Other devices developed by the Northern Irish company to treat insomnia, anxiety and weight management have previously received various levels of FDA approval.
Belfast-based health technology company Neurovalens has received ‘de novo’ approval from the US Food & Drug Administration (FDA) for its prescribed treatment for symptoms associated with post-traumatic stress disorder (PTSD).
The treatment, a non-invasive medical device called ‘Modius Spero’, is specially designed to help treat PTSD symptoms, according to the company.
It works by stimulating the deep parts of the brain, associated with the stress response and mental health regulation, using small and safe electrical pulses – known as electric vestibular system stimulation – delivered to the skin behind each ear for 30 minutes every day, says its manufacturer.
The program will be available by prescription from July to US military veterans, through their partner government department, following US clinical trials where two-thirds of participants with PTSD using Modius Spero reported significant and clinical improvement in symptoms, supporting the device’s effectiveness as a non-invasive treatment for PTSD, said Neurovalens.
The Northern Irish company’s chief executive Dr Jason McKeown said: “Neurovalens is on a mission to provide low-risk, non-invasive treatments for chronic health problems such as PTSD.
“Receiving regulatory approval for Modius Spero’s medical devices from the FDA validates it as a treatment for patients suffering from PTSD, and is a milestone for the company.” Neurovalens also has a European medical device compliance certificate to sell its products in the EU.
Other ‘Modius’ devices developed by Neurovalens for the treatment of insomnia, anxiety and weight management have previously received various levels of FDA approval, and use the same non-invasive method of neurostimulation to target the right areas of the brain.
The method “allows the device[s] passive operation, so we can avoid the need for surgical implantation”, McKeown told SiliconRepublic.com in 2024. “This allows the devices to be considered very low risk, so they can be given much earlier in the treatment process.”
Neurovalens has been in operation for over a decade and is led by McKeown, chief project officer Iain Hendrick, chief executive Sinead Watson and chief technology officer Chris McCabe.
It said that to date, it has raised around £20m in equity and debt funding from UK investors including Wharton Asset Management, IQ Capital, Techstart Ventures, ACF Investors, Beltrae Partners, Investment Fund for Northern Ireland, Clarendon Fund Managers, Whiterock, Innovation Ulster Limited and British Business Bank.
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