Stereotaxis Submits EMAGIN Catheter for Regulatory Clearance as it Pioneers Robotics for Endovascular Surgery
Stereotaxis (NYSE: STXS) has submitted an FDA 510(k) application for its EMAGIN™ 5F catheter, the first robotically navigated catheter designed to expand Robotic Magnetic Navigation into broader endovascular applications. The device is a 5-French diameter catheter guide for navigating complex venous and arterial vasculature.
The EMAGIN brand will include a comprehensive portfolio of robotic catheters and wires, targeting treatments for stroke, cancer, and cardiovascular disease. The company plans to submit for European CE Mark clearance this month and anticipates launching EMAGIN 5F in the second half of 2025 following regulatory approvals.
The catheter is manufactured by Stereotaxis' fully-owned subsidiary Access Point Technologies in Minnesota. The technology aims to enable efficient and safe navigation to difficult-to-reach vascular anatomy, with potential applications in interventional cardiology, radiology, and neurology.
Stereotaxis (NYSE: STXS) ha presentato una domanda 510(k) all'FDA per il suo catetere EMAGIN™ 5F, il primo catetere navigato roboticamente progettato per espandere la Navigazione Magnetica Robotica in applicazioni endovascolari più ampie. Il dispositivo è un catetere guida di diametro 5-French per navigare nella complessa vascolarizzazione venosa e arteriosa.
Il marchio EMAGIN includerà un portafoglio completo di cateteri e fili robotici, mirati a trattamenti per ictus, cancro e malattie cardiovascolari. L'azienda prevede di presentare la richiesta per la marcatura CE europea questo mese e anticipa il lancio dell'EMAGIN 5F nella seconda metà del 2025, dopo le approvazioni regolatorie.
Il catetere è prodotto dalla controllata di Stereotaxis, Access Point Technologies, in Minnesota. La tecnologia mira a consentire una navigazione efficiente e sicura verso anatomie vascolari difficili da raggiungere, con potenziali applicazioni in cardiologia interventistica, radiologia e neurologia.
Stereotaxis (NYSE: STXS) ha presentado una solicitud 510(k) a la FDA para su catéter EMAGIN™ 5F, el primer catéter navegado robóticamente diseñado para expandir la Navegación Magnética Robótica a aplicaciones endovasculares más amplias. El dispositivo es un catéter guía de 5 French de diámetro para navegar por la compleja vasculatura venosa y arterial.
La marca EMAGIN incluirá un portafolio integral de catéteres y cables robóticos, dirigidos a tratamientos para el accidente cerebrovascular, el cáncer y las enfermedades cardiovasculares. La empresa planea solicitar la aprobación de la marca CE europea este mes y anticipa lanzar el EMAGIN 5F en la segunda mitad de 2025 tras las aprobaciones regulatorias.
El catéter es fabricado por la subsidiaria de propiedad total de Stereotaxis, Access Point Technologies, en Minnesota. La tecnología tiene como objetivo permitir una navegación eficiente y segura hacia anatomías vasculares de difícil acceso, con aplicaciones potenciales en cardiología intervencionista, radiología y neurología.
스테레오택시스 (NYSE: STXS)는 EMAGIN™ 5F 카테터에 대한 FDA 510(k) 신청서를 제출했습니다. 이는 로봇으로 탐색되는 첫 번째 카테터로, 로봇 자기 탐색 기술을 더 넓은 혈관 내 응용 분야로 확장하기 위해 설계되었습니다. 이 장치는 복잡한 정맥 및 동맥 혈관을 탐색하기 위한 5-French 직경의 카테터 가이드입니다.
EMAGIN 브랜드는 뇌졸중, 암 및 심혈관 질환 치료를 목표로 하는 로봇 카테터 및 와이어의 포괄적인 포트폴리오를 포함할 것입니다. 회사는 이번 달에 유럽 CE 마크 승인을 신청할 계획이며, 규제 승인을 받은 후 2025년 하반기에 EMAGIN 5F를 출시할 것으로 예상하고 있습니다.
