Clinical validation.

In collaboration with the National Council of Research.

Database includes 10.000 subjects in the age range from 30 to 90 years.

Clinical validation obtained through national and international multi-center studies with the most important centers for the diagnosis of osteoporosis in Europe coordinated by the Internal Scientific Committee composed of the most influential medical personalities internationally.

Performance.

From the following table reported below, a direct comparison of main reference parameters reported in literature shows how EchoS presents always and by far (in some cases with a higher order of magnitude) and for all references parameters a superior reproducibility and precision.

Database includes 10.000 subjects, in the age range from 30 to 90 years, grouped into 5-y intervals and, in each age interval, they were further split into three subgroups based on their BMI. The subjects underwent the following diagnostic examinations: DXA scan of lumbar spine and/or proximal femur, TBS calculation, echographic scan with EchoS system and FRAX® questionnaire for the estimation of fracture risk.

 In each identified subgroup, these data were used to calculate the corresponding pairs reference spectral models for the following bone conditions: “osteoporotic/healthy”, which is assessed through the Osteoporosis Score value, and “frail/non-frail”, which is assessed through the Fragility Score value. All the obtained models were also included in the database and associated to the relevant subgroups.

Diagnostic accuracy of the proprietary technology has been clinically tested according to international scientific frameworks and the results, published in several international medical journals, showed a strong correlation with the current gold standard technologies in terms of bone density at lumbar vertebrae and femoral neck and risk of fracture through FRAX®  questionnaire.

Reference Sites.

Dr. Maria Luisa Brandi
University of Florence and Metabolic Bone Diseases Unit,
University Hospital of Florence, Italy.

Dr. Adolfo Diez-Perez
Department of Internal Medicine,
Hospital del Mar, Barcelona, Spain.

Dr. Jean-Yves Reginster
University of Liège and Bone and Cartilage Metabolism Unit
Liège, Belgium.

Dr. Cyrus Cooper
MRC Lifecourse Epidemiology Unit, University of Southampton,
Southampton General Hospital,
Southampton SO16 6YD, United Kingdom.

Dr. Maurizio Muratore
ASL Lecce, P. O. Galateo, UO Reumatologia, San Cesario di Lecce, Italy.

Dr. Stefano Gonnelli
Policlinico “Le Scotte”, Dipartimento di Scienze Mediche,
Chirurgiche e Neuroscienze, AOU, Siena, Italy

Dr. Maurizio Rossini, Dr. Davide Gatti
Policlinico Borgo Roma Gianbattista Rossi, Sezione di Reumatologia,
AOUI Verona, Italy.

Dr. Marco Matucci Cerinic
Dipartimento di Biomedicina, Divisione di Reumatologia AOU Careggi,
Villa Monna Tessa, Florence, Italy.

Dr. Giovanni Arioli
AO “Carlo Poma”, UO Riabilitazione Specialistica, Pieve di Coriano, Italy.

Dr. Gerolamo Bianchi, Dr. Giuseppe Girasole
Azienda Sanitaria Genovese, UO Reumatologia, Ospedale La Colletta, Arenzano, Genova, Italy.

A new concept of ultrasound

bone densitometry.

Strong correlation with DXA technology.

The first non-invasive technology enables to evaluate both bone density and bone fragility in the axial reference sites for the diagnosi of osteoporosis: lumbar spine and femoral neck.

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