Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China
Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China
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).
圣路易斯和上海,2024年11月25日(GLOBE NEWSWIRE)——Stereotaxis(纽约证券交易所代码:STXS)和上海微创医疗技术有限公司(688351.SH,“MicroPort EP”)今天宣布中国国家药品监督管理局(NMPA)对Genesis RMN系统进行监管批准。
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.
该批准是一个重要的里程碑,它为中国的医生和患者提供了微创机器人技术的最新进展。MicroPort EP正在通过其专注于电生理学界的现有销售团队启动Genesis的全面商业发布。Genesis的批准是Stereotaxis与MicroPort EP之间更广泛合作的关键要素,该合作涉及Stereotaxis的机器人系统、机器人导航导管和MicroPort EP的哥伦布三维测绘系统的开发、整合和商业化。MicroPort EP是中国领先的医疗器械公司之一,其心血管医疗器械产品组合旨在诊断和治疗心律失常。Stereotaxis 和 MicroPort EP 此前曾在 2021 年 8 月宣布合作。
"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."
微创环保总裁孙义勇博士表示:“我们很荣幸能与Stereotaxis合作,将创世纪系统的优势带到中国。”“我们期待推出这项重要技术,并继续我们的合作伙伴关系,为中国的电生理学界提供最先进的创新。”
"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."
Stereotaxis董事长兼首席执行官戴维·菲舍尔表示:“我们很高兴在中国获得国家药监局对创世纪系统的批准。”“这项批准是另一个关键里程碑,因为我们为关键重点地区的显著增长奠定了基础。我们对推进重大创新的投资凸显了我们对开拓医疗技术前沿的承诺,以改善全球心血管疾病患者的生活。”
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.
Genesis是机器人磁导航技术的最新创新。机器人磁导航为微创血管内手术引入了机器人精度和安全性的好处。Genesis RMN系统已获得美国食品药品管理局的批准并获得CE认证,美国和欧洲的系统已被用于治疗数千名患者。
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 .
关于立体定向
Stereotaxis(纽约证券交易所代码:STXS)是用于微创血管内介入的创新外科机器人技术的先驱和全球领导者。其使命是为介入实验室发现、开发和交付机器人系统、仪器和信息解决方案。这些创新帮助医生以机器人的精度和安全性提供无与伦比的患者护理,扩大微创治疗的覆盖面,并提高手术室的生产力、连接性和智能性。Stereotaxis技术已被用于治疗美国、欧洲、亚洲和其他地方的15万多名患者。欲了解更多信息,请访问 .
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.
本新闻稿包括可能构成 “前瞻性” 陈述的陈述,通常包含 “相信”、“估计”、“项目”、“期望” 或类似表述。前瞻性陈述本质上涉及风险和不确定性,可能导致实际结果出现重大差异。导致或助长此类差异的因素包括但不限于公司在可持续水平上管理支出的能力、对公司产品在市场上的接受程度、全球经济状况对客户购买其技术的能力和意愿的影响、竞争因素、医疗保健政策的变化、对第三方供应商的依赖、监管批准的时机、疫情或其他灾难的影响,以及与我们最近收购相关的apT声明,包括收购带来的任何预期收益,以及公司向美国证券交易委员会提交的定期文件和其他文件中讨论的其他风险。通过发表这些前瞻性陈述,公司没有义务在本新闻稿发布之日之后更新这些陈述以进行修订或更改。无法保证公司会确认与其采购订单和其他承诺相关的收入,因为其中一些采购订单和其他承诺会受到公司无法控制的突发事件的影响,可能会被修改、修改、延迟或取消。
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer
Stereotaxis 联系方式
大卫·L·菲舍尔
董事长兼首席执行官
Kimberly Peery
Chief Financial Officer
金伯利·皮里
首席财务官
314-678-6100
Investors@Stereotaxis.com
314-678-6100
Investors@Stereotaxis.com