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Devices Radiology Regulatory

 News Release - July 9, 2007

biospace med Introduces Cutting-Edge, Low-Dose Orthopedic X-ray Imager

PARIS and ATLANTA, July 9 (HSMN NewsFeed) -- biospace med, developer of the EOS ultra-low dose 2D/3D orthopedic X-ray imager, announced today the achievement of three significant milestones.

On the heels of obtaining its CE mark for marketing EOS in Europe and receiving approval from the Health Canada Medical Device Bureau, biospace med has filed a 510k application with the FDA to seek clearance to market EOS in the United States.

In addition, the first two commercial installations have been completed and are now operational in Bordeaux, France and Pecs, Hungary. Four other Canadian and European hospitals have been involved during the R&D phase of development and performed over 3,000 images of both adult and pediatric cases.

About the EOS imager

EOS ultra-low dose 2D/3D is based upon a patented particle detector technology for which Georges Charpak received the Nobel Prize in Physics. This detector, which allows images to be obtained with a low dose of radiation, is part of a system that is capable of very long length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan.

EOS differs in several respects from a traditional X-ray or CT. One of the most important features is the ability to capture an accurate, undistorted, full or partial body image with a large reduction in radiation dose. In addition, multi-planar images are obtained simultaneously in an upright, weight-bearing position, which is unavailable with CT. Whole body, standing position imaging is especially valued by orthopedic surgeons when examining spine and joint alignment.

At St. Justine Hospital for Children in Montreal, Canada, over 1,000 pediatric patients with spine deformities, such as scoliosis, have had EOS long-length imaging at very low dose, which is particularly important, as children are much more sensitive to the harmful effects of radiation.

A U.S. Government study, to be published next year, determined that the per capita radiation dose from clinical imaging exams has risen by 600% between 1980 and 2006, with a major contributor being CT exams, whose numbers have increased over 20 times during this period(1). "EOS low dose and image formats can make an important contribution toward reducing unnecessary radiation exposure for otherwise clinically indicated X-ray exams," explained Marie Meynadier, CEO of biospace med.

How EOS works

The patient stands in the imager and a vertical drive mechanism moves a "C" arm down the height of the patient, or any desired length. The "C" arm contains two separate imaging systems capable of simultaneously capturing both a frontal and side image.

The highly sensitive X-ray detector enables low-dose image capture, creating a "head to toe" image within approximately 20 seconds for an adult and about half as long for shorter pediatric patients. The fully digital system produces a front and side view of the patient, which is instantly available for viewing. Unlike standard X-rays, there is no film, no need to adjust for distortion and no need to digitally stitch together multiple images.

biospace med has developed an advanced workstation, which is designed to generate a 3D skeletal image from the two planar images. It will automatically determine a variety of angles and posture calculations between individual bones, enabling new ways to more globally evaluate a patient's postural abnormality. This workstation is not part of the company's 510(k) notice and is currently not available for sale in the U.S.

About biospace med

biospace med has developed a patented X-ray particle detector, which led to an X-ray imaging system that can simultaneously capture multi-planar, full- body X-rays with large reductions in radiation. The company's lead product, EOS ultra-low dose 2D/3D, allows full-body imaging of patients in a weight- bearing position. An advanced workstation, designed to generate a 3D skeletal image from the two planar images, has been developed. The company has corporate headquarters in Paris and Atlanta with an office in Montreal, and is targeting a $2 billion orthopedic imaging marketplace. biospace med is venture-backed by a pool of investors led by Edmond de Rothschild Investment Partners. Learn more at

(1) Rabin, RC, "With Rise in Radiation Exposure, Experts Urge Caution," New York Times, June 19, 2007.

Source: biospace med

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