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Sunlight Announces FDA Approval of Sunlight OmnisenseTM
Rehovot, Israel (January 23, 2000) Sunlight Medical today announced that it has received FDA approval for the sale of the Sunlight OmnisenseTM in the US. Omnisense, developed by Sunlight of Rehovot, Israel, is a unique medical device that assists physicians in the diagnosis of osteoporosis, one of the world’s most widespread diseases. Omnisense has been also approved for monitoring bone changes in women during the early years following menopause.

Omnisense is based on a patented, non-invasive ultrasound technology, and is designed to assess skeletal fragility. Its Speed of Sound (SOS) measurements can be used, in conjunction with other clinical risk factors, as an aid to physicians in the determination of fracture risk.

Omnisense is also the first non-X-ray based diagnostic device approved by the FDA for monitoring bone changes in women aged 50-65. "The 50-65 menopausal age range is where we see the sharpest decline in bone strength," according to Dr. Irit Yaniv, Medical Director at Sunlight. "The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a patient's measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years)," states Dr. Yaniv.

"We are very excited with the FDA approval of our PMA," said Dr. Chen Barir, Chairman and CEO of Sunlight. "Omnisense is already selling successfully worldwide, but the FDA approval is an important milestone in the global recognition of our technology, and will enable our penetration into the US market."

Osteoporosis is a metabolic disorder that causes loss of bone mass and strength and may ultimately lead to fractures and even death. Osteoporosis is a global epidemic; Over 200 million women worldwide are afflicted with osteoporosis. Forty percent of all women over the age of 60 will suffer an osteoporotic fracture, and approximately 20% of patients with a hip fracture will die within one year due to complications. Osteoporosis is now a treatable disease, but diagnosing patients early is crucial to successful treatment.

Omnisense offers a reliable alternative to expensive X-ray based devices that have been commonly used until now. In addition to its high precision and reliability, Omnisense is compact, cost-effective, user- and patient-friendly, and can be easily installed in any practice, large or small. A complete examination takes only a few minutes.

Sunlight is an international company, headquartered in Rehovot, Israel. It is a world leader in providing technology-intensive solutions for primary care clinics.