OMNISENSE 7000S/8000S

Clinical Summary #1

A New Method for Ouantitive Ultrasound 
Measurements at Multiple Skeletal Sites  

A study of Omnisense by pioneers and leaders in the fields of Osteoporosis and Ultrasound Technology

Reinhard Barkmann, Edvard Kantorovich, Chaim Singal, Didier 
Hans, Harry K. Genant, Martin Heller, and Claus-Christian Gluer 
Journal of Clinical Densitometry, Vol. 3, No. 1, 1-7, Spring 2000

Omnisense's unique technology (Omnipath™) and methodology yield reproducible results that effectively discriminate between fractured and non-fractured populations.

Technology
Omnisense is designed to measure the speed of sound (SOS) of ultrasonic waves axially transmitted along the bone. Axial transmission technology (Omnipath™) improves accuracy and precision by eliminating the effects of soft tissue and temperature. It also enables measurements on bones that were previously inaccessible. The article describes the innovative technology and methods used by Omnisense in clinical procedures.

Precision Testing
One aspect of this study was to determine Omnisense's precision, that is, its ability to yield reproducible results. Repetitive measurements were taken from healthy subjects to establish Omnisense's precision rating. Precision is given in terms of coefficient of variance or CV with a lower number indicating a better rating. Intra-observer precision errors ranged from 0.2% to 0.3% for triplicate measurements with repositioning at the measured sites. Inter-observer errors ranged from 0.3% to 0.7%.

Fracture Discrimination
Discrimination is a device's ability to differentiate between fractured and non-fractured populations. To determine Omnisense's discrimination ability, subjects with osteoporotic fractures were measured against a control group of healthy subjects. The results showed that Omnisense's SOS of the distal 1/3 radius were significantly lower in the fractured group. As a low SOS is the indicator for unhealthy bone, Omnisense's discriminating ability makes it suitable for fracture risk assessment.

Conclusion
Omnisense's patented technology and unique methodology give Omnisense superior precision and an enhanced ability to identify patients at risk for fracture. It is a useful device in the assessment of bone status by offering the possibility of measuring at a large variety of bone sites.

Osteoporosis
Bone Densitometry
''For better prevention, detection, diagnosis,
and treatments of Osteoporosis''
278 S. Lincoln St., Minster, OH 45865
Phone: 1-888-999-4774
Fax: 1-419-628-4005
Email: info@bonedensitometry.com

"As president, I have committed my company to providing medical facilities with "state-of-the-art" bone densitometry equipment to help them do a better job with preventing, testing for, screening for, detecting, diagnosing, and treating Osteoporosis which ravage so many women and men. Our diagnostic equipment will speed up the prevention, detection, diagnosis, and treatment of Osteoporosis and osteoporotic bone disorders in men and women. The key to preventing Osteoporosis in women and men is early detection, diagnosis, and treatment. This means measuring, testing, screening, detecting, and diagnosing low bone mass in women and men early in their lifetimes so that effective treatment can stop the Osteoporosis dead in its tracks." Together, we can help protect families from this terrible disease.

Sincerely,
Mark Piening

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