OrthoScan replaces x-ray imaging with touchy-feely approach

Finger sensor provides 3D data about spine

OrthoScan Technologies has devised a novel way to image spinal deformities, one that eliminates the need for ionizing radiation. The system, Ortelius800, produces 3D views of the backbone using a fingertip sensor and a set of computer algorithms. The tool is being marketed as an x-ray-free alternative for diagnosing and monitoring vertebral deformity in young, growing patients.

Approximately 3% to 4% of teenagers worldwide are diagnosed with an abnormal curvature of the spine known as scoliosis. Around 5% of the general population is also thought to have kyphosis, another cause of spinal irregularity. Patients diagnosed with either condition typically undergo regular radiographic scanning to monitor the effect of treatment. These frequent checks are particularly important for adolescents, whose skeletons are still maturing, according to Yehiel Tal, vice president of international marketing and business development for OrthoScan.

"If somebody is growing very fast, the deformity can also progress very fast," he said. "In a matter of months, required treatment can change from a corset to surgery."

Periodic examinations with radiography can expose patients to excessive radiation, particularly if they are children. Studies with the Ortelius800 have no such drawback. Touch-sensitive position sensors monitor the progression of scoliosis or kyphosis, providing regular updates.

Practitioners wearing a fingertip sensor palpate a patient's backbone from the cervical spine downwards. Three-D spatial coordinates registering the sensor's position are relayed to a computer, which uses the accumulated examination data to reconstruct three separate views of the spine: posterior-anterior, sagittal, and apical. This 3D information helps boost the accuracy of physicians' diagnoses, Tal said.

"Scoliosis is a 3D curvature. If you try to characterize it using x-ray radiographs, which are only 2D, you get partial information," he said.

Tal cites the system's mobility, ease of use, and cost-effectiveness as significant advantages over x-ray and MR scanners. Ortelius800 can simply be plugged into a 110 V or 220 V power supply and operated by physical therapists, assistants, or nurses after just a couple days' training, he said. It is the lack of radiation, however, that OrthoScan is concentrating on as the key selling point.

"This was basically the drive to develop the product," Tal said. "A typical scoliosis patient has to undergo monitoring three times a year, on average, with x-ray radiographs. And the patients do not know that the intensity of x-ray radiation for scoliosis radiographs is higher than, for example, a chest x-ray, by a factor of 10 to 20."

A relative newcomer to the medical imaging scene, OrthoScan was founded in 2000 by a group of private investors and entrepreneurs, and it currently employs around 20 staff. The company's main office is in Sherborn, MA, while all R&D and production is carried out in Yokneam, Israel.

General practitioners and spine surgeons throughout Europe were the first to test the fledgling company's initial product offering, which was first granted the CE mark and has since passed FDA review. Ortelius800 systems have been installed in France, Turkey, Spain, Italy, Sweden, Finland, and Denmark. OrthoScan is taking steps to expand its distribution network in Germany, France, and the U.K.

"We are trying to focus on opinion leaders in the field of spine surgery," Tal said. "After establishing this customer base, we will gradually start activities in the U.S. market."

Launch of Ortelius800 is just the first step toward OrthoScan's publicized mission, to become a premier supplier of radiation-free diagnostic products for the orthopedic market. A compact version of the imaging system, dedicated to screening school-age children for scoliosis, is in development.