share_log

Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting With FDA

Monogram Technologies Provides 510(k) Submission Update Following Positive Meeting With FDA

Monogram Technologies 在與FDA的積極會議後提供510(k)提交更新
Accesswire ·  12/18 21:31

Management Anticipates That it has Sufficiently Addressed the FDA's Concerns to Mitigate the Need for a Clinical Data Request

管理層預計已充分解決FDA的關注,以減輕對臨床數據請求的需求

Management Anticipates a Comprehensive AIR Response in Q1 2025

管理層預計在2025年第一季度將提供全面的AIR響應

AUSTIN, TX / ACCESSWIRE / December 18, 2024 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today provided an update from its Submission Issue Request (SIR) meeting with the U.S. Food and Drug Administration ("FDA") on December 17, 2024, regarding its 510(k) premarket filing submission for the Company's mBôs TKA System (the "Application").

美國德克薩斯州奧斯丁 / ACCESSWIRE / 2024年12月18日 / Monogram Technologies Inc.(納斯達克:MGRM)("Monogram"或"公司"),一家專注於改進盈健醫療的人工智能驅動的機器人公司,最初聚焦於骨科手術,今天提供了關於其510(k)預市場申請提交的更新,該申請涉及公司的mBôs TKA系統("申請"),並與美國食品藥品管理局("FDA")於2024年12月17日舉行的提交問題請求(SIR)會議有關。

The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review. On September 30, 2024, Monogram received an Additional Information Request ("AIR") from the FDA. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR. The FDA informed the Company that the Company had 180 days from the date of the AIR to provide a complete response to the AIR, or the FDA would consider the Application withdrawn.

該申請於2024年7月19日提交,並通過了初步的FDA行政審查。2024年9月30日,Monogram收到了FDA的額外信息請求("AIR")。FDA通知公司,該申請被暫時保留,待AIR的完整響應完成。FDA通知公司,公司有180天的時間來提供對AIR的完整響應,或者FDA將視申請爲撤回。

On November 20, the Company submitted written responses, including planned remediations where applicable for all deficiencies noted in the AIR, and requested a Submission Issue Request (SIR) meeting with the FDA to review select responses. A critical focus for the Company has been whether the proposed nonclinical testing effectively mitigates FDA concerns that could necessitate clinical data. On December 11, 2024, the Company received a Submission Issue Request (SIR) review letter that provided preliminary written comments on particular topics of interest before the SIR meeting scheduled for December 17, 2024. On December 17, 2024, the Company conducted a Submission Issue Request (SIR) meeting with the FDA.

在11月20日,公司提交了書面回覆,包括針對AIR中提到的所有缺陷計劃的補救措施,並請求與FDA進行提交問題請求(SIR)會議以審查部分回覆。公司重點關注的是,擬議的非臨床測試是否有效緩解了FDA所關切的問題,這些問題可能需要臨床數據。2024年12月11日,公司收到了一封提交問題請求(SIR)審查信,提供了在2024年12月17日安排的SIR會議之前對特定興趣話題的初步書面評論。2024年12月17日,公司與FDA舉行了提交問題請求(SIR)會議。

Management believes its comprehensive plans to address the Additional Information Request (AIR) could effectively satisfy the agency and anticipates that in light of its proposed testing, it will be unlikely that the FDA will request clinical data as part of its submission. The Company is actively executing the additional testing and anticipates that it will provide a comprehensive AIR response in the first quarter of 2025. Obtaining clearance would be a significant milestone for its mission to advance the standard of care in orthopedic medicine. The Company is already working on the next-generation version of the mBôs TKA System.

管理層相信其全面的計劃可以有效滿足額外信息請求(AIR)的要求,並預計考慮到其提出的測試,FDA不太可能要求將臨床數據作爲其提交的一部分。公司正在積極執行額外的測試,並預計將在2025年第一季度提供全面的AIR響應。獲得許可將是其推進骨科醫學護理標準使命的一個重要里程碑。公司已經在開發下一代的mBôs TKA系統。

"This meeting reaffirmed our strategic decision to effectuate a multigenerational product strategy and submit the mBôs TKA System for FDA clearance on an accelerated timeline," said Ben Sexson, CEO of Monogram Technologies. "This meeting resolved outstanding questions and was a significant step forward in our path toward commercialization of the mBôs TKA System and execution of our long-term road map. The feedback and guidance provided by the FDA during the Submission Issue Request meeting validate the robustness of our approach. Importantly, the absence of a requirement for clinical data further underscores the confidence we have in the strength of our submission. The Agency's comments provided valuable clarity and affirmed that the proposed testing plans are well aligned with their expectations. We are optimistic that the additional data we are generating will comprehensively address the outstanding items and further reinforce our submission. We remain committed to achieving FDA clearance as quickly as possible, driven by our mission to advance the standard of care in orthopedic medicine."

