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).
聖路易斯和上海,2024年11月25日(環球新聞)-- stereotaxis(紐交所:STXS)與上海微創醫療科技有限公司(688351.SH,"微創醫療EP")今天宣佈,Genesis RMN系統獲得中國國家藥品監督管理局(NMPA)的監管批准。
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.
這一批准是一個重要的里程碑,使得最新的微創機器人科技可以在中國提供給醫生和患者。微創醫療EP正在通過其現有的銷售團隊,專注於電生理社區,啓動Genesis的全面商業推廣。Genesis的批准是stereotaxis與微創醫療EP之間更廣泛合作的重要組成部分,該合作涉及stereotaxis的機器人系統、機器人導航導管以及微創醫療EP的Columbus 3D地圖系統的開發、整合和商業化。微創醫療EP是中國領先的醫療設備公司之一,擁有用於診斷和治療心律失常的心血管醫療設備組合。stereotaxis與微創醫療EP曾在2021年8月宣佈了他們的合作。
"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."
"我們很自豪能夠與stereotaxis合作,將Genesis系統的好處帶給中國,"微創醫療EP總裁孫逸勇博士說。"我們期待着推出這一重要科技,並繼續我們的合作,以爲中國的電生理社區提供最先進的創新。"
"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."
"我們很高興在中國獲得NMPA對Genesis系統的批准,"stereotaxis董事長兼首席執行官大衛·菲舍爾表示。"這一批准代表着一個又一個關鍵的里程碑,因爲我們爲在關鍵的重點區域實現顯著增長奠定基礎。我們對推進重大創新的投資鞏固了我們致力於開拓醫療科技前沿,以改善全球心血管疾病患者生活的承諾。"
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是最新的機器人磁導航技術創新。機器人磁導航將機器人精確度和安全性帶入微創血管內手術。Genesis RMN系統已獲得FDA許可並且有CE標誌,系統已在美國和歐洲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Stereotaxis
Stereotaxis(紐交所:STXS)是微創血管介入創新手術機器人領域的先驅和全球領導者。其使命是發現、開發和提供用於介入實驗室的機器人系統、儀器和信息解決方案。這些創新幫助醫生以機器人精確度和安全性提供無與倫比的患者護理,擴大微創治療的可及性,並提高手術室中的生產力、連接性和智能性。Stereotaxis技術已在美國、歐洲、亞洲及其他地區用於治療超過150,000名患者。有關更多信息,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.
本新聞稿包含可能構成「前瞻性」聲明的陳述,通常包含「相信」,「估計」,「預測」,「預期」或類似表述的詞語。前瞻性聲明固有地涉及風險和不確定性,可能導致實際結果與其顯著不同。導致或有助於此類差異的因素包括但不限於公司能否將費用管理在可持續水平上,市場對公司產品的接受程度,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,與醫療保健政策相關的變化,對第三方廠商的依賴,監管批准的時間,大流行病或其他災難的影響,以及與我們最近收購APt相關的陳述,包括從收購中預期的任何好處,以及公司在其採購訂單和其他承諾方面的營收確認的無保證,因爲其中一些採購訂單和其他承諾受到公司無法控制的不確定因素的影響,可能會被修訂、修改、延遲或取消。通過發表這些前瞻性聲明,公司不承擔更新這些聲明的責任,也不承諾在本新聞稿發佈日期之後對這些聲明進行修訂或更改。
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer
立體定向聯繫方式:
David L. Fischel
董事長兼首席執行官
Kimberly Peery
Chief Financial Officer
Kimberly Peery
首席財務官
314-678-6100
Investors@Stereotaxis.com
314-678-6100
Investors@Stereotaxis.com
譯文內容由第三人軟體翻譯。