FDA grants breakthrough device designation to osteoporosis ‘vibration belt’
The FDA granted breakthrough device designation to a belt that uses proprietary vibration technology to stop the progression of bone loss and prevent the onset of osteoporosis, according to an industry press release.
The OsteoBoost vibration belt (Bone Health technologies) can reduce the risk for osteoporosis by delivering 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, according to the company. This localized vibration therapy can stop the progression of bone loss and prevent the onset of osteoporosis, according to the release.
“The ability to prescribe a wearable device with no associated risk will be a game changer in the care of bone health,” Shane Mangrum, MD, co-founder of Bone Health Technologies, told Healio. “Pharmacological treatments will still have an important role in the care of osteoporosis for those people at severe risk. But now we can start earlier in the trajectory of care for bone health — before patients develop fractures and the downstream issues that come with fractures. Early intervention and prevention can make all the difference.”
An initial study showed that one 30-minute treatment with the vibration belt reduced bone loss activity among 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 NIH funded a $2 million study to determine if the positive effects of OsteoBoost could be demonstrated in a longer study with a broader population,” the release stated. “This larger, pivotal study is currently enrolling patients and is scheduled to be completed in early 2022.”
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.