Medical Device Daily Correspondent
ZICHRON YAAKOV, Israel – Breast cancer screening system developer Mirabel Medical Systems (Austin, Texas), closed an over-subscribed $9 million second-round of funding on April 5, led by Stockton Partners (New York), a private equity firm.
Mirabel said it plans to use the funds to bring its T-Scan 2000ED breast cancer screening system to market over the next 12 months with the focus on younger women.
Mirabel Medical was born in 1993 as TransScan Medical, in Migdal HaEmek, Israel, where the company continues to develop its proprietary, innovative electrical impedance scanning (EIS), at its research, development and manufacturing operations center.
Even though early detection is widely acknowledged as the best preventative of breast cancer disease and death, routine mammography in younger women is like using a hammer to kill a fly, because of the risk of exposure to X-irradiation.
"It appears that Mirabel Medical Systems is poised to transform breast cancer screening for younger women," said Ken Goldman, Stockton Partners managing director. "We are excited about working with this technology and this management team, and look forward to helping Mirabel Medical become the undisputed leader in the development of innovative cancer screening solutions."
Stockton Partners chairman Harvey Krueger, who is also vice chairman of Lehman Brothers, will be joining the Mirabel Medical board of directors.
T-Scan is the first system designed to be used in routine annual breast cancer risk screening in women ages 30 to 40, for wide-scale early detection of breast cancer, usually based on clinical breast exam (CBE).
EIS patented technologically is adapted to the more dense mammary tissue in younger women. The test is non-invasive, and harmlessly measures changes in impedance of low-level electric signals as they pass through breast tissue. Like an ultrasound, the painless 10-minute exam provides immediate results, identifying changes in signal flow patterns that point to an increased risk for breast cancer. Women determined to be at high risk for breast cancer following a T-Scan screening would be referred for mammography, decreasing screening costs and iatrogenic risk.
Mirabel has submitted a premarket approval application to the FDA for T-Scan 2000ED and it has been assigned expedited review status by the agency, based on its potential to provide clinically meaningful advantages over existing screening technology in women under 40 years of age.
"We are extremely encouraged by the strong support we've received from physicians involved in the clinical trials," said Mirabel president and CEO Ron Ginor, MD. "With more than 20,000 exams completed as part of our clinical development – and nearly 3,000 exams performed in just the last few months – we are convinced that this system will play a critical role in identifying young women who are at increased risk for breast cancer and who would most likely benefit from additional imaging."
The T-Scan 2000ED is currently available for investigational use only pending FDA approval. In 1999, an earlier version of the TS2000 underwent clinical trials in the U.S., Europe and Israel and received FDA approval as an adjunct to mammography.
The company anticipates that the updated device will be available on the commercial market in the next 12 months.
Breast cancer is the leading cause of cancer death in women between age 25 and 40, and will strike one of every 217 women by age 40.