IZOZF - Izotropic Updates Timelines for Clinical Study and Fabrication of Initial Izoview Units

(TheNewswire)

VANCOUVER, BC - TheNewswire – June 3, 2021 – Izotropic Corporation (“ Izotropic ” or the “ Company ”) (CSE: IZO ) (CNSX:IZO.CN) (OTC: IZOZF )(FSE: 1R3 ) a Company commercializing“Izoview”, a true 3D, dedicated Breast Computed Tomography (CT)imaging technology for the diagnostic identification of breastcancers, provides updates on the following:

• - Izoview, 5 th generation, enhanced product design forperformance improvements, added usability, increasing competitiveadvantages and target market

• - Clinical study and regulatory pathway for regulatoryauthorization and market preparation process

• - Product and clinical development milestones for theinitial Izoview device

Izotropic announced today it has completed acomprehensive review of its R&D strategy to yield a differentiatedoffering for the Company’s priority markets, while positioning thebusiness for continual innovation and disruptive breakthroughs. Acombination of Covid-19 related delays and discussions with keysuppliers of primary components for the Izoview system led the Companyto revise its original commercialization efforts, which has resultedin a more robust device design and capability. This will align theCompany’s core functions and commercial solutions for optimizationacross target customer needs as the competitive landscape evolves overtime.

Izoview: 5 th Generation Product and Target Market

The Company’s original strategy was to closely mirrorthe 4 th generation Breast CT device now under clinical investigationat UC Davis for the Company’s FDA study and finalize user andpatient handling requirements. As Covid-19 set in, the Company beganto factor in the evolving dynamics, the impacts on supply chains, andthe associated challenges of running a clinical study during apandemic. At the same time, next-generation primary components becameavailable and the Company therefore decided to adjust the businessplan to its benefit.  As a result, now going into the initialclinical study comparing Izoview with diagnostic mammography,Izotropic expects to deliver a better performing system, with asubsequent broader product offering and a more competitively pricedBreast CT system.

More than U.S. $25M has been invested across allaspects of the breast CT system, with the majority of this capital onR&D and clinical studies at UC Davis Medical Center, fundedprimarily by the National Institutes of Health in the U.S. Over thepast 2 years Izotropic has made specific investments related toengineering capabilities, onboarding personnel, and investigating andfinalizing the Izoview platform strategy. The Company has alsoadvanced its technical planning and documentation, sourced andpurchased critical components, implemented a quality managementsystem, which is all necessary to make Izoview a high-performingdevice for mass use.

Capital expenditures of late have resulted in internaland external engineering teams establishing platform functionality andconfirming that upgrade and testing plans will be optimal for thebreast imaging environment and compliant within relevant regulatoryjurisdictions.

In addition, the Company continues to invest in futureactivities associated with our initial clinical study and productlaunch, including logistics planning, and engagement with potentialcollaborators, insurance payors, hospitals, clinics, and patients.

The 4 th generation prototype at UC Davis was builtand tested by founder and director Professor John M. Boone Ph.D. andis currently being used in a university hospital setting for academicand clinical research purposes. The significance of upgrades toimprove performance is demonstrated by data published comparing4 th generation breast CT image performance against its predecessors. Thelatest model at UC Davis was built using state-of-the-art technologyof its day that enabled over three times higher resolution compared to the initial prototype (Gazi et al.2015) .  In addition to hardware improvements,Izotropic is developing new image reconstruction software utilizingthe latest machine learning algorithms to deliver both high resolutionand low noise images at low radiation dose levels. Aside from improveddetection capabilities, Izotropic anticipateshigher resolution 3D images could provide more accurate marginanalysis (viewing edges of a tumor), lesion characterization(determining the qualities of an abnormality for accurate diagnosis),and higher spatial resolution (the imaging ability to differentiatebetween internal breast structures) (Aminololama-Shakeri et al.2016) . The Company intend sto investigate these aspects in follow-on clinical studies afterinitial market authorization.

The initial target market for Izoview is in the U.S.and consists of over 8,500 hospitals and diagnostic imaging clinicsthat may benefit from having one or more Breast CT imaging units(GlobalData 2019).

When considering market positioning, 3D breast imagingis currently conducted mainly with costly and time-consumingMRI. Izoview’s dedicated 3D breast imaging system shields the restof the body from radiation and acquires images in approximately 10seconds. Izotropic intends to price the Izoview system at less thanhalf the price of whole-body MRI.

