power supply compatibility and 80% smaller system cabinet, enabling flexible deployment
- Integrated magnetic shielding and streamlined connectivity, simplifying installation logistics
The regulatory pathway appears well-structured, with CE Mark already secured and FDA 510(k) submission in progress. The company's 2025 strategic roadmap encompasses critical elements for successful commercialization:
- Expanding compatible catheter portfolio across EP and vascular applications
- Establishing real-world clinical validation
- Developing x-ray system compatibility
- Optimizing supply chain and installation processes
While this first order is promising, several factors will influence commercial success:
- Pricing strategy and hospital ROI metrics
- Competition from established surgical robotics players
- Clinical data generation and publication timeline
- Manufacturing scalability and margin profile
ST. LOUIS, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it has received the first order for its latest generation robotic system, GenesisX™.
“We are thrilled to announce the first firm order for GenesisX from a pioneering European hospital,” said David Fischel, Stereotaxis Chairman and CEO. “Establishing the first GenesisX robotic lab is a critical milestone for us as we advance towards full commercial launch. We look forward to demonstrating the performance and reliability of GenesisX in the demanding clinical environment. GenesisX promises to transform the accessibility of Robotic Magnetic Navigation and is central to our mission of driving broad robotic adoption throughout endovascular surgery.”
GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic Navigation while significantly enhancing the accessibility of the technology for healthcare providers. 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 obtained CE Mark in Europe in 2024 and has been submitted to the FDA for 510(k) clearance in the United States. During 2025, Stereotaxis plans to gain regulatory approvals in Europe and the US for a portfolio of compatible EP and vascular catheters, demonstrate real-world use of GenesisX, enhance compatibility of GenesisX with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch.
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 150,000 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, 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
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