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AppliedVR Renames its FDA-Approved RelieVRx Therapeutic Drug & Publishes Results of Durability Study



Company also names Charisse Y. Sparks, M.D., FAAOS as Chief Medical Officer


LOS ANGELES, March 22, 2022 /PRNewswire/ -- AppliedVR, a pioneer advancing the next generation of immersive therapeutics, today announced a new name for its flagship virtual reality (VR) therapeutic. EaseVRx, which was granted De Novo approval by the FDA last November for chronic lower back pain, will now be known as RelieVRx. The renaming followed extensive conversations with chronic pain specialists, healthcare professionals and patients who reinforced the outcomes and pain relief delivered by the product.


"At AppliedVR, we are committed to solving unmet needs in chronic pain. Building on our substantial body of evidence, we applied the same rigor in researching how to market the first FDA-approved virtual reality-based treatment to best meet the needs of our customers," said Matthew Stoudt, co-founder and CEO of AppliedVR. "While ease of use is definitely an important part of our design, ultimately we wanted a name that better reflected how our innovative product intends to provide life-changing relief. With demonstrated efficacy data, 'RelieVRx' better captures the core benefit of pain relief that the healthcare industry is looking for: a prescription treatment option that provides a unique modality while addressing unmet patient needs."


AppliedVR plans to launch RelieVRx in a few select markets this year while the company continues to build device distribution infrastructure and payer partnerships in preparation of its full market launch in 2023. The company also is engaged in health economics and outcomes research (HEOR) studies designed to demonstrate the value that RelieVRx delivers compared to traditional chronic pain treatment modalities.


AppliedVR announces peer-reviewed study that demonstrates RelieVRx can deliver durable pain relief


A new study published in The Journal of Pain reported the three-month follow-up results from a previous eight-week randomized controlled trial (RCT) of RelieVRx conducted by AppliedVR. The study, which included surveys of RCT participants in the previous trial, found that RelieVRx yielded superior benefits three months post treatment compared to a VR sham control group across many of the pain-related indices measured. Specifically, the study highlighted that:

  • Mean pain-intensity improvement was 30.3%;

  • Mean improvement in pain interference with activity was 36.6%;

  • Mean improvement in pain interference with mood was 28.8%;

  • Mean improvement for pain interference with sleep was 19.8%; and

  • Mean improvement in pain interference with stress was 37.4%;

Many of these results are considered "clinically meaningful" and suggest durable effects of RelieVRx over time. AppliedVR will now examine RelieVRx's effectiveness at six months post-treatment and also intends to design an RCT that enhances participation from diverse participants, examining for consistent effects from previous RCTs across race, ethnicity, socioeconomic, education and other factors.


"We were very pleased to see such strong results for our home-based virtual reality program for chronic pain. Low back pain is the most prevalent chronic pain condition worldwide. Many people have trouble accessing pain specialists and treatments that provide lasting relief," said Dr. Beth Darnall, the AppliedVR chief science advisor, Stanford pain scientist, and senior author of the study. "These results show lasting and meaningful effects three months after the end of VR treatment. Soon we will have results from our study of six-month durability of treatment effects, and we are particularly excited about our in-progress research that's testing treatment effectiveness across diverse populations."


AppliedVR Names Charisse Y. Sparks, M.D., FAAOS as Chief Medical Officer


AppliedVR also announced today that it named Charisse Y. Sparks, M.D., as Chief Medical Officer, supporting the company's deepening research, preparation for full market launch, and potential expansion of its FDA-approved device for other indications. Dr. Sparks is a Fellow of the American Academy of Orthopaedic Surgeons, a renowned American Board of Orthopedic Surgery certified surgeon, fellowship-trained trauma specialist and health-equity advocate.


She joins AppliedVR from DePuySynthes, The orthopaedics company of Johnson & Johnson, where she was Vice President leading medical, clinical and pre-clinical affairs for trauma, extremities, craniomaxillofacial, biomaterials and animal health. Prior to DePuySynthes, Dr. Sparks helped multiple U.S. Level III hospitals transition to Level II hospitals by shepherding the implementation of trauma care - a transition that allowed them to care for higher-acuity patients closer to their homes without requiring transfer to a Level I trauma center.


Dr. Sparks was just the third African-American female selected for specialized trauma fellowship training, which she completed at the Harvard Medical School. She is deeply committed to addressing and eliminating health inequities for people of color, and her leadership was an important piece in the ongoing Johnson & Johnson Our Race To Health Equity initiative.


At AppliedVR, Dr. Sparks will lead all medical, clinical, regulatory and quality aspects of the company. She will also work to ensure its products are broadly accessible to all populations, especially underserved communities. Dr. Sparks sees the opportunity to have an immediate and lasting impact on patient care and the healthcare industry through the adoption of VR treatments for chronic pain.


"Emerging digital technologies like virtual reality provide a safe, scalable and cost-effective treatment option for everyone experiencing chronic pain. These transformational immersive technologies should not be reserved for the communities that already have the best insurance and access to the highest-quality care," Dr. Sparks said. "Racial, ethnic and economic disparities in chronic pain management are well established. Reliable studies show that these disparities show up in the undertreatment of pain as well as overdose deaths, which continue to increase. I am looking forward to making immersive therapeutics a standard of care in chronic pain management and establishing AppliedVR as a leader in health equity for the digital health industry."


A Johns Hopkins Medical Center study published in The Journal of Pain reported that chronic pain can cumulatively cost as much as $635 billion a year, which is more than the annual costs of cancer, heart disease, and diabetes combined. Dr. Sparks also will assist with the ongoing NIDA-funded clinical trials in which AppliedVR is collaborating with both Geisinger and the Cleveland Clinic to test VR as an opioid-sparing tool for chronic and acute pain.


About RelieVRx

RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence-based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.


About AppliedVR

AppliedVR is pioneering evidence-based, immersive VRx—a new category of prescription digital therapeutics – that includes RelieVRx, the first virtual reality-based treatment for chronic lower back pain to be granted FDA De Novo approval as a Class II medical device. Backed by an unparalleled body of evidence, AppliedVR's mission is to solve pain through immersive therapeutics with the ultimate goal of a virtual reality pharmacy in every home. By developing the infrastructure and partnerships necessary to transform the pain treatment paradigm, AppliedVR empowers patients to live life—beyond chronic pain. Trusted by more than 200 of the world's leading health systems and thousands of healthcare professionals globally, AppliedVR's immersive therapeutics have been used by approximately 60,000 patients to date in pain management and wellness programs. For more information, visit www.appliedvr.io.


Press Contact

Sam Moore press@appliedvr.io


SOURCE AppliedVR