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Israeli Med Tech Mazor Surgical Technologies Set To Lauch First Product
By Estee Pierce
4/26/2004
Caesarea, Isreal -- With market approvals in hand from regulatory groups in both the U.S. and Europe, venture-backed Israeli medical device start-up Mazor Surgical Technologies will launch its robotics platform, SpineAssist, for use in pedicle screw insertion for spine fusion procedures.

The product is slated to debut in July, Mazor's Chief Executive Ori Hadomi told VentureWire. SpineAssist's chief feature is a robotic device, about 2.3 inches long, that is light enough – at 250 grams - to be attached to a patient's spine. This "robot" is linked to software loaded with pre-operative Computer-Aided Tomography, or CT, images. Using these images, a surgeon may program in advance where on the spine a screw needs to be inserted.

Hadomi believes SpineAssist has an edge over competitors' products - it offers more guidance, he says. And, importantly, it costs less.

The pedicle screw placement surgery is an increasingly popular treatment for patients with trauma-induced fractures, as well as in reconstructions of the spine after degenerative or scoliotic disease. According to Mazor's estimates, each year more than 500,000 of the surgeries are performed in the U.S. alone. But while the surgery is great when it works, it is notoriously risky. Should a doctor miss the destination site on the spine by even a millimeter, a patient could be paralyzed for life.

Today there are two methods to navigate through the vertebrae to insert screws in the spine. One is the long-standing free hand approach, where a surgeon goes in directly to the spine to insert a five-millimeter wide screw. This is an invasive and traumatic procedure, Hadomi said, one that requires the exposure of bone, increasing risk of infection and causing blood loss.

More recently, some med tech firms have developed navigational mega-systems that use optical motion tracking software so doctors can remotely track the location of surgical tools relative to anatomic features. The most popular of these systems, Stealth Station, is sold by med tech giant Medtronic Sofamor Danek Inc. There are also a number of upstart navigational platforms being commercialized by private, venture-backed firms, such as Munich, Germany-based BrainLAB, which sells the VectorVision platform for orthopedic surgical navigation, and CBYON, a Mountain View, Calif.-based firm that also sells visualization tools for use in spine surgery.

So how exactly does this SpineAssist system differ from currently available navigational devices?

"It's just like the difference between taking a taxi and driving a car with a GPS system," Hadomi said. During the SpineAssist procedure, the robot directs the doctor to the location on the spine drilling should take place, right down to the trajectory and angling of the drill, eliminating the need to open the back and expose the bone. "What we provide is basically a cab service for surgeons, so that once they know to identify on the CT where they want to place the screw, all they need to do is mount the SpineAssist on the vertebrae." Such a process could take much of the risk out of the operation, Hadomi believes.

Caesarea, Isreal-based Mazor has tested the SpineAssist system in surgeries at the Cleveland Clinic Foundation in Ohio, as well as at several spine centers in Israel, including Sheba Medical center, Rabin Medical Center and Carmel hospital.

Suzanne Ratzloff, a medical technology analyst who serves as president of market research provider Health Research International, noted that the functional differences between the high-end navigational systems and SpineAssist are analogous to those between a desktop computer and a laptop. "The former is a large, stationery system that can be used across a broad spectrum of applications but which usually involves substantial user training, dedicated user interface (that is, the individual must "come to it," so to speak) and a real commitment by the company and/or end-user to integrate it into the normal work flow," she said.

While SpineAssist will face the same sort of challenges as any other new medical technology, Ratzloff said she believes its advantages over cumbersome navigation systems will give it an advantage in routine clinical use.

There's also the price, Hadomi said. SpineAssist will cost a hospital roughly $100,000 for equipment, and an additional $900 or so per patient for the disposable clamp. Major navigational systems can cost more than three times this amount, he said.

So is Mazor gearing up for its robot to play David to big med tech's Goliath? Not at all says Hadomi. He is more than willing to negotiate. "We believe that there is synergy between our agenda and between the big players in the area." He noted that while industry giant Johnson & Johnson is a shareholder in the company - through past investments made by its venture affiliate Johnson & Johnson Development Corp. - the company has no commercial rights to Mazor's product, nor any distribution rights. "We do work with them closely and of course consider the synergies, but welcome the collaboration with others," he said.

Mazor was founded in 2001 as an incubator company of Technion, in order to house inventions by Moshe Shoham, head of the institute's robotic laboratory. The company has raised about $9.5 million to date from investors including Johnson & Johnson Development Corp., the Shalom Equity Fund, Alice Ventures, DOR Ventures and Proseed Venture Capital.

http://www.mazorst.com