Vancouver, British Columbia--(Newsfile Corp. - January 30, 2024) - 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 characterization of tissue with an application in breast imaging, announces that further to its January 8th disclosure, it has received a response from the U.S. FDA.
The FDA's mammogram and ultrasound team has responded to Izotropic with additional questions regarding its pre-submission seeking definitive guidance on a Class II 510(k) pathway. The FDA had previously agreed in writing to provide a more definitive response to Izotropic within the month of January. Izotropic's management, regulatory, and engineering teams will respond to the FDA's questions and will promptly report the outcomes of the FDA's response once it becomes available.
As of the date of this news announcement, there has been no material change to the Company's regulatory plans and no definitive decision provided by the FDA.
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 be found 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 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 has not yet been approved or cleared for sale.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/196131
SOURCE: Izotropic Corporation
