VANCOUVER, BC – TheNewswire - May 15, 2023 – Izotropic Corporation (“Izotropic” or the “Company”) (CSE:IZO) (OTC:IZOZF) (FSE:1R3), a medical device company commercializing IzoView, a dedicated breast CT (computed tomography) imaging platform, for the more accurate detection and diagnosis of breast cancers, announces the Company conducted a pre-submission meeting with the FDA on April 28, 2023 to present a detailed and updated protocol and accompanying statistical analysis plan (SAP). The SAP is a technical document that outlines the analytical approach of the data that is gathered during the clinical study. The new protocol proposes a reduced patient number and broader device comparator to our original submission which could also reduce overall recruitment time. The completion of the SAP is a critical step and must be completed prior to study initiation as it determines the patient numbers and how all data will be analyzed for statistical significance of the primary endpoint, as well as analysis of additional exploratory and other endpoints.
At the suggestion of the agency from our initial meeting, key details on the clinical workflow that incorporated operational considerations from the Company’s clinical study hospital partners was also discussed. The focus was to indicate and incorporate potential clinical benefits for patients participating in the study.
CEO Dr. John McGraw commented, “overall this was a very productive meeting as part of our ongoing discussions with the FDA under the pre-market approval submission process. The ongoing dialogue with the agency provides support for a clinical study design that is aligned with all corporate, commercial, and clinical objectives. The agency suggested further meetings be held to review the various technical aspects of the device while the study is underway, which will include testing protocols and hardware and software device characteristics. These future meetings aim to streamline our path to market and ideally reduce the normal review time by the agency on the final regulatory submission for approval. An initial response from this submission is expected in approximately four weeks and any resulting material
development will be announced when received”.
The Company notes that it is also investigating different 510(k) pathways for market clearance and will continue discussion with the agency focused on bringing IzoView to market as efficiently as possible.
ON BEHALF OF THE BOARD
John McGraw, CEO
Investor Relations Contact:
Toll Free: 1-833-IZOCORP ext.1
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.
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.
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