A next-generation screening device from Israel’s Real Imaging is good news for millions of women with dense breasts
The “Real Imager 8” (RI-8) device from Israel’s Real Imaging is poised to become a safer, painless and more accurate screening method to complement mammography, especially for women with dense breast tissue.
As the company finishes clinical trials and approaches the market stage, it has signed on major new investors from the life-science and med-tech fields in Canada and Hong Kong including China Everbright, the largest investment bank in Hong Kong.
The device is particularly appealing to China and other Asian-Pacific countries where incidence of breast cancer is rising, CEO Maiki Yoeli says.
The technology was innovated by serial inventor and electro-optical engineer Boaz Arnon, who lost his mother to breast cancer in 2004. Determined to find an accurate, cost-effective screening alternative to mammography, he invented MIRA (for Metabolic Imaging and Risk Assessment).
MIRA objectively assesses imaging biomarkers associated with metabolic processes in the breast tissue, explains Dr. David Izhaky, Real Imaging’s vice president for research and development.
“A cancer is smarter than us and will trick the human body such that our body will generate blood vessels and a specific environment to enable the tumor to grow and expand,” Izhaky explains. “Those metabolic changes precede the anatomic ones. Once detection is targeted to this stage, there is a good chance that the cancer can be caught at a very early stage.”
He adds that “instead of inviting women for screening based on age, we’d like to invite them for screening based on risk. It is all about risk, and if that risk can be followed over time, we might be able to prevent cancer.”
In the general world population, most women under 40 years old — and 40 percent of women over the age of 40 — have dense breasts. Plus, the majority of Asian women have dense breast tissue. This in itself is considered a risk factor for cancer. But dense tissue also makes mammography much less effective as a screening tool.A tumor usually appears as a white object on a mammogram because of its density. If the entire breast is dense, however, a tumor is much more difficult to see when the radiologist analyzes the image. “The way it’s often described is like trying to find a polar bear in a snowstorm,” says Yoeli.Women with dense breasts therefore must be screened with an additional modality such as ultrasound, or undergo an invasive exam such as an MRI. Yoeli explains that the RI-8 device isn’t necessarily meant to replace mammography but to become the standard adjunct system for breast cancer screening for women with dense breast tissue. And, he adds, “The MIRA test is less expensive than other imaging alternatives.”
The device is now in advanced clinical trials in Israel and at the Karolinska Institute in Sweden, with two additional trials beginning in major US cancer centers. The RI-8 has already received the CE Mark in Europe, and Real Imaging is applying for additional regulatory approval from the US Food and Drug Administration and agencies in other countries.
“We have done clinical trials in six medical centers in Israel, and have imaged hundreds of women,” says Yoeli. “In one peer-review published blind study, the efficacy of the technology demonstrated a sensitivity above 90 percent, and even higher for women with dense breast tissue.”
Dr. Miri Sklair-Levy, director of the Breast Imaging Center at Israel’s Sheba Medical Center, was the principal investigator in some of the early clinical trials. She reported that “preliminary results suggest that MIRA technology imaging has both high sensitivity for the detection of breast pathology and high specificity.” Moreover, at last year’s meeting of 60,000 American and European radiologists at the Radiological Society of North America, Real Imaging’s technology presentation was voted a promising innovation and was highlighted in the conference bulletin.
“We believe our technology will lead the fight against breast cancer,” says Izhaky.
Published by the Israel Ministry of Foreign Affairs, 28 July 2014