AppliedVR Is First VR Provider Approved by FDA for Pain Treatment
We all know VR is good for things such as gaming and entertainment, but did you know that VR health is a rising industry?
On November 11th 2021, the U.S. Food and Drug Administration approved marketing EaseVRx.
AppliedVR, a leader in the development of immersive therapeutics for chronic low back pain, announced today that the U.S. Food and Drug Administration has approved EaseVRx as a de novo therapeutic. This is a continuation of its breakthrough 2020 device designation. This news comes just days after AppliedVR announced its $36 million Series B funding round. It brings its total funding to $71 millions.
The below video is a story of how a patient who used EaseVRx to help her alleviate pain.
Patient Madora from Los Angeles says
“a device like this so thoroughly interrupts the constant feedback of the brain and body and the pain going back and forth like nothing else that i've tried. I found it to be life-changing like taking my health to a whole other level. I really think everybody who is in pain should have access to something like”
I have ehlers-danlos syndrome which is a rare genetic disorder. It's a failure to make stable collagen. For me, I got very sick around age 14 and that is when my pain started very severe pain that kept me from functioning and my pain only got worse as i got older. Every day of my life was like having the worst flu you could have plus I'd been in a bad car accident. That's pretty much what everything of what my life felt like.
My pain was so bad at one point I just had no choice except to go on very heavy painkillers so I was on morphine every day of my life plus some other drugs to make it strong enough so that I could at least lie down and try to sleep, because I was at the point of suicide, because my quality of life was so poor. But I was pretty determined to hopefully get off one day if my health got better and that did happen.
At the end of last year i broke my foot quite badly and that resulted in several surgeries. The last surgery I had was in the spring and it was incredibly painful and a problem with that is that for someone like me with my underlying disease to start having a lot of pain feedback again could really take me down
I was given the applied vr pain device to try a few months ago. This device was so amazing. I never would have thought something like this could be that profound, but from the first few sessions of using it, I could relax in a way much more deeply than I could ever access on my own. I also love that I can use it in my house whenever I need to. It just made me feel so good and I noticed when I was out in the world. I could hear birds more and I felt the breeze more. It just opened up my senses in a way that i think pain just narrowed everything down.
When you are in pain you can come to really hate yourself and your body because it tortures you. To have my whole nervous system tuned down as far as just perceiving pain all the time, there's just nothing that I've done that does that specific thing I've done other things for pain that have been very helpful too but this one thing of just interrupting all the perceiving of the pain.
EaseVRx is a prescription-use medical device that comes with preloaded software content. It's a proprietary platform that provides pain management training using cognitive behavioral skills and other behavioral techniques. It utilizes a virtual reality (VR), immersive system that provides VR content and incorporates mindfulness exercises, relaxation-response exercise, biopsychosocial pain education, diaphragmatic breath training, stress management exercises, executive functioning games, and relaxation-response exercise.
EaseVRx is a prescription-only medical device that comes with preloaded software content. It delivers pain management training using cognitive behavioral skills and other behavioral techniques. It utilizes a virtual reality (VR), immersive system that provides VR content and incorporates mindfulness exercises, relaxation-response exercise, biopsychosocial pain education, diaphragmatic breath training, stress management exercises, executive functioning games, and relaxation-response exercise.
EaseVRx, a medical device that can be prescribed for pain management, has preloaded software content. It is built on a proprietary platform and uses cognitive behavioral skills and other behavioral techniques to deliver the training. It utilizes a virtual reality (VR), immersive system to deliver VR content. This includes mindfulness exercises, relaxation-response exercises, biopsychosocial pain education and diaphragmatic breathing exercises.
EaseVRx software content is a VR-based, eight-week program that reduces pain severity and its impact. Chronic low back pain sufferers can use the clinically-validated, evidence-based program for coping skills and new, useful habits to reduce pain intensity.
