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Frequently Asked Questions

1) What is the Omnipath® - Axial Transmission Technology?
Sunlight's patented axial transmission technology, Omnipath®, is based on the measurement of the speed of ultrasonic waves (SOS) propagating along the bone. Omnipath™ enables measurement along the bone's maximal strength axis, eliminating soft tissue effects and providing a more accurate measurement.

Scientific References about Omnipath®

An In Vitro Investigation of the Dependence on Sample Thickness of the Speed of Sound along the Specimen, C.F. Njeh, D. Hans, C. Wu, E. Kantorovich, M. Sister, T. Fuerst, H.K. Genant, Medical Engineering and Physics, 1999; 21 (9): 651-659
Temperature Effect on Speed of Sound Measurements at the Third Proximal Phalanx, I. Yaniv, T. Schwartz, Y. Niv, Presented at the Third International Congress on Osteoporosis, March 1999, Xian
Effect of Age, Anatomic Site and Soft Tissue on Quantitative Ultrasound, S. Pearce, M.B. Hurtig, J. Runciman, J. Dickey, Presented at ASBMR, September 2000, Toronto

2) What is being measured with Omnisense?
Omnisense measures Speed of Sound (SOS) expressed as meters per second. SOS is the most appropriate technology to measure bone strength since multiple bone properties - microstructure, elasticity, cortical thickness, bone density - affect the result. DXA measurements are based on bone mineral density only, a limited predictor of bone strength which changes over time.

Scientific References about SOS

Ultrasound Velocity and Cortical Bone Characteristics In Vivo, H. Sievanen, S. Cheng, S. Ollikainen, K. Uusi-Rasi, Osteoporosis International, 12:5, 2001
The Biomechanical Properties of the Phalanx Assessed by an In-Vivo Quantitative Ultrasound Technique, A. Daniel, T. Schwarz, G. Landman, C. Singal, M. Weiss, Y. Niv, Presented at the ASBMR-IBMS 2nd Joint Meeting, December 1998, California
An In Vitro Investigation of the Dependence on Sample Thickness of the Speed of Sound along the Specimen, C.F. Njeh, D. Hans, C. Wu, E. Kantorovich, M. Sister, T. Fuerst, H.K. Genant, Medical Engineering and Physics, 1999; 21 (9): 651-659)

3) Does Omnisense measure trabecular bone?
Metabolic changes occur in both the cortical and trabecular layers of bone. It is known that the bone remodeling process is less active in the cortical bone than in the trabecular bone. However, although changes in the cortical layer are much smaller in magnitude than those occurring at the trabecular layer, Omnisense is sensitive to these changes. Omnisense is extremely sensitive and, as such, can follow even the slightest bone changes.

Clinical evidence shows that the slope of the radius reference curve (annual rate of bone change) and the DXA of the spine behave similarly after the age of menopause.

4) How precise is Omnisense?
Omnisense's precision at the radius is 0.4%, one of the highest precision ratings in the industry. Precision is important because it gives the system the ability to monitor bone changes due to aging, treatment and other disorders.

Based on the Omnisense's high precision levels, the FDA approved its indication for use in monitoring bone changes in the relevant age groups (50-65, peri & post-menopause).

The precision values at both the radius and phalanx sites are close to the annual rate of change for the early post menopausal years. Therefore, when monitoring normal healthy women in the early post-menopausal range who are not being treated with bone-affecting drugs, there should be a two to four year time interval between SOS measurements.

Scientific References about Precision

Determination of the In Vivo Precision of Sunlight Omnisense Bone Sonometer in Italy, R. Mora, L. Pedrotti, B. Bertani, Presented at the 29th European Symposium on Calcified Tissues, Zagreb, Croatia, May 2002
Quantitative Ultrasound (QUS): Intra and Inter Precision in a Multi-Center Study Against its Potential Monitoring Ability, D. Hans, H. Resch, M. Weiss, R.S. Lorenc, C. Perron, A. Figueiral, D.O. Slosman, Presented at the 29th European Symposium on Calcified Tissues, Zagreb, Croatia, May 2002
The Importance of Precision - New Hopes for Monitoring Osteoporosis Treatment by QUS, M. Weiss, E. Segal, S. Ish Shalom, Presented at the World Congress of Osteoporosis, June 2000, Chicago
A New Method For Quantitative Ultrasound Measurements At Multiple Skeletal Sites - First Results Of Precision And Fracture Discrimination, R. Barkmann, E. Kantorovich, C. Singal, D. Hans, H.K. Genant, M. Heller, C. Glüer, Journal of Clinical Densitometry, 2000, 3:1, 1-7

5) How well can a measurement at the wrist predict the risk of fracture of hip or spine?

Studies done with Omnisense demonstrate that Omnisense measurement of the radius produces a fracture prediction ability equal to that of DXA obtained at the hip and spine. Furthermore, Omnisense measures a major fracture site - the wrist. This peripheral site is the earliest to fracture, often preceding hip and spine fractures by as much as 10 to 28 years.

