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Neurovalens
Wara Samar

22nd January 2025

Say No to Chronic Insomnia with Modius Sleep 

Insomnia affects a significant portion of the global population, with studies indicating its prevalence ranges from 10% to 30%, and in some cases, even reaching 50%-60%. Imagine a non-invasive solution to treat chronic insomnia—this is where Neurovalens steps in. As a trailblazer in neurostimulation, the company is redefining the boundaries of medical technology by addressing some of the most pressing health challenges. Dr. Jason McKeown, CEO of Neurovalens, shares his journey, the groundbreaking work behind their FDA-cleared devices, and the future of non-invasive neurotechnology. 

A Vision Rooted in Medicine

Dr. McKeown’s path to leading Neurovalens began in the UK, where he worked as an Emergency Medicine doctor before accepting an academic position at the University of California, San Diego, in 2016. “It was here that we first developed a technique to non-invasively stimulate deep brain structures like the hypothalamus and brainstem,” he explains. This breakthrough led to the foundation of Neurovalens, a UK-based medical device company committed to developing FDA-approved technologies. Today, the company’s portfolio includes FDA-cleared treatments for chronic insomnia and generalized anxiety, with plans for two FDA de novo approvals for obesity and PTSD treatments by 2025.

Revolutionizing Sleep Therapy with Modius Sleep 

Modius Sleep, winner of the National Sleep Foundation’s SleepTech® Award, represents a significant leap in treating chronic insomnia. Worn for just 30 minutes daily, the device delivers a small and safe electrical pulse into the areas of the brain that control circadian rhythms and sleeping patterns. Clinical trials published in Brain Stimulation demonstrate its efficacy, with 95% of participants experiencing improved sleep after a four-week regimen—results sustained for at least 12 weeks post-treatment. “This is a game-changer for patients who can now manage chronic insomnia from the comfort of their homes,” says Dr. McKeown.

The Case for Non-Invasive Neurostimulation 

Traditional neurostimulation often involves surgically implanted devices, posing risks and high costs. Neurovalens’ non-invasive approach eliminates these barriers. “By offering a safe alternative, we can transition neurostimulation from a last resort to a first-line therapy, accessible to more patients and at a fraction of the cost,” Dr. McKeown notes. 

Developing FDA-cleared devices like Modius Sleep required navigating rigorous regulatory processes. “Many companies opt for the wellness market to avoid FDA scrutiny,” Dr. McKeown explains. “We’ve always aimed to produce validated medical devices prescribed by doctors, which demanded robust planning, extensive R&D, and substantial funding.” Despite these challenges, the FDA clearances have validated Neurovalens’ commitment and opened doors for future innovation.

Looking Ahead: A Vision for the Future 

Neurovalens is on the cusp of transformative advancements, with de novo approvals for obesity and PTSD devices anticipated in 2025. The company is also exploring further applications for its technology, aiming to provide safer alternatives to medication for children. “The non-invasive neurotechnology sector is rapidly growing, offering unprecedented opportunities to treat diseases earlier and more safely,” Dr. McKeown predicts. 

Partnerships have been integral to Neurovalens’ journey. Collaborations with local Northern Irish entities, such as Ulster University and Elite Electronics, have been pivotal. “From initial concepts to FDA-approved devices now used globally, our partnerships have been key,” says Dr. McKeown. He emphasizes the importance of understanding the MedTech landscape. “Navigating FDA pathways, ensuring reimbursement, and securing funding are critical. Be prepared for a long, costly R&D phase before entering the market,” he advises.

A Catalyst for Change in Global Healthcare  

Neurovalens’ work is a testament to the transformative potential of neurostimulation. As the company gears up for a $50 million Series B funding round in 2025, its journey underscores the power of innovation in reshaping healthcare. Platforms like MedTech World play a vital role in fostering collaboration and growth within the industry. “For companies like Neurovalens, connecting with global innovators and gaining recognition are invaluable,” Dr. McKeown acknowledges. 

With a commitment to advancing neurotechnology, Neurovalens is set to leave an indelible mark on the MedTech landscape, transforming lives through non-invasive, safe, and effective solutions.

Countdown to MedTech World Dubai 

Time is ticking—MedTech World Dubai is almost here! Don’t miss this opportunity to connect with global healthcare innovators and industry leaders. Whether you’re looking to expand your network, explore cutting-edge technologies, or forge impactful collaborations, this event is your gateway to driving meaningful change in healthcare. Act now to secure your spot and lock in your ticket before prices increase!

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