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Izotropic Engages Clinical Research Organization in Preparation for Clinical Study

Izotropic Engages Clinical Research Organization in Preparation for Clinical Study

Izotrotic公司聘請臨牀研究機構為臨牀研究做準備
newsfile ·  2022/07/19 08:10

Vancouver, British Columbia--(Newsfile Corp. - July 19, 2022) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a MedTech company commercializing IzoView, an advanced breast CT (computed tomography) imaging platform for the more accurate detection and diagnosis of breast cancer, announces it has engaged a world-leading clinical research organization (CRO) ICON plc ("ICON") to help prepare for its upcoming clinical study and submission for market authorization in the U.S.

温哥華,不列顛哥倫比亞省-(Newsfile Corp.-2022年7月19日)-Izotrotic公司(CSE:以藏)(OTCQB:IZOZF)(FSE:1R3)("各向同性“或”公司),一家將先進的乳腺CT(計算機斷層掃描)成像平臺IzoView商業化的MedTech公司宣佈,它已經聘請了世界領先的臨牀研究組織(CRO)ICON plc(“ICON”)來幫助準備即將在美國進行的臨牀研究並提交市場授權。

With over 20 years of experience and having completed 500+ trials over the last five years, ICON's Medical Device team has been engaged to support multiple aspects of Izotropic's clinical research study including contracting, start-up, data collection and analysis, and report writing for FDA submission. ICON's senior experts work directly with the FDA, including the Division of Radiological Health.

ICON的醫療器械團隊擁有20多年的經驗,在過去五年中完成了500多項試驗,一直致力於為Izotroy的臨牀研究研究提供多方面的支持,包括承包、啟動、數據收集和分析,以及為FDA提交的報告撰寫。ICON的資深專家直接與FDA合作,包括放射健康部門。

"Engaging ICON means we are confidently moving forward with our business plans to bring IzoView to market efficiently," said Dr. John McGraw, CEO. "We plan to run a multi-site study with leading U.S. hospitals which will help to expedite patient recruitment and broadens the clinical experience with IzoView. When operating a multi-site study, it is critical that the same set of processes and procedures from start to finish are followed at each site for every patient to mitigate exclusion and maintain data integrity, and ICON's expertise enhances that capability."

首席執行官約翰·麥格勞博士説:“參與ICON意味着我們正在自信地推進我們的業務計劃,將IzoView有效地推向市場。我們計劃與美國領先的醫院一起進行一項多站點研究,這將有助於加快患者招募,並擴大IzoView的臨牀體驗。在進行多站點研究時,至關重要的是,每個站點從頭到尾都遵循相同的一套程序和程序,以減少排斥並保持數據完整性,而ICON的專業知識增強了這一能力。“

About ICON plc
ICON is the world's leading clinical research organization, powered by healthcare intelligence. From molecule to medicine, ICON advances clinical research providing outsourced development and commercialization services to pharmaceutical, biotechnology, medical device, government, and public health organizations. ICON develop new innovations, drive emerging therapies forward, and improve patient lives. With headquarters in Dublin, Ireland, ICON employ approximately 39,300 employees in 138 locations in 53 countries.

關於ICON PLC
ICON是世界領先的臨牀研究組織,由醫療保健智能提供支持。從分子到醫學,ICON推進臨牀研究,為製藥、生物技術、醫療器械、政府和公共衞生組織提供外包開發和商業化服務。圖標開發新的創新,推動新興療法向前發展,並改善患者的生活。ICON總部設在愛爾蘭都柏林,在53個國家和地區的138個辦事處僱用了大約39,300名員工。

ON BEHALF OF THE BOARD

我代表董事會

Investor Relations Contact:
James Berard
Email: jberard@izocorp.com
Cell: 778-228-2314
Toll Free: 1-833-IZOCORP ext.1

投資者關係聯繫人:
詹姆斯·貝拉德
電子郵件:jberard@izocorp.com
電話:778-228-2314
免費電話:1-833-IZOCORP分機1

Media Inquiries Contact:
Jaclyn Thast
Email: jaclyn@izocorp.com
Toll Free: 1-833-IZOCORP ext.3

媒體問詢聯繫人:
雅克林·塔斯特
電子郵件:Jaclyn@izocorp.com
免費電話:1-833-IZOCORP轉3

About Izotropic Corporation
Izotropic Corporation is the only publicly traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers. To expedite patient and provider access to IzoView, Izotropic's initial clinical study intends to demonstrate superior performance of diagnostic breast CT imaging over diagnostic mammography procedures. In follow-on clinical studies, Izotropic intends to validate platform applications, including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstructive surgery.

關於Izotroy公司
Izotroy公司是唯一一家將專門的乳腺CT成像平臺IzoView商業化的上市公司,該平臺用於更準確地檢測和診斷乳腺癌。為了加快患者和供應商使用IzoView的速度,Izotroy的初步臨牀研究打算證明診斷性乳房CT成像比診斷性乳房X光檢查程序具有更好的性能。在後續的臨牀研究中,Izotroy公司打算驗證平臺應用,包括放射學中的乳房篩查、外科腫瘤學中的治療計劃和監測,以及整形和重建外科中的乳房重建和植入監測。

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

欲瞭解有關Izotroy公司的更多信息,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. 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.

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信息和陳述:“預期”、“相信”、“設想”、“估計”、“預期”、“打算”、“可能”、“計劃”、“預測”、“項目”、“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。這些陳述不是對業績的保證,涉及風險,包括與資本要求有關的風險,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,以反映新的信息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信息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。所有圖片僅用於説明目的。IzoView尚未獲準出售。

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