Israeli device now in clinical trials avoids radiation, guesswork, discomfort and other downsides that make mammography an imperfect screening tool.
Early detection is the key to improving breast cancer survival rates, but mammography is not the ideal method to accomplish this goal. On this point, medical experts across the globe agree.
Not as clear is what could do the job without the disadvantages of mammography — which often causes pain or discomfort; emits radiation; cannot properly image dense breast tissue; relies on a radiologist’s interpretation of the image; and is not recommended for routine screening of women under age 40 or 50.
Of several approaches being developed worldwide, an Israeli solution pioneered by electro-optical engineer Boaz Arnon holds particular promise in providing a game-changing device for early detection of breast cancer.
Arnon’s mother, Ruth, succumbed to the disease in 2004. Through Real Imaging, the company he founded in 2006, he was determined to offer an accurate alternative that would address all issues of concern and still be cost-effective.
Appropriately named RUTH, the device he invented uses a new trademarked platform he calls MIRA (functional Multidimensional Infra-Red Analysis). Built on principles from existing technologies and mathematics, MIRA enables functional quantitative analysis of 3D and infrared signals emitted from cancerous and benign breast tissue.
“Our solution is not sensitive to age or breast density, and works without radiation,” Arnon tells ISRAEL21c. “We image the patient from a distance of 70 centimeters (25.5 inches), with no physical contact or radiation, and we have developed an automatic method that aims to detect breast cancer early, easily and as cheaply as possible.”
No more guesswork
“Physicians should be highly praised for their success rate in diagnosing breast cancer with the tools available today,” says Arnon, “but still, the death rate from breast cancer is unacceptable.”
Breast cancer is by far the most frequent cancer among women, with an estimated 1.38 million new cancer cases diagnosed in 2008 (accounting for 23 percent of all cancers), and is now the most common cancer both in developed and developing regions.
Though a medical doctor will oversee screenings with RUTH, “automatic” is one of its most key features. Results will not have to be interpreted by human eyes, thanks to the device’s unique process of calibration using mathematical algorithms formulated from three-dimensional models of hundreds of women with and without malignancies. The algorithms provide unprecedented accuracy, as Real Imaging has demonstrated in blind studies.
“Our sensitivity results show 90 percent accuracy for women of all ages,” says Arnon. By comparison, mammography usually is about 80 percent accurate, and not even that high in younger patients.
“This is not guesswork; it is science. We have proof we can explain clinically that our method is working,” he says.
More than 2,000 women have been involved in clinical trials for RUTH since 2007 at six Israeli hospitals – Hadassah-Ein Kerem in Jerusalem, Sheba Medical Center at Tel Hashomer, Beilinson Hospital and Assuta Medical Center in Tel Aviv, Meir Medical Center in Kfar Saba and Kaplan Medical Center in Rehovot. The entire procedure takes only a few minutes.
“We now have the fifth generation of the RUTH device,” says Arnon. “Before the end of this year, we will probably have one [being tested] in Europe as well.”
On sale as soon as 2012
The company aims to achieve CE approval this year, certifying that its product has met the health, safety and environmental requirements of the European Union, and will submit the product for approval from the US Food and Drug Administration the following year.
“We hope to start sales next year,” says Arnon, whose previous major successful invention was a Lumio virtual keyboard that can be projected on a surface.
He expects RUTH to cost less than mammography equipment but to be used, initially, as an adjunct to that existing methodology.
The device is manufactured in Israel and the company of 30 employees is based in Airport City near Tel Aviv. Arnon reveals that the proprietary technology might have other useful applications, “but right now we’re concentrating on this one. If we succeed in this area, we will have achieved our goal.”
Privately held until recently, Real Imaging raised $13 million from private investors in England, the United States and Israel. The firm is now being publicly traded on the Tel Aviv Stock Exchange following a reverse merger in May.
“We did quite a lot to bring this technology to reality,” says Arnon. The company’s management team includes people with expertise in manufacturing, physics, mathematics and finance, and is chaired by Prof. Moshe Many, vice chairman of TEVA Pharmaceuticals and president of the Ashkelon Academic College.
Real Imaging’s scientific advisory board consists of two US physicians – Edward Sickles, who served as chief of the Breast Imaging Section at the UCSF Medical Center in San Francisco for almost 30 years, and Michael Linver, director of mammography for X-Ray Associates of New Mexico and clinical professor of radiology at the University of New Mexico.