Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China
Stereotaxis (NYSE: STXS) and MicroPort EP announced that China's National Medical Products Administration (NMPA) has approved the Genesis RMN® System. This approval enables the commercialization of advanced robotic technology for minimally-invasive procedures in China. MicroPort EP will lead the commercial launch through its existing electrophysiology sales teams. The approval is part of a broader collaboration between both companies, announced in August 2021, which includes development and integration of robotic systems, navigated catheters, and MicroPort EP's Columbus™ 3D mapping system. The Genesis system, already FDA-cleared and CE-marked, has been used to treat thousands of patients in the US and Europe.
Stereotaxis (NYSE: STXS) e MicroPort EP hanno annunciato che l'Amministrazione Nazionale dei Prodotti Medici della Cina (NMPA) ha approvato il Genesis RMN® System. Questa approvazione consente la commercializzazione di tecnologia robotica avanzata per procedure minimamente invasive in Cina. MicroPort EP guiderà il lancio commerciale attraverso i suoi attuali team di vendita in elettrofisiologia. L'approvazione fa parte di una collaborazione più ampia tra le due aziende, annunciata nell'agosto 2021, che comprende lo sviluppo e l'integrazione di sistemi robotici, cateteri navigati e il sistema di mappatura 3D Columbus™ di MicroPort EP. Il sistema Genesis, già autorizzato dalla FDA e marchiato CE, è stato utilizzato per trattare migliaia di pazienti negli Stati Uniti e in Europa.
Stereotaxis (NYSE: STXS) y MicroPort EP anunciaron que la Administración Nacional de Productos Médicos de China (NMPA) ha aprobado el Genesis RMN® System. Esta aprobación permite la comercialización de tecnología robótica avanzada para procedimientos mínimamente invasivos en China. MicroPort EP liderará el lanzamiento comercial a través de sus actuales equipos de ventas en electrofisiología. La aprobación es parte de una colaboración más amplia entre ambas compañías, anunciada en agosto de 2021, que incluye el desarrollo e integración de sistemas robóticos, catéteres navegados y el sistema de mapeo 3D Columbus™ de MicroPort EP. El sistema Genesis, ya aprobado por la FDA y marcado con CE, se ha utilizado para tratar a miles de pacientes en EE. UU. y Europa.
스테레오택시스 (NYSE: STXS)와 마이크로포트 EP가 중국 국가의약품관리국(NMPA)이 제네시스 RMN® 시스템을 승인했다고 발표했습니다. 이 승인을 통해 중국에서 최소 침습 절차를 위한 고급 로봇 기술의 상용화가 가능해집니다. 마이크로포트 EP는 현재의 전기 생리학 판매 팀을 통해 상업적 출시를 주도할 것입니다. 이 승인은 2021년 8월에 발표된 두 회사 간의 더 넓은 협력의 일환으로, 로봇 시스템, 네비게이션 카테터 및 마이크로포트 EP의 Columbus™ 3D 매핑 시스템의 개발 및 통합을 포함합니다. 제네시스 시스템은 이미 FDA의 승인을 받고 CE 마크를 획득하였으며 미국과 유럽에서 수천 명의 환자를 치료하는 데 사용되었습니다.
Stereotaxis (NYSE: STXS) et MicroPort EP ont annoncé que l'Administration nationale des produits médicaux de Chine (NMPA) a approuvé le Genesis RMN® System. Cette approbation permet la commercialisation d'une technologie robotique avancée pour des procédures peu invasives en Chine. MicroPort EP dirigera le lancement commercial à travers ses équipes de vente en électrophysiologie existantes. L'approbation fait partie d'une collaboration plus large entre les deux entreprises, annoncée en août 2021, qui comprend le développement et l'intégration de systèmes robotiques, de cathéters navigués et du système de cartographie 3D Columbus™ de MicroPort EP. Le système Genesis, déjà approuvé par la FDA et marqué CE, a été utilisé pour traiter des milliers de patients aux États-Unis et en Europe.
