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FDA Sets Meeting Date With Izotropic

FDA Sets Meeting Date With Izotropic

FDA與伊索特羅皮克公司確定了會議日期
newsfile ·  02/19 13:00

Vancouver, British Columbia and Sacramento, California--(Newsfile Corp. - February 19, 2025) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing imaging-based products utilizing innovative and emerging technologies for the more accurate screening, diagnoses, and treatment of breast cancers, announces that the U.S. Food and Drug Administration ("FDA") has set the Company's pre-submission meeting date, further to its January pre-submission filing.

The Company filed a pre-submission with the FDA on the subject of its clinical study design for the approval of its first medical imaging device, the IzoView Breast CT Imaging System ("IzoView"). The FDA has scheduled the pre-submission meeting for March 20, 2025.

Izotropic intends to launch IzoView with contrast-enhancement for breast cancer screening adjunctive to digital breast tomosynthesis, commonly referred to as 3D mammography, for patients with dense breast tissue. Dense breast tissue is both a risk factor for developing breast cancer and a patient characteristic that affects ~50% of the women in the U.S. Dense breast tissue makes the current standard-of-care breast cancer screening modalities less effective at detecting cancers. Contrast-enhanced breast CT has proven more than promising in research studies at UC Davis Medical Center ("UC Davis") in Sacramento, California, where the technology was founded and from which Izotropic has the exclusive global licensing rights. Four successive breast CT systems have been built and tested in clinical trials for research purposes at UC Davis, funded primarily by U.S. government grants, resulting in a fully de-risked technology with a large volume of published, peer-reviewed scientific research supporting its capabilities and potential.

Izotropic is committed to its mission to bring new devices and technologies to the market and will continue to seek out opportunities to increase efficiency and expedite patient access to its products to achieve better outcomes for patients and save lives from breast cancer.

About Izotropic:
More information about Izotropic Corporation can be found on its website at izocorp.com and by reviewing its profile on SEDAR at sedarplus.ca.

關於Izotropic:
有關Izotropic Corporation的更多信息可以在其網站izocorp.com上找到,以及通過查看其在SEDAR上的資料sedarplus.ca。

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.

前瞻性聲明:
本文件可能包含"前瞻性聲明",這些聲明基於公司管理層、業務以及公司對其所處相關市場和經濟環境的當前估計、假設、預測和期望。公司在可能的情況下,已嘗試通過使用諸如"預期"、"相信"、"設想"、"估計"、"期望"、"打算"、"可能"、"計劃"、"預測"、"項目"、"目標"、"潛在"、"將"、"會"、"可能會"、"應該"、"繼續"、"考慮"等詞彙及與未來事件、趨勢或前景、以及未來運營或財務績效有關的討論相關的其他類似表達和衍生詞來識別這些信息和聲明,儘管並非所有前瞻性聲明都有這些標識性詞彙。

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 has not yet been approved or cleared for sale.

這些聲明不保證業績,並涉及風險,包括與資本需求相關的風險以及難以控制或預測的不確定性,因此,它們可能導致公司的未來業績與這些聲明的內容和含義顯著不同。前瞻性聲明僅在其作出之日期相關,公司沒有義務更新或修訂任何前瞻性聲明,以反映新信息或未來事件或情況的發生,除非法律要求這樣做。公司及其股東、管理人員和顧問對任何人基於此處所含信息採取的任何行動及其結果不承擔任何責任,包括但不限於公司證券的買賣。本文檔中的任何內容不應被視爲任何形式的醫療或其他建議。所有圖像均僅用於說明目的。IzoView尚未獲得批准或清關作爲銷售。

Contacts:
Robert Thast
Interim Chief Executive Officer
Telephone: 1-604-220-5031 or 1-800-IZOCORP ext. 3
Email: bthast@izocorp.com

聯繫方式:
羅伯特·薩斯特
臨時首席執行官
電話:1-604-220-5031 或 1-800-IZOCORP 分機 3
電子郵件: bthast@izocorp.com

General Inquiries
Telephone: 1-604-825-4778 or 1-800-IZOCORP ext. 1
Email: info@izocorp.com

一般諮詢
電話:1-604-825-4778 或 1-800-IZOCORP 分機 1
電子郵件:info@izocorp.com

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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本頁的譯文內容由軟件翻譯。富途將竭力但卻不能保證翻譯內容之準確和可靠,亦不會承擔因任何不準確或遺漏而引起的任何損失或損害。