이 카테터는 미네소타에 있는 스테레오택시스의 완전 자회사인 Access Point Technologies에서 제조됩니다. 이 기술은 도달하기 어려운 혈관 해부학에 대한 효율적이고 안전한 탐색을 가능하게 하여, 심혈관 중재, 방사선학 및 신경학에서의 잠재적 응용을 목표로 하고 있습니다.
Stereotaxis (NYSE: STXS) a soumis une demande 510(k) à la FDA pour son cathéter EMAGIN™ 5F, le premier cathéter navigué par robot conçu pour étendre la Navigation Magnétique Robotique à des applications endovasculaires plus larges. Le dispositif est un cathéter de guidage de 5 French de diamètre pour naviguer dans la vasculature veineuse et artérielle complexe.
La marque EMAGIN comprendra un portefeuille complet de cathéters et de fils robotiques, visant des traitements pour les AVC, le cancer et les maladies cardiovasculaires. L'entreprise prévoit de soumettre une demande de marquage CE européen ce mois-ci et anticipe le lancement de l'EMAGIN 5F dans la seconde moitié de 2025, après les approbations réglementaires.
Le cathéter est fabriqué par la filiale entièrement détenue de Stereotaxis, Access Point Technologies, au Minnesota. La technologie vise à permettre une navigation efficace et sûre vers des anatomies vasculaires difficiles d'accès, avec des applications potentielles en cardiologie interventionnelle, en radiologie et en neurologie.
Stereotaxis (NYSE: STXS) hat einen FDA 510(k)-Antrag für seinen EMAGIN™ 5F Katheter eingereicht, den ersten robotisch navigierten Katheter, der entwickelt wurde, um die Robotische Magnetnavigation auf breitere endovaskuläre Anwendungen auszudehnen. Das Gerät ist ein 5-French Durchmesser Katheterführer zur Navigation durch komplexe venöse und arterielle Gefäße.
Die EMAGIN-Marke wird ein umfassendes Portfolio von robotischen Kathetern und Drähten umfassen, die auf Behandlungen für Schlaganfall, Krebs und Herz-Kreislauf-Erkrankungen abzielen. Das Unternehmen plant, diesen Monat einen Antrag auf europäische CE-Kennzeichnung einzureichen und erwartet, den EMAGIN 5F in der zweiten Hälfte des Jahres 2025 nach den behördlichen Genehmigungen auf den Markt zu bringen.
Der Katheter wird von Stereotaxis' vollumfänglicher Tochtergesellschaft Access Point Technologies in Minnesota hergestellt. Die Technologie zielt darauf ab, eine effiziente und sichere Navigation zu schwer erreichbaren Gefäßanatomien zu ermöglichen, mit potenziellen Anwendungen in der interventionellen Kardiologie, Radiologie und Neurologie.
- FDA 510(k) submission completed for new EMAGIN catheter
- European CE Mark submission planned this month
- Expands into new medical applications (stroke, cancer, cardiovascular)
- In-house manufacturing through owned subsidiary
- Revenue impact dependent on pending regulatory approvals
- Launch timeline uncertain until regulatory clearance
- Market adoption and clinical value yet to be demonstrated
Insights
Stereotaxis's FDA submission for its EMAGIN 5F catheter represents a significant strategic expansion that could substantially broaden the company's addressable market. This regulatory milestone opens potential entry into multiple high-value clinical applications including stroke treatment, cancer procedures, and cardiovascular interventions - markets considerably larger than their current focus.
The development has several key financial implications. First, this initial catheter appears to be just the beginning of a planned comprehensive product portfolio under the EMAGIN brand, suggesting a substantial product pipeline. Second, manufacturing through their fully-owned subsidiary Access Point Technologies provides vertical integration advantages, potentially supporting margins and supply chain control.
Investors should focus on two critical timeline elements: the regulatory approval process (with clearances expected in H2 2025) and subsequent commercialization strategy. The company plans to initially focus on demonstrating clinical value across multiple applications rather than immediate widespread deployment, indicating a methodical approach to market development.
The endorsements from prominent physicians at major institutions (Beth Israel Lahey Health/UMass and Guy's and St Thomas' NHS) provide important clinical validation but also hint at likely initial adoption centers. With over 150,000 patients already treated with their technology globally, Stereotaxis has established clinical infrastructure to build upon for this expansion.