Izotropic’s revenue streams will include capitalequipment sales, lease payments, or pay-per-use, providing customerswith options which meet their unique needs. Additional revenue itemswill include maintenance contracts, sterile disposables, softwarefeature upgrades, and additional hardware modules.

Clinical Study and RegulatoryPathway

Initial market launch is planned for the U.S. withother jurisdictions to follow. The U.S. FDA requires a Pre-MarketApproval (PMA) with the Company’s proposed clinical study designbeing developed by Izotropic Advisor Dr. Craig Abbey, who has servedon breast imaging device Scientific Review Panels for the FDA. Thepurpose of the clinical study is to demonstrate superior performanceof diagnostic breast CT imaging over diagnostic mammographyprocedures. The overall study will take an estimated 18-24 monthswhich includes the requirement for 12-month follow-up to confirm thatdiagnosed negative cases remain negative. During the negative casevalidation period, Izotropic will be focused on building customerinterest, expediting additional platform applications, testing modulesand accessories, and initiating new clinical studies for additionalindications of use within the Breast CT platform.

“We’re setting up to increase customer appeal withmore add-ons and building in additional revenue streams. Izotropicplans to offer solutions across the gamut of breast health care,including screening and diagnosis in radiology, treatment planning andmonitoring in surgical oncology, and breast reconstruction and implantmonitoring in plastic and reconstruction surgery”, said CEO Dr. JohnMcGraw.

Izotropic is collecting and incorporating feedback tofinalize the clinical study design through its partnership with ExciteInternational, a global network of insurance payors, health systems,clinician scientists, and end-users. This process is designed toincrease speed of global adoption upon regulatory approval. Details ofthe initial clinical study and study partners will be issued in apress release prior to the commencement of the study.

Product and Clinical DevelopmentTimelines for Izoview

Due to the Covid-19 pandemic and the materialadjustments to the initial business plan, the Company’s timelineprojections for clinical development have changed. Anticipatedmilestones are now as follows:

Anticipated Milestones

Q3 2021

• - 3D imaging reconstruction software implementationbegins

  - Mechanical and electrical design completed

  - Clinical trial design finalized

Q4 2021

• - Completion of industrial design

  - Izoview fabrication begins and initial device build

  - Clinical trial site selection

Q1 2022

• - Reconstruction software pipeline complete

  - Medical device certification including electrical,radiation, and mechanical

  - First device with demonstration of image quality on aphantom

Q2 2022

• - First human breast imaging on Izoview

  - Clinical trial device units begin production andfirst Izoview unit is shipped to begin clinical study

Q3 2022

• - Module building and testing for additionalproducts

  - Customer interest initiatives

  - Design second clinical study

Dr. John McGraw commented, “To recap, when I joinedIzotropic the initial business plan was to essentially duplicate thecurrent Breast CT model with minor upgrades and submit one Izoviewunit in a small clinical study to fast-track market approval. AlthoughCovid-19 limited progress and the ability to expedite our plans,recent advancements, new opportunities, and collaborations havematerialized to enhance the Izoview system and expand our productpipeline for the future. There are a greater number of applicationsfor Izoview than initially envisioned. While the primary focus isobtaining market authorization and commercializing Breast CT as adiagnostic imaging device, the revised business plan now is to exploreand provide solutions and applications across women’s breast healthand I am committed on every level to execute on this aggressiveplan.”

ON BEHALF OF THE COMPANY

For investor relations inquiries,contact:

James Berard
Email: jberard@izocorp.com
Cell: 778-228-2314
Toll Free: 1-833-IZOCORP ext.1

References

Aminololama-Shakeri S, Hargreaves JB, Boone JM,Lindfors KK (2016) Dedicated Breast CT: Screening Technique of theFuture. Curr Breast Cancer Reports 8:242–247. https://doi.org/10.1007/s12609-016-0227-2

Gazi PM, Yang K, Burkett GW, et al (2015) Evolution ofspatial resolution in breast CT at UC Davis. Med Phys 42:1973–1981. https://doi.org/10.1118/1.4915079

Forward-Looking Statements

This document may contain statements that are“Forward-Looking Statements,” which are based upon the currentestimates, 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 Companynor its shareholders, officers, and consultants, shall be liable forany action and the results of any action taken by any person based onthe information contained herein, including without limitation thepurchase or sale of Company securities. Nothing in this documentshould be deemed to be medical or other advice of any kind.

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