Top: Healthy Vertebrae Above: Osteoporotic bone

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2 Top: Healthy Vertebrae Above: Osteoporotic bone 2

3 OSTEOPOROSIS IS A DISEASE OF THE BONES, WHICH LEADS TO AN INCREASED RISK OF FRACTURE. IN OSTEOPOROSIS, THE DENSITY AND QUALITY OF BONE ARE REDUCED. THE LOSS OF BONE OCCURS SILENTLY AND PROGRESSIVELY. Osteoporosis is a worldwide and growing problem. One out of three women and one out of five men over 50 years old will experience osteoporotic fractures in their remaining lifetime. In many cases, treatment delays are extended because osteoporosis is not detected in time. Osteoporosis accounts for more disability and life years lost than rheumatoid arthritis. The most important risk factors for osteoporosis are advanced age (in both men and women) and female sex. For women, estrogen deficiency following menopause is correlated with a rapid reduction in bone mineral density, while in men, a decrease in testosterone levels has a deteriorating effect. While osteoporosis occurs in people from all ethnic groups, European or Asian ancestry predisposes to osteoporosis. Those with a family history of fracture or osteoporosis are at an increased risk; the heritability of osteoporosis and low bone mineral density is relatively high. Those who have already had a fracture are at least twice as likely to have another fracture, compared to someone of the same age and sex. Other factors predisposing to osteoporosis are, for example, excessive alcohol use, vitamin D deficiency, smoking, malnutrition, high dietary protein and being underweight. OsCare Sono is specifically developed for the early detection of osteoporosis, and for INCREASED BURDEN OF OSTEOPOROTIC FRACTURES WORLDWIDE M HIP FRACTURES WORLDWIDE M HIP FRACTURES WORLDWIDE 200 NORTH AMERICA EUROPE the assessment of bone health. Together with other clinical risk factors, the OsCare Sono measurement result aids the physician in estimating risk of osteoporosis. The measurement is easily accessible, accurate, cost effective and without radiation exposure. LATIN AMERICA The Breaking Spine, International Osteoporosis Foundation ASIA Calcium, exercise and vitamin D can help to prevent osteoporosis. Medical treatment and lifestyle changes can further prevent bone loss. 3

4 The properties of a bone affect the way it conducts sound - and also ultrasound. A healthy, elastic bone allows sound to travel fast. In osteoporosis, the bone s mineral density is lower and the cortical layer is thinner. The bone is less elastic and the speed of sound will be lower than normal. DESIGNED FOR: Osteoporosis Risk Assessment Fracture Risk Estimation OsCare Sono works by emitting and receiving pulses of ultrasound along the radial bone. The low 200 khz frequency used by OsCare Sono allows the signals to penetrate deep into the bone. This way the device can accurately measure the speed of sound in the bone and determine how healthy it is. The bidirectional measurement together with the patented calculation algorithm help eliminate the effects of soft tissue. Based on clinical study data, OsCare Sono calculates the statistical T-score and Z-score. T-score compares the measured speed of ultrasound to the average speed of ultrasound measured from healthy young females. T-score is reported as a number of standard deviations from the average. A T-score of greater than -1 (green area in the OsCare report) tells that the measurement result is in the same range as the result in most healthy young females and the risk for osteoporosis is low. Assessment of Bone Health For subjects with a T-score between -1 and -2.5 (yellow area in the report), counseling on bone health should be given and further investigation considered - especially if there are other risk factors present that may contribute to osteoporosis. All subjects with an OsCare T-score of less than -2.5 (red area in the report) should be further investigated as the relative risk for osteoporosis as detected by DXA is significant. Z-score is used to compare the result with the average measurement from others of the same age, ethnicity and gender, reported as a number of standard deviations from this average. A low Z-score indicates the possibility of other contriburing factors, in addition to ageing, to an osteoporotic diagnosis. 4

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6 OSCARE SONO PARTS Sensor: Handheld measurement probe Hub: Data transfer unit and sensor rest. Connection to PC via USB plug Handle: Hand support for the patient Ruler: Measure for bone lenght for optimal sensor position 6

