FDA okays AppliedVR's virtual reality system for chronic back pain

The FDA on Tuesday authorised marketing of AppliedVR's prescription-use immersive virtual reality (VR) system EaseVRx to help reduce chronic lower back pain in adults. Christopher Loftus, acting director at the FDA's Office of Neurological and Physical Medicine Devices, noted that the "authorisation offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain."

EaseVRx, which is intended for self-use at home, comprises a VR headset attached to a breathing amplifier that directs a patient's breath toward the headset's microphone for use in deep breathing exercises. The device's VR programme is based on principles of behavioural therapy – such as deep relaxation, attention-shifting and interoceptive awareness – intended to address the physiological symptoms of pain and help provide some relief through a skills-based treatment programme. The eight-week programme consists of 56 VR sessions, lasting from 2 minutes to 16 minutes, that are intended to be used daily.

EaseVRx, reviewed via the FDA's de novo pathway, was evaluated in a clinical study of 179 participants with chronic lower back pain who were assigned to undergo the immersive 3D programme or a control 2D programme that did not use cognitive behavioural therapy methods of treatment. Participants were asked to rate pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress.

Positive data in pain study

At the end of treatment, 66% of EaseVRx participants experienced a ≥30% decrease in pain, while 46% said their pain had reduced by at least half. For controls, the rates were 41% and 26%, respectively. At one-month follow-up, all EaseVRx participants continued to report a 30% reduction in pain and at the two- and three-month marks, the 30% reduction in pain remained for all outcomes with the exception of pain intensity. By contrast, the control group reported a reduction in pain below 30% at one-, two-, and three-month follow-up for all outcomes.

The device gained an FDA breakthrough designation last year for treatment-resistant fibromyalgia and chronic intractable lower back pain. Earlier this month, AppliedVR announced $36 million in Series B funding.

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