A significant development for digital therapeutics and digital health solutions with clinical indications has taken place. The US FDA has granted market authorization in the US to the EaseVRx virtual reality system from AppliedVR indicated for the treatment of chronic pain. EaseVRx is the first and only FDA-approved at-home immersive virtual reality (VR) pain treatment indicated as an adjunct treatment for chronic lower back pain (cLBP). The FDA reviewed EaseVRx through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type.
See the official statement from the U.S. Food and Drug Administration:
FDA Authorizes Marketing of Virtual Reality System for Chronic Pain Reduction
This important benchmark was achieved one year after being accepted into the US FDA breakthrough devices program, making it one of the first Virtual Reality based systems to have received that designation.
Compelling results were seen in a controlled, double blind clinical study using the EaseVRx Virtual Reality technology. In the study 66% of EaseVRx participants reported a greater than 30% reduction in pain, compared to 41% of control participants who reported a greater than 30% reduction in pain. Furthermore, 46% of EaseVRx participants reported a greater than 50% reduction in pain compared to 26% of control participants. No serious adverse events were observed or reported during the study.
It bodes well for the immersive therapeutics sector to see cutting edge medical technology developed for real clinical applications, done responsibly and with rigor in a relatively short period of time. Applied VR also has a number of other virtual reality devices under development for diseases including anxiety and general pain. We can see a pathway to a future where immersive virtual reality devices can help improve patient outcomes across a number of conditions.
What exactly is the EaseVRx Virtual Reality Pain Management System?
The EaseVRx Headset is a prescription-use medical device with preloaded software content on a proprietary hardware platform that delivers pain management training based on cognitive behavioral skills and other behavioral methods. It uses an immersive virtual reality (VR) system that delivers VR content while incorporating biopsychosocial pain education, diaphragmatic breathing training, mindfulness exercises, relaxation-response exercises and executive functioning games.
The EaseVRx solution is the first in a new class of pain treatment options. It is an at-home non-invasive immersive virtual reality therapeutic that has been clinically validated to improve the lives of patients experiencing cLBP.
Following its first FDA approval, AppliedVR plans to continue testing to demonstrate the clinical efficacy and cost-effectiveness of using VR to treat pain, most notably completing multiple health economics and outcomes (HEOR) studies with commercial payers. We look forward with anticipation to the future developments of the EaseVRx technology.
About BML Technology
BML Technology understands digital health. At the intersection of medical technology, clinical research and patient-centric healthcare BML drives the mainstream adoption of digital technology in healthcare. Offering a full range of services to the digital health ecosystem BML manages the complex stakeholder interactions necessary to get digital health solutions to market and gain adoption.
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