LOS ANGELES, Nov. 16, 2021 /PRNewswire/ -- 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.
EaseVRx 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 software content comprises an eight-week, VR-based program that helps people reduce symptom severity and the impact of their pain. People with chronic low back pain follow the clinically validated, evidence-based program to develop coping skills while also creating new, helpful habits that can reduce pain intensity and pain interference.
"Today's FDA approval marks a monumental day for AppliedVR, for the immersive therapeutics sector and, most importantly, for those people suffering from chronic lower back pain," said Matthew Stoudt, co-founder and CEO of AppliedVR. "Chronic low-back pain can be a debilitating and an incredibly costly problem, but now we're one step closer to achieving our goal of making immersive therapeutics the standard of care for pain."
AppliedVR's FDA submission was supported by two randomized controlled trials (RCTs), evaluating the effectiveness of a VR-based program for self-treatment of chronic pain at home. Both studies concluded that a self-administered, skills-based VR treatment program was not only a feasible and scalable way to treat chronic pain, it also was effective at improving on multiple chronic pain outcomes.
The first study, published in JMIR Formative Research, analyzed data from people suffering from chronic lower-back or fibromyalgia pain over a 21-day period. Participants using EaseVRx significantly reduced five key pain indicators — each of which met or exceeded the 30-percent threshold for clinical meaningfulness.
In its pivotal RCT studying the safety and efficacy of EaseVRx over an eight week period, participants in the EaseVRx group on average reported substantial improvements at post-treatment, including a 42% reduction in pain intensity; 49% reduction in activity interference; 52% reduction in sleep interference; 56% reduction in mood interference; and a 57% reduction in stress interference.
Engagement and usability data are critical to providers and payers who must evaluate the likelihood that members/patients will use a digital therapeutic — especially on themselves outside of clinical settings. In the pivotal study, EaseVRx participants demonstrated high engagement with the average completion of 5.4 sessions per week and indicated satisfaction with ease of use on the System Usability Scale (rating the device easier to use than an ATM and top email services).
"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 couldn't be more thrilled to achieve this important milestone," said Josh Sackman, AppliedVR co-founder and president. "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."
Low back pain is one of the most common chronic conditions that people face worldwide and represents one of the top reasons why people miss work. Additionally, it's an extremely costly problem for insurers as many look to cut costs related to back surgery. Recent research indicated that, when combined with neck pain, lower back pain costs nearly $77 billion to private insurance, $45 billion to public insurance, and $12 billion in out-of-pocket costs for patients.
Chronic pain, more broadly, is costly and contributes to other health crises, including the opioid epidemic. A previous Johns Hopkins study in The Journal of Pain found that chronic pain can cumulatively cost as high as $635 billion a year — more than the annual costs of cancer, heart disease and diabetes combined.
"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.
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
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.