FDA Grants Breakthrough Device Designation for VR Treatment of Mental Illnesses

A UK startup that uses virtual reality to help deliver cognitive-behavioral therapy has received Breakthrough Device designation from the Food and Drug Administration for its treatment of schizophrenia and other serious mental illnesses, a process that will help speed its final approval if clinical trials pan out.

The OxfordVR treatment uses virtual reality headsets to guide patients through everyday situations like going to a store, taking a bus or visiting a doctor’s office, which can cause fear and anxiety in sufferers. of psychosis. The prescription service relies on automated prompts to deliver cognitive behavioral therapy (CBT), a form of talk therapy that attempts to teach skills to manage or modify behavior, over a six-week course.

The FDA’s grant of breakthrough device status will speed up testing and approval of the startup’s VR treatment, for which trials have already been conducted with the US charity Wounded Warrior Project and the National Health Service. from the United Kingdom. A clinical review of the OxfordVR Gamechange treatment published in April by the medical journal The Lancet found it to be effective in treating patients with severe agoraphobia or distress.

“Serious mental illness is a huge problem that cannot be solved with existing approaches alone. It is a huge win for patients and the mental health industry that the FDA recognizes that this technology has the potential to be a more effective way to treat people with some of the toughest mental health issues,” says Deepak Gopalkrishna, CEO and co-founder of OxfordVR.

About 14 million Americans suffer from some form of serious mental illness, and conditions such as schizophrenia spectrum disorders with psychotic symptoms can be among the most severe. While CBT and other forms of talk therapy have been adopted as the preferred treatment method for schizophrenia, many patients still require powerful antipsychotic medications that come with severe side effects to manage delusions and the hallucinations.

Automating this type of therapy session could reduce the burden on oversubscribed mental health services, Gopalkrishna says. “There is a huge unmet need for people with serious mental illness…we are enabling the scale of high-quality care by automating important components of care delivery at very low cost.”

The London-based startup, which has raised more than $24m so far in venture capital, was a spin-off from Oxford University Professor Daniel Freeman’s research into how virtual reality can treat paranoia . The virtual reality-powered sessions have been effective because patients receive treatment in situations tailored to their condition, Gopalkrishna says. “We choose virtual reality because the brain perceives these environments as real and allows us to deploy automated CBT to essentially rewire the brain without needing a therapist present 100% of the time,” he says.

About $5.5 billion was invested in mental health-focused startups last year, according to CB Insights data. The use of virtual reality in medical settings, however, remains nascent outside of trials by OxfordVR, Spanish rivals Amelia Virtual Care and Limbix, as well as the now decades-old application of the technology to treat post-traumatic stress disorder among veterans.

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