Michael Barbella, Managing Editor12.06.22
Bone Health Technologies (BHT) is sharing positive results of its pivotal Osteoboost Vibration Belt trial.
Study data indicate that Osteoboost can reduce vertebral bone strength loss without causing any serious side effects or adverse events. The trial used computed tomography to measure the change in vertebral bone strength after a year of treatment; the results showed a decreasing rate of decline of bone strength, including vertebral bone density and cortical bone strength, with all endpoint measures improving.
“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,” BHT CEO Laura Yecies said.
The trial was conducted in partnership with Laura Bilek, Ph.D., 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.
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 significant step forward for treating osteopenia and potentially preventing 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 U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. BHT has raised $4.75 million in capital from 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. An FDA review submission is pending.
Bone Health Technologies is a Redwood City, Calif.-based company that applies science and medical expertise to create better health outcomes for those at risk of developing osteoporosis and associated bone fractures.
Study data indicate that Osteoboost can reduce vertebral bone strength loss without causing any serious side effects or adverse events. The trial used computed tomography to measure the change in vertebral bone strength after a year of treatment; the results showed a decreasing rate of decline of bone strength, including vertebral bone density and cortical bone strength, with all endpoint measures improving.
“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,” BHT CEO Laura Yecies said.
The trial was conducted in partnership with Laura Bilek, Ph.D., 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.
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 significant step forward for treating osteopenia and potentially preventing 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 U.S. Food and Drug Administration (FDA) Breakthrough Device Designation. BHT has raised $4.75 million in capital from 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. An FDA review submission is pending.
Bone Health Technologies is a Redwood City, Calif.-based company that applies science and medical expertise to create better health outcomes for those at risk of developing osteoporosis and associated bone fractures.
