The Los Angeles-based startup received a breakthrough device designation from the FDA for using VR to manage chronic pain. It recently published the results of a 92-person virtual trial testing VR for pain management at home.
A virtual reality program intended to treat fibromyalgia and chronic lower back pain received a breakthrough device designation from The Food and Drug Administration. AppliedVR, the Los Angeles-based startup developing it, said the designation was a milestone toward using VR as a digital therapeutic for chronic pain.
“It’s a great statement form the FDA that they believe in this as a modality, broadly speaking,” Co-Founder and CEO Matthew Stoudt said in a call. “It helps accelerate our pathway through the FDA. We’re able to have faster discussions with them as we go through the process.”
The FDA’s Breakthrough Devices program is intended to speed up the review process for medical devices that provide better treatment for life-threatening or debilitating conditions. To be eligible, devices must represent a breakthrough technology, or one with no cleared alternatives.
AppliedVR received the breakthrough designation after publishing the results of a randomized study of 97 people who used a self-administered VR program to manage chronic pain at home. It recruited people with low-back pain or fibromyalgia through online advertisements, and randomly assigned them to a 21-day VR program or an audio-only version of the same program. The study was not blinded.
Stoudt said patients are provided the devices, and are supposed to do short exercises, roughly three to seven minutes, every day.
“We don’t want you to live your life in a headset. Our objective is to drive neurobehavioral change. To teach you skills outside of the headset to self-regulate your pain,” he said. “We hear time and time again from patients that this has retrained me on how to breathe through my pain, control my pain, process my pain.”
Image Credit: AppliedVR