IZOZF - Izotropic Files Class II Pre-Submission with FDA & Releases Details on Predicate Devices

(TheNewswire)

V ancouver , BC – TheNewswire – S eptember 6, 2023 – IzotropicCorporation (“ Izotropic ” orthe “ Company ”) (CSE: IZO ) (OTC: IZOZF )(FSE: 1R3 ), a medical device company commercializing IzoView, a CT(computed tomography) imaging system, that produces images of anatomyfor non-invasive tissue characterization with the first application inbreast imaging, announced today that it has completed a pre-submissionapplication to the U.S. Food and Drug Administration (FDA) to solidifyits plans to initially pursue market clearance for IzoView as a Class II device through a 510(k) pre-market notification submission with the following Indication for Use :

ThelzoView CT Imaging System is intended to produce cross-sectionalimages of anatomy that can be imaged in the 30 cm aperture by computerreconstruction of x-ray transmission data for non­invasivevisualization of tissue.

ThelzoView CT Imaging System is indicated for use in the non-invasivevisualization of breast tissue, as an adjunct tool to mammography, byproviding x-ray computer reconstructed images as an aid for qualifiedhealthcare providers.

Upon an anticipated acceptance of the pre-submissionapplication from the FDA, the Company intends to complete the510(k)-submission using pre-existing data from phantom images obtainedfrom the IzoView system located in its engineering facility in Sacramento, California, later this year, withthe objective of obtaining market clearance in the second half of2024. Receiving this regulatory clearance would enable Izotropic tobegin marketing and selling IzoView CT Imaging Systems in theU.S.

The Company also intends to secure collaborations withnotable hospitals to utilize IzoView as an investigational device.Such partnerships are expected to generate clinical data that wouldsupport new IzoView products and Indications for U se for new regulatory submissions in the future. See theattached (below) Figure 1:Go To Market Plan .

Explanation of Changes: Class IIIPre- Market Approval to ClassII 510(k)

In June of 2023, Izotropic announced that it was modifying its FDA market approval pathway and strategy by deferring its plan toundertake a Class III device classification requiring Pre-MarketApproval (PMA). The decision to seek regulatory clearance as a ClassII device resulted after the completion of an operational plan estimated that costs to market (including aclinical study on human patients) would be three times higher thaninitially predicted before factoring in operating costs (at least $10+million in pre-commercial regulatory investment), and the timelinetwice as long as initially anticipated at a conservative four years toobtain market approval under the Class III PMA pathway.

Under the Class III pathway, Izotropic was seeking FDAapproval for IzoView Breast CT to be used as a stand-alone diagnosticimaging device through a clinical study comparing its capabilitiesagainst current standard-of-care breast diagnostic modalities,including diagnostic mammography, tomosynthesis, and breastultrasound. Under the Class II pathway, Izotropic is seeking FDAclearance for the IzoView CT Imaging System to be indicated for breasttissue characterization, adjunct to mammography, an aid for healthcareproviders, with an intended use to produce CT images of anatomy. TheIzoView CT Imaging System is fully engineered and is easilyretrofitted to accommodate imaging of other body appendages such ashands and feet. The Class II pathway affects both the way Izotropicpresents IzoView and the parameters in which IzoView will initially beused by providers in a healthcare setting as a broader investigationalimaging device.

Supporting Class II 510(k)Pathway

According to the FDA, a “510(k) requiresdemonstration of substantial equivalence to another legally U.S.marketed device. Substantial equivalence means that the new device isas safe and effective as the predicate. A device is substantiallyequivalent if, in comparison to a predicate it: has the same intendeduse as the predicate; and has the same technologicalcharacteristics as the predicate; or has the same intended use as thepredicate; and hasdifferent technological characteristics and does not raise differentquestions of safety and effectiveness; and the information submitted to FDAdemonstrates that the device is as safe and effective as the legallymarketed device. A claim of substantial equivalence does not mean thenew and predicate devices needs to be identical. ”

Given these parameters, Izotropichas selected two predicate devices to support it's Class II 510(k)pathway in discussions with the FDA: CurveBeam HiRise and NeuroLogica OmniTom .

The following predicate table, Figure 2: Izotropic Class II Device SubmissionPredicates , showcases select information,including Intended Use and Indication for Use statements for all threedevices. IzoView is comparable, with each system having specificanatomical indications.

Figure 2: Class II Device Submission Predicates .

Given the similarities to the CurveBeam HiRise andNeuroLogica OmniTom devices that are already cleared for sale in theU.S., Izotropic is proceeding confidently with its plans under theClass II 510(k) regulatory pathway.

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 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.

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[1] http­­s://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

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