Osteoboost Health has announced the US-wide availability of Osteoboost, the first and only FDA-cleared prescription medical device for low bone density, according to the company.
The wearable device, which uses targeted vibration therapy, has been designed to address a treatment gap for the more than 60 million Americans with low bone density. Already prescribed by over 1,000 physicians, including those at 30+ academic medical centers, the device delivers therapy directly to the spine and hips, areas at high risk for osteoporotic fractures.
“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. “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.”
The device has been cleared as a Class II FDA De Novo Breakthrough Device for postmenopausal women with osteopenia, the precursor condition to osteoporosis. The company reports that 54% of postmenopausal women in the United States are osteopenic, and more than half of all fragility fractures occur during this stage.
The device’s effectiveness was evaluated in a double-blinded, placebo-controlled clinical trial at the University of Nebraska Medical Center. According to the results, postmenopausal women with osteopenia who used Osteoboost at least three times weekly experienced an 85% reduction in the loss of bone density in the spine, an 83% reduction in the loss of bone strength in the spine, and a 55% reduction in the loss of bone density in the hip.
“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,” said Dr. Yevgeniya Kushchaeva, Clinical Director of University of South Florida Health Adult Endocrinology, and Medical Director of Adult Osteoporosis Program. “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.”
The company also announced new strategic investments from AARP, Harvard Business School Angels, and She’s Independent, plus a follow-on investment from Esplanade Healthtech Ventures. To increase accessibility, Osteoboost Health has partnered with Beluga Health to offer online prescription consultations, allowing patients to obtain a prescription either through their personal physician or online.
According to the company, more women will suffer an osteoporotic fracture than experience a heart attack, stroke, and breast cancer combined, with such fractures costing the U.S. healthcare system $46 billion annually.
