IZOZF - Izotropic Completes Pre-Submission Meeting With U.S. FDA
(TheNewswire)
VANCOUVER, BC, November 1, 2023 – TheNewswire – Izotropic Corporation (“ Izotropic ” or the “ Company ”)(CSE: IZO ) (OTC: IZOZF )(FSE: 1R3 ), a medical device company commercializing IzoView, a CT(computed tomography) imaging system, that produces images of anatomyfor non-invasive tissue characterization with an application in breastimaging, announced today that it completed its previouslyannounced pre-submission meeting withthe U.S. FDA.
The purpose of the meeting was to discuss theCompany’s pre-submission application, obtain feedback and confirmnext steps. The meeting was attended by Izotropic's management,technical and engineering team members, and its FDA consultant, MatrixMedical Devices.
The meeting allowed Izotropic to clarify its revised regulatorystrategy , whichfocuses on a broadened intended use and market authorization under the510(k) pathway. While further discussionwith the agency regarding the details of this regulatory strategy willbe required to ensure its viability, the FDA appeared open to theCompany’s new market clearance direction.
As is required and for the purposes of concurrence,Izotropic will submit meeting minutes to the FDA for their reviewprior to any further disclosure.
ON BEHALF OF THE BOARD
Mr. Robert Thast, CEO
Cell: 604-220-5031
Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
About Izotropic
More information about Izotropic Corporation can befound on its website at izocorp.com and by reviewing its profile on SEDAR at sedar.com.
Forward-Looking Statements
This document may contain statements that are"Forward-Looking Statements," which are based upon thecurrent estimates, assumptions, projections, and expectations of theCompany's management, business, and its knowledge of the relevantmarket and economic environment in which it operates. The Company hastried, where possible, to identify suchinformation 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" andother similar expressions and derivations thereof in connection withany discussion of future events, trends or prospects or futureoperating or financial performance, although not all forward-lookingstatements contain these identifying words.
These statements are not guarantees of performance andinvolve risks, including those related to capital requirements anduncertainties that are difficult to control or predict, and as such,they may cause future results of the Company's activity to differsignificantly from the content and
implications of such statements. Forward-LookingStatements are pertinent only as of the date on which they are made,and the Company undertakes no obligation to update or revise anyForward-Looking Statements to reflect new information or theoccurrence of future events or circumstances unless otherwise requiredto do so by law. Neither the Company nor its shareholders, officers,and consultants shall be liable for any action and the results of anyaction taken by any person based on the information contained herein,including, without limitation, the purchase or sale of Companysecurities. Nothing in this document should be deemed to be medical orother advice of any kind. All images are for illustrative purposesonly. IzoView is not yet approved for sale.
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