Elbit Medical sets goals on image-guided therapy

MRI offers real-time view of ultrasound effect

Elbit Medical Imaging (EMI) is preparing to test the strength of the market for noninvasive image-guided therapy. The Israeli investment and holding company has been infusing capital into an MRI-guided ultrasound treatment initiative for the past four years. The resulting system has passed its first regulatory hurdle and is ready for commercial sale in Europe.

Credit for developing the noninvasive ultrasound technology lies with EMI's subsidiary, InSightec Image-Guided Treatment. InSightec was formed after EMI sold imaging assets, which had been marketed through its Elscint subsidiary, to Picker and GE in November 1998 but retained intellectual property in focused ultrasound therapy. GE added its expertise in image-guided treatment, and the high-tech subsidiary launched in January 1999. Shares are currently split between EMI (54%) and GE (20%), with InSightec employees holding the remainder.

EMI's large and continuous investment in InSightec's R&D has been supported by profitable real estate investments, according to Yitzhaki Shimon, EMI president. Results released in June show EMI's income for Q1 2003 increased 24% to $25.3 million compared with the same period last year, while gross profit rose 53% to $7.9 million.

The company owns a growing string of Plaza Center shopping malls throughout Central and Eastern Europe. Its second subsidiary, Elscint, operates a chain of hotels in Western Europe under the Park Plaza brand and has just opened an exclusive entertainment center in Israel. Elscint sold its remaining interests in manufacturing, assembling, and engineering of diagnostic imaging technologies in December 2002.

"We have invested almost $20 million each year in InSightec," Shimon said. "It can be very difficult to raise this kind of money. But if you have a company with a good cash flow, like we have from the hotels and shopping centers, then there is no problem."

InSightec's system relies on the heating power of a tightly focused ultrasound beam to clot blood vessels and "cook" problematic tumors. The technology is integrated in GE's Signa 1.5T closed-bore MRI unit and controlled from the scanner console. Operators can monitor the procedure on anatomical images by using real-time MR thermometry.

"It has been known for many years that high-intensity focused ultrasound can coagulate tissue inside the body without damage to surrounding tissue," said Jacob Vortman, CEO of Insightec. "However, the lack of real-time feedback kept the technology from becoming a clinical system. We needed a technique that would give the user real-time feedback on the area being targeted inside the body and the outcome of that therapy."

The image-guided system is currently approved for use in Europe and Israel as an outpatient procedure for women with painful uterine fibroids, offering a noninvasive alternative to hysterectomy. Hospitals can purchase the integrated ultrasound technology for $1 million, providing they already have the requisite MR scanner.

"Our system is highly integrated with GE's MR scanner. Reaching this level of seamless integration required a lot of effort from our side and from GE's side, and we have no plans to do it with any other MRI," Vortman said.

FDA approval for the uterine fibroid procedure is still in process. Vortman is hopeful it will be completed by the end of 2003, allowing U.S. commercial sales to begin in 2004. Research is also under way to apply therapeutic ultrasound to the treatment of benign breast fibroadenomas and brain tumors. Liver and bone tumors could be next on the list, Vortman said.

"We planned from day one that this would be a modular system, so by changing and adding modules we could address as many applications as possible," he said. "Many different clinical applications will eventually find their way to this image-guided system."