Two randomized controlled trials (RCTs) were conducted by AppliedVR to support its FDA submission. These RCTs evaluated the effectiveness of a VR-based program that can be used at home for chronic pain relief. Both studies found that self-administered skills-based VR treatments were not only feasible and scalable, but also effective in improving multiple chronic pain outcomes.
The first study was published in JMIR Formative research. It analyzed data from patients with chronic lower-back pain or fibromyalgia over a 21-day period. EaseVRx users experienced significant reductions in five pain indicators. Each of these indicators met or exceeded the threshold of clinical significance at 30 percent.
The pivotal RCT that examined the safety and efficacy EaseVRx over a period of eight weeks found that participants in the EaseVRx treatment group reported significant improvements, including a 42% decrease in pain intensity, 49% reductions in activity interference, 52% reductions in sleep interference, 56% reductions in mood interference, and a 57% reduction stress interference.
Providers and payers must assess the likelihood that patients/members will use digital therapeutics, especially outside of clinical settings. This includes usability and engagement data. EaseVRx participants showed high engagement, with an average of 5.4 sessions completed per week. They also indicated satisfaction with the System Usability Scale (which rated the device as easier than top email services and ATMs) during the pivotal study.
Low back pain is a common condition that affects millions of people worldwide. It's also one of the leading reasons people leave work. Insurers are often looking to reduce costs associated with back surgery, making it a very costly problem. Recent research has shown that lower back pain can be combined with neck pain to cost nearly $77 billion to private insurance and $45 billion to government insurance. Patients also have to pay $12 billion out-of-pocket expenses.
Chronic pain is more widespread and costly. It also contributes to other health crises such as the opioid epidemic. An earlier Johns Hopkins study published in The Journal of Pain showed that chronic pain can cost as much as $635 billion per year. This is more than the annual costs of heart disease, cancer and diabetes.
AppliedVR's FDA approval was its first. The company plans to continue to test VR for pain treatment. This includes multiple studies that assess the economics and outcome (HEOR) of VR using commercial payers. AppliedVR is also collaborating with Geisinger, Cleveland Clinic and others to conduct separate NIDA-funded clinical studies that will test VR as an opioid-sparing treatment for chronic and acute pain.
AppliedVR has been trusted by over 200 of the most prestigious health systems around the globe. The technology has been used in pain management and wellness programs by over 60,000 patients.
Christopher M. Loftus M.D. is the acting director of the Office of Neurological and Physical Medicine Devices at the FDA's Center for Devices and Radiological Health. He says that millions of Americans suffer from chronic lower back pain that can impact multiple areas of their lives. Chronic lower back pain can be managed by pain reduction. Today's authorization allows for pain relief that doesn't include opioid pain medication when used in conjunction with other treatments for chronic lower back pain.
Low back pain is a common condition that affects millions of people worldwide. It's also one of the leading reasons people leave work. Insurers are often looking to reduce costs associated with back surgery, making it a very costly problem. Recent research has shown that lower back pain can be combined with neck pain to cost nearly $77 billion to private insurance and $45 billion to government insurance. Patients also have to pay $12 billion out-of-pocket expenses
Chronic pain is more widespread and costly. It also contributes to other health crises such as the opioid epidemic. An earlier Johns Hopkins study published in The Journal of Pain showed that chronic pain can cost as much as $635 billion per year. This is more than the annual costs of heart disease, cancer and diabetes.
Chronic lower back pain is a condition that causes severe to moderate pain in the lower back for a period of three months or more. It is the most common chronic pain condition in the U.S. Chronic pain can affect mobility and daily activities. It has been linked with anxiety, depression, reduced quality of life, and dependence on opioids. The current treatment options for chronic lower back pain include prescription and over-the counter pain medications, exercise and transcutaneous electrical neuro stimulation. Cognitive behavioral therapy (CBT), which focuses on the emotional, cognitive, and behavioral aspects of patients' negative beliefs about pain and movement, can be used to decrease chronic pain.
Two randomized controlled trials (RCTs) were conducted by AppliedVR to support its FDA submission. These RCTs evaluated the effectiveness of a VR-based program that can be used at home for chronic pain relief. Both studies found that self-administered skills-based VR treatments were not only feasible and scalable, but also effective in improving multiple chronic pain outcomes.
