The Food and Drug Administration has granted AppliedVR De Novo clearance to market its EaseVRx virtual reality system to treat chronic lower back pain. 

The prescription device includes a VR headset and controller plus a “Breathing Amplifier” that’s used to train the user in deep breathing. Patients can participate in 56 VR sessions that use cognitive behavioral therapy to treat pain. The sessions offer content like exercises in breathing, mindfulness, relaxation-response and executive function.

The FDA evaluated the system with a randomized, double-blind study of 179 participants with chronic lower back pain who received either the 3D EaseVRx program or a 2D control option without cognitive behavioral therapy. The participants were then followed for 8.5 months.

Researchers found 66% of EaseVRx users reported a greater than 30% reduction in pain after treatment, compared with only 41% of those in the control group. After one month, all study participants using EaseVRx continued to report a 30% reduction in pain. And after two and three months, the 30% reduction continued for all metrics except for pain intensity. But the control participants reported a reduction in pain below 30% after each month follow-up for all metrics.

AppliedVR has conducted other studies to research the impact of the EaseVRx system. The De Novo clearance comes about a week after the company announced it had raised $36 million in Series B funding. It had raised another $29 million in March. EaseVRx landed FDA Breakthrough Device designation in October 2020. 

"We worked tirelessly over the past few years to build an unmatched body of clinical evidence that demonstrates the power of VR for the treatment of pain, and [we] couldn't be more thrilled to achieve this important milestone," Josh Sackman, AppliedVR cofounder and president, said in a statement. 

"But our mission does not stop with this one approval. We're committed to continuing research that validates our efficacy and cost-effectiveness for treating chronic pain and other indications."

WHY IT MATTERS

The FDA and AppliedVR are positioning the new tool as a way to treat chronic lower back pain without relying on opioids. According to data compiled by the Centers for Disease Control and Prevention, opioids continue to be commonly prescribed for lower back pain when patients seek help, even though there’s a lack of evidence on efficacy. 

“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” Dr. Christopher M. Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.

“Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”

THE LARGER TREND

Other companies aiming to use VR to treat pain include XRHealth, which scored $9 million in funding in June, and Karuna Labs, which raised $3 million in seed funding in 2019. 

VR is also being used in the healthcare space to train medical students, sedate patients during minor procedures and help radiologists see scans in 3D.