The EMAGIN 5F catheter represents a technically significant advancement in robotic navigation for endovascular procedures. The core innovation - magnetic distal tip control in a 5-French diameter catheter - addresses a fundamental challenge in endovascular surgery: navigating tortuous vasculature safely and efficiently.
What makes this development particularly noteworthy is its cross-specialty application potential. While robotics has gained traction in certain surgical specialties, endovascular intervention has seen robotic adoption. Stereotaxis is positioning this technology as a platform solution across interventional cardiology, radiology and neurology - a convergence approach that could accelerate adoption if proven effective.
The technical differentiation lies in the magnetic navigation methodology. Unlike mechanical robotic systems that push catheters from the proximal end, magnetic navigation pulls from the distal tip, potentially offering better control in complex anatomies while reducing vascular trauma risks. This approach is particularly valuable in neurointerventional procedures where vessel fragility and tortuosity present significant challenges.
The endorsement from Prof. Timo Krings, a respected figure in neurointerventional radiology, specifically highlights these technical advantages for neurovascular applications. Similarly, Dr. Kalpa De Silva's comments suggest promising applications in complex coronary interventions and renal denervation procedures. Both applications represent high-complexity, high-value procedures where robotic precision could meaningfully improve outcomes.
ST. LOUIS, March 03, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced FDA regulatory submission for the first robotically navigated catheter designed to expand usage of Robotic Magnetic Navigation into the broader endovascular field.
EMAGIN™ 5F is the first in a family of robotically navigated endovascular devices being developed by Stereotaxis. The EMAGIN brand – short for Endovascular Magnetic Intervention – will encompass a comprehensive portfolio of robotic catheters and wires. EMAGIN 5F is a catheter guide with a 5-French diameter used to navigate tortuous venous and arterial vasculature. Robotic navigation of the catheter directly from the distal tip, using precise magnetic fields, is designed to enable efficient and safe navigation to otherwise difficult-to-reach vascular anatomy. It expands the established benefits of Robotic Magnetic Navigation into multiple new clinical applications including minimally-invasive procedures used to treat stroke, cancer, and cardiovascular disease.
“Robotic Magnetic Navigation offers significant promise to address clinical challenges we face in the neurointerventional field by enabling safe and rapid navigation through tortuous vasculature,” said Prof. Timo Krings, Chair of the Division of Neurointerventional Radiology at Beth Israel Lahey Health in Boston and Professor of Radiology at UMass TH Chan School of Medicine. “I’m excited by the opportunity to help pioneer this technology, evaluate and demonstrate its clinical value, and explore entirely new applications that may become possible. Our field is uniquely poised to benefit from robotics and we look forward to advancing the technology and clinical science over the coming years.”
“The evolution of robotics in interventional cardiology is inevitable and will be of significant benefit to patients, physicians, and healthcare systems,” said Dr. Kalpa De Silva, Interventional Cardiologist at St Thomas’ Hospital, Guy's and St Thomas' NHS Foundation Trust in London. “I see significant promise in the use of the robotically-steered EMAGIN catheter to enhance the safety, precision, and efficiency of various challenging procedures including renal denervation and complex percutaneous coronary interventions. I look forward to helping pioneer this technology.”
Stereotaxis submitted a 510(k) application for EMAGIN 5F with the FDA and expects to submit the catheter for European CE Mark clearance this month. EMAGIN 5F was designed and is manufactured by Stereotaxis’ fully-owned subsidiary Access Point Technologies in Minnesota. Stereotaxis expects to launch EMAGIN 5F following anticipated approvals in the second half of this year, with a focus on demonstrating clinical value for Robotic Magnetic Navigation in multiple new endovascular applications.
“Robotic Magnetic Navigation is a platform technology that can offer significant clinical value across endovascular medicine,” said David Fischel, Stereotaxis Chairman and CEO. “We are thrilled to announce this milestone as we embark on the journey to make Stereotaxis a multi-specialty robotics leader advancing clinical care in interventional cardiology, radiology and neurology.
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
FAQ
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