[KOAMEX 2024] Neudive Develops Digital Therapeutic Device for Autism Spectrum Disorder

[Rapportian] Neudive, founded in 2022, is developing a social skills improvement 'Digital Therapeutic' (DTx) for children and adolescents with neurodevelopmental conditions including Autism Spectrum Disorder and Social Communication Disorder (SCD). The company's product under development, 'NDTx-01 Buddy-in,' is a digital therapeutic aimed at improving social situational awareness and interaction in children and adolescents with Autism Spectrum Disorder or Social Communication Disorder. With the goal of obtaining digital therapeutic device regulatory approval in 2025, Neudive successfully completed an exploratory clinical trial in 2023 and received approval for a confirmatory clinical trial plan from the Ministry of Food and Drug Safety in May of this year.

NDTx-01 Buddy-in presents various situations commonly encountered at school and provides missions and problems to be completed, with the goal of improving social situational awareness and interaction in children and adolescents with Autism Spectrum Disorder or Social Communication Disorder. In particular, through completing situation-specific missions and solving assigned tasks, children and adolescents can improve not only their weak situational awareness and interaction abilities, but ultimately their social skills as well.

Meanwhile, the initial safety and efficacy of NDTx-01 Buddy-in were confirmed through the statistical significance of key indicators on the Korean version of the Vineland Adaptive Behavior Scales, Second Edition (K-VABS-II), conducted during the 2023 exploratory clinical trial.

Source: Rapportian (https://www.rapportian.com)