Following a 2021 FDA marketing authorization, AppliedVR will leverage Komodo’s platform in clinical trial to study the real-world clinical impact of its RelieVRx product on patients living with chronic lower back pain
April 28, 2022 09:00 AM Eastern Daylight Time
SAN FRANCISCO--(BUSINESS WIRE)--Komodo Health today announced a new partnership with AppliedVR, the leader in therapeutic virtual reality (VR) for pain management. The FDA recently granted AppliedVR’s De Novo request for its flagship product, RelieVRx, and is now tapping into Komodo’s technology platform to further demonstrate the therapeutic impact of RelieVRx for patients living with chronic lower back pain. Using Komodo’s technology, AppliedVR will combine its proprietary insights with Komodo’s real-world data to conduct clinical research into the efficacy, cost savings, and health system value that RelieVRx delivers compared to traditional chronic pain treatment modalities. The comprehensive, longitudinal view of real-world patient experiences will enable AppliedVR to better understand how treatment outcomes vary in subsets of this patient population, evaluate the healthcare resource utilization of patients, and quantify the clinical impact and cost effectiveness of RelieVRx in the market. This is particularly important as patients, providers, and payers make decisions about the safety and efficacy of pain management therapies.
Chronic pain affects tens of millions of Americans and takes a $635 billion estimated economic toll each year. Low back pain is the leading cause of global disability and approximately 8% of American adults — or 16 million people — experience chronic low back pain (CLBP). Related to the cost of chronic pain, the opioid crisis represents an economic cost of more than $1 trillion. A Komodo Health analysis found that nearly 30% of CLBP patients begin their treatment journey with opioids and more than 63% of those CLBP patients had a history of opioid use, representing a significant unmet need for new approaches to chronic pain management.
“With the power of the Komodo platform, we are gaining important insights into the value that RelieVRx delivers beyond the patient-reported outcomes collected from clinical trials, and we are quantifying the impact we can deliver for stakeholders across the industry,” said Josh Sackman, president and co-founder at AppliedVR. “Komodo has already proven to be invaluable as both a technology and a thought partner, helping us to combine the power of decentralized trials with robust data and technology to demonstrate clinical and economic value as we make this new category of immersive therapeutics available to patients in need.”
Within Komodo’s technology, the AppliedVR research team can look beyond the more traditional self-reported pain levels to better understand the impact of RelieVRx on real-world clinical encounters and signals such as surgery rates, chiropractic visits, opioid prescription volume, and more.
In addition to this health economics and outcomes research (HEOR) collaboration, AppliedVR will also launch a clinical study, featuring four trial cohorts and one synthetic control arm leveraging real-world data from Komodo. The synthetic control arm will consist of a de-identified patient cohort who are similar to trial patients but are not included in the study and were not exposed to the treatment or placebo control. Because it is built on the largest database of longitudinal patient journeys spanning all settings of care, the Komodo platform allows AppliedVR to conduct a multi-year retrospective analysis evaluating RelieVRx’s impact in real-world care settings.
“AppliedVR is at the cutting edge of pain management, not only developing innovative technologies but applying comprehensive research rigor to prove the value of the therapy for those suffering from chronic pain,” said Komodo Health President and co-founder, Web Sun. “This partnership marks a massive step forward in validating the efficacy of virtual reality as an important alternative in chronic pain treatment. It’s also a powerful example of the accelerated innovation that’s possible through a cloud- and digital-first approach to addressing unmet patient needs.”
The findings will be used to demonstrate the real-world clinical and economic value of the therapy and support AppliedVR in establishing strong payer relationships, building broader distribution networks, and pursuing label expansions and additional VR-powered technologies. RelieVRx, the first and only VR-based chronic pain therapy to be granted FDA De Novo approval, is a prescription-use immersive virtual reality system intended to provide adjunctive treatment for patients with a diagnosis of moderate to severe 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 a FDA De Novo request 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.
About Komodo Health Komodo Health is a technology platform company creating the new standard for real-world data and analytics by pairing the industry’s most complete view of patient encounters with enterprise software and machine learning that connects the dots between individual patient journeys and large-scale health outcomes. Across Life Sciences, payer, provider, and developers, we help our customers unearth patient-centric insights at scale — marrying clinical data with advanced algorithms and AI-powered software solutions to inform decision making, close gaps in care, address disease burden, and help the enterprise create a more cost-effective, value-driven healthcare system. For more information, visit komodohealth.com.