Bone Health Technologies said it has received FDA clearance for Osteoboost, a non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia (low bone density).
Osteoboost is a wearable belt device, worn on the hips, that delivers targeted, calibrated vibration to the lumbar spine and hips. Osteoboost is indicated to reduce bone strength and density decline in postmenopausal women and is the first and only solution specifically designed to improve bone health during osteopenia. This breakthrough technology is safe, medication-free, and easy to use at home, making it suitable for a wide variety of patients with bone density loss.
An estimated 52 million Americans have osteopenia, the precursor to osteoporosis, driving an addressable market of over $30B in the U.S. and $100B globally. Half of all women suffer from fractures during their lifetime, and most of these fractures occur during the osteopenia stage.
Osteoboost was reviewed through the FDA’s De Novo classification process and received Breakthrough Device Designation. The Osteoboost clearance creates an entirely new class of therapeutics for low bone density outside of pharmacological intervention. Notably, Osteoboost also represents the first therapeutic mechanism specifically designed and cleared for intervention during the osteopenia stage. Until now, patients with osteopenia have lacked effective therapeutic options. Before Osteoboost, the standard of care for osteopenia focused on regular weight-bearing exercise and calcium supplementation — neither of which have been proven to significantly slow the loss of bone density.
Osteoboost was granted clearance based on data from an NIH-funded double-blinded, sham-controlled study conducted at the University of Nebraska Medical Center. The data, which were shared at the 2023 ENDO and ASBR conferences, demonstrate the efficacy of Osteoboost in directly stimulating bone growth and preserving bone mineral density and strength by sending low-frequency vibrations directly to the lumbar spine and hips.
