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Mirabel Medical Systems: Startup gets money for breast cancer test By Robert Elder Mirabel Medical Systems Inc., an Austin-based startup awaiting federal approval of its promising breast cancer-screening technology, has attracted new investment and an expanded clinical trial for the U.S. Army. Mirabel is expected to announce today that it has received an additional $9 million in investment from Stockton Partners and Denali Ventures, among other investors. The company also has received a second $1 million grant to expand clinical trials for the U.S. Army, which started studying the company's device last year. Army officials say their interest stems from the large number of minority female soldiers. African American and Hispanic women are more likely to develop breast cancer. Mirabel's "T-Scan" system uses a low-level electric current to assess the risk of breast cancer in women younger than 40. Tests for U.S. Federal Drug Administration approval, which is pending, were conducted in part in Austin. Even if it's approved, it probably will be close to two years before Mirabel's machines hit the market. The Mirabel device could fill a gap in screening for the disease. X-ray mammography isn't generally recommended for women younger than 40 — its effectiveness is limited in examining the relatively dense breast issue of younger women — and physical self-examination is far from a surefire way to detect problems early on. "We believe this technology can be used very inexpensively and very simply alongside a clinical breast exam," said Dr. Ron Ginor, Mirabel's CEO. "It's another tool for women with increased risk of breast cancer." There are about 250,000 U.S. women under 40 living with breast cancer, according to the company. Eventually, Ginor said, he thinks that the device's screening for breast cancer could become another routine test, like pap smears and blood tests for prostate cancer. The T-Scan works this way: A woman lies flat on an examination table, holding a device about the size of two D-size batteries in her hand. The device sends a low-level current through her body. Cancerous and healthy cells affect the current differently, and the machine provides a detailed reading of any anomalies. During the exam, a technician runs a probe over the woman's breasts to provide a detailed image of the findings. The findings don't pinpoint or conclusively identify cancer. Rather, they help identify early stage tumors and precancerous lesions; a positive T-Scan result indicates a woman is at significantly higher risk. Dr. Mark Akin, an Austin physician who treated patients with T-Scan as part of the FDA trial, likens the screening to a pap smear, which looks for abnormalities on the cervix. Ginor said the machines will cost about $40,000 each, and physicians are likely to charge about $50 for each exam. That's about half the cost of a X-ray mammogram, but X-rays generally are covered by health insurance. Ginor said it usually takes one to two years after FDA approval for insurers to agree to cover a new procedure. But the company already has compiled "exhaustive financial analyses" to try to bolster its case for insurance coverage, Ginor said. Akin said insurers' reaction is a wild card for Mirabel. "As a physician, dealing with them every day, I don't have a clue what insurers will decide", he said. "But I think (acceptance) will evolve because a significant percentage of women who get cancer at a young age have small children, active careers and face losing 40 to 50 years of their expected lifespan." The company has published medical research that looks at other uses for the device, Ginor said. These include evaluating nodules on thyroids and detecting skin cancer, among other possible applications. Ginor, a radiation oncologist, founded Mirabel in 2003. Investors have put in $20 million so far. The company acquired the technology from an Israeli company, Trans Scan Medical. Israeli venture firm Denali Ventures funded both Trans Scan and Mirabel. Ginor was a partner in Denali from 2000 to 2003, when he founded Mirabel. Ginor also helped found Medinol Ltd., a coronary stent company. Medical-devices giant Boston Scientific Corp. acquired licensing rights from Medinol in 1998. Ginor said he put Mirabel in Austin because of the region's breadth of technical workers. He worked with Dell Inc. to modify the computers that power the T-Scan devices. Further, Ginor said he needed a young, tech-savvy city where women would be more likely to accept screening. "Here, a 35-year-old woman is quite sophisticated about technology," Ginor said. "They expect it." Mirabel Medical Systems Closes $9 Million Funding AUSTIN, TEXAS, April 5, 2005 – Mirabel Medical Systems, developer of the T-Scan™
breast cancer screening system, closed a $9 million second-round of funding
today. The over-subscribed round was led by Stockton Partners, a New York based
private equity firm. The funding will allow Mirabel Medical to continue plans to
bring the T-Scan™ 2000 ED to market over the next 12 months. Mirabel Medical Systems, T-Scan and the T-Scan 2000ED are trademarks of Mirabel Medical Systems, Inc. All other company or product names are the registered trademarks, or trademarks of their respective owners. Mirabel Medical Systems Inc. |