FDA Grants Breakthrough Device Designation To VR Mental Illness Treatment

FDA Grants Breakthrough Device Designation To VR Mental Illness Treatment

A British startup that uses virtual reality to help deliver cognitive behavior therapy has been granted a Breakthrough Device designation by the Food and Drug Administration for its treatment for schizophrenia and other serious mental illnesses, a process that will help expedite its ultimate approval if clinical trials pan out.

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

The FDA’s grant of breakthrough device status will fast-track the testing and approval of the startup’s VR treatment, for which has already run trials with US-based veterans charity Wounded Warrior Project and the UK’s National Health Service. A clinical review of OxfordVR’s Gamechange treatment published in April by the medical journal The Lancet found that it was effective at treating patients with severe agoraphobia, or distress.

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

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

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

The London-based startup, which has raised over $24 million to date in venture backing, was a spinout from the research of University of Oxford professor Daniel Freeman into how virtual reality can treat paranoia. The VR-powered sessions were effective because patients are given treatment in situations tailored to their conditions, says Gopalkrishna. “We choose virtual reality because the brain perceives those environments as real, and allow us to deploy automated CBT to essentially rewire the brain without needing a therapist present 100% of the time,” he says.

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

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