NIA Small Business Showcase: Bone Health Technologies

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Osteopenia, the precursor to osteoporosis, is a highly common skeletal condition with accelerated loss of bone mass and increased risk of bone fracture. If bone density loss is not mitigated, patients become osteoporotic and are at increased risk of bone fractures—particularly of the hips and spine. Such fractures decrease independent living, shorten lifespans, and increase morbidity. Clinical guidelines for treating osteopenia focus on high-impact exercise, which can be effective for maintaining bone density. But compliance is low. The alternative is prescribed medications (e.g., bisphosphonates). Rare but serious adverse events from prolonged administration of these medications limit their use to patients with osteoporosis. More than 90% of osteoporosis patients are not taking these medications, primarily because of the serious side effects. Accordingly, there is an urgent need for an effective and convenient intervention to treat osteopenia before it progresses to osteoporosis.

Bone Health Technologies has developed the Osteoboost Vibration Belt, a wearable home-use device designed to provide controlled, safe, and therapeutic mechanical stimulation directed to the bones of the hips and spine, which can mitigate bone mass loss and fracture risk.

Osteopenia affects about 43 million Americans, and an additional 10 million have osteoporosis. There is an unmet need for an effective, non-drug treatment for low bone density and an early intervention to prevent osteoporosis.

Although whole-body vibration treatment has been shown to be effective at mitigating bone loss, it is inconvenient because it requires the user to stand still on a vibrating platform for 20 to 30 minutes per day. In contrast, Osteoboost is a wearable belt that allows the user to do normal activities while getting the daily vibration treatment. Osteoboost also targets therapeutic vibration to the hips and lower spine, two of the most common anatomic regions for osteoporotic fractures. In addition, the Osteoboost advantages are offered in a low-cost solution.

Product Development and Regulatory Strategy

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In January 2024, Osteoboost received FDA clearance through the de novo pathway. Results from the clinical trial were used to support FDA clearance for the treatment of osteopenia in postmenopausal women. Bone Health Technologies plans to conduct additional clinical trials that will enable an expansion of patient populations to include men with osteopenia and all patients with osteoporosis.