VANCOUVER, BC – February 19, 2020 – Izotropic Corporation (“Izotropic” or the “Company”) (CSE: IZO) (OTC US: IZOZF) (FRA: 1R3) Izotropic Corporation is pleased to announce that a notice of allowance has been received from the United States Patent and Trademark office (“USPTO”) for the patent application No. 15/669829, entitled “Measuring Breast Density Using Breast Computed Tomography”. This notice of allowance is the final step before the patent is formally issued.
This patent covers the use of Izotropic Corporation’s dedicated Breast CT Imaging System to measure breast density. Breast CT demonstrates greater accuracy than mammography, the current gold standard for cancer screening and measuring for breast density. This is an important development in the Company’s strategic plan which is expected to provide another competitive advantage and significantly impact both the adoption and use of the Company’s technology in a real-world setting. Dr. John Boone, Principal Founder and Director, elaborates below.
In February 2019, the U.S. Congress ordered the FDA to “establish a national minimum standard to include breast density information in mammography reports”, which would standardize the explanations of “the effect of breast density in masking the presence of breast cancer on a mammogram” in the reports received by patients after mammography imaging tests. More than 30 U.S. states now require personal breast density reporting.
According to the National Cancer Institute (NCI), nearly half of all women age 40 and older who get mammograms are found to have dense breasts. Dense breast tissue appears white on a mammogram- so do suspicious lesions and tumors. The density of the tissue as well as the compression required for mammography and tomosynthesis breast imaging could obscure abnormalities that may otherwise be further investigated if they were observed using these imaging modalities in non-dense breast tissue. Currently, only a mammogram can diagnose and confirm breast density. Dense breast tissue cannot be felt on a clinical or self-breast exam.
Comments from Dr. John Boone, Principal Founder and Director
“Breast density is important for two reasons (1) women with denser breasts are thought to have a higher risk of breast cancer, and (2) breast cancer is harder to detect using 2D mammography in women with dense breasts. In the world of health care where “personalized medicine” is now a widely accepted priority, an accurate assessment of breast density then sets the stage for designing each individual woman’s breast cancer screening protocol. Historically, breast density is judged subjectively on two-dimensional mammograms by the interpreting radiologist using a four-point scale. We have shown that the truly 3D volume data sets that are produced using breast CT result in more accurate quantitative estimates of breast density, and this approach significantly outperforms mammography. Therefore, Breast CT may play an important role in quantifying breast density as a woman enters her breast cancer screening years.
We have also shown using realistic and comprehensive computer simulations that breast CT, owing to its three-dimensional nature, suffers far less in detection probability than two-dimensional mammography in women with dense breasts. Hence, breast CT or the more expensive and time-consuming breast MRI, are likely to be better screening and diagnostic tools in women with dense breasts than 2D mammography.”
Understanding Breast Density
Radiologists use a grading system called BI-RADS (Breast Imaging Reporting and Data System) to categorize breast density. The NCI explains how breast density is measured. BI-RADS classifies breast density into four categories:
(A) Almost entirely fatty breast tissue, found in about 10% of women
(B) Scattered areas of dense glandular tissue and fibrous connective tissue (scattered fibroglandular breast
tissue) found in about 40% of women
(C) Heterogeneously dense breast tissue with many
areas of glandular tissue and fibrous connective tissue, found in about 40% of women
(D) Extremely dense breast tissue, found in about 10% of women
The Company will continue to file and prosecute key patents as an integral part of commercializing Breast CT. This welcome development comes weeks after the Company received a notice of allowance from the USPTO for patent application No. 11/913494, entitled “Biopsy Systems For Breast Computed Tomography”. A system based on thisintellectual property would give physicians the ability to image and obtain samples of suspicious lesions and tumors for pathology testing using the Company’s Breast CT Imaging System.
ON BEHALF OF THE BOARD
Robert Thast, Chief Executive Officer
Applied Radiology- FDA Breast Density Reporting Coverage
Radiologybusiness.com- Federal Law on Breast Density Reporting
National Cancer Institute- Dense Breasts
Izotropic Corporation- Patent Application No. 11/913494 Notice of Allowance News Release
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 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, fully funded $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.