Bone Health Technologies (BHT), a leading innovator of technologies for improving bone health, announces topline results of its pivotal trial of the Osteoboost Vibration Belt. The results found that using Osteoboost more than three times per week in each of four quarters provided a statistically significant reduction in the loss of vertebral bone strength among participants— with no reported device-related serious adverse events.
The trial, which used CT scan analysis to measure the change in vertebral bone strength after one year of treatment, showed a decrease in the rate of decline of multiple subcomponents of bone strength, including vertebral bone density and cortical bone strength, with all endpoint measures improving.
The trial by BHT was conducted in partnership with Laura Bilek, PhD, the Associate Dean for Research in the College of Allied Health Professions at the University of Nebraska Medical Center (UNMC) and expert in clinical research for the treatment of low bone mass. The randomized, double-blinded sham-controlled trial enrolled 126 patients.
“There is a clear public health need and patient desire for a non-pharmacological intervention for bone strength. Osteoboost is the first non-drug intervention to demonstrate clinical CT evidence of improved vertebral bone strength,” said Laura Yecies, CEO of BHT.
The study also found high compliance for the treatment – those who completed the trial used the device an average of four times per week, an excellent result for a home-use device. As a belt, wearing the device for the 30-minute treatment sessions is easy to incorporate into daily activities. The study demonstrated a clear dose response with larger strength gains associated with more frequent use.
These results demonstrate a huge step forward for the treatment of osteopenia and the potential prevention of osteoporosis. There are currently no approved prescription treatments for most of the 53 million patients with osteopenia. Many of these patients will progress to osteoporosis, yet pharmaceutical treatments for osteoporosis have a very low adoption rate. This trial gives hope that breakthrough device technology such as Osteoboost may finally allow those suffering from bone-density-related problems to receive a non-drug treatment from the comfort of their own home with no serious adverse side effects.
BHT’s Osteoboost technology is based on NASA research which has proven that mechanical stimulation of bones through vibration can improve bone density. The Company has received three grants from the NIH and has also received FDA Breakthrough Device Designation. BHT has raised $4.75M in capital from leading investors in women’s health and is supported by investigators, board members, and advisors expert in the women’s health, osteoporosis, and orthopedics field, including Karen Drexler, Drs Nancy Lynch, Dolores Shoback, Anne Schafer, and Laura Bilek.
Osteoboost is limited by Federal Law to Investigational Use. Submission for FDA review is pending.