About EaseVRx
EaseVRx is a prescription-use medical device that comes with preloaded software content. It's a proprietary platform that provides pain management training using cognitive behavioral skills and other behavioral techniques. It utilizes a virtual reality (VR), immersive system that provides VR content and incorporates mindfulness exercises, relaxation-response exercise, biopsychosocial pain education, diaphragmatic breath training, stress management exercises, executive functioning games, and relaxation-response exercise.
EaseVRx software content is a VR-based, eight-week program that reduces pain severity and its impact. Chronic low back pain sufferers can use the clinically-validated, evidence-based program for coping skills and new, useful habits to reduce pain intensity.
EaseVRx consists 56 VR sessions, each lasting between 2 and 16 minutes. These sessions can be used in conjunction with a daily treatment program of eight weeks. Each session incorporates elements from the above principles in order to give the user skills to reduce pain interference in everyday activities.
EaseVRx uses the principles of CBT as well as other behavioral therapy techniques to reduce pain and interference. The prescription device is designed for self-use at home and includes a VR headset, controller, and a "Breathing Amplifier". This directs the patient's breathing towards the headset's microphone to perform deep breathing exercises. The VR program employs established principles of behavioral therapy to treat pain. These principles include deep relaxation and attention-shifting. Interoceptive awareness is the ability to access, understand, and respond to internal signals.
FDA evaluated EaseVRx's safety and effectiveness in a double-blinded, randomized clinical study that included 179 patients suffering from chronic lower back pain. Participants were randomly assigned to either the EaseVRx immersive 3D program or the control 2-D program which did not use skills-based CBT. Participants were followed up for an average of 8.5 months following their enrollment in the trial. This included a baseline assessment period of two weeks, an eight-week VR training program, and a post-treatment assessment at one, two and three months.
The first study was published in JMIR Formative research. It analyzed data from patients with chronic lower-back pain or fibromyalgia over a 21-day period. EaseVRx users experienced significant reductions in five pain indicators. Each of these indicators met or exceeded the threshold of clinical significance at 30 percent.
66% of EaseVRx participants experienced a greater pain reduction than 30%, while 41% of the control participants experienced a pain reduction of greater than 30%. Additionally, 46% of EaseVRx participants reported greater than 50% pain relief compared to 26% for control participants. All participants in the EaseVRx program reported a 30% decrease in pain at one month. At the two- and three months follow-up marks the 30% reduction was maintained for all outcomes, except pain intensity. The control group, however, reported a decrease in pain of 30% at the one, two, and three-month follow up for all outcomes.
The pivotal RCT that examined the safety and efficacy EaseVRx over a period of eight weeks found that participants in the EaseVRx treatment group reported significant improvements, including a 42% decrease in pain intensity, 49% reductions in activity interference, 52% reductions in sleep interference, 56% reductions in mood interference, and a 57% reduction stress interference.
Providers and payers must assess the likelihood that patients/members will use digital therapeutics, especially outside of clinical settings. This includes usability and engagement data. EaseVRx participants showed high engagement, with an average of 5.4 sessions completed per week. They also indicated satisfaction with the System Usability Scale (which rated the device as easier than top email services and ATMs) during the pivotal study.
EaseVRx's effectiveness was evaluated by participants who were asked to rate the following outcomes over the course of an eight-week program. Participants were asked to rate their pain intensity, pain interference, mood, sleep, pain interference, and stress interference. Participants experienced an average decrease in pain intensity by 1.31 points during the eight-week treatment. Participants reported that they experienced a decrease of pain interference, which ranged from 1.95 to 1.27 points below their scores at the beginning of treatment.
During the study, no serious adverse reactions were reported or observed. Around 20.8% of participants experienced discomfort with the headset, while 9.7% experienced motion sickness or nausea.
