AppliedVR secures breakthrough device status for virtual reality therapy

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The FDA breakthrough device designation for EaseVRx from AppliedVR will get the proven virtual reality-based therapeutic programme into the hands of people suffering from pain

Quick read

➨ The FDA breakthrough device designation will give patients being treated for treatment-resistant fibromyalgia and chronic intractable lower back pain more timely access to the programme
➨ AppliedVR secured the designation for EaseVRx after successfully completing the programme’s first randomised controlled trial, which evaluated virtual reality-based therapy for self-management of chronic pain at home
➨ Results from the trial were impressive, with EaseVRx found to be feasible, scalable and effective at improving on multiple chronic pain outcomes

The story

AppliedVR has achieved breakthrough device status from the US Food and Drug Administration (FDA) for EaseVRx, a virtual reality programme aimed at improving self-regulation of cognitive, emotional and physiological responses to stress and pain.

The FDA breakthrough device designation will give patients being treated for treatment-resistant fibromyalgia and chronic intractable lower back pain more timely access to the programme.

AppliedVR secured the designation for EaseVRx after successfully completing the programme’s first randomised controlled trial, which evaluated virtual reality-based therapy for self-management of chronic pain at home.

Results from the trial were impressive, with EaseVRx found to be feasible, scalable and effective at improving on multiple chronic pain outcomes.

Most notably, patients on EaseVRx found their pain intensity reduced 30%, while pain-related activity, mood, sleep and stress interference all decreased significantly.

Matthew Stoudt, chief executive officer and co-founder of AppliedVR, welcomed the FDA designation and promised to get EaseVRx “into the hands of people suffering from pain”. 

He said: “Providers believe in it, patients want it, and payers are coming around to it.”

AppliedVR is engaged in several other trials for digital therapy, including feasibility studies with multiple well-known payers and with the University of California at San Francisco to study how digital technologies, including virtual and augmented reality, can be used to improve care access for underserved populations.

The Los Angeles-headquartered company is advancing two clinical trials of RelieVRx and EaseVRx with Geisinger and Cleveland Clinic to study virtual reality as an opioid-sparing tool for acute and chronic pain.

The National Institute on Drug Abuse, part of the National Institutes of Health, awarded grants to fund the trials.

Commenting on the impact of the FDA designation on patient access to virtual reality-based therapy, Dr Beth Darnall, AppliedVR’s chief science adviser, said: “Virtual reality is a promising skills-based behavioural medicine that has been shown to have high patient engagement and satisfaction.”

“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.”

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Main image: AppliedVR

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