Description of the Invention
Each year, worldwide, more than 2 million women are diagnosed with breast cancer, the second most common cancer in women. Breast cancer accounts for approximately 26% of all cancers diagnosed today. The NIH estimates that in the USA alone, in 2017, there were over 250,000 new cases diagnosed and ~ 40,000 deaths from breast cancer. 1 in 8 women are expected to be diagnosed with breast cancer in their lifetimes. Like other cancers, breast cancer is most successfully treated if the disease is caught early. There is universal consensus that early and regular screening for breast cancer is important; if breast cancer is detected sufficiently early, the 5-year survival rate generally exceeds 95%. Mammography is typically used for screening; however for much of the population, most notably, women with dense breasts, x-ray mammography misses too many cancers. The sensitivity of x-ray screening decreases from 86-89% in women with fatty breasts to an unacceptable 62-68% for women with extremely dense breasts (Kerlikowske 2011; Carney 2003). Magnetic resonance imaging (MRI) is sometimes used for supplementary screening of women at high risk for breast cancer, but the cost of purchasing and operating MRI systems limits widespread use.
Molecular Breast Imaging (MBI), developed by company’s founding scientist, employing injected radiotracers that accumulate in metabolically active tissue to visualize cancerous tissue, is effective in detecting more breast cancers in women with dense breast tissue than a mammogram alone. The company has developed a novel, large LD-PEM sensor that seamlessly ‘tiles’ numerous independent sensor blocks to achieve full coverage of an entire breast without gaps and dead zones. Our patent-pending solid-state technology facilitates construction of a full-size detector that enables simultaneous image acquisition of the entire breast. This means image acquisition is rapid (high clinic throughput). Highly sensitive radiation detection enables high-resolution, low-dose molecular breast imaging.
Organ-specific PET imaging for breast cancer
FDG emits a signal detected simultaneously in 2D sensor arrays
Large sensor area for sensitive reconstruction of 3D images
Current benchmarks indicate that the radiation exposure with a LD-PEM scan could be comparable to x-ray mammography, allowing low dose functional breast imaging screening for a much wider risk profile
Molecular breast imaging was pioneered by the Radialis CSO, Dr. Alla Reznik while she worked for General Electric. The field was further advanced by Radialis co-founder, Dr. Irving Weinberg who developed the first Positron Emission Mammography system for Naviscan. Radialis’ imaging system is dramatically more sensitive than any other molecular breast imaging device on the market. High imaging sensitivity means that the system will be able to more accurately stage cancers while requiring clinically-significantly-lower doses of radiotracers.
Finished product development, about to start U.S. FDA registration（501K）
breast cancer, low dose, positron emission