Izotropic Files Pre-Submission Application With U.S. FDA for Breast CT Imaging System

VANCOUVER, BC - August 18, 2020 – Izotropic Corporation has announced the filing of a Pre-Submission Application with the U.S. Food and Drug Administration (FDA), initiating the market approval process for its commercial Breast CT Imaging System. This development is a major milestone for the company, its stakeholders, and advocates for breast CT and women’s health.

Dr. John Boone, Principal Founder and Company Director, expressed his satisfaction with this progress, highlighting his over 20 years of work on breast CT development. Dr. Anita Nosratieh, Company FDA Consultant, emphasized the importance of the pre-submission process in ensuring an efficient path forward by obtaining necessary feedback on clinical and non-clinical testing. Dr. John McGraw, Company Executive VP of Commercial Operations, noted the significance of early engagement with regulatory agencies like the FDA for a smooth regulatory process.

The Izotropic Breast CT Imaging System aims to transform breast cancer imaging by producing high-resolution 3D images without the need for painful breast compression, a common drawback of traditional mammography. The technology, developed by Dr. John M. Boone and researchers at UC Davis, has been supported by approximately $20 million in research funding and over 15 years of research and development, including a current $2.9M U.S. clinical trial at UC Davis Medical Center.

Izotropic Corporation holds an exclusive worldwide license from the University of California, Davis, to commercialize this innovative breast CT imaging technology. The company is optimistic about the future adoption of Breast CT as a prominent imaging modality and is committed to working closely with the FDA to expedite patient access to its system. Updates on the pre-submission meeting, FDA approval processes, and US payor adoption will be announced to keep shareholders informed.