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home / news releases / IZOZF - Izotropic Reacts to Supply Chain Disruptions and Updates Izoview Engineering Timelines


IZOZF - Izotropic Reacts to Supply Chain Disruptions and Updates Izoview Engineering Timelines

(TheNewswire)



VANCOUVER, BC – TheNewswire - JUNE 29,2022 Izotropic Corporation (“ Izotropic ” orthe “ Company ”) (CSE: IZO ) (OTC: IZOZF )(FSE: 1R3 ), a company commercializing a dedicated breast CT (computedtomography) imaging platform, IzoView, for the more accurate detection and diagnosis of breastcancers , announces timeline updates for theinitial IzoView commercial prototype build.

  • Supply chain issues and unforeseen impacts onengineering work have resulted in an estimated delay of up to 3quarters to the Company’s previously projectedtimelines

  • Engineering teams are revising aspects of IzoView andbuilding redundancy into critical components to mitigate furtherdisruptions to the supply chain.

  • The clinical study design is being modified to allowfor a larger patient recruitment pool, consequently faster overallclinical study time and enhanced market acceptance.

The Company has been reacting and strategizing aroundwell-known trickle-down effects impacting global supply chains becauseof Covid-19. Supplier timelines for components necessary for IzoViewhave been rapidly changing and pushed back multiple times due tofluctuations in the supplier's component lead times. In reaction tothe instability, Izotropic’s engineering teams have redesignedinternal aspects to make IzoView a more flexible machine. This willreduce engineering risks to better maintain performance and mitigatefurther delays and dependence on specific components or suppliers.

In addition, the Company experienced unforeseen delaysin transitioning from its previous third-party engineeringfirm, StarFish Medical, toits in-house engineering and development team, now based inSacramento, CA. With the engineering transition, there were delaysthat included changing custom components towards more modularsubsystem parts that now allow for increased device flexibility,modular testing, and future expandability of the IzoView platform. TheCompany is now in complete control of the final development of IzoViewwith a strong engineering group and a mandate to continue to simplifyand streamline all aspects of development for flexibility and ease ofmanufacturing.

The Company now estimates that supply chain issues andother matters have set back previously projected timelines by 2 to 3quarters, putting validation, certification, and testing required forshipping of the first clinical prototype unitfor its clinical study out to Q1 2023. Updates on execution pointswill be regularly disclosed to shareholders going forward.

To further mitigate the impact of delays, the Companyhas taken advantage of panel discussions with EXCITEInternational to modify its clinical study design to expand the comparatorgroup. This will allow for faster participant recruitment by expandingthe number of eligible patients for the study, which in turn isexpected to decrease the overall length of the clinical study time.  This proposed change is also aimed at increasing market adoption ofthe device following market authorization and assisting in recapturingthe aforementioned time delays associated with IzoView’s overallcommercialization plan.

Izotropic continues its ongoing dialogue with the USFDA to obtain feedback on proposed modifications to the trial designas well as providing additional details on study plans prior to anInvestigational Device Exemption submission required to initiate theclinical study.

Izotropic is in advanced discussions with well-knownleading U.S. hospitals regarding clinical study participation, with afocus on sites with a high number of patients seen daily fordiagnostic imaging for breast cancer. These engaging discussions havealso provided input into future opportunities and new Breast CTproduct applications and indications. As part of the critical path tofinalize agreements with these key hospitals, the Company willfinalize its proposed clinical study revisions, obtain ethics approvaland work through contracting at each site.

The Company is engaging an independent ClinicalResearch Organization (CRO) to manage the clinical study and helpfacilitate these activities. After considerable due diligence onseveral specialty and prominent global CROs's the Company expects tofinalize and announce a comprehensive agreement in early July.

ON BEHALF OF THE BOARD

Dr. John McGraw, CEO

Investor Relations Contact:

James Berard

Email: jberard@izocorp.com

Cell: 778-228-2314

Toll Free: 1-833-IZOCORP ext.1

Media Inquiries Contact:

Jaclyn Thast

Email: jaclyn@izocorp.com

Toll Free: 1-833-IZOCORP ext.3

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 such information and statements byusing 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 derivationsthereof in connection with any discussion of future events, trends orprospects or future operating or financial performance, although notall forward-looking statements contain these identifying words. Thesestatements are not guarantees of performance and involve risks 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 forsale.

Copyright (c) 2022 TheNewswire - All rights reserved.

Stock Information

Company Name: Izotropic Corp
Stock Symbol: IZOZF
Market: OTC
Website: izocorp.com

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