The FDA gives initial approval for a VR system for the treatment of chronic low back pain

As a first for the FDA, the agency approved a virtual reality device for the treatment of low back pain, offering an opioid-free alternative to many current pain management regimens.

The newly approved EaseVRx device comes from AppliedVR. It uses cognitive behavioral therapy and other therapeutic techniques to guide patients through games, lessons, and exercises to reduce their chronic back pain. The immersive software loads on a VR headset and is used by patients in solo sessions at home every day for eight weeks, with sessions ranging from two to 16 minutes long.

With FDA’s de novo approval, AppliedVR can now begin marketing the device throughout the United States. It is only indicated for prescription use by patients aged 18 years and older who have been diagnosed with moderate to severe back pain lasting longer than three months.

“Millions of adults in the United States live with chronic low back pain, which can affect several aspects of their daily lives,” said Christopher Loftus, MD, acting director of the FDA’s Department of Neurological and Physical Devices. “Pain reduction is a crucial component in living with chronic low back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medication when used in conjunction with other treatment methods for chronic low back pain.”

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EaseVRx’s therapeutic offering includes pain education and games to improve executive functions such as memory and self-control along with breathing, mindfulness and relaxation response exercises. The VR content helps patients develop not only coping skills but also new habits to reduce the intensity and interference of their chronic pain.

FDA approval was supported by two clinical trials, both of which ultimately showed that EaseVRx was both scalable and effective as a pain treatment. The first followed about 100 patients for 21 days and compared the VR system with a program that was only silent. After the trial period, patients in the VR group reported significantly higher reductions in their pain intensity and interference, as well as improvements in sleep, mood, and stress.

The second, placebo-controlled trial, meanwhile, put 179 patients through the entire eight-week program. Once again, the VR program outperformed placebo, with improvements of at least 40% each in pain, mood, stress and sleep. In addition, patients using EaseVRx reduced their use of over-the-counter analgesics throughout the treatment period – while those in the placebo group did not – and also reported higher user satisfaction ratings for the VR device.

“We have worked tirelessly over the last few years to build an unrivaled amount of clinical evidence demonstrating the power of VR to treat pain, and we could not be more excited to reach this important milestone,” said Josh Sackman, co-founder and chairman of AppliedVR. “But our mission does not stop with this one endorsement. We are committed to continuing research that validates our effectiveness and cost-effectiveness in treating chronic pain and other indications.”

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To that end, the Los Angeles-based company will now expand its focus by using its VR to treat other forms of acute and chronic pain and prove its effectiveness as an opioid-free alternative.

These efforts will be supported by AppliedVR’s latest Series B funding round, which the company announced last week. The $ 36 million financing was courtesy of F-Prime Capital, JAZZ Venture Partners, Sway Ventures and SVB Ventures, doubling the company’s lifetime financing to a total of $ 71 million.


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