Naitive Technologies: Osteoporosis screening tool secures Breakthrough Designation

LONDON, Oct. 10, 2023 /PRNewswire/ -- Naitive® Technologies, a population health company, has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for OsteoSight^tm, its technology for estimating bone mineral density (BMD) from routine X-rays. OsteoSight was developed to address the unmet need for earlier diagnosis of osteoporosis, a condition that is characterized by a progressive decrease in bone density, which frequently goes unnoticed until a patient suffers a debilitating fragility fracture.

Worldwide, a fragility fracture occurs every 3 seconds, costing global healthcare systems $400Bn annually.[1] In the United States alone, 50% of women and 25% of men over the age of 50 will experience a fracture caused by osteoporosis,[2] costing US healthcare systems $57Bn.[3] The Bone Health and Osteoporosis Foundation reports that fragility fractures are responsible for more hospitalizations than stroke, breast cancer, and heart attacks combined.[4] Despite this, it's estimated that up to 75% of those affected remain undiagnosed and untreated.[5]  

OsteoSight aims to enhance detection rates by leveraging the subtle signals contained within the tens of thousands of X-rays that are taken every day, often for unrelated concerns. By automatically including an estimate of bone density, along with an osteoporosis classification based on World Health Organization (WHO) guidelines, into the radiology report, physicians can be alerted sooner to their patient's bone health. Earlier identification of osteoporosis can enable physicians to initiate intervention before a fragility fracture occurs.

"While treatments exist that can help slow the progression of bone loss, the biggest challenge we face is the persistent underdiagnosis of osteoporosis and low bone density," said Prof. Robert Pignolo, Professor of Medicine, Geriatric Medicine and Gerontology at the Mayo Clinic and member of the Scientific Advisory Board of Naitive Technologies. "Patients are still being diagnosed after a fracture, instead of during a period of timely intervention. By screening patients who are having routine X-rays, we have a real opportunity to identify early bone loss and osteoporosis and prevent fractures. I'm delighted that the FDA has seen OsteoSight's potential, and I'm excited to see the difference it will make in clinical practice."

The FDA's Breakthrough Device Program is intended to provide patients with more timely access to medical devices that have the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. As part of the program, the FDA will expedite development, assessment, and review of OsteoSight for regulatory clearance. 

"We are thrilled that OsteoSight has received Breakthrough Device Designation," said Dr. Will Briggs, CEO and Founder of Naitive. "It's a key milestone for our technology and validates our strong belief that OsteoSight has the potential to revolutionize the way we find patients at-risk for osteoporosis. We look forward to bringing this technology to market and helping improve patient outcomes."

About Naitive® Technologies

Naitive is an early-stage, VC-backed population health company, providing digital technologies that help clinicians and healthcare systems improve the screening, diagnosis, treatment, and monitoring of chronic diseases, with a focus on bone health.

Led by a team of MDs and PhDs from Oxford and Cambridge, and backed by a deeply experienced Board of Directors and advisors, Naitive was founded so that patients with, or at risk of, chronic diseases are identified earlier, diagnosed accurately, and receive the best possible care.

For media inquiries, please contact: Catherine Kelly, COO at [email protected]

For more information, please visit: https://naitive.com/breakthroughdesignation

Disclaimer: This press release is for informational purposes only and does not constitute medical advice. Consult with a qualified healthcare professional for any medical concerns or treatment options related to osteoporosis.

[1] International Osteoporosis Foundation

[2] Bone Health and Osteoporosis Foundation

[3] Lewiecki et al. (2019) JBMR Plus 3(9): e10192

[4] Milliman et al. (2019) National Osteoporosis Foundation

[5] Saunders et al. (2019) Biomed J Sci Tech Res 23(1):2574

SOURCE Naitive Technologies