C&R Research To Conduct U.S. Clinical Trial for Korea's First Digital Therapeutic for Insomnia

C&R Research announced on Thursday that it has secured a contract to conduct a pivotal clinical trial in the U.S. for AIMneXt's digital therapeutic (DTx) Somzz. This project is part of the Ministry of Trade, Industry and Energy's initiative to promote collaboration in AI-based sleep technology, which is being led by Seoul National University Hospital (SNUH). AIMneXt has been chosen as a beneficiary to receive support for this clinical trial necessary for regulatory approval.

Somzz is recognized as Korea's first approved DTx, functioning as a software-based medical device that provides cognitive-behavioral therapy for insomnia (CBT-I) through a mobile application. It aims to enhance sleep quality by offering sleep education, behavioral interventions, and real-time feedback to users.

C&R Research's Medical Device (MD) Team will collaborate with its U.S. subsidiary, Trial Informatics, to assist AIMneXt in obtaining FDA approval and expanding into the global market. The MD Team and Trial Informatics will ensure the clinical trials adhere to international standards, utilizing Trial Informatics' electronic data capture (EDC) platform, BOIM, to improve data quality and operational processes.

This trial is significant as it serves as a milestone for the entry of Korean DTx into the U.S. market. It is expected to provide Korean companies and healthcare institutions with valuable experience in global clinical trial operations and enhance their ability to generate clinical evidence needed for international regulatory approvals.

Yoon Moon-tae, CEO of C&R Research, emphasized the importance of clinical evidence and regulatory approvals in the digital therapeutics sector. He noted that as demand increases for Korean digital therapeutics worldwide, the current project could serve as a valuable reference for companies aiming for FDA approval.

C&R Research is seeking to diversify its growth by extending its global clinical trial capabilities beyond its traditional focus on pharmaceuticals into the medical device and DTx sectors.