Vibrating Belt Gets FDA ‘Breakthrough Device’ Designation for Osteoporosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has given “Breakthrough Device” designation to a vibrating belt that lowers the risk of bone fractures caused by osteoporosis. When worn around the waist, the OsteoBoost Vibration Belt delivers gentle stimulation to the hips and spine, simulating the effects of exercise and strengthening bones.

Osteoporosis is caused by the loss of bone mineral density (BMD) and is one of the most common health conditions associated with old age. More than 10 million Americans suffer from osteoporosis and 43 million have its precursor, osteopenia.

About 1 in 2 women and 1 in 4 men over the age of 50 will suffer an osteoporosis-related fracture, usually in their hip or spine. Breaking a bone is especially traumatic for the elderly and can lead to a cascade of health problems, including chronic pain, disability and early death.

Osteoporosis is currently treated with changes in diet, exercise and bisphosphonate drugs such as Fosamax, which slow the loss of BMD. However, long term use of bisphosphonates can lead to side effects such as bone, muscle or joint pain, as well as nausea and heartburn.

“For years, I have wanted a better option for my patients with low bone density that doesn’t have the potential side effects and the inconvenience of current drug treatments. With OsteoBoost we’ve created a safe, drug-free alternative that is easy and convenient. Now my patients with osteopenia have a new way to improve their bone health and reduce their risk of fracture,” says Dr. Shane Mangrum, co-founder of San Francisco-based Bone Health Technologies, which makes the OsteoBoost belt.

OsteoBoost uses whole body vibration (WBV) technology originally developed for NASA to improve the bone health of astronauts in a weightless environment. Here on earth, WBV has been found to improve bone mineral density, but it requires users to stand on a stationary vibrating platform, which isn’t always practical.

Because OsteoBoost is wearable, users can go for a walk or perform simple household chores while getting treatment. It’s recommended the device be used in 30-minute sessions, 3 to 5 times a week.

In a small clinical trial, OsteoBoost reduced bone loss in postmenopausal women by an average of 14%, a reduction similar to bisphosphonates. The National Institutes of Health is funding a larger, $2 million study of OsteoBoost that is currently enrolling postmenopausal patients. It is scheduled to be completed in early 2022.

If that study is successful, the FDA’s Breakthrough Device designation will speed up the agency’s review of OsteoBoost and help bring it to market sooner. The belt is not currently available for purchase and will require a a prescription when it is.

A 2011 Canadian study found that WBV did not improve bone mineral density in postmenopausal women who used a vibrating platform daily for a year while also taking vitamin D and calcium supplements.

"Although commercially available WBV devices are marketed to and used by patients, the beneficial effects of WBV on fracture risk and BMD have not been established, and recent randomized, controlled trials in postmenopausal women have shown conflicting results," said lead researcher Angela Cheung, MD, at University Health Network in Toronto. "Women would be farther ahead in making sure that they are exercising regularly and eating nutritious foods."

FDA Designates First Virtual Reality Device for Chronic Pain

By Pat Anson, PNN Editor

AppliedVR, a Los Angeles-based virtual reality company, has announced that its EaseVRx headset has received Breakthrough Device Designation from the Food and Drug Administration for treating fibromyalgia and chronic intractable low back pain.

EaseVRx is the first virtual reality (VR) device to get a Breakthrough Designation from the FDA for treating a chronic pain condition. The designation speeds up the development and review of new medical devices that treat life-threatening or irreversibly debilitating diseases or conditions. It could also speed up insurance coverage of VR therapy for chronic pain.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” Matthew Stoudt, CEO and co-founder of AppliedVR, said in a statement.

“Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.” 

AppliedVR funded a recent clinical trial that showed VR therapy can be self-administered at home to treat chronic pain. Patients living with fibromyalgia or chronic lower back pain were given VR headsets and instructed to watch at least one virtual reality program daily for 21 days.

The programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is to help patients learn how to manage their pain and other symptoms by distracting them and making their pain seem less important

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy. Their pain intensity was reduced an average of 30 percent. Physical activity, mood, sleep and stress levels also improved.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Beth Darnall, PhD, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

PNN columnist Madora Pennington, who lives with chronic pain from Ehlers-Danlos Syndrome, recently reviewed one of AppliedVR’s headsets. She said watching VR programs helped calm and relax her.

“The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to,” Madora wrote. “After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.”

AppliedVR’s technology is being used in hundreds of hospitals, but is not expected to be available for home use until next year. The company is working with Geisinger Health and Cleveland Clinic on two studies to see if VR therapy can be used as an opioid-sparing tool for acute and chronic pain.

VR for Phantom Limb Pain

Virtual reality technology received another boost this week when the Department of Defense awarded Chicago-based Coapt a $2.3 million grant to develop virtual reality therapies for phantom limb pain. Wounded veterans and amputees who have lost arms or legs often suffer from nerve pain and other sensations from their missing limbs.

"Phantom limb pain is a serious and persistent challenge for many upper and lower-limb amputees, and new, technology-based therapies have incredible promise," Blair Lock, co-founder and CEO of Coapt, said in a statement. "Preliminary work has shown that VR-based, actuated therapy can manage pain more effectively and have lasting effects. This grant will allow us to further study this therapy and bring to market a solution for those suffering from phantom limb pain in a way that also happens to be engaging."

Coapt has previously developed a VR-based therapy to help upper-limb amputees improve control of their prostheses. The technology also shows promise as a treatment for phantom limb pain. Coapt will use the grant money to further study the effectiveness of VR therapy and create a commercially viable product for both civilians and veterans with upper and lower-limb amputations.