CurveBeam AI’s OssView Bone Fragility Software Gains Breakthrough Status

CurveBeam AI has earned U.S. Food and Drug Administration (FDA) breakthrough status for its OssView medical diagnostic software.
 
OssView calculates a Structural Fragility Score (SFS) that determines bone microstructural deterioration. This assists clinicians in determining bone fragility and fracture risk in 70+ year old females.
 
The current standard of care to determine fragility fracture risk is bone mineral density (BMD) measurements via dual energy X-Ray (DXA). In some cases, other fracture risk software tools are used to further identify fracture risk.
 
These approaches to date have been limited—when compared to these techniques, SFS has shown performance to support a Breakthrough Device Designation. Bone density defined-osteoporosis can miss up to 80% of fragility fractures—fractures that can be irreversibly debilitating and impact mortality.
 
“Most fractures occur in women with modest deficits in BMD called ‘osteopenia’,” said Ego Seeman, Professor of Medicine and Endocrinologist, Departments of Medicine and Endocrinology, Austin Health, University of Melbourne, Melbourne Australia, told the press. “The many women in the community with osteopenia who are at risk of a fracture are unlikely to be offered treatment because of the mistaken belief that finding BMD in the osteopenia range means the bone is not fragile.”
 
BMD measures amount bone, not breakdown of 3D bone architecture.
 
“Even modest bone loss producing osteopenia concurrently destroys the architecture of bone which weakens the bone greatly,” Seeman said. “An increase in holes in the outer shell of the bone (cortical porosity) reduces bone strength to the 7th power, loss of the inner honey-comb spongy (trabeculae) bone reduce strength to the 3rd power; disproportionate to the bone loss producing this destruction and disproportionate to the modest reduction in BMD found in osteopenia.” 
 
SFS is calculated from a high resolution peripheral quantitative computed tomography (HR-pQCT) scan of the wrist. CurveBeam AI aims to offer point-of-care, high resolution CT platforms to improve access to patients for medical providers dealing with patients who are non-osteoporotic.
 
SFS aids in assessment of bone architecture breakdown quickly, easily, and safely. The test helps identify patients with osteopenia or normal bone density with fracture risk, so treatment can be given to prevent fragility fractures.
 
“We are extremely pleased to be moving forward with the SFS diagnostic through the FDA Breakthrough Device Program,” said Greg Brown, CEO of CurveBeam AI. “There is a clear need for an improved clinical aid like SFS to help clinicians more effectively assess bone health and prevent fractures. We are looking forward to progressing its clearance with the FDA.”