Beyond Medicine, Korea's First Dental Digital Therapeutic Device 'Clickless DTx' Designated Innovative Medical Device

Beyond Medicine's innovative digital therapeutic device, 'Clickless DTx,' has been designated as the first innovative medical device (No. 82) in the domestic dental field, thereby shifting the paradigm of temporomandibular disorder (TMD) treatment. TMD, which affects over 200 million people worldwide and more than 2 million annually in Korea, has historically suffered from limitations such as high recurrence rates with existing drug and device treatments and insufficient effectiveness of self-management. Clickless DTx introduces AI-based digital therapeutic technology to resolve these challenges. This non-invasive treatment method, which helps patients improve their behavior and habits through an app after hospital prescription, is fundamentally different from existing drug-centric treatments. This not only enhances patient self-management but also improves clinical efficacy, offering new hope for TMD treatment. Having successfully completed exploratory and confirmatory clinical studies with leading domestic institutions such as Seoul National University Dental Hospital, its results have been published in international academic journals, proving its technological prowess. Aiming for regulatory approval and commercialization in the latter half of 2025, the company has already established a prescription environment by collaborating with over 1,000 dental clinics and hospitals nationwide. Particularly, since it can be distributed to private dental clinics on a non-reimbursable basis, free from the reimbursement system centered on university hospitals, rapid market expansion is anticipated. Its global market expansion is also active. It has completed preliminary FDA review in the U.S. and technological verification with local dental specialty distributors. Currently, it is proceeding with localization projects with institutions such as the University of Illinois Chicago, and is preparing to enter major Asian countries like Japan and Singapore, positioning itself as a global leader. Kim Dae-hyun, CEO of Beyond Medicine, stated, "Clickless DTx will become a global success story for dental-based digital therapeutics, presenting a new turning point for digital healthcare," and expressed his aspiration to provide TMD patients with a better life through innovative technology and strategy.