Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women

Abstract Approximately 43 million Americans suffer from osteopenia, a highly common skeletal condition defined by accelerated bone loss. If bone 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 life, and increase morbidity. Clinical guidelines for treating osteopenia include both dietary modifications and high impact exercise. While diet and exercise can be effective at maintaining bone mineral density (BMD), compliance is low. The alternative is bisphosphonates, which effectively inhibit bone resorption. However, due to the potential for serious adverse events with prolonged use, bisphosphonates are only prescribed once bone mass reaches osteoporotic, or near-osteoporotic levels, when the antifracture benefits of bisphosphonates considerably outweigh their potential for harm. Recently, devices that deliver mechanical stimulation to the weight-bearing skeleton have been shown to provide significant benefits for hip and spine BMD. These whole body vibration (WBV) platforms require the user to stand on a vibrating platform each day to mimic the effects of high-impact exercise. Despite promising results with WBV platforms, these devices have had limited commercial success as they are expensive ($1,500-$5,000), cumbersome to use, and inconvenient. To address the need for a safe, effective, convenient, and cost-effective osteopenia treatment, Bone Health Technologies has developed OsteoBoost, a wearable, home-use device designed to deliver localized mechanical stimulation to the hips and spine. With clinical evidence that OsteoBoost provides short- and long-term benefits for combating the effects of osteopenia, the goal of this Commercialization Readiness Pilot (CRP) is to support the commercialization of a cost-competitive OsteoBoost device. First, to determine if bone turnover markers (BTMs) can be used to provide patients with an earlier indication of therapeutic effectiveness than a 6-month DXA scan, we will evaluate the effects of OsteoBoost treatment on key BTMs in a 3-month, sham-controlled clinical study (Aim 1). Second, we will update the OsteoBoost design with a reduced cost of goods sold (COGS) to enable profitable commercial launch (Aim 2). Third, we will conduct a comprehensive set of verification and validation testing on our COGS- reduced device and submit a De Novo application to the FDA for OsteoBoost (Aim 3). The successful completion of these aims will allow us to commercialize this refined system within 2.5 years of the funding of this proposal, thus providing a much-needed comprehensive treatment option for the millions of Americans with osteopenia.