Izotropic Completes Pre-Submission Meeting With U.S. FDA
Izotropic Completes Pre-Submission Meeting With U.S. FDA
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.
不列颠哥伦比亚省温哥华--(新闻文件公司-2023 年 11 月 1 日)- Izotropic Corporation(CSE:IZO)(场外交易代码:IZOZF)(FSE:1R3) (”Izotropic“或者”公司“)是一家商业化CT(计算机断层扫描)成像系统izoView的医疗设备公司,该系统可生成用于非侵入性组织表征的解剖图像,并将其应用于乳房成像。该公司今天宣布,它完成了先前宣布的与美国食品药品管理局的提交前会议。
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.
会议的目的是讨论公司的提交前申请,获得反馈并确认后续步骤。Izotropic的管理、技术和工程团队成员及其FDA顾问Matrix Medical Devices出席了会议。
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.
这次会议使Izotropic得以阐明其修订后的监管战略,该战略侧重于扩大510(k)途径下的预期用途和市场授权。尽管需要与该机构就该监管战略的细节进行进一步的讨论,以确保其可行性,但美国食品和药物管理局似乎对该公司新的市场许可方向持开放态度。
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.
按照要求并出于同意的目的,在进一步披露之前,Izotropic将向FDA提交会议记录供其审查。
ON BEHALF OF THE BOARD
代表董事会
Mr. Robert Thast, CEO
Cell: 604-220-5031
首席执行官罗伯特·萨斯特先生
手机:604-220-5031
Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
联系人:
电子邮件:info@izocorp.com
免费电话:1-833-IZOCORP ext.1
About Izotropic
关于 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.
有关Izotropic Corporation的更多信息,请访问其网站izocorp.com,也可以在sedar.com上查看其在SEDAR上的个人资料。
Forward-Looking Statements
前瞻性陈述
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 “前瞻性陈述” 的陈述,这些陈述基于公司管理层、业务的当前估计、假设、预测和预期及其对运营所在相关市场和经济环境的了解。公司尽可能尝试使用 “预期”、“相信”、“设想”、“预期”、“预期”、“打算”、“可能”、“可能”、“计划”、“预测”、“项目”、“目标”、“潜力”、“将”、“可能”、“应该”、“继续”、“考虑” 等词语来识别此类信息和陈述尽管并非所有前瞻性陈述都包含这些识别性词语,但与讨论未来事件、趋势或前景或未来运营或财务业绩有关的表述和衍生词。
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.
这些陈述不是业绩保证,涉及风险,包括与资本要求和难以控制或预测的不确定性有关的风险,因此,它们可能导致公司活动的未来业绩与此类声明的内容和影响显著不同。前瞻性陈述仅自发表之日起具有相关性,除非法律另有要求,否则公司没有义务更新或修改任何前瞻性陈述以反映新信息或未来事件或情况的发生。公司及其股东、管理人员和顾问均不对任何人根据本文所含信息采取的任何行动和行动(包括但不限于购买或出售公司证券)承担任何责任。本文件中的任何内容均不应被视为任何形式的医疗或其他建议。所有图像仅用于说明目的。izoView 尚未获准出售。
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