Development of Breast CT
Breast CT was invented and developed initially as an academic pursuit by Drs. John M. Boone and Thomas R. Nelson along with many graduate students and senior academic collaborators at UC Davis. Nearly two decades of research and development and approximately $20 million USD in grant funding have been invested into developing this groundbreaking breast CT imaging technology.
Commercialization efforts began when Izotropic obtained the exclusive global licensing rights to the technology.
Trials & Data
Four successive working breast CT models have been built and tested at UC Davis Medical Center, each incorporating efficiencies and new cutting-edge technological advancements as they became available. Advancements include breast positioning design, tabletop modifications, positioning aids, x-ray detector and x-ray tube technologies, specialized x-ray beam shaping filters, and many other subtleties that improved the imaging system’s clinical performance and contributed to the current, very high-resolution imaging capability.
The specialized knowledge garnered by the iterative and evolutionary nature of the development of Breast CT at UC Davis is a highly-valued asset that will allow the Company to complete the design of its first commercial platform and expectantly deliver a superior product to the market.
Currently, the University of California, Davis is conducting an NIH-funded clinical evaluation on an additional 400 women. At the same time, the company, in collaboration with the UC Davis team and StarFish Medical, a design, engineering and manufacturing firm, is developing a fifth, commercial-ready system. This system will be used for regulatory approval, market launch, and commercial sales.
Izotropic is in the unique position and intends to use data collected from breast CT prototypes and clinical trials funded by the NIH in the FDA approval process of the Izotropic Breast CT Imaging System. Using existing data would result in a substantial reduction in clinical study costs, reducing the timeline associated in bringing breast CT to market and expediting return on investment.
The Commercial Model
In Q2 2020 Izotropic engaged StarFish Medical, Canada’s largest medical device design, development and contract manufacturing company, to complete the final design and development of the Company’s commercial breast CT model.
FDA Approval of Breast CT
In Q2 2020 Izotropic engaged company advisor and FDA Consultant, Anita Nosratieh Ph.D., to develop and manage the Company’s application for FDA medical device approval of its dedicated Breast CT Imaging System.
The first stage towards FDA approval is focused on developing a detailed pre-submission strategy and application, which will be managed by Nosratieh. Her extensive experience includes a position as a lead reviewer at the FDA in the approval process of breast cancer screening and diagnostic devices.
The pre-submission meeting provides the opportunity to open a dialogue and obtain FDA feedback prior to the actual submission for medical device approval, resulting in a smoother and more efficient approval process which may expedite patient access to breast CT. Tasks associated with the application include finalizing product and indication for use statements, device labelling terms, and clinical and validation study designs to verify future breast CT marketing claims.
The Company expects the development and submission of the application for the pre-submission meeting to be completed within 8-10 weeks. An interactive period of clarifying questions may then be entered into, resulting in a formal written response from the FDA. The typical timeline for the formal response is 90 calendar days. Once the formal written response is received, the Company can schedule the pre-submission meeting.