Confirmatory Clinical Trial Plan for Social Skills Digital Therapeutic Approved by Ministry of Food and Drug Safety

Neudive received approval from the Ministry of Food and Drug Safety (MFDS) on May 24, 2024 for the confirmatory clinical trial plan for its social skills digital therapeutic NDTx-01 (Buddy-in). This is a multi-institutional, randomized, evaluator-blinded, superiority confirmatory clinical trial designed to evaluate the safety and efficacy of the cognitive therapy software 'NDTx-01' for improving social situational awareness and interaction in children and adolescents with Autism Spectrum Disorder or Social Communication Disorder.

The confirmatory clinical trial protocol was developed based on statistically significant efficacy evaluation results confirmed through the exploratory clinical trial conducted in 2023, and was finalized through review by the Ministry of Food and Drug Safety, with final approval granted on May 24th. The confirmatory clinical trial will be conducted at Samsung Seoul Hospital, Daegu Catholic University Medical Center, and Seoul St. Mary's Hospital — all of which participated in the exploratory clinical trial — with the addition of Yangsan Pusan National University Hospital.