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Izotropic Completes Pre-Submission Meeting With U.S. FDA

Izotropic Completes Pre-Submission Meeting With U.S. FDA

Izotropic 完成了與美國食品藥品管理局的投稿前會議
newsfile ·  2023/11/01 20:00

Vancouver, British Columbia--(Newsfile Corp. - November 1, 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 an application in breast imaging, announced today that it completed its previously announced pre-submission meeting with the U.S. FDA.

不列顛哥倫比亞省溫哥華--(新聞文件公司-2023 年 11 月 1 日)- Izotropic Corporation(CSE:IZO)(場外交易代碼:IZOZF)(FSE:1R3) (”Izotropic“或者”公司“)是一家將CT(計算機斷層掃描)成像系統izoView商業化的醫療器械公司,該系統可生成用於非侵入性組織特徵的解剖學圖像,應用於乳房成像。該公司今天宣佈,它完成了先前宣佈的與美國食品藥品管理局的提交前會議。

The purpose of the meeting was to discuss the Company's pre-submission application, obtain feedback and confirm next steps. The meeting was attended by Izotropic's management, technical and engineering team members, and its FDA consultant, Matrix Medical Devices.

會議的目的是討論公司的預提交申請,獲取反饋並確認後續步驟。Izotropic的管理、技術和工程團隊成員及其食品藥品管理局顧問Matrix Medical Devices出席了會議。

The meeting allowed Izotropic to clarify its revised regulatory strategy, which focuses on a broadened intended use and market authorization under the 510(k) pathway. While further discussion with the agency regarding the details of this regulatory strategy will be required to ensure its viability, the FDA appeared open to the Company's new market clearance direction.

這次會議使Izotropic得以闡明其修訂後的監管戰略,該戰略側重於擴大510(k)路徑下的預期用途和市場授權。儘管需要與該機構就該監管戰略的細節進行進一步討論以確保其可行性,但美國食品和藥物管理局似乎對該公司新的市場清關方向持開放態度。

As is required and for the purposes of concurrence, Izotropic will submit meeting minutes to the FDA for their review prior to any further disclosure.

根據要求並出於同意的目的,Izotropic將在進一步披露之前向美國食品和藥物管理局提交會議記錄供其審查。

ON BEHALF OF THE BOARD

代表董事會

Mr. Robert Thast, CEO
Cell: 604-220-5031

首席執行官羅伯特·薩斯特先生
手機:604-220-5031

Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1

聯繫人:
電子郵件:info@izocorp.com
免費電話:1-833-IZOCORP ext.1

About Izotropic

關於 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.

有關Izotropic Corporation的更多信息,請訪問其網站izocorp.com,也可以在sedar.com上查看其在SEDAR上的個人資料。

Forward-Looking Statements

前瞻性陳述

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.

本文件可能包含 “前瞻性陳述” 的陳述,這些陳述基於公司管理層、業務的當前估計、假設、預測和預期及其對運營所在相關市場和經濟環境的了解。公司儘可能嘗試使用 “預期”、“相信”、“設想”、“預期”、“預期”、“打算”、“可能”、“可能”、“計劃”、“預測”、“項目”、“目標”、“潛力”、“將”、“可能”、“應該”、“繼續”、“考慮” 等詞語來識別此類信息和陳述儘管並非所有前瞻性陳述都包含這些識別性詞語,但與討論未來事件、趨勢或前景或未來運營或財務業績有關的表述和衍生詞。

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.

這些陳述不能保證業績,涉及風險,包括與資本要求和難以控制或預測的不確定性相關的風險,因此,它們可能導致公司活動的未來業績與此類陳述的內容和含義存在重大差異。前瞻性陳述僅在發表之日起具有相關性,除非法律另有要求,否則公司沒有義務更新或修改任何前瞻性陳述以反映新信息或未來事件或情況的發生。公司及其股東、高級管理人員和顧問均不對任何人根據此處包含的信息採取的任何行動和結果承擔責任,包括但不限於購買或出售公司證券。本文件中的任何內容都不應被視爲任何形式的醫學或其他建議。所有圖片僅用於說明目的。izoView 尚未獲準出售。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

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。
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