IZOZF - Izotropic Reports High Degree of Confidence after Pre-Submission Meeting with FDA
(TheNewswire)
VANCOUVER, BC - TheNewswire - December15, 2020 - IzotropicCorporation (" Izotropic " orthe " Company ") (CSE: IZO ) (C NSX : IZO. CN ) (OT C : IZOZF ) (FSE: 1R3 ) announces it has received the finalizedmeeting minutes from the U.S. Food and Drug Administration (FDA) inconnection with the Company's recent pre-submission meeting and themarket approval process for its commercial BreastCT Imaging System.
Dr. John McGraw , Executive Vice-President of Commercial Operations, stated,"I am pleased to report that the meeting with the FDA was verybeneficial for Izotropic and the comments received have validated ourclinical study plan and development efforts to date. The initialindication for use for breast CT as a diagnostic device has beenconfirmed, and we have come away from the meeting with a high degreeof confidence in our U.S. market approval plan movingforward."
At the October 20 th , 2020 meeting, company representationincluded the scientific and commercialization teams, engineering andregulatory advisors, and the project management team from engineeringfirm StarFish Medical . The meeting focused on 4 key areas: product and indicationfor use statements, device labeling terms, and clinical and validationstudy designs to verify future breast CT marketing claims. The Company's scientific and commercialization teams met after receiving the finalized minutes andfeedback from the FDA and have set action items to accelerateobjectives focused on engineering, clinical trial planning, and payorengagements to bring breast CT to the market.
Dr. McGraw further commented on the future ofIzotropic: "Looking ahead, we have a strong treasury and capableteams with which to execute all aspects of our current business plan.We are advancing towards important forthcoming business objectives,including identifying additional indications for use, accessories, andadditional products, all aimed at making breast CT an indispensabletool for improving the outcomes of breast cancer."
ON BEHALF OF THE BOARD
Robert Thast
Chief Executive Officer
For investor relations inquiries contact:
Dan Sammartino
Phone: 1-778-962-0234
Email: IR@izocorp.com
For general inquiries contact:
Izotropic Corporation
Phone: 1-833-IZOCORP
Email: info@izocorp.com
About Izotropic Corp.
Izotropic Corporation and its wholly owned U.S.operating subsidiary, Izotropic Imaging Corp. have been established tocommercialize the next generation of breast imaging technology forearly diagnosis of breast cancer. The Izotropic Breast CT ImagingSystem produces high resolution breast images in 3D. A single 10second breast CT scan acquires approximately 500 images, withoutpainful breast compression, providingradiologists with fully 3D viewing of the scanned breast. Mammographyscanning requires compression of the breast between 2 imaging plates,resulting in 2D images.
The Company has the exclusive worldwide license fromthe University of California, Davis to commercialize the technologydeveloped by principal founder and Company director Dr. John M. Booneand researchers at UC Davis. The license includes all intellectualproperty, trade secrets, patents and patent-pending applications thatare the foundation of the Company’s breast CT imaging platform.
Approximately $20 million in research funding and over15 years of research and development have been invested in developingthis groundbreaking breast CT imaging technology. Research includes acurrent, ongoing $2.9M U.S. clinical trial at UC Davis Medical Center.
The Company founders believe that this technology willbe a disruptive entry to the market, overcoming many of the challengesfaced by existing breast imaging modalities.
Forward Looking Statements
This document may contain forward-looking statementsthat are based on the Company's expectations, estimates andprojections regarding its business and the economic environment inwhich it operates. These statements are not guarantees of futureperformance and involve risks and uncertainties that are difficult tocontrol or predict. Therefore, actual outcomes and results may differmaterially from those expressed in these forward-looking statementsand readers should not place undue reliance on such statements.Statements speak only as of the date on which they are made and theCompany undertakes no obligation to update them publicly to reflectnew information or the occurrence of future events or circumstances,unless otherwise required to do so by law.
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