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Exclusive Reference Database

The Omnisense includes a unique reference curve for each of the recommended skeletal sites:
the distal 1/3 radius, the mid-shaft tibia, the proximal third phalanx, and the fifth metatarsal.

Reference databases were collected in various geographic regions. All subjects were between the ages of 20 - 90 and met strict eligibility criteria. Each skeletal site was measured in accordance with Omnisense's strict measurement methodology. Omnisense reference databases currently support the following populations:

Caucasian - Male and Female

North American - Male and Female

Latin American - Female

Asian - Male and Female

Peak Bone Strength
Data was collected and analyzed to establish the Omnisense reference curve and peak speed of sound (SOS) for each site.

The graph depicts SOS results as a function of age for the Caucasian female distal 1/3 radius. Note that the SOS increases to a peak of 4158 m/sec at the age of 41 with a population standard deviation of 102 m/sec, and declines thereafter.

Site Age of Peak Bone Strength
 Radius 41
 Phalanx 36
 Metatarsal 40
 Tibia 30

When comparing Omnisense SOS to bone density assessment devices such as DXA, SOS measurements peak at a later age, demonstrating that Omnisense SOS measurements reflect various bone properties. In addition to mineral density, SOS measurements take into consideration such bone properties as elasticity, cortical thickness, and micro-architecture.

WHO Compliant
The Omnisense reference curve meets the WHO criteria for osteoporosis, defined as the proportion of subjects with measurement results of 2.5 standard deviations or more below the norm for healthy young adults. When measured by Omnisense, the prevalance of osteoporosis among Caucasian post-menopausal women aged 60-90 is similar to that identified by the WHO Study Group that defined the criteria for osteoporosis*.

Proven
Much discussion has been devoted to the appropriate sample size needed to establish a statistically significant reference database. Sunlight researchers have taken the initiative to gather measurement data from over 6000 subjects measured at 14 different centers from around the world. These subjects were not pre-selected nor were there any special qualification criteria applied to them. Both the system curve and the new curve were then compared by their mean and standard deviation. No statistical differences were found to exist, reinforcing the validity of the Omnisense reference curve.

*"Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis," Report of a WHO Study Group, WHO Technical Report Series #843, World Health Organization, Geneva 1994



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