Stereotaxis (NYSE: STXS) und MicroPort EP haben angekündigt, dass die Nationale Arzneimittelbehörde Chinas (NMPA) das Genesis RMN® System genehmigt hat. Diese Genehmigung ermöglicht die Kommerzialisierung fortschrittlicher Robotertechnologie für minimalinvasive Verfahren in China. MicroPort EP wird den kommerziellen Start über seine bestehenden Vertriebsteams für Elektrophysiologie leiten. Die Genehmigung ist Teil einer umfassenderen Zusammenarbeit zwischen beiden Unternehmen, die im August 2021 angekündigt wurde und die Entwicklung und Integration von robotergestützten Systemen, navigierten Kathetern und dem Columbus™ 3D-Mapping-System von MicroPort EP umfasst. Das Genesis-System, das bereits von der FDA genehmigt und mit dem CE-Zeichen versehen ist, wurde zur Behandlung von Tausenden von Patienten in den USA und Europa eingesetzt.
- Obtained regulatory approval for Genesis RMN System in China, opening a major new market
- Partnership with established local player MicroPort EP for immediate commercialization
- Integration with existing sales infrastructure reduces market entry costs
- None.
Insights
The NMPA approval of Genesis RMN® System marks a significant strategic expansion into China's lucrative electrophysiology market. The partnership with MicroPort EP provides Stereotaxis with an established distribution network and local market expertise, critical for penetrating the Chinese healthcare sector. The collaboration's scope, encompassing system integration and catheter development, positions STXS for potential long-term revenue growth in Asia's largest medical device market.
The Genesis platform's existing FDA clearance and CE mark, combined with this new NMPA approval, creates a global commercialization trifecta across major markets. With over 150,000 patients treated using Stereotaxis technology, the company demonstrates strong clinical validation. The integration with MicroPort EP's Columbus™ 3D mapping system could accelerate market adoption by offering a comprehensive solution for electrophysiology procedures.
China's cardiovascular medical device market presents a substantial growth opportunity for Stereotaxis. The country's aging population and rising cardiovascular disease burden drive increasing demand for advanced medical technologies. MicroPort EP's established presence in China's electrophysiology sector provides immediate market access and local regulatory expertise, potentially accelerating commercial adoption.
The timing of this approval coincides with China's healthcare reform initiatives promoting adoption of innovative medical technologies, particularly in specialized procedures like cardiac ablation. This market entry could significantly impact STXS's revenue potential, given China's market size and growing healthcare expenditure.
ST. LOUIS and SHANGHAI, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS) and Shanghai MicroPort EP Medtech Co., Ltd. (688351.SH, “MicroPort EP”), today announced regulatory approval of the Genesis RMN® System by China’s National Medical Products Administration (NMPA).
This approval is a significant milestone, making available the latest advances in minimally-invasive robotic technology to physicians and patients in China. MicroPort EP is initiating full commercial launch of Genesis through its existing sales teams focused on the electrophysiology community. Approval of Genesis is a key element in a broader collaboration between Stereotaxis and MicroPort EP which entails the development, integration and commercialization of Stereotaxis’ robotic system, robotically-navigated catheters, and MicroPort EP’s Columbus™ 3D mapping system. MicroPort EP is one of China’s leading medical device companies with a portfolio of cardiovascular medical devices designed to diagnose and treat arrythmias. Stereotaxis and MicroPort EP previously announced their collaboration in August 2021.
“We are proud to partner with Stereotaxis to bring the benefits of the Genesis system to China,” said Dr. Yiyong Sun, President of MicroPort EP. “We look forward to launching this significant technology and continuing our partnership to provide China’s electrophysiology community with the most advanced innovations.”
"We are delighted to receive NMPA clearance for the Genesis System in China," said David Fischel, Stereotaxis Chairman and CEO. "This approval represents another key milestone as we establish the foundations for significant growth across key focus geographies. Our investment to advance the substantial innovations underscores our commitment to pioneering the frontiers of medical technology to improve the lives of patients with cardiovascular disease around the world.”
Genesis is the latest innovation in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to minimally-invasive endovascular procedures. The Genesis RMN System has FDA clearance and is CE marked, with systems across the United States and Europe having been used to treat thousands of patients.
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, 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
FAQ
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