FDA Grants Breakthrough Device Designation for CurveBeam AI's OssView™ Bone Fragility Software
HATFIELD, Pa., Sept. 12, 2022 /PRNewswire/ -- CurveBeam AI, Ltd announced its medical diagnostic software, OssView™, has received US Food and Drug Administration (FDA) Breakthrough Device Designation. OssView calculates a Structural Fragility Score (SFS), which determines bone microstructural deterioration, a clinical aid to assist a medical provider in determining bone fragility and fracture risk in over 70-year-old females.
OssView is investigational only and is not available for sale in the United States.
The goal of the FDA Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices that provide for more effective treatment or diagnosis of irreversibly debilitating diseases by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval or clearances.
Benefits associated with acceptance into the Breakthrough Devices Program include prioritized review of FDA 510(k) applications.
The current standard of care to determine fragility fracture risk in patients is bone mineral density (BMD) measurements obtained 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 in performance. When compared to these techniques, SFS has shown performance to support a Breakthrough Device Designation. Bone density defined-osteoporosis can miss up to 80%1 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. "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 the amount of bone; it does not measure the breakdown of three-dimensional 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."
Medicare spent an estimated $57 billion in 2018 to provide care for patients who suffered osteoporotic fractures, according to the National Osteoporosis Foundation. SFS gives doctors an additional clinical tool to better aid in assessing fracture risk in non-osteoporotic patients to prevent fragility fractures.
"The challenge is to identify and pre-emptively treat those women at risk of a first or subsequent fracture among the many with osteopenia," said Seeman.
SFS is calculated from a high resolution peripheral quantitative computed tomography (HR-pQCT) scan of the wrist. CurveBeam AI intends 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 the assessment of bone architecture breakdown quickly, easily, and safely. This test helps a doctor 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."
About CurveBeam AI
CurveBeam AI specializes in cone beam CT imaging and complementary AI applications for orthopedics and bone health. CurveBeam AI's global operations headquarters for product development, Quality & Regulatory, manufacturing and operations including marketing, sales and customer care are in Hatfield PA, USA. CurveBeam AI's corporate office in Melbourne, VIC, Australia, covers AI research & development, AI Quality and regulatory corporate finance, and IP functions. CurveBeam AI, which has 51 employees, is an unlisted public company backed by several major professional investors and is targeting an Initial Public Offering in 2023.
1 Samelson E et al, Cortical and trabecular bone microarchitecture as an independent predictor of incident fracture risk in older women and men in the Bone Microarchitecture International Consortium (BoMIC): a prospective study.Lancet .Published online November 28, 2018 http://dx.doi.org/10.1016/S2213-8587(18)30308-5
SOURCE CURVEBEAM AI
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