Scientific References about Fracture Prediction

Discrimination of Proximal Hip Fracture by Quantitative Ultrasound Measurement at the Radius, M. Weiss, A. Ben-Shlomo, P. Hagag, S. Ish-Shalom, Osteoporosis International (2000) 11:411-416
Multisite Quantitative Ultrasound: Precision, Age- and Menopause-related Changes, Fracture Discrimination, and T-score Equivalence with Dual-energy X-ray Absorptiometry, K.M. Knapp, G.M. Blake, T.D. Spector, I. Fogelman, Osteoporosis International, 2001, 12(6):456-464
Does Combining the Results from Multiple Bone Sites Measured by a New Quantitative Ultrasound Device Improve Discrimination of Hip Fracture?, D. Hans, S.K. Srivastav, C. Singal, R. Barkmann, C.F. Njeh, E. Kantorovich, C. Glüer, H.K. Genant, Journal of Bone and Mineral Research, 1999, 14(4):644-651

6) Is there a difference between weight bearing and non-weight-bearing bone in predicting the risk of fracture?
In predicting the risk of fracture it is important to keep in mind that osteoporosis is a systemic disease that affects the entire skeleton. Ergo, one bone can potentially predict fracture risk as well as another. The key to the prediction of fracture risk lies in the device's sensitivity to bone change. In test after test, the Omnisense has proven itself sensitive to bone changes due to aging and in response to treatment.

Scientific References about Skeletal Status

The Relationship Between Clinically Available Techniques for Assessment of Skeletal Status of the Forearm and Failure Load of the Distal Radius, M.E. Muller, W.D. Bartholomew, C.E. Webber, M.L. Bouxsien, Presented at ASBMR, September 2000, Toronto

7) Will you be able to measure hip and spine in the future?
Since osteoporosis is a systemic disease, there is no real need to measure the hip or the spine, as long as peripheral site measurements are able to predict fractures as well as DXA. Hip and spine are the traditional DXA sites. So far, Omnisense's clinical studies show that by measuring other sites, fractures can be predicted at least as well as by DXA.

8) Does Omnisense comply with WHO diagnosis criteria?
Yes, Omnisense is WHO compliant. The Omnisense reference database has the same osteoporosis prevalence as spine and forearm DXA crossing the -2.5 diagnosis line at approximately 75 years of age.

Scientific References about WHO Compliance

Reference Database for Bone Speed of Sound Measurement by a Novel Quantitative Multi-site Ultrasound Device, M. Weiss, A. Ben Shlomo, P. Hagag, M. Rapoport, Osteoporosis International (2000) 11:688-696
Multi-site Bone Ultrasound Measurements on a North American Reference Population, D.L. Kendler, H.K. Genant, M. McClung, C. Rosen, N. Watts, Presented at the American College of Rheumatology 63rd Annual Meeting, November 1999, Boston and In Press
Can the WHO Osteoporosis Criteria Be Applied to Ultrasound Measurements?, S. Ish-Shalom, I. Yaniv, C. Singal, Y. Niv, Presented at the 11th Annual Workshop on Calcified Tissues, February 1999, Eilat

9) Is it possible to monitor treatment by measuring with Omnisense?
Yes, the Omnisense QUS device has demonstrated the ability to monitor treatment effects in a number of studies. For example, significant group increases in SOS induced by Alendronate were detected by Omnisense 6-12 months after initiation of treatment.

Scientific References about Treatment Monitoring

Estrogen Replacement Therapy Effect on Speed Of Sound at Multiple Skeletal Sites, M. Weiss, A. Ben Shlomo, P. Hagag, M. Rapoport, S. Ish-Shalom, Maturitas, 35(2000) 237-243
Quantitative Ultrasound Measurements Detect Skeletal Changes in Cortical Bone Following HRT Use, K.M. Knapp, C. Singl, G.M. Blake, I. Fogelman, T.D. Spector, Presented at the 11th International Workshop on Calcified Tissues, February 1999, Eilat
Early Effect of Alendronate or Raloxifene Treatment in Osteoporotic Women Monitored by Multi-site QUS, M. Weiss, E. Segal, A. Ben Shlomo, P. Hagag, S. Ish Shalom, Presented at ASBMR, September 2000, Toronto

10) Which reference databases are available for Omnisense, and how many adults were measured to generate them?
Sunlight collected reference databases for different ethnic groups worldwide (Asian and Caucasian). These groups were subdivided into male and female and child and adult sub-groups. More than 5,000 subjects were measured to generate the different RDBs. Omnisense includes unique databases for males and females, for the different ethnic groups, for each skeletal site.

11) Are there any measurement limitations?
While most devices that have some measurement limitations, including problems with obese subjects, edema, temperature dependency, and more, Omnisense technology combined with multi-site capability minimizes these problems. Nevertheless, there may be problems measuring patients with a previous fracture on the measured limb or very thick soft tissue. In each of these cases, measurement at other sites to circumvent the problem is recommended.

12) Is Omnisense operator-dependent?
Specific methodology and proprietary software algorithms have been developed in order to avoid the problem of operator dependency. In order to ensure precision, the operator must follow the exact methodology recommended by Sunlight, and train himself/herself until a precise result is achieved. The Inter-operator CV is similar to the Intra-operator CV.

13) Is the measurement dependent upon room temperature?
The Omnisense result is independent of temperature, within a range of 10°C-35°C. The true phantom SOS value is temperature dependent. For this reason, the measurement obtained during System Quality Verification depends upon the temperature in a well documented and known fashion. However, measurement of patients with Omnisense is independent of room temperature. Unlike Omnisense, other QUS devices are temperature dependent.

14) What is the warranty period of the device?
The warranty period of the device is 12 months from date of delivery to the end-user. There is an option to either extend the warranty period at the end of the first year, or purchase a longer warranty period in advance.

15) What is the life span of the probe?
The actual life span of the probe is approximately three years, or 3,000 measurements (whichever comes first). The warranty of the probe and the device covers 12 months from delivery.

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