AppliedVR announced that it received FDA breakthrough device designation for its fibromyalgia and lower back pain treatment.
Los Angeles-based AppliedVR’s EaseVRx product is designed to treat treatment-resistant fibromyalgia and chronic intractable lower back pain. With the breakthrough nod, EaseVRx is now one of the first virtual reality (VR) digital therapeutics to earn that designation for treating conditions related to chronic pain, according to a news release.
AppliedVR completed a randomized, controlled trial to evaluate VR-based therapy for chronic pain self-management, reporting results that showed the self-administered, skills-based VR treatment program for chronic pain was feasible and scalable, plus it was effective at improving on multiple outcomes.
EaseVRx helps patients learn self-management skills based on cognitive behavioral therapy (CBT) principles and other behavioral methods. The program, designed by AppliedVR in partnership with top pain experts and researchers, seeks to improve self-regulation of cognitive, emotional and physiological responses to stress and 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,” AppliedVR CEO & co-founder Matthew Stoudt said in the release. “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.”
The company is currently engaged in multiple trials for improving care across underserved populations, while it is also advancing two clinical trials to study VR as an opioid-sparing tool for acute and chronic pain. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), recently awarded grants worth $2.9 million to fund those trials.