Emotive, a company specializing in digital therapeutic devices, announced that its digital therapeutic device for improving symptoms of ADHD (Attention Deficit Hyperactivity Disorder) in children, "STAR RUCKUS," received certification for digital medical device manufacturing from the Korea Medical Device Safety Information Center (NIDS) on the 14th. This certification is one of the first applications under the "Digital Medical Product Act" established on January 23, 2025.

STAR RUCKUS is a game-based digital therapeutic device developed as a non-drug treatment solution aimed at improving ADHD symptoms. It is specifically designed for children aged 6 to under 13 who face challenges with medication treatment, serving as an alternative or complementary treatment method.

There is increasing demand from guardians and medical professionals for digital-based non-drug treatment alternatives due to concerns about side effects such as growth delay and appetite suppression associated with long-term medication use.

STAR RUCKUS is an attention and impulse control training app that can be enjoyed like a game. Patients prescribed by a doctor at a hospital can enter a serial key into the app to begin a four-week intensive training. The training is designed to be consistently performed in daily life, and the training data is provided to medical professionals in report form to monitor treatment effects.

Emotive conducted joint research with Seoul National University Hospital and Hanyang University Hospital for the development and clinical trials of STAR RUCKUS, and recently demonstrated significant symptom improvement in both attention and hyperactivity through confirmatory clinical trials. The company is currently preparing for the Ministry of Health and Welfare's notification process, with hospital prescriptions expected to commence in the first quarter of 2025.

Min Jung-sang, CEO of Emotive, stated, "In the domestic medication-centered ADHD treatment environment, the role of non-drug-based therapeutic devices for growing children is very important," and explained, "STAR RUCKUS is a certified professional DTx as a 'therapeutic device,' not just a simple game or content, but a medical device with proven clinical efficacy and safety, securing both marketability and public interest."

Emotive plans to expand its DTx pipeline into various mental health areas beyond children's ADHD, including Autism Spectrum Disorder (ASD), adult ADHD, and Mild Cognitive Impairment (MCI). STAR RUCKUS is also preparing for multinational clinical trials and FDA approval procedures for entry into the U.S. and European markets.

Popular News