Osteoporosis Prevention Product Wins FDA Breakthrough Device Designation
San Francisco, CA, December 15, 2020 – 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.
Founded in 2018 by Shane Mangrum, MD, Dan Burnett, MD, and Michael Jaasma, Ph.D., Bone Health Technologies is focused on improving the lives of millions of people who are currently at risk of developing osteoporosis and subsequent bone fractures. “For years, I have wanted a better option for my patients with low bone density that doesn’t have the potential side effects and the inconvenience of current drug treatments. With OsteoBoost we’ve created a safe, drug-free alternative that is easy and convenient. Now my patients with osteopenia have a new way to improve their bone health and reduce their risk of fracture,” said Dr. Shane Mangrum.
Derived from NASA technology which proved that mechanical stimulation of bones through vibration would improve bone health in astronauts, OsteoBoost is the first product of its kind. Localized vibration delivered via a comfortable, easy-to-use belt has the potential to change the way osteopenia and osteoporosis are prevented and treated for millions of Americans.
About Bone Health Technologies: Bone Health Technologies is a San Francisco based company that applies science and medical expertise to create better health outcomes for women and men at risk of developing osteoporosis and the associated bone fractures. Initially created in the med-tech incubator TheraNova, Bone Health Technologies is poised to become the new standard of care in treating both osteoporosis and osteopenia (the precursor to osteoporosis). Visit www.bonehealthtech.com for more information.