IZOTROPIC REPORTS HIGH DEGREE OF CONFIDENCE AFTER PRE-SUBMISSION MEETING WITH FDA
Izotropic Corporation (“Izotropic” or the “Company”) (CSE: IZO) (OTC US: IZOZF) (FSE: 1R3) announces it has received the finalized meeting minutes from the U.S. Food and Drug Administration (FDA) in connection with the Company’s recent pre-submission meeting and the market approval process for its commercial Breast CT Imaging System.
Dr. John McGraw, Executive Vice-President of Commercial Operations, stated, “I am pleased to report that the meeting with the FDA was very beneficial for Izotropic and the comments received have validated our clinical study plan and development efforts to date. The initial indication for use for breast CT as a diagnostic device has been confirmed, and we have come away from the meeting with a high degree of confidence in our U.S. market approval plan moving forward.”
At October 20th, 2020 meeting, company representation included the scientific and commercialization teams, engineering and regulatory advisors, and the project management team from engineering firm StarFish Medical. The meeting focused on 4 key areas: product and indication for use statements, device labeling terms, and clinical and validation study designs to verify future breast CT marketing claims. The Company’s scientific and commercialization teams met after receiving the finalized minutes and feedback from the FDA and have set action items to accelerate objectives focused on engineering, clinical trial planning, and payor engagements to bring breast CT to the market.
Dr. McGraw further commented on the future of Izotropic: “Looking ahead, we have a strong treasury and capable teams 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, and additional products, all aimed at making breast CT an indispensable tool for improving the outcomes of breast cancer.”
ON BEHALF OF THE BOARD
Chief Executive Officer
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About Izotropic Corp.
Izotropic Corporation and its wholly owned U.S. operating subsidiary, Izotropic Imaging Corp. have been established to commercialize the next generation of breast imaging technology for early diagnosis of breast cancer. The Izotropic Breast CT Imaging System produces high resolution breast images in 3D. A single 10 second breast CT scan acquires approximately 500 images, without painful breast compression, providing radiologists with fully 3D viewing of the scanned breast. Mammography scanning requires compression of the breast between 2 imaging plates, resulting in 2D images.
The Company has the exclusive worldwide license from the University of California, Davis to commercialize the technology developed by principal founder and Company director Dr. John M. Boone and researchers at UC Davis. The license includes all intellectual property, trade secrets, patents and patent-pending applications that are the foundation of the Company’s breast CT imaging platform.
Approximately $20 million in research funding and over 15 years of research and development have been invested in developing this groundbreaking breast CT imaging technology. Research includes a current, ongoing $2.9M U.S. clinical trial at UC Davis Medical Center.
The Company founders believe that this technology will be a disruptive entry to the market, overcoming many of the challenges faced by existing breast imaging modalities.
Forward Looking Statements
This document may contain forward-looking statements that are based on the Company’s expectations, estimates and projections regarding its business and the economic environment in which it operates. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to control or predict. Therefore, actual outcomes and results may differ materially from those expressed in these forward-looking statements and readers should not place undue reliance on such statements. Statements speak only as of the date on which they are made and the Company undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances, unless otherwise required to do so by law.