Belfast, Northern Ireland-based Neurovalens designed its Modius technology to use low-level electrical signals to non-invasively stimulate areas of the brain known to regulate key functions, such as the management of sleep, anxiety and overall metabolic health. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes.
The company also picked up an FDA nod for its Modius Sleep device for treating insomnia in October 2023 and launched it last year. It then received FDA clearance for Modius Calm for anxiety in April 2024, The company has also raised approximately £20 million (nearly $27 million) to date, including $8.1 million earlier this year.
Modius Lean, the latest offering from Neurovalens, helps manage weight by delivering an electrical pulse to the brain for a period of 60 minutes before bed. Users can take part in other activities, like watching TV or reading, while this occurs. A clinical trial of 241 overweight and obese adults found that participants who used Modius Lean experienced a clinically meaningful reduction of 13% in visceral fat over six months while preserving lean muscle mass.
With de novo clearance, Neurovalens can now begin selling Modius Lean directly to people in the U.S. with a prescription. The company now plans to turn to new clinical trials for Modius in other conditions. It currently has the system pending approval for post-traumatic stress disorder (PTSD).
“Receiving an FDA De Novo approval for Modius Lean is a significant milestone for Neurovalens, one which takes us back to the original mission of the company,” Dr. Jason McKeown, CEO of Neurovalens, said. “At a time when studies estimate three in four adults in the U.S. are considered overweight or have obesity and that rate is predicted to keep rising, Modius Lean offers a low risk, non-invasive, therapeutic alternative to weight loss drugs and dangerous crash diets. By targeting harmful visceral fat, Modius Lean has the potential to improve body composition, leading to better metabolic outcomes and improved health and quality of life.
“Neurovalens is focused on achieving continued growth in the U.S. market and adding the Modius Lean to our suite of certified medical devices moves us further towards that goal.”
