The use of Bindex is rapidly advancing the way osteoporosis is diagnosed all over the world. This new technology is used in the world's largest osteoporosis screening campaign. On May 2016, Bone Index Ltd. received 510(k) clearance for the first generation Bindex model.
Undiagnosed osteoporosis is a worldwide challenge. In the US alone osteoporosis is responsible for two million broken bones every year, costing over 19 billion dollars. Experts forecast that by 2025, the costs will rise to 25.3 billion dollars. One of the biggest challenges is the limited availability of osteoporosis diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs. "This is why Bindex is a game-changer," said Bone Index's CEO, Dr. Ossi Riekkinen.
Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.
"The clearance process with the FDA was very fast, only 6 months, thanks to our World's top class R&D team. The technique is based on extensive clinical evidence with over 2500 patients and the position in the current care of osteoporosis is clear," said Bone Index's CTO, Dr. Janne Karjalainen.
"Bindex is unique technology. Now we have a total of 19 patents globally including the US, China, Japan, and large European countries. The United States is a very significant market and we are actively seeking a partner who has the capabilities to take advantage of this unique opportunity. The overall aim is to prevent osteoporotic fractures and improve the quality of life of families in the US," Dr. Riekkinen concluded.