SUMMARY:
- The U.S. Food and Drug Administration today authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain.
- Healthcare providers will soon be able to prescribe a virtual reality treatment that uses cognitive behavioral therapy to help patients manage their lower back pain.
FDA Grants AppliedVR Approval for First Virtual Reality Therapeutic to Treat Chronic Low Back Pain.
AppliedVR, a pioneer advancing the next generation of immersive therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo approval for its flagship immersive therapeutic, EaseVRx, to treat chronic low back pain, which previously received breakthrough device designation in 2020. The news also comes on the heels of AppliedVR announcing its $36 million series B funding round, bringing its total funding to $71 million.
“Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “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.”
EaseVRx employs the principles of CBT and other behavioral therapy techniques for the purpose of reduction of pain and pain interference. The prescription device, which is intended for at-home self-use, consists of a VR headset and a controller, along with a “Breathing Amplifier” attached to the headset that directs a patient’s breath toward the headset’s microphone for use in deep breathing exercises. The device’s VR program uses established principles of behavioral therapy intended to address the physiological symptoms of pain and aid in pain relief through a skills-based treatment program. These principles include deep relaxation, attention-shifting, interoceptive awareness–the ability to identify, access, understand and respond appropriately to the patterns of internal signals—and perspective-taking, distraction, immersive enjoyment, self-compassion, healthy movement, acceptance, visualization, knowledge of pain and rehabilitation.
The EaseVRx treatment program consists of 56 VR sessions that are 2-16 minutes in length, which are intended to be used as part of a daily eight-week treatment program. Each session incorporates elements of the aforementioned principles to provide the user with skills to achieve relief and reduction in the interference of pain in daily activities.
The FDA evaluated the safety and effectiveness of EaseVRx in a randomized, double-blinded clinical study of 179 participants with chronic lower back pain who were assigned to one of two eight-week VR programs: the EaseVRx immersive 3-D program or a control 2-D program that did not utilize skills-based CBT methods of treatment. After enrollment in the trial, participants were followed for a period of 8.5 months total, including a two-week baseline assessment period, an eight-week VR program, a post-treatment assessment, and follow-up at one, two, three, and six months after completion of the program.
At the end of treatment, 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. At one-month follow-up, all participants in the EaseVRx group continued to report a 30% reduction in pain and at the two- and three-month follow-up marks, the 30% reduction in pain remained for all outcomes with the exception of pain intensity. In contrast, the control group reported a reduction in pain below 30% at one-, two-, and three-month follow-up for all outcomes.
To evaluate the effectiveness of EaseVRx, at the end of the eight-week program, participants were asked to rate the following outcomes on a 10-point scale, with 10 being the greatest value: pain intensity, pain interference on activity, pain interference on mood, pain interference on sleep and pain interference on stress. On average, participants experienced a decrease in pain intensity of 1.31 points over the eight weeks of treatment. Participants also reported a decrease in pain interference for all measured outcomes that ranged from .95 points to 1.27 points down from their respective scores at the start of treatment.
No serious adverse events were observed or reported during the study. Approximately 20.8% of participants reported discomfort with the headset and 9.7% reported motion sickness and nausea.
EaseVRx was granted Breakthrough Device designation. To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.
The FDA reviewed EaseVRx through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
“Pain is often treated with a purely biomedical approach with key aspects of pain left untreated,” said Dr. Beth Darnall, AppliedVR chief science advisor and Stanford pain scientist. “Our research shows that VR can scale effective ‘whole-person’ chronic pain care that people can conveniently use in the comfort of their own home. As the immersive therapeutics category leader, AppliedVR is now best positioned to drive a paradigm shift towards accessible pain care.”
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. AppliedVR also is currently collaborating with Geisinger and Cleveland Clinic to advance separate NIDA-funded clinical trials that test VR as an opioid-sparing tool for acute and chronic pain.
AppliedVR is already trusted by more than 200 of the world’s leading health systems. The technology has been used by approximately 60,000 patients to date in pain management and wellness programs.
About Chronic lower back pain:
Chronic lower back pain, which is defined as moderate to severe pain in the lower back lasting longer than three months, is one of the most common chronic pain conditions in the U.S. Chronic pain may inhibit mobility or daily activities and has been linked to anxiety and depression, poor perceived health or reduced quality of life and dependence on opioids. Current treatment plans for chronic lower back pain often include, among other options, prescription and over-the-counter pain medications, exercise, steroid injections, surgery and transcutaneous electrical nerve stimulation. Cognitive behavioral therapy (CBT) may be used to reduce the burden of chronic pain and increase function through an emotional, cognitive and behavioral approach to shift negative beliefs held by patients about the relationship between their pain and movement.
About EaseVRx:
EaseVRx is a prescription-use medical device with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral skills and other behavioral methods to patients diagnosed with chronic pain. It uses an immersive virtual reality (VR) system that delivers VR content while incorporating biopsychosocial pain education, diaphragmatic breathing training, mindfulness exercises, relaxation exercises and executive functioning games. The medical device integrates an all-in-one, head-mounted display with a Software Application and a Breathing Amplifier™ to enable the diaphragmatic breathing exercises. The device is intended to be self-administered, unsupervised in the patient’s home while the patient is in a seated position. Each device is intended for a single patient, is meant for repeated use, does not include non-medical software, and is only effective when treating chronic pain.
Indication for Use
EaseVRx 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.
Safety Information and Warnings
- If a user experiences motion sickness, dizziness, headache, or eye strain when using the device, stop use of the device and resume therapy per your doctor’s advice.
- Use only in a safe environment. This product creates an immersive virtual reality experience that blocks your view of your actual surroundings. Please move to an indoor safe and comfortable area and take care of your surroundings. Do not get close to dangerous areas like stairs, windows, heat source or other hazardous areas. Sit down before wearing the headset and stay seated during use of the headset.
- If you are wearing a pacemaker or other implanted medical device, do not use it until you consult a doctor or medical device manufacturer.
- Do not wind cables around the neck. Tangled cables can cause strangulation.
- EaseVRx must be turned off and power supply must be disconnected from the AC outlet before performing any repair and maintenance procedure. Failure to do so may result in electric shock.
- Safety and effectiveness have not been demonstrated in patients with moderate to severe depression.
- If you suffer from the following, please consult your doctor before use:
- Hearing and visual impairment
- Hypersensitivity to flashing light or motion
- Injury to eyes, face, or neck that prevents comfortable use of VR
- Have a history of epilepsy, suffer from physical, mental or heart disease
- Have any serious medical condition
About AppliedVR:
AppliedVR is pioneering evidence-based, immersive VRx—a new category of prescription digital therapeutics—including its product EaseVRx, the first virtual reality-based treatment for pain to receive FDA 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.