The Food and Drug Administration has granted breakthrough designation to AppliedVR's platform that treats chronic lower back pain.
The Los Angeles-based company said the designation opens the door for broader use of virtual reality technology in healthcare.
The nod from the FDA helps patients receive more timely access to breakthrough technologies that could provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions, the company said.
"Chronic pain is a huge issue and for the FDA to say that this technology has the potential to be a better modality than anything else out there, that provides huge credibility for the VR space as a whole and our approach as a company," Matthew Stoudt, AppliedVR CEO and co-founder told Fierce Healthcare.
AppliedVR's virtual reality platform—which uses goggles and headsets to create an immersive, 3D virtual world—has been aimed at alleviating everything from labor pains during childbirth to the pain from burns to discomfort experienced undergoing infusions for cancer treatment.
In total, AppliedVR works with more than 240 hospitals to provide virtual reality therapy to help ease patients' acute pain after surgery or during hospitalization. The company also is working on clinical trials with Geisinger and Cleveland Clinic to study VR as a replacement for prescription opioids.
The FDA designation, announced Wednesday, accelerates patient and provider access to AppliedVR’s EaseVRx platform to address treatment-resistant fibromyalgia and chronic intractable lower back pain, according to Stoudt.
AppliedVR's technology is not the first virtual reality platform to receive FDA breakthrough status.
Last year, the agency granted breakthrough designation to SyncThink for its VR device that assesses concussion. Vicarious Surgical also won FDA breakthrough device designation for its virtual reality-based robot-assisted surgical device.
But AppliedVR's EaseVRx is now one of the first virtual reality digital therapeutics to get breakthrough designation to treat conditions related to chronic pain.
AppliedVR performed a randomized controlled trial evaluating the effectiveness of people using a virtual reality program at home on themselves to manage their pain. According to that study, published in JMIR-FR, the company's digital pain management program was effective at improving on multiple chronic pain outcomes—each of which met or exceeded the 30% threshold to be clinically meaningful, the company said.
As part of the study, half of the study participants were given VR headsets and watched virtual programs in which they could play games, swim with dolphins, or view scenery. Participants in the VR group saw a significant decrease in pain intensity and pain interference with activity and stress, according to the study.
"Today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain," Stoudt said. “Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.”
Recent research indicates 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. Cognitive behavioral therapies like VR are now seen by many providers as an effective alternative or complement to pharmacological interventions.
AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive behavioral therapy (CBT) principles and other behavioral methods. The program was designed by AppliedVR, in partnership with the top pain experts and researchers, to improve self-regulation of cognitive, emotional, and physiological responses to stress and pain.
The company is working to build a VR pharmacy that personalizes therapies, content, and media based on patient needs. The company has developed more than 40 different VR modules to provide relaxation, engagement, and mindfulness.
In August, the Centers for Medicare and Medicaid Services (CMS) unveiled a proposed rule that would create a new, faster Medicare coverage process for devices the FDA gives a “breakthrough” designation to. If finalized, that rule would enable faster Medicare reimbursement for emerging technologies like VR, Stoudt said.
Healthcare VR is a growing sector, and other digital health companies are using the technology to address different conditions and medical issues, including mental health.
U.K.-based Oxford VR, which is backed by Optum Ventures, offers a clinically validated virtual reality platform to treat mental health patients. MindMaze recently raised $100 million in funding for its virtual reality technology that has primarily been used for stroke victim therapy in European hospitals.