PROJECT SUMMARY Chronic pain affects up to 116 million Americans and is one of the most common reasons adults seek medical care. Pain treatment and management is traditionally based primarily around pharmacological management methods, which typically involve opioids. Opioids are commonly prescribed for chronic pain, but these agents can yield inconsistent results, have significant adverse event profiles, and greatly increase the risk of the patient developing an Opioid Use Disorder (OUD). Chronic pain is linked to opioid dependence, and 20-30% of patients prescribed opioids for chronic pain misuse them. Despite the immense number of people receiving prescription therapeutics for pain, pain is also one of the most untreated or undertreated medical conditions. The dual epidemics of chronic pain and OUD pose a significant unmet need for low-risk, integrative, non-opioid pain management tools that minimize the risk of addiction. AppliedVR, Inc. (appliedVR) plans to leverage our existing success with virtual reality (VR) technology to address the unmet need for better opioid-sparing therapeutic alternatives to treat chronic pain with EaseVRx, our software-based VR medical device. EaseVRx is intended to offer users a prescription pain management tool that (a) manages the symptoms associated with chronic pain and (b) reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy strategies commonly used in interdisciplinary pain rehabilitation programs. This Direct-to-Phase II project will advance EaseVRx development and commercialization by evaluating EaseVRx efficacy in a proof-of-concept clinical trial in 100 patients with chronic low back pain. This trial will assess EaseVRx’s effectiveness in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving quality of life. We will also develop a VR-based surveying tool to allow for the collection of patient-reported outcomes inside the VR headset or application, in order to capture that outcome data and effectively measure EaseVRx efficacy. Additionally, we will prepare pre-submission materials for FDA Class II software-as-medical device clearance. Successful completion of this Phase II project will demonstrate EaseVRx’s efficacy in treating chronic pain and reducing opioid usage and will have resulted in pre-submission conversations with the FDA, significantly advancing the development program. Our ultimate goal is to bring EaseVRx to healthcare providers and use this VR-based opioid-sparing pain treatment to improve the lives of patients suffering from chronic pain.

PROJECT NARRATIVE appliedVR is developing its software-based virtual reality device, EaseVRx, as an opioid-sparing therapeutic alternative for patients with chronic pain. EaseVRx is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. This project will evaluate EaseVRx efficacy in a proof-of-concept clinical trial in patients with chronic low back pain.