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8 The OsCare Sono measurement is conveniently taken on the radius bone of the non-dominant forearm. The assessment can be easily performed also in low threshold locations, as the subject does not have to undress for the measurement. The sensor is lightweight and connects via USB to a standard Windows PC, making it easy to perform measurements where needed. Real time ultrasound waveforms are shown during the measurement. Based on the shape of the waveforms the operator can easily confirm that the sensor is correctly positioned to provide the best possible contact to the bone and thus a reliable measurement. The device compares the measurement result to the available reference population data and calculates the T- and Z-score values, indicating if the patient has an increased risk of osteoporosis and future fractures. A qualified doctor can now use this data, in combination with other data available on the patient, and prescribe further examinations, when needed. The doctor may also provide advice on diet and a healthy lifestyle. Easy to install software Basic user training leads to quick patient measurement of 5 min on average OsCare Sono calculates the T- and Z-Score values based on reference population data OsCare Sono delivers valuable information about the risk of osteoporosis SCIENTIFIC ARTICLES 1. M. Määttä, P. Moilanen, J. Timonen, P. Pulkkinen, R. Korpelainen, T. Jämsä, Association between low-frequency ultrasound and hip fractures comparison with DXA-based BMD, BMC Musculoskelet Disord, 15:208, P. Moilanen, M. Määttä, V. Kilappa, L. Xu, P.H. Nicholson, M. Alén, J. Timonen, T. Jämsä, S. Cheng, Discrimination of fractures by low-frequency axial transmission ultrasound in postmenopausal females, Osteoporos Int, 24(2): , V. Kilappa, P. Moilanen, L. Xu, P.H. Nicholson, J. Timonen, S. Cheng, Low-frequency axial ultrasound velocity correlates with bone mineral density and cortical thickness in the radius and tibia in pre- and postmenopausal women, Osteoporos Int 22(4): , M Muller, D Mitton, P Moilanen, V Bousson, M Talmant, P Laugier. Prediction of bone mechanical properties using QUS and pqct: study of the human distal radius, Med Eng Phys Jul;30(6): P. Moilanen, Ultrasonic guided waves in bone, IEEE Trans. Ultrason. Ferroelect. Freq. Contr., 55(6): , P. Moilanen, M. Talmant, V. Kilappa, P.H.F. Nicholson, S. Cheng, J. Timonen, P. Laugier, Modeling the impact of soft tissue on axial transmission measurements of ultrasonic guided waves in long bones, J. Acoust. Soc. Am., 124(4): , P. Moilanen, P. H. Nicholson, V. Kilappa, S. Cheng, and J. Timonen, Assessment of the cortical bone thickness using ultrasonic guided waves: modelling and in vitro study, Ultrasound Med Biol, 33: , P. Moilanen, M. Talmant, V. Bousson, P. H. F. Nicholson, S. Cheng, J. Timonen, and P. Laugier, Ultrasonically determined thickness of long cortical bones: Two-dimensional simulations of in vitro experiments, J. Acoust. Soc. Am, 122: , P. Moilanen, V. Kilappa, P.H.F. Nicholson, J. Timonen, S. Cheng, Thickness sensitivity of ultrasound velocity in long bone phantoms. Ultrasound Med Biol, 30: ,

9 Top: UI view; measurement Above: UI view; measurement results 9

10 Compact in size Mobile Low-frequency (200 khz) axial ultrasound velocity correlates well with bone mineral density (BMD) and cortical thickness, giving valuable information on bone strength Detection of cortical bone with patented soft tissue disturbance effect elimination No ionizing radiation measurement can be repeated when needed OsCare Sono is cost-effective and enables large scale screening No specialized nurse qualified for taking X-rays needed User interface software runs in standard Windows operating system No dedicated PC needed Reliable and quick procedure 10

11 Type: OUD-01-C The device meets applicable CE requirements. Dimensions: Sensor head: 105 x 37 x 87 mm (LxWxH) Table top unit: 150 x 30 mm (DxH) Weight: 0,4 kg Power input: 5 V 500 ma (2,5 W) from USB Continuous Measuring sound propagation speed range: m/s Accuracy of measurement: +/- 50 m/s Ultrasound Sensor (line sensor 4 elements, ~200 khz) Serial number is on the underside of the table top unit. There are no electrical contacts to patient. Protection against electrical shock is class II BF-type Transportation and storage: Temperature 0 70 C Relative humidity of % Pressure mbar Operating conditions: Temperature C Relative humidity % Pressure mbar 11

12 OSCARE MEDICAL OY Äyritie 22 FI Vantaa Finland