VANCOUVER, BC, November 1, 2023 – Izotropic Corporation (“Izotropic” or the “Company”) (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), 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.
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.
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.
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.
ON BEHALF OF THE BOARD
Mr. Robert Thast, CEO
Toll Free: 1-833-IZOCORP ext.1
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.