Neurovalens Receives FDA De Novo Approval for PTSD Treatment Device Modius Spero
Key Insights
Belfast-based Neurovalens (search) has secured FDA de novo approval for Modius Spero (search), a non-invasive medical device designed to treat post-traumatic stress disorder (search) symptoms through electrical vestibular system (search) stimulation.
The device delivers small electrical pulses to the skin behind each ear for 30 minutes daily, targeting deep brain areas associated with stress response and mental health regulation.
Clinical trials demonstrated that two-thirds of PTSD (search) participants using Modius Spero (search) reported significant and clinically meaningful symptom improvement, supporting its effectiveness as a treatment option.
Belfast-based health technology company Neurovalens (search) has achieved a significant regulatory milestone with the US Food and Drug Administration (search)'s de novo approval for its Modius Spero (search) device, specifically designed to treat symptoms associated with post-traumatic stress disorder (search) (PTSD (search)). This approval opens the door for the Northern Irish company to expand its presence in one of the world's largest medical markets.
Device Technology and Mechanism
The Modius Spero (search) operates through electrical vestibular system (search) stimulation, delivering small and safe electrical pulses to the skin behind each ear for a period of 30 minutes daily. This non-invasive approach targets deep parts of the brain associated with stress response and regulation of mental health, according to the company.
The technology allows the device to operate without surgical implantation, making it a lower-risk treatment option that can be offered much earlier in the treatment pathway, as explained by CEO Dr. Jason McKeown.
Clinical Evidence and Effectiveness
US clinical trials provided compelling evidence for the device's effectiveness, with two-thirds of participants with PTSD (search) using Modius Spero (search) reporting significant and clinically meaningful improvement in symptoms. This data supported the FDA's approval of the device as a non-invasive treatment option for PTSD.
Market Access and Availability
Starting in July, the Modius Spero (search) will become available on prescription to US military veterans through the Department of Veterans Affairs. This represents a major step for the health tech company, providing access to the substantial US medical market.
Dr. Jason McKeown, CEO of Neurovalens (search), emphasized the company's mission: "Neurovalens remains on a mission to offer low risk, non-invasive treatments for chronic health issues such as PTSD (search). By focusing on a treatment that addresses the underlying cause, we know this can have a transformative impact on the lives of patients."
Broader Product Portfolio
The Modius Spero (search) joins other devices in Neurovalens (search)' portfolio that have previously received various levels of FDA approval. The company has developed additional Modius devices for treating insomnia (search), anxiety (search), and weight management, all utilizing the same non-invasive neurostimulation approach to target relevant brain areas.
Company Background and Funding
Neurovalens (search) has been operating for more than a decade under the leadership of CEO Dr. Jason McKeown, along with chief project officer Iain Hendrick, chief regulatory officer Sinead Watson, and chief technology officer Chris McCabe. The company has raised approximately £20 million 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 the British Business Bank.
The company also maintains European medical device regulation compliance certification, enabling sales of its products in the EU market.