Modius Sleep, Neurovalens’ Non-Invasive Chronic Insomnia Treatment, Receives FDA Approval for US Market Entry

Belfast-based health-tech startup Neurovalens has achieved a significant milestone with the approval of its non-invasive chronic insomnia treatment, the Modius Sleep band, by the US Food and Drug Administration (FDA). This regulatory green light paves the way for the company to enter the lucrative US market, strategically positioning itself ahead of its anticipated Series B investment round scheduled for next year.

The Modius Sleep band distinguishes itself as a non-invasive solution for chronic insomnia, leveraging electrical stimulation directed at crucial brain and nervous system areas. Users are advised to wear the device for 30 minutes before bedtime, engaging in activities like watching TV or reading. The FDA approval allows Neurovalens to sell Modius Sleep directly to patients with a prescription, marking a significant step in the company's mission to address sleep disorders through innovative and accessible solutions.

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Dr. Jason McKeown, CEO of Neurovalens, expressed his enthusiasm for the milestone, highlighting the impact of Modius Sleep on patients' lives. He emphasized the device's non-invasive nature, contrasting it with previous products that merely quantified symptoms. The CEO underscored the significance of having Modius Sleep certified as a medical device for chronic insomnia, positioning the company for growth in the competitive US market.

Following extensive clinical trials conducted in both the United States and Northern Ireland, Neurovalens is now poised to explore additional medical applications for its technology. Dr. McKeown mentioned the company's plans to seek approval for treating anxiety and obesity, indicating the potential for their low-risk, non-invasive therapeutic intervention to address a range of serious medical conditions.

Neurovalens, founded in 2015 by Dr. McKeown and neurologist Paul McGeoch, has garnered significant support from investors, raising $1.3 million in equity capital from prominent entities such as Wharton Asset Management, IQ Capital, Techstart Ventures, Angel Co Fund, Beltrae Partners, Clarendon Fund Management, and the British Business Bank. The successful FDA approval positions the company favorably as it prepares for its Series B funding round in the coming year.

As Neurovalens looks toward the future, the company remains committed to advancing its technology and expanding its reach in the health-tech sector. With a focus on transformative, non-invasive therapeutic interventions, the Belfast startup is ready to make a big difference in a number of medical conditions, potentially changing the way sleep disorders are treated and improving patient outcomes.