FDA Consultant Joins Izotropic Advisory Board
Vancouver, British Columbia--(Newsfile Corp. - May 20, 2020) - Izotropic Corporation (CSE: IZO) (OTC Pink: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company") is pleased to announce that Anita Nosratieh Ph.D., as a new member of the Company's Advisory Board.
Nosratieh began her career as a lead reviewer at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) where she worked with companies seeking approval of breast cancer screening and diagnostic devices. As lead reviewer, she gained first-hand knowledge of the standards and practices companies need to make it through the early stage development process to regulatory approval. Nosratieh then transitioned to be the FDA/CDRH's Senior Advisor for Innovation, working to shorten the time for FDA approval and patient access to medical devices. In this capacity, she worked directly with innovation incubators and accelerators, providing outreach and education on regulatory requirements for companies in the early stages of product development. She also managed the CDRH Payor Communication Task Force, a program that facilitates communication between device manufacturers and payors to potentially shorten the time between FDA approval or clearance and coverage decisions.
In 2016 she was a recipient of an Outstanding Service Award from the FDA in recognition of her dedication to the advancement of public health. She holds a doctorate in Biomedical Engineering and in her free time, she serves as a regulatory mentor in the Johns Hopkins University Business Plan Competition providing feedback to early stage life science companies.
Nosratieh left the FDA for a Managing Consultant position at Navigant Inc. in their Life Science practice. In this role, she advises manufacturers on regulatory requirements throughout the product life cycle.
"Anita has extensive experience with the early stage life science industry, having worked with dozens of companies in the preclinical and clinical stages of product development in a career path spanning government, consulting, and nonprofit sectors. Anita brings a unique skill set and valuable knowledge to an already strong scientific and medical advisory board. We are fortunate to have attracted her support and it is fair to say that the Company's confidence level has been elevated as we prepare to enter the FDA marketing stage. With the recently announced StarFish Medical partnership in place, the Company is also confident about its schedule for finalizing development of the first commercial Breast CT model for the market." - Robert Thast, CEO
The Company is also granting 100,000 stock options each to two new advisors at an exercise price of $0.20 per share for a 2- year term, expiring at the close of business on May 19, 2022. The options vest immediately.
ON BEHALF OF THE BOARD
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 (UC 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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