A path has opened for patients with temporomandibular joint disorder to receive treatment and rehabilitation using smartphones. BeyondMedicine, a company specializing in digital therapeutic devices, said on the 24th that its temporomandibular joint disorder treatment and management software Clickless has obtained Class 2 digital medical device approval from the Ministery of Food and Drug Safety.
With this approval, the company said Clickless became the first digital therapeutic in the world as well as in Korea to be approved for the purpose of treating temporomandibular joint disorder.
Behavioral and psychological factors such as stress, clenching, and bruxism are known to be major causes of temporomandibular joint disorder. Physical therapy and drug therapy are mainly used, but there is a limitation in that the relapse rate is about 50%. Kim Dae-hyun, CEO of BeyondMedicine, a periodontist, founded the company to solve the treatment limitations felt while treating patients in clinical settings for 13 years and developed Clickless.
Clickless is a six-week digital therapy program that combines cognitive behavioral therapy (CBT)-based behavior correction, meditation-based relaxation therapy, masticatory muscle rehabilitation exercises, and treatment data monitoring. Patients can receive treatment anytime, anywhere via smartphone. Medical staff can check treatment progress and establish personalized treatment plans through a dedicated dashboard.
Clickless was designated as an innovative medical device by the Ministery of Food and Drug Safety, a first in the dental field. In a pivotal clinical trial conducted at Hallym University Medical Center, more than 96% of patients showed an average pain reduction of more than threefold. The results were published in the Journal of Medical Internet Research (JMIR).
BeyondMedicine plans to begin full-scale distribution of Clickless to domestic hospitals and clinics starting in March 2026, and then pursue entry into overseas markets such as the United States, Europe, and Singapore.
Park Sang-yoon, a professor of oral and maxillofacial surgery at Hallym University School of Dentistry who led the pivotal trial, said, "As the clinical trial confirmed efficacy and safety, we expect it will be widely used in future treatment settings for temporomandibular joint disorder."