Diagnosing Cortical Bone Health with Ultrasound

CHALLENGE
Osteoporosis is a common disease in which more bone is being resorbed than rebuilt. The loss is systemic, ocurring both in the outer cortical bone and the trabeculare bone, resulting in increased fracture risk. Osteoporosis occurs unnoticed and is only often observed once a fracture occurs. Current detection methods can only determine osteoporosis at advanced stages of the disease progression. Early detection is vital because the highest fracture risk is not seen in people diagnosed to have osteoporosis, but in those diagnosed to be healthy, where osteoporosis has not been detected yet.

OPPORTUNITY
In the EU, 27,5 million people were estimated to have osteoporosis at an estimated economic burden of €3 billion. Currently 80% of people with increased fracture risk are underdiagnosed and undertreated. Bone mineral density (BMD) is measured by X-ray (DXA), which has limitations such as the radiation burden and inability to detect people at risk with normal or reduced BMD.

SOLUTION
The cortical ultrasound backscatter (Porous) analysis offers a novel way to detect microstructural changes in the cortical bone. Porous combines the
ability to measure cortical microstructure (pore size distribution in the range 20μm – 200μm) with precise porosity and thickness measurements to revolutionize the diagnosis of the onset of osteoporosis and thereby prevent fragility fractures. The new innovation, originating from Charité University Hospital Berlin, utilises non-ionizing 3D ultra-sound technology combined with novel image guidance and sophisticated spectral signal processing to ensure a simple and user-independent assessment.  Potentially, with Porous, the onset and progression of pathological changes can be detected long before the first osteoporotic fracture occurs and when preventive action can still be taken.

STATUS
Currently finalizing product development and first in-human validation, planned market introduction in early 2023.