IZOZF - Izotropic Completes QSUB Meeting With FDA Regarding Clinical Study Acceleration
(TheNewswire)
VANCOUVER, BC – TheNewswire - May 15, 2023 – Izotropic Corporation (“ Izotropic ” or the “ Company ”)(CSE: IZO ) (OTC: IZOZF )(FSE: 1R3 ), a medical device company commercializing IzoView, adedicated breast CT (computed tomography) imaging platform, for themore accurate detection and diagnosis of breast cancers, announces theCompany conducted a pre-submission meeting with the FDA on April 28,2023 to present a detailed and updated protocol and accompanyingstatistical analysis plan (SAP). The SAP is a technical document thatoutlines the analytical approach of the data that is gathered duringthe clinical study. The new protocol proposes a reduced patient numberand broader device comparator to our original submission which couldalso reduce overall recruitment time. The completion of the SAP is acritical step and must be completed prior to study initiation as itdetermines the patient numbers and how all data will be analyzed forstatistical significance of the primary endpoint, as well as analysisof additional exploratory and other endpoints.
At the suggestion of the agency from our initialmeeting, key details on the clinical workflow that incorporatedoperational considerations from the Company’s clinical studyhospital partners was also discussed. The focus was to indicate andincorporate potential clinical benefits for patients participating inthe study.
CEO Dr. John McGraw commented, “overall this was avery productive meeting as part of our ongoing discussions with theFDA under the pre-market approval submission process. The ongoingdialogue with the agency provides support for a clinical study designthat is aligned with all corporate, commercial, and clinicalobjectives. The agency suggested further meetings be held to reviewthe various technical aspects of the device while the study isunderway, which will include testing protocols and hardware andsoftware device characteristics. These future meetings aim tostreamline our path to market and ideally reduce the normal reviewtime by the agency on the final regulatory submission for approval. Aninitial response from this submission is expected in approximatelyfour 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 theagency focused on bringing IzoView to market as efficiently aspossible.
ON BEHALF OF THE BOARD
John McGraw, CEO
Investor Relations Contact:
Email: info@izocorp.com
Toll Free: 1-833-IZOCORP ext.1
About Izotropic Corporation
Izotropic Corporation is the only publicly tradedcompany commercializing a dedicated breast CT imaging platform,IzoView, for the more accurate detection and diagnosis of breastcancers. To expedite patient and provider access to IzoView,Izotropic's initial clinical study intends to demonstrate superiorperformance of diagnostic breast CT imaging over diagnosticmammography procedures. In follow-on clinical studies, Izotropicintends to validate platform applications, including breast screeningin radiology, treatment planning and monitoring in surgical oncology,and breast reconstruction and implant monitoring in plastic andreconstructive surgery.
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-Looking Statements are pertinent only as of the date on whichthey are made, and the Company undertakes no obligation to update orrevise any Forward-Looking Statements to reflect new information orthe occurrence of future events or circumstances unless otherwiserequired to do so by law. Neither the Company nor its shareholders,officers, and consultants shall be liable for any action and theresults of any action taken by any person based on the informationcontained herein, including, without limitation the purchase or saleof Company securities. Nothing in this document should be deemed to bemedical or other advice of any kind. All images are for illustrativepurposes only. IzoView is not yet approved for sale.
Copyright (c) 2023 TheNewswire - All rights reserved.