Osteoporosis, a disease that weakens bones to the point that they can break easily, affects some 10 million Americans. About 80% of those affected are women. Osteoporosis affects 1 in 4 women aged 65 or older, and over a lifetime, half of all women will break a bone because of osteoporosis.
Until now, treatments to stop the loss of bone density from osteoporosis — or to regain healthy bone tissue — have been scarce. The standard of care for people with early-stage disease has been to take calcium or vitamin D supplements, or to perform weight-bearing exercises. But neither approach has been proven to significantly slow the loss of bone density.
Enter Osteoboost, newly approved by the U.S. Food and Drug Administration (FDA) to help postmenopausal women diagnosed with osteopenia — a condition characterized by lower-than-normal bone density — which can be a warning sign for developing more severe osteoporosis. Osteoboost is a wearable medical device developed by the small business Bone Health Technologies (BHT) as the first nonpharmacological prescription treatment of its kind. Osteoboost provides mechanical stimulation, via vibration, to the bones of the spine and hips.
“This is a huge step forward for older women who have lacked treatment options and are seeking an effective way to protect their bone health,” said Laura Yecies, M.B.A., M.S.F.S., CEO of BHT, which tapped NIA support to demonstrate the effectiveness of the device.
Todd Haim, Ph.D., NIA Senior Advisor on Biomedical Innovation, called Osteoboost a critical step forward in the field: “This promising device aligns with and furthers NIA’s mission of supporting research that will help older adults live longer, stronger, more independent lives.”
Breaking boundaries, not bones
BHT’s device is one of only 16 orthopedic devices approved through FDA’s De Novo Classification Process, an expedited review pathway for certain medical devices that appear to be safe and effective and that have no competitor product on the market. FDA based its approval of Osteoboost on data from a double-blinded, sham-controlled study funded by NIA.
“This is the first time there’s ever been a nondrug prescription treatment approved for bone density,” Yecies said. “This FDA clearance creates an entirely new class of therapeutics for low bone density.”
Worn at the waist, Osteoboost delivers calibrated vibrations to the lumbar spine and hips — bones that are most vulnerable to bone loss — which reduce the effects and severity of osteopenia in postmenopausal women. It received FDA’s Breakthrough Device designation, an acknowledgment that it should be expedited for patient access because it could provide more effective treatment than the standard of care for a debilitating disease or condition.
“We haven’t had an early-use, long-term intervention — the equivalent of a statin given to lower cholesterol — for low bone density,” Yecies said. Most treatments have been drugs with serious side effects, meaning that patients can’t take them for long. “Now we have this wearable medical device that is very safe and benign in terms of risk and has shown efficacy in early use.”
Letting nature take the lead
Osteoboost is premised on natural mechanical forces that stimulate bone strength and density. When we subject healthy bones to stress, they will adapt.
“If you lift weights, mechanical forces go through your bones, stimulating your bone cells,” Yecies said. “Mechanical forces naturally stimulate bones to increase their density and strength. Applying the vibration directly to the vulnerable anatomy — hips and lumbar spine — can show this benefit.”
Earlier research on whole-body vibrations has demonstrated improvements in ankles, distal tibias, and other lower leg bones. But the vibrations dissipated as they moved away from the source, and none of those studies led to technologies or treatments cleared by FDA.
BHT, which is based in Redwood City, California, worked closely on this problem with the inventor of Osteoboost, Shane Mangrum, M.D., an Atlanta-based pain and rehabilitation specialist. “He was seeing patients with vertebral compression fractures, which are very hard to treat,” Yecies said. “When he saw the research on whole-body vibration platforms, he first had the idea of a vibrating chair. It sounds like a good idea, but it wound up making people nauseated.”
Eventually the team hit on the winning idea — a device worn around the hips like a belt — and BHT applied for a Phase I Small Business Innovation Research (SBIR) grant from NIA in 2014. BHT used the funding for a proof-of-concept and pilot test of the prototype device, which proved promising.
NIA awarded BHT a Phase II SBIR grant in 2018 that included a clinical trial to test the safety and effectiveness of Osteoboost, conducted at the University of Nebraska Medical Center in Omaha. In 2022 BHT applied for further NIA support through the Commercialization Readiness Pilot (CRP) Program to improve the manufacturability of the device and to conduct a sham-controlled trial focused on bone turnover markers, which included 94 participants from Omaha and from the Northern California Institute for Research and Education in San Francisco.
Results showed participants using Osteoboost lost dramatically less bone strength and density compared with those in the sham group. Even better: No serious side effects were reported.
Funding fuels innovation
Technologies (BHT)
Like any new device, treatment, or protocol on the path to commercialization, Osteoboost wouldn’t exist without early-stage funding. But support for emerging osteoporosis interventions is particularly scarce.
“I don’t think Osteoboost was venture-fundable before the first wave of NIA-funded research,” Yecies said. “It’s very hard to get funding for osteoporosis programs — that’s why we turned to NIA. Our early research ended up having an excellent outcome and then the FDA approval. During that time, we received the CRP grant to help us develop our commercial version. Without NIA, Osteoboost would not exist.”
The osteoporosis market is a significant one, estimated at more than $30 billion in the United States and $100 billion globally. But for Yecies, that’s just a part of the larger story.
“There are no new drugs right now in clinical trial, which is why we’re working on getting funding for additional research,” Yecies said. “We applied for a grant to research bone density in women who are breast cancer survivors. We also want to study the device in women with osteoporosis and in men. This is a field sorely lacking in innovation, and we intend to change that.”
