IZOZF - Izotropic Announces Meeting Date with FDA
(TheNewswire)
VANCOUVER, BC - TheNewswire - September 28, 2020 - Izotropic Corporation (" Izotropic " or the " Company ") (CSE: IZO ) (CNSX: IZO.CN ) (OTC: IZOZF ) (FSE: 1R3 ) is pleased toannounce that the Company's Executive and Scientific Advisory Teamswill meet with --the U.S. Food and Drug Administration (FDA) onOctober 20, 2020.
Further to the newsrelease issued August 18,2020, the Company filed a Pre-Submission Application with the FDAwhich began the market approval process for the Company's commercialBreast CT Imaging System.
The next step in this process is the pre-submissionmeeting where the Company will present and obtain feedback from theFDA on product and indication for use statements, device labellingterms, future marketing claims and study designs.
Study designs were developed by Advisor Dr. Abbey, who has served as a Scientific Reviewerfor the FDA where he sat on independent review panels to evaluatereader studies proposed by companies seeking FDA approval of medicalimaging devices. Notably, Dr. Abbey sat on the independent reviewpanel for the approval of Hologic's Digital Breast Tomosynthesis, andU-System's Automated Breast Ultrasound System (ABUS).
"This meeting with the FDA is asignificant ste--p towards finalizing clinical trial design which willenable the Company to efficiently move forward with clinical trialplanning. The pre-submission process allows the Company to invest itstime and financial resources more efficiently on studies that willgenerate the evidence needed to obtain FDA approval." said JohnMcGraw , PhD, EVP ofCommercial Operations.
The FDA pre-submission meeting is step5 in the Company's FDA ApprovalProcess Timeline , with an anticipated completiondate of May 2022. Material developments regarding market approvalapplications in the US and other contemplated jurisdictions will bedisclosed as they occur.
The Company believes Breast CT willbecome a prominent and widely adopted imaging modality in the years tocome and it looks forward to working with the FDA and completing theapplication process, in order to expedite patient access to its BreastCT Imaging System.
ON BEHALF OF THE BOARD
Robert Thast
Chief Executive Officer
Phone: 1-833-IZOCORP
Email: info@izocorp.com
Website: izocorp.com
About Izotropic Corp.
Izotropic Corporation and its whollyowned U.S. operating subsidiary, Izotropic Imaging Corp. have beenestablished to commercialize the next generation of breast imagingtechnology for early diagnosis of breast cancer. The Izotropic BreastCT Imaging System produces high resolution breast images in 3D. Asingle 10 second breast CT scan acquires approximately 500 images,without painful breast compression, providing radiologists with fully3D viewing of the scanned breast. Mammography scanning requirescompression of the breast between 2 imaging plates, resulting in 2Dimages.
The Company has the exclusive worldwidelicense from the University of California, Davis to commercialize thetechnology developed by principal founder and Company director Dr.John M. Boone and researchers at UC Davis. The license includes allintellectual property, trade secrets, patents and patent-pendingapplications that are the foundation of the Company's breast CTimaging platform.
Approximately $20 million in researchfunding and over 15 years of research and development have beeninvested in developing this groundbreaking breast CT imagingtechnology. Research includes a current, ongoing $2.9M U.S. clinicaltrial at UC Davis Medical Center.
The Company founders believe that thistechnology will be a disruptive entry to the market, overcoming manyof the challenges faced by existing breast imaging modalities.
Forward Looking Statements
This document may containforward-looking statements that are based on the Company'sexpectations, estimates and projections regarding its business and theeconomic environment in which it operates. These statements are notguarantees of future performance and involve risks and uncertaintiesthat are difficult to control or predict. Therefore, actualoutcomes and results may differ materially from those expressed inthese forward-looking statements and readers should not place unduereliance on such statements. Statements speak only as of the date onwhich they are made and the Company undertakes no obligation to updatethem publicly to reflect new information or the occurrence of futureevents or circumstances, unless otherwise required to do so bylaw.
Copyright (c) 2020 TheNewswire - All rights reserved.