Orthopedic cone-beam CT supplier CurveBeam AI has received the FDA’s breakthrough device designation for software that computes risk of fracture in patients with osteopenia.
The product, called OssView, is still in development and not available for commercial distribution in the U.S.
In announcing the agency’s recognition of the product’s promise and the attendant advantages the designation brings, CurveBeam AI notes the system’s usefulness for patients found not to have osteoporosis on tests for bone mineral density (BMD) using standard dual-energy X-ray (DXA) imaging.
In some cases, the company points out, DXA and associated software are not sensitive enough to identify which of these non-osteoporotic patients have the “lesser” bone-thinning condition, osteopenia, but are still at heightened risk for fragility fractures.
That’s more than 80% of patients screened for osteoporosis, CurveBeam says, citing a 2018 study.
CurveBeam says OssView works by calculating a structural fragility score (SFS), which “determines bone microstructural deterioration, a highly accurate indicator for bone fragility and fracture risk.”
The company says SFS is used when patients are scanned with high-resolution peripheral quantitative computed tomography (HR-pQCT).
In the announcement, posted Sept. 12, CurveBeam AI quotes Ego Seeman, an endocrinologist at the University of Melbourne in Australia.
“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,” Seeman says. “Even modest bone loss producing osteopenia concurrently destroys the architecture of bone, which weakens the bone greatly.”
CurveBeam AI points to figures from the National Osteoporosis Foundation showing that Medicare spent around $57 billion in 2018 to care for patients who suffered osteoporotic fractures.
CurveBeam plans to offer point-of-care HR-pQCT platforms upon completing the FDA review process.
The company is based in Pennsylvania, has 51 employees and is aiming for an initial public offering in 2023.
Full announcement here.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.