Core Viewpoint - Neurovalens has received FDA De Novo approval for its non-invasive weight management product, Modius Lean, which utilizes neurostimulation technology to aid in weight loss and body composition management [4][6][7]. Product Development - Modius Lean is designed to send gentle electrical pulses to the brain 60 minutes before sleep, helping to reduce visceral fat while maintaining lean body mass [6]. - The product has shown a clinically significant improvement, with a 13% average reduction in visceral fat over six months in a study involving 241 overweight and obese adults [6]. Market Strategy - With the De Novo approval, Neurovalens can now sell Modius Lean directly in the U.S. market with a prescription, marking a significant step in the company's long-term growth strategy [6][7]. - The company plans to expand its clinical research to include additional indications, having already submitted an application for PTSD [6]. Financial Background - Neurovalens has raised approximately £20 million (around $27 million), including an $8.1 million funding round completed earlier this year [6]. Industry Context - The CEO of Neurovalens highlighted that about three-quarters of adults in the U.S. are considered overweight or obese, indicating a growing market for low-risk, non-invasive treatment options like Modius Lean [7].