Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China
Rhea-AI Summary
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.
Positive
- 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
Negative
- None.
News Market Reaction – STXS
On the day this news was published, STXS gained 10.24%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
