Izotropic Confirms FDA Pre-Submission Meeting Date
Izotropic Confirms FDA Pre-Submission Meeting Date
Vancouver, British Columbia--(Newsfile Corp. - September 27, 2023) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a CT (computed tomography) imaging system, that produces images of anatomy for non-invasive tissue characterization with the first application in breast imaging, announced today it has confirmed a pre-submission meeting date with the U.S. Food and Drug Administration (FDA) scheduled for October 25, 2023.
溫哥華，不列顛哥倫比亞省-(Newsfile Corp.-2023年9月27日)-Izotrotic公司(CSE：以藏)(OTCQB：IZOZF)(FSE：1R3)(“各向同性“或”公司IzoView是一家將CT(電腦斷層成像)成像系統IzoView商業化的醫療設備公司，IzoView是一種產生解剖圖像的CT(電腦斷層成像)成像系統，它在乳房成像中的第一個應用是產生解剖圖像。該公司今天宣佈，它已經確認了定於2023年10月25日與美國食品和藥物管理局(FDA)舉行的提交前會議日期。
Further to its news release on September 6, 2023, Izotropic completed a pre-submission application to the FDA to solidify its plans to pursue market clearance for IzoView as a Class II device through a 510(k) pre-market notification submission.
繼2023年9月6日發佈新聞稿後，Izotroy完成了向FDA提交的預提交申請，以鞏固其通過510(K)上市前通知提交為IzoView作為II類設備爭取市場許可的計劃。
The purpose of the upcoming meeting is to discuss the application, obtain feedback, and confirm next steps. The meeting will take place in Rockville, Maryland, and will be attended by Izotropic's management, technical and engineering team members, and its FDA consultant, Matrix Medical Devices.
即將舉行的會議的目的是討論申請、獲得反饋並確認下一步行動。會議將在馬利蘭州的羅克維爾舉行，Izotroy公司的管理、技術和工程團隊成員及其FDA顧問Matrix Medical Devices將出席會議。
The Company will issue a news release in due course after the meeting to report on its progress.
公司將在會後適當時候發佈新聞稿，報告其進展情況。
ON BEHALF OF THE BOARD
我代表董事會
Mr. Robert Thast, CEO
Cell: 604-220-5031
首席執行官Robert Tast先生
電話：604-220-5031
Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
聯繫方式：
電子郵件：info@izocorp.com
免費電話：1-833-IZOCORP分機1
About Izotropic
More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com.
關於等方向性
欲瞭解有關Izotroy公司的更多資訊，請訪問公司網站：izocorp.com，或查看公司在SEDAR上的簡介：sedar.com。
Forward-Looking Statements
This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information and statements by using words such as "anticipate," "believe," "envision," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.
前瞻性陳述
本文檔可能包含“前瞻性陳述”，這些陳述基於對公司管理層、業務的當前估計、假設、預測和預期，以及對公司運營所處的相關市場和經濟環境的瞭解。在可能的情況下，本公司已嘗試通過使用下列詞語來識別此類資訊和陳述：“預期”、“相信”、“設想”、“估計”、“預期”、“打算”、“可能”、“計劃”、“預測”、“專案”、“目標”、“潛在”、“將”、“將”、“可能”、“可能”、“應該”、“繼續，關於未來事件、趨勢或前景或未來經營或財務業績的任何討論，“考慮”及其他類似表述及其派生，儘管並不是所有前瞻性表述都包含這些識別詞語。
These statements are not guarantees of performance and involve risks, including those related to capital requirements and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation, the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposes only. IzoView is not yet approved for sale.
這些陳述不是對業績的保證，涉及風險，包括與資本要求和難以控制或預測的不確定性有關的風險，因此，它們可能導致公司未來活動的結果與此類陳述的內容和影響大不相同。前瞻性陳述僅在作出之日起具有相關性，公司沒有義務更新或修改任何前瞻性陳述，以反映新的資訊或未來事件或情況的發生，除非法律另有要求。本公司及其股東、高級管理人員和顧問均不對任何人根據本文所含資訊採取的任何行動以及任何行動的結果負責，包括但不限於購買或出售公司證券。本文檔中的任何內容都不應被視為任何類型的醫療或其他建議。所有圖片僅用於說明目的。IzoView尚未獲準出售。
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譯文內容由第三人軟體翻譯。