Osteoboost Health has officially launched its wearable device Osteoboost across the United States, marking a significant step in bone health innovation. The company says Osteoboost is the first and only prescription medical device to receive FDA clearance for the treatment of low bone density.
The device uses targeted vibration therapy and is designed to treat areas most vulnerable to osteoporotic fractures, specifically the spine and hips. It has already been prescribed by more than 1,000 healthcare professionals, including clinicians at over 30 academic medical centres.
“The longevity conversation is everywhere, but people rarely mention bone health even though it is fundamental to aging with confidence,” said Laura Yecies, CEO of Osteoboost Health. She added, “Osteoboost empowers people to lead longer, stronger, and more active lives. And while the belt is sophisticated medical technology rigorously tested and validated for efficacy, the treatment is so easy – 30 minutes a day of gentle vibration therapy that can be done while walking, cooking, or other daily activities.”
Cleared as a Class II FDA De Novo Breakthrough Device, Osteoboost is indicated for postmenopausal women with osteopenia – a condition affecting 54% of this demographic in the US. Osteopenia is considered a precursor to osteoporosis, and more than half of fragility fractures occur at this stage.
The device underwent a double-blind, placebo-controlled clinical trial at the University of Nebraska Medical Center. Results demonstrated a significant reduction in bone loss for users: an 85% decrease in spinal bone density loss, 83% reduction in spinal bone strength loss, and a 55% drop in hip bone density loss for women using the device at least three times per week.
“It’s been a long time since we’ve seen any new innovation for bone health, and yet every day I see patients who are terrified of the risks they face just walking down the street. Osteoboost did this the right way. They spent years investing in the clinical trial and FDA approval processes – not an easy feat even for larger pharmaceutical companies,” said Dr. Yevgeniya Kushchaeva, Clinical Director of University of South Florida Health Adult Endocrinology and Medical Director of the Adult Osteoporosis Program.
To boost accessibility, Osteoboost Health has partnered with Beluga Health to provide online prescription consultations. Patients can also be prescribed the device through their own doctor.
The company has attracted strategic backing from AARP, She’s Independent, Harvard Business School Angels, and Esplanade Healthtech Ventures, which returned with a follow-on investment.
Osteoboost Health notes that more women will suffer an osteoporotic fracture than experience a heart attack, stroke, or breast cancer combined—with associated costs to the US healthcare system totalling $46 billion annually.
