The US Food and Drug Administration (FDA) granted UK-based Oxford VR a breakthrough device designation for its game Change VR treatment to deliver immersive cognitive behavior therapy (CBT) to people suffering from schizophrenia and other mental illnesses in June of this year. The FDA's breakthrough device program is intended for medical devices or device-led combination products that improve disease treatment or diagnosis. The program's goal is to accelerate the development, assessment, and review of medical devices in order to provide patients and healthcare providers with timely access.
According to GlobalData's Epidemiology & Market Size database, approximately 1.2 million people in the UK and 2.7 million people in the US are thought to have schizophrenia, with schizophrenia spectrum disorders being among the most debilitating of mental illnesses. Schizophrenia is frequently treated with cognitive behavioral therapy (CBT), but depending on the severity of the disorder, people may also be prescribed anti-psychotics to reduce delusions and hallucinations. Because anti-psychotics can cause drowsiness, agitation, and blurred vision, virtual reality (VR) technologies that can improve recovery without anti-psychotics are an appealing option.
The National Health Service (NHS) and the US veteran's charity Wounded Warrior Project have both conducted clinical trials with gameChangerVR. The NHS study included 346 patients with a clinical diagnosis of schizophrenia spectrum disorder or an affective disorder with psychotic systems. The study discovered evidence that VR therapy reduced anxious avoidance and distress in everyday situations. OxfordVR received a $12.5 million Series A funding round from Optum Ventures in 2020, with support from Luminous Ventures. The investment aided the growth of the company's immersive VR therapy and was the largest investment funding for VR in the UK and Europe at the time. This follows a 2018 project supported by a £4m ($5.7m) grant by the UK National Institute for Health Research (NIHR), which saw OxfordVR’s technology implemented in the NHS.
Other companies, in addition to OxfordVR, have been experimenting with VR to treat mental illnesses and disorders. In 2020, XRHealth launched a VR therapy application to treat attention deficit hyperactivity disorder (ADHD). Patients are given a VR headset that allows them to make video calls and send in-app messages to an XRHealth clinician, who works with them to develop a personalized care plan. In addition, EaseVRx received FDA approval last year to use VR-based CBT and other behavioral methods to combat pain perception in patients with chronic lower back pain.
The impact of Covid-19, the Russia-Ukraine conflict, and other global crises on mental health has been significant, resulting in increased demand for mental health services due to increased stress and anxiety. As patients and physicians seek alternatives to in-person care, digital health innovation has accelerated. Furthermore, the influx of cases on already overburdened healthcare systems during the pandemic is driving the development of emerging technologies such as virtual reality care to alleviate pressure.
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