VANCOUVER, BC – February 23, 2023 – Izotropic Corporation (“Izotropic” or the “Company”) (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a medical device company commercializing IzoView, a dedicated breast CT (computed tomography) imaging platform, for the more accurate detection and diagnosis of breast cancers, releases statements from select key members of its technical and scientific teams advocating for the commercialization and clinical capabilities of breast CT technology for the very first time.
Dr. John M. Boone, Ph.D., is the founder of breast CT technology at UC Davis Medical Center, from where Izotropic licensed the exclusive global technology rights to develop IzoView. Beginning with a feasibility grant from the National Institutes of Health and approximately $20 million USD in subsequent grant funding, four successive breast CT research scanners were built and tested in clinical trials at The Boone Lab at UC Davis:
“We’ve done extensive studies on mammo[graphy], tomosynthesis, and breast CT… As we looked at the data, it was clear that when you have contrast-enhanced breast CT, it can virtually replace all other diagnostic examinations, including mammo[graphy], tomo[synthesis], ultrasound, and even MR (Magnetic Resonance Imaging).” – Dr. John M. Boone
Dr. Shadi Shakeri, MD, FSBI, a fellowship-trained radiologist, specializes in breast imaging, including digital mammography, tomosynthesis, breast computed tomography, ultrasound, and magnetic resonance imaging. Dr. Shakeri has been in charge of the clinical aspects of breast CT clinical trials since 2017 at UC Davis. Her work has included clinical study design, recruiting, speaking to patients, and viewing and evaluating breast CT images, making her a unique authority on the capabilities and validity of breast CT technology:
“When we started using contrast with the breast CT, the data that we saw, the images that we saw just blew you out of the water… there was just no comparison at all to mammography… I have seen, actually, cancers that are centimeters in size, so walnut-sized cancers that you absolutely have no idea exists in that breast when you look at it with either a traditional mammogram or tomosynthesis images. You take that same patient with that same walnut-sized cancer, and you do a breast CT with contrast, and it lights up like a lightbulb that you can see from across the room, and there is no doubt in anyone's mind that that is something that needs to be pursued, biopsied so that the patient can move on and get her treatment." – Dr. Shadi Shakeri.
Dr. Craig Abbey, Ph.D., is a professional Researcher at the University of California, Santa Barbara, where his interests include modeling human observer strategies for performing visual tasks in the presence of image noise and other degradations and assessment of medical imaging devices and image processing in terms of performance in diagnostic and quantitative tasks. As a leader in his field, Dr. Abbey has served as a Scientific Reviewer for the FDA, where he sat on independent review panels to evaluate reader studies proposed by companies seeking FDA approval of medical imaging devices. Notably, Dr. Abbey sat on the independent review panel for the approval of Hologic's Digital Breast Tomosynthesis and U-System's Automated Breast Ultrasound System (ABUS).
Dr. Abbey has been working closely with Izotropic on the design of its forthcoming clinical study for USA market authorization as a diagnostic device:
“Medical imaging devices go through a special process at the FDA… the imaging device is only as good as it helps the radiologist make an accurate decision, and so what you have to demonstrate in order to get through the FDA is that your imaging device will lead to greater diagnostic accuracy in radiologists… I have great hopes for the breast CT device, and I believe it is capitalizing on something that will be very useful and very beneficial to the women who undergo it. But the beauty of these studies is that it really doesn't matter what my hopes and dreams are. The study is designed to demonstrate it, or not." – Dr. Craig Abbey.
Click here to see the full statements from Dr. Boone, Dr. Shakeri, Dr. Abbey, and more.
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About Izotropic Corporation
Izotropic Corporation is the only publicly traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers. To expedite patient and provider access to IzoView, Izotropic's initial clinical study intends to demonstrate the superior performance of diagnostic breast CT imaging over diagnostic mammography procedures. In follow-on clinical studies, Izotropic intends to validate platform applications, including breast screening in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstructive surgery.
This document may contain statements that are "Forward-Looking Statements," which are based upon the current estimates, assumptions, projections, and expectations of the Company's management, business, and its knowledge of the relevant market and economic environment in which it operates. The Company has tried, where possible, to identify such information 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" and other similar expressions and derivations thereof in connection with any discussion of future events, trends or prospects or future operating or financial performance, although not all forward-looking statements contain these identifying words.
These statements are not guarantees of performance and involve risks, including those related to capital requirements and uncertainties that are difficult to control or predict, and as such, they may cause future results of the Company's activity to differ significantly from the content and implications of such statements. Forward-Looking Statements are pertinent only as of the date on which they are made, and the Company undertakes no obligation to update or revise any Forward-Looking Statements to reflect new information or the occurrence of future events or circumstances unless otherwise required to do so by law. Neither the Company nor its shareholders, officers, and consultants shall be liable for any action and the results of any action taken by any person based on the information contained herein, including, without limitation, the purchase or sale of Company securities. Nothing in this document should be deemed to be medical or other advice of any kind. All images are for illustrative purposes only. IzoView is not yet approved for sale.