Izotropic Files Pre-Submission Application with U.S. FDA
Vancouver, British Columbia--(Newsfile Corp. - August 18, 2020) - Izotropic Corporation (CSE: IZO) (OTC Pink: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company") is pleased to announce that it has filed a Pre-Submission Application with the U.S. Food and Drug Administration (FDA) marking the beginning of the market approval process for the Company's commercial Breast CT Imaging System.
The Pre-Submission Application filing has been a highly anticipated event for the Company and is a major milestone for the inventors, stakeholders and advocates for breast CT and women's health.
Principal Founder and Company Director, Dr. John Boone; Company FDA Consultant, Dr. Anita Nosratieh; and Company Executive VP of Commercial Operations, Dr. John McGraw provided comments on the filing:
Dr. John Boone: "I have been working on the development of breast CT for over 20 years; we scanned the first patient using cone beam breast CT in 2004, scanned the first cancer patient in early 2005, and performed the first contrast-enhanced breast CT exam in 2006. It is so satisfying to see this exciting first step towards having our breast CT technology become a clinical reality. I take my cues from the breast imaging radiologists that I have worked with for decades, as they feel that breast CT images will indeed have an important role to play in breast cancer imaging. I am simply thrilled to be a part of this team."
Dr. Anita Nosratieh: "The pre-submission process is a mechanism to obtain feedback on both clinical and non-clinical testing needed to support market approval, ensuring the most efficient path forward. For the Company, this means not wasting any time or resources on studies that will not generate the evidence needed to demonstrate safety and effectiveness. I am passionate about advancing women's health and received my doctoral training under John Boone before I joined the U.S. FDA to regulate these types of products. Now to be directly involved in helping this become a reality that will benefit many women is not only a privilege but also a personal dream come true."
Dr. John McGraw: "It's been my experience that early engagement with regulatory agencies such as the FDA helps companies move smoothly and efficiently through the regulatory process and Izotropic has the team to drive and manage the process. This filing is a critical step for the Company and will help to accelerate corporate activities and provides confidence to customers and stakeholders that the management team can achieve our objectives as scheduled."
The Company believes Breast CT will become a prominent and widely adopted imaging modality in the years to come and it looks forward to working with the FDA and completing the application process, in order to expedite patient access to its Breast CT Imaging System.
The Company will continue to announce updates to keep its shareholders informed as to its progress and timelines towards the pre-submission meeting, FDA approval processes and US payor adoption of its Breast CT Imaging System.
ON BEHALF OF THE BOARD
Chief Executive Officer
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.
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