Clinically Proven ASD Digital Therapy... Neudive's 'Buddy-in' Arrives

Statistical Significance of K-VABS-II Scores Confirmed in Confirmatory Clinical Trial Across 5 Institutions; MFDS Manufacturing Certification Obtained... Designed for Repeated Home-Based Training and Parental Involvement

Korea's first cognitive behavioral therapy (CBT)-based digital medical device for children and adolescents with Autism Spectrum Disorder (ASD) and Social Communication Disorder (SCD) has arrived. Neudive announced on the 1st that 'Buddy-in' has obtained digital medical device manufacturing certification (D Certificate No. 26-4017) from the Ministry of Food and Drug Safety.

Buddy-in is a mobile CBT-based digital medical device targeting children and adolescents aged 10 to 18 with Autism Spectrum Disorder or Social Communication Disorder. Users install a smartphone app as prescribed by a medical professional and complete a total of 30 social skills training sessions — five times per week over six weeks.

Buddy-in is a product that digitally implements the core training processes of conventional face-to-face cognitive behavioral therapy (CBT) and social skills training (SST). It implements the CBT flow of 'assessment → case reconceptualization → goal setting → cognitive restructuring → skill training and practice → generalization and maintenance → follow-up assessment' through a mobile-based scenario game and algorithmic structure, and applies structured teaching and modeling-centered SST based on Social Information Processing (SIP).

Furthermore, whereas conventional face-to-face therapy was administered within the limited time and space of medical institutions, Buddy-in is designed to allow repeated practice in home and everyday environments. Patients can practice social situations via smartphone without visiting a medical institution, and the system is designed to support the generalization and maintenance of social skills through real-life-based training.

Neudive emphasized that Buddy-in is structured to allow children and adolescents to independently conduct social skills training through a mobile app. The company also noted that it is designed to enable caregivers to check children's training history and performance data in real time, and to support repeated practice in real-life social situations. The product leverages the advantages of digital-based independent training while also enabling parental involvement to support linkage to everyday environments and generalization of social skills.

In addition, usage history, session completion status, performance results, and compliance are automatically recorded and managed digitally. Medical staff and caregivers can check progress in real time through a professional monitoring system, and performance data is linked to medical consultations.

Neudive confirmed the clinical efficacy of Buddy-in in a confirmatory clinical trial conducted at five domestic institutions. The study involved a total of 86 children and adolescents with ASD/SCD. The test group (NDTx-01 + conventional treatment) showed a statistically significant improvement in the change in Adaptive Behavior Composite (ABC) scores on the Korean version of the Vineland Adaptive Behavior Scales (K-VABS-II) compared to the control group (Treatment As Usual only).

A Neudive representative stated: "This manufacturing certification is an important milestone demonstrating the commercialization potential of digital medical devices in the domestic ASD/SCD field. Going forward, we plan to pursue a step-by-step approach including entry into medical institution prescriptions following new health technology assessment."

Source: Young Doctors (http://www.docdocdoc.co.kr)