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Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China

Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China

Stereotaxis Genesis機器系統在中國獲得監管批准
GlobeNewswire ·  11/25 08:21

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).

聖路易斯和上海,2024年11月25日(GLOBE NEWSWIRE)——Stereotaxis(紐約證券交易所代碼:STXS)和上海微創醫療技術有限公司(688351.SH,「MicroPort EP」)今天宣佈中國國家藥品監督管理局(NMPA)對Genesis RMN系統進行監管批准。

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.

該批准是一個重要的里程碑,它爲中國的醫生和患者提供了微創機器人技術的最新進展。MicroPort EP正在通過其專注於電生理學界的現有銷售團隊啓動Genesis的全面商業發佈。Genesis的批准是Stereotaxis與MicroPort EP之間更廣泛合作的關鍵要素,該合作涉及Stereotaxis的機器人系統、機器人導航導管和MicroPort EP的哥倫布三維測繪系統的開發、整合和商業化。MicroPort EP是中國領先的醫療器械公司之一,其心血管醫療器械產品組合旨在診斷和治療心律失常。Stereotaxis 和 MicroPort EP 此前曾在 2021 年 8 月宣佈合作。

"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."

微創環保總裁孫義勇博士表示:「我們很榮幸能與Stereotaxis合作,將創世紀系統的優勢帶到中國。」「我們期待推出這項重要技術,並繼續我們的合作伙伴關係,爲中國的電生理學界提供最先進的創新。」

"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董事長兼首席執行官戴維·菲舍爾表示:「我們很高興在中國獲得國家藥監局對創世紀系統的批准。」「這項批准是另一個關鍵里程碑,因爲我們爲關鍵重點地區的顯著增長奠定了基礎。我們對推進重大創新的投資凸顯了我們對開拓醫療技術前沿的承諾,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是機器人磁導航技術的最新創新。機器人磁導航爲微創血管內手術引入了機器人精度和安全性的好處。Genesis RMN系統已獲得美國食品藥品管理局的批准並獲得CE認證,美國和歐洲的系統已被用於治療數千名患者。

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 .

關於立體定向
Stereotaxis(紐約證券交易所代碼:STXS)是用於微創血管內介入的創新外科機器人技術的先驅和全球領導者。其使命是爲介入實驗室發現、開發和交付機器人系統、儀器和信息解決方案。這些創新幫助醫生以機器人的精度和安全性提供無與倫比的患者護理,擴大微創治療的覆蓋面,並提高手術室的生產力、連接性和智能性。Stereotaxis技術已被用於治療美國、歐洲、亞洲和其他地方的15萬多名患者。欲了解更多信息,請訪問 .

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.

本新聞稿包括可能構成 「前瞻性」 陳述的陳述,通常包含 「相信」、「估計」、「項目」、「期望」 或類似表述。前瞻性陳述本質上涉及風險和不確定性,可能導致實際結果出現重大差異。導致或助長此類差異的因素包括但不限於公司在可持續水平上管理支出的能力、對公司產品在市場上的接受程度、全球經濟狀況對客戶購買其技術的能力和意願的影響、競爭因素、醫療保健政策的變化、對第三方供應商的依賴、監管批准的時機、疫情或其他災難的影響,以及與我們最近收購相關的apT聲明,包括收購帶來的任何預期收益,以及公司向美國證券交易委員會提交的定期文件和其他文件中討論的其他風險。通過發表這些前瞻性陳述,公司沒有義務在本新聞稿發佈之日之後更新這些陳述以進行修訂或更改。無法保證公司會確認與其採購訂單和其他承諾相關的收入,因爲其中一些採購訂單和其他承諾會受到公司無法控制的突發事件的影響,可能會被修改、修改、延遲或取消。

Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer

Stereotaxis 聯繫方式
大衛·L·菲舍爾
董事長兼首席執行官

Kimberly Peery
Chief Financial Officer

金伯利·皮裏
首席財務官

314-678-6100
Investors@Stereotaxis.com

314-678-6100
Investors@Stereotaxis.com


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