"此次會議重申了我們執行多代產品策略的戰略決策,並計劃在加速時間表上提交mBôs TKA系統以獲得FDA的批准," Monogram Technologies首席執行官Ben Sexson表示。"此次會議解決了懸而未決的問題,並在我們商業化mBôs TKA系統的道路上邁出了重要一步。FDA在提交問題請求會議中提供的反饋和指導驗證了我們方法的可靠性。重要的是,缺乏臨床數據的要求進一步強調了我們對提交強度的信心。機構的評論提供了寶貴的清晰度,並確認所提議的測試計劃與他們的期望很好地對齊。我們對我們正在生成的額外數據能夠全面解決懸而未決的事項,並進一步強化我們的提交充滿信心。我們仍然致力於儘快獲得FDA的批准,以推動我們在骨科醫學中提升護理標準的使命。"

Upcoming Milestones

即將到來的里程碑

  • The Company anticipates it will respond to the FDA AIR with supplemental data in Q1 2025.

  • The Company is seeking to obtain regulatory clearance to conduct clinical trials in India with strategic partner Shalby Hospitals.

  • The Company anticipates shipping a robot to India to initiate clinical trial training by January 2025.

  • The Company is seeking to obtain FDA clearance for the mBôs TKA System.

  • Continue exploring domestic relationships.

  • Seek to continue expanding international relationships (the Company will be exhibiting at Arab Health in January 2025).

  • 公司預計將在2025年第一季度對FDA的AIR作出補充數據的回應。

  • 公司正尋求獲得在印度進行臨床試驗的監管批准,合作伙伴爲Shalby醫院。

  • 公司預計將在2025年1月向印度運送一臺機器人以啓動臨床試驗培訓。

  • 公司正在尋求獲得mBôs TKA系統的FDA批准。

  • 繼續探索國內關係。

  • 尋求繼續擴大國際關係(公司將在2025年1月參加阿拉伯健康展)。

About Monogram Technologies Inc.

關於Monogram Technologies Inc.

Monogram Technologies (NASDAQ:MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.

莫諾格科技(納斯達克:MGRM)是一家以人工智能驅動的機器人公司,專注於改善人類健康,初步側重於骨科手術。該公司正在開發一種產品解決方案架構,以通過結合3D打印、愛文思控股機器視覺、人工智能和下一代機器人,實現患者優化的骨科植入物的大規模生產。

Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.

莫諾格的mBôs精準機器人手術系統旨在自主執行優化路徑,以高精度插入其FDA批准的mPress壓入式植入物。目標是平衡更合適的骨骼保護型膝關節置換。該公司最初計劃生產和營銷機器人手術設備及相關軟件、骨科植入物、組織消融工具、導航消耗品和其他必要的重建關節置換程序儀器。正在探索mBôs與mVision導航的其他臨床和商業應用。

Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.

莫諾格已獲得FDA對mPress植入物的批准,併爲其機器人產品申請510(k)清關。該公司在市場推廣其產品之前,必須獲得FDA的批准。莫諾格無法估計這些批准的時間或保證能夠獲得這樣的批准。

The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.

該公司認爲,其mBôs精準機器人手術助手結合了人工智能和新穎導航方法(mVision),將能夠爲患者提供更個性化的膝關節植入物,導致平衡且更加適合的膝關節置換,採用骨骼保護型植入物。莫諾格預計,其導航的mBôs精準機器人和mVision導航可能還有其他臨床和商業應用。

To learn more, visit .

要了解更多信息,請訪問。

Forward-Looking Statements

前瞻性聲明

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties. For example, the Company's statement regarding the Company's proposed use of net proceeds is a forward-looking statement. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the prospectus and the Company's other filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.

本新聞稿可能包含《1995年私人證券訴訟改革法》的意義下的「前瞻性聲明」。本新聞稿中除了歷史事實陳述以外的聲明可能構成前瞻性聲明,並不保證未來的業績或結果,並涉及多種風險和不確定性。例如,公司的聲明關於公司擬定的淨收益使用方案,是前瞻性聲明。前瞻性聲明,除了歷史事實外,很可能會受到其他無法預知的未來事件和情況的影響,包括未來的一些因素是或不是在我們的控制之下,以及公司可能考慮或未考慮的因素;因此,這些聲明不能保證或保證未來業績的任何方面。實際的發展和結果很可能會因多種因素而與任何前瞻性聲明存在重大差異,包括招股說明書和公司其他提交給SEC的文件中描述的因素。該公司不承擔更新本聲明中任何前瞻性聲明的義務。所有前瞻性聲明僅在本新聞稿日期有效。

Investor Relations

投資者關係

Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us

克里斯·泰森
執行副總裁
MZ北美
直接電話:949-491-8235
MGRM@mzgroup.us

SOURCE: Monogram Technologies Inc.

來源:Monogram Technologies Inc.


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論