Sunlight Omnisense™ 7000S Becomes the Only Bone Sonometer with FDA Approval
to Measure Multiple Skeletal Sites, Offering Practitioners Confidence and
Flexibility in the Diagnosis and Monitoring of Osteoporosis
Somerset, N.J., U.S.A. (June 19, 2001) Sunlight Medical Inc. today announced that the Sunlight Omnisense™ 7000S bone sonometer gained FDA approval for bone strength measurements at multiple sites. Additional skeletal sites will enhance the device's precision and measurement flexibility, offering physicians a better overall picture of bone health. Formerly approved in the United States for measuring only the distal radius (forearm), the Omnisense 7000S is successfully used internationally by practitioners at the point of care to assist in the diagnosis and management of osteoporosis. With its patented Omnipath™ technology, the Omnisense 7000S is the only multi-site ultrasound-based device available on the market today.
The use of multiple skeletal site measurements has been common in older technologies such as dual x-ray absorptiometry (DXA). Sunlight, however, is the first to incorporate the approach in an ultrasound device. "Sunlight's technology is on the cutting edge of osteoporosis disease management," remarked Markus Maritz, president of Sunlight Medical, Inc. "With the FDA approval, we can now bring this multi-site capability into the physician's office very effectively."
Osteoporosis, a systemic disease in which bones gradually become porous and are subject to fractures, develops at different rates in different bones. Strength assessment at several key points, as opposed to one, allows the physician to obtain data from all sites for a more accurate overall picture of skeletal strength. "Combining the results of cortical and cancellous bone, or weight bearing and non-weight-bearing sites, can optimize fracture risk assessment," explained Dr. Irit Yaniv, Sunlight's vice president and medical director. "This allows the physician to reach a more conclusive diagnosis."
"The potential of the Omnisense 7000S to perform multi-site measurements greatly expands the clinical utility of quantitative ultrasound," echoed Harry K. Genant, M.D., executive director of the Osteoporosis and Arthritis Research Group at University of California, San Francisco. "By measuring at several sites - such as the non-weight-bearing distal radius (forearm) and the weight-bearing metatarsal (foot) - the physician obtains improved confidence for the prediction of fracture risk in patients with suspected osteoporosis."
Dr. Yaniv advises that multi-site measurements enable the physician to identify and monitor even minor bone changes. Early postmenopausal bone changes can be monitored closely with a scan every two to three years, allowing the physician to take a proactive stance against osteoporosis. For diagnosed patients, the approval helps the physician to better track the disease's progress and the efficacy of its treatment. "Another clinical benefit of utilizing multiple skeletal sites is that it allows the physician to more easily track the effects of certain metabolic diseases, such as hyperthyroidism," according to Dr. Yaniv.
Sunlight Medical, Inc. is the North American subsidiary of Sunlight Medical, an international company headquartered in Israel. Sunlight develops, manufactures and markets cutting-edge medical devices for use in the office or clinic. Sunlight OmnisenseTM 7000S is sold in more than 30 countries and has gained wide recognition in the international medical community.
For more information on Sunlight Medical and the Sunlight Omnisense TM 7000S bone sonometer, contact Markus Maritz at (800) 750 6011 or Jean Vincent at (315) 685 6709 or (212) 879 5589.