FDA Clears First Non-drug Prescription Device for Women with Osteopenia

FDA has cleared OsteoBoost, developed by Bone Health Technologies, the first vibration belt shown to reduce loss of bone strength and density in postmenopausal women with osteopenia.

Because the technology helps to fill an unmet need, FDA reviewed the medication-free device through its de novo marketing authorization process before granting OsteoBoost a Breakthrough Device designation.

“In osteopenia, there aren’t good [treatment] options,” Dave McGurl, vice president of regulatory affairs at MCRA Bone Health Technologies, told MD+DI.

OsteoBoost was considered a de novo submission because there isn’t another device in the class 2 space that would be a direct comparator, MCGurl said.

Differentiating OsteoBoost

Using vibration technology for bone health isn’t a new concept. NASA has studied whole-body vibration technology for its astronauts, who are at risk of losing bone density because they spend time in zero gravity.

NASA’s technology straps in astronauts from the shoulders to the bottom of their feet and basically vibrates by compressing then relaxing the body, said Derek Hillstrom, VP of engineering at Bone Health Technologies. 

“The problem with that is it’s not very conducive to be able to do anything else at the same time," Hillstrom told MD+DI. "You’re stuck standing the whole time, so … we wanted to make something that would allow the user to be somewhat mobile.”

As a result, OsteoBoost is a belt, which users secure with Velcro. They press a power button to start the vibrating and go about their business. The thinking behind the design is that being able to do things like walk, which also is good for bone health, would offer an additive effect to women wearing the OsteoBoost on their hips and spine, according to Hillstrom.

Determining Parameters

Vibration technology has been among the options studied for bone strength and density. That body of research helped determine the device’s optimal therapeutic range for bone growth.

“That’s within the 20 to 40 hertz [range], so 20 to 40 times per second it’s vibrating,” Hillstrom said.

Company engineers then capped the amount of force in the vibration, or maximum vibration amount, based on Occupational Safety and Health Administration (OSHA) guidelines.

“There’s nothing specifically like [OsteoBoost] on the market, so there really is limited information. That’s why we have to go by OSHA and not FDA guidelines for vibration,” Hillstrom said.

Other considerations when designing the device included potential treatment locations. Hillstrom says that one of the reasons they focused on the hips and lower spine was because that’s where problems caused by weaker bones tend to be most catastrophic. While there are other locations where treatment might help build stronger bones, there are challenges with applying vibration to some body areas, according to Hillstrom.

For example, using a device like OsteoBoost to vibrate higher up on the spine might cause too much vibration of the brain or optical pathways, which isn’t good, he says.

Comfort and ease of use are important design goals since this is a wearable for patient use, Hillstrom said.

“This for me was a very interesting product because it’s the first product that I’ve worked on that is used primarily by the patient and not by a medical professional,” he said. “That has been a learning experience and making sure that our device is easy, intuitive, that it’s clear to the patient what is going on at any time without them having a medical background.”

An internal lithium-ion battery, which must be periodically recharged, powers the OsteoBoost, which has an expected use life of 12 months.

OsteoBoost’s Research

OsteoBoost was granted clearance based on data from an NIH-funded study of 126 post-menopausal women ages 52 to 82 diagnosed with osteopenia, defined by a DXA T-score between -1.0 and -2.49.

“In a 12-month triple-blind, randomized, sham-controlled clinical trial of postmenopausal women with Osteopenia, OsteoBoost demonstrated a 0.48% reduction in bone strength for patients who used the device per the protocol, a statistically significant difference compared to the 2.84% reduction in bone strength for patients who used a sham, non-therapeutic version of the device per the protocol,” according to Bone Health Technologies. “OsteoBoost also reduced loss of vertebral bone density as measured by CT scan, demonstrating a 0.29% reduction in patients who used the device, a statistically significant difference compared to the 1.97% reduction for patients who used the sham device.”

Compliance matters, according to Bone Health Technologies, which notes there were no statistically significant differences between the treatment groups of the primary analysis population. But when they studied the per-protocol population (all those who completed an average of at least three sessions a week, of at least 24 minutes of total device use daily, over the 12 months of the study) the results reached clinical significance.

There were no reported serious adverse events.

Among the study’s limitations is that researchers did not study whether benefits from OsteoBoost reduced fracture risk and bone fragility.

“Because there are not really established stages that would be considered clinically important, we presented it [to the agency] as this change we saw in one year is impactful,” McGurl said.

It’s important for companies seeking device clearance to work with FDA before starting a trial, to make sure the study is going to satisfy FDA’s needs, McGurl noted.

“You don’t want to spend significant money and find out the FDA would have preferred different changes to, for example, a clinical study,” McGurl said.

Marketing Plans

The company is contemplating next steps for OsteoBoost, according to Hillstrom.

“We are just getting started with the device with our FDA approval, so as time goes on, we will look for unmet needs and apply our device and technology as needed to expand that,” he said. “We would love to have the opportunity to test this on men with osteoporosis and even women and men who are pre-osteopenia.”

In the meantime, the focus is on marketing the prescription device to healthcare providers and end users.

The company has not yet set the price for OsteoBoost.

“… but our goal is to make OsteoBoost affordable and accessible to the millions of patients who need it. OsteoBoost is a prescription-only device and as a result, pricing for individuals will depend on their insurance plan and co-pays,” according to a public relations representative.

Bone Health Technologies is in discussions with a number of payers/insurers regarding pricing and coverage for OsteoBoost, according to the representative.

Bone Health Technologies expects to begin shipping the device later this year and plans to begin accepting pre-orders in the next few months. 

Interested patients can sign up to be notified about the device’s availability on the company’s website www.bonehealthtech.com.

As many as 18 million Americans currently have osteopenia, and nearly everyone over age 50 is at risk, according to the National Council on Aging.