EaseVRx received Breakthrough device designation. A device must be designed to diagnose or treat a life-threatening condition or disease. It must also meet the following criteria: The device must be a breakthrough technology, there must not be any other approved or cleared alternatives, the device must have significant advantages over the existing ones; and the device must be in the best interests of patients.
The FDA reviewed EaseVRx via the De Novo Premarket Review Pathway, which is a regulatory pathway that allows for low- to moderate-risk devices and new types. The FDA has established special controls for this type of device, including labeling requirements and performance testing. These special controls along with the general controls provide reasonable assurance for safety and effectiveness of devices of this type when they are met. This creates a new regulatory category, which means that any subsequent device of the same type, with the same intended uses, may go through FDA's premarket process (510(k). Devices can be granted marketing authorization if they demonstrate substantial equivalence as a predicate.
Curebase & AppliedVR Partners to Run Multiple VR Therapy Clinical Trials
Back in August 2021, Curebase, a company that aims to make clinical research more accessible, and AppliedVR announced a one yea partnership. AppliedVR will use Curebase's platform to conduct five clinical trials to evaluate the efficacy of VR therapy for chronic pain.
Curebase's clinical trials will be focused on a self-administered at-home VR therapy program. Curebase software manages online patient recruitment, consent, participant engagement and collects patient-reported outcomes. Curebase will also support clinical workflows such as randomization schema, communication with research coordinators, oversight of PIs and coordination for VR headset distribution and kit distribution.
Curebase founder and CEO Tom Lemberg says that AppliedVR can deliver a high-end patient experience to participants from anywhere in the country using the Curebase method. AppliedVR has committed to five studies in a year using Curebase's decentralized clinical trial platform. This is a testament to how Curebase technology and infrastructure offer the best virtual research solution available. Curebase is uniquely able to meet the demands of the digital therapeutic market, enabling them to provide innovative research solutions and innovation in digital medicine. Applied VR will be able to recruit faster, have better trial compliance rates and have a quicker research timeline thanks to our unique approach.
University of California, San Francisco S.O.L.V.E. Health Tech and AppliedVR Publish Research Assessing VR Readiness for Treating Chronic Pain in Safety-Net Settings
The UCSF and AppliedVR research concluded that VR can be used by providers to treat chronic pain in underserved communities. It is scalable and low-risk, and has the potential for high patient satisfaction.
The study was published in the Journal of Medical Internet Research. It included interviews with current and former VR users (n=15), who used the clinically proven VR platform by AppliedVR.
This research provided valuable insight into the challenges that the healthcare industry must face to bring the most recent in digital medicine, such as VR, to the less-served and more diverse patient population. In under-resourced healthcare systems, many of the technology implementation challenges are greater.
Neither users nor non-users identified the greatest obstacle to adoption as a lack of reimbursement. While current users have positive feedback from patients, safety-net stakeholders suggested that existing VR content might need to be more appealing or relevant to a wider patient population.
All respondents also mentioned the difficulty of integrating VR into current pain management workflows in a variety of clinical settings. This adoption challenge is especially acute in safety-net settings because of resource and staffing limitations.
The UCSF-AppliedVR study is the first to evaluate how providers who care for patients with disabilities, such as Medicaid beneficiaries, can integrate VR into their pain management strategies. Dr. Sarkar will continue to evaluate VR's useability for patients often underrepresented in clinical trials.
Josh Sackman, co-founder and president of AppliedVR says
"Our goal is to make pain management in VR accessible to everyone. Research like this is crucial to understand how VR can be made more affordable, more effective, and more equitable. Digital medicine should not be seen as a new innovation that falls into the same pitfall as the COVID-19 epidemic. How can billions of dollars invested in digital health be of any use if it doesn't reach the most vulnerable people?
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. AppliedVR is backed by a vast array of evidence and has a mission to alleviate pain using immersive therapeutics. The ultimate goal is to have a virtual reality pharmacy in every household. AppliedVR helps patients live a life beyond chronic pain by creating the infrastructure and partnerships that will transform the pain treatment paradigm.
