Bone Health Technologies, creator of the OsteoBoost Vibration Belt that promises to reduce the risk of osteoporosis, has been granted “Breakthrough Device” designation by the US Food & Drug Administration. The FDA awards Breakthrough Device designation to products “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.”
OsteoBoost uses proprietary vibration technology that delivers gentle mechanical stimulation to the hips and spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption and potentially create new bone. This localized vibration therapy’s effect is to stop the progression of bone loss and prevent the onset of osteoporosis. An initial study showed that just one 30-minute treatment with OsteoBoost reduced bone loss activity in all study participants, providing an average decrease of 14%, a reduction on par with bisphosphonate drugs. The initial study results were so promising that the National Institutes of Health funded a $2 million study to determine if the positive effects of OsteoBoost could be demonstrated in a longer study with a broader population. This larger, pivotal study is currently enrolling patients and is scheduled to be completed in early 2022.
1 in 2 women and 1 in 4 men over the age of 50 will suffer an osteoporosis-related fracture during their lifetime, costing the healthcare system over $19 Billion. With more than 1 million people per year experiencing a fracture due to low bone density, osteoporosis has become an epidemic in the United States.