Beyond Medicine (CEO Daehyun Kim) announced on the 28th that its digital therapeutic device, 'Clickless DTx', was designated as the first innovative medical device (No. 82) in the dental field by the Ministry of Food and Drug Safety.
Beyond Medicine, a digital healthcare startup, uses AI-based digital therapeutic technology to help patients with temporomandibular disorder (TMD) improve their symptoms through self-management with solutions prescribed after visiting a hospital.
In particular, it stands out for its technological and market differentiation in that it has implemented an app-based, non-invasive treatment method that focuses on behavior control and habit improvement, rather than the existing drug/device-centered treatment.
The number of TMD patients in Korea is estimated to be over 2 million per year, and it is known that over 200 million people worldwide suffer from this symptom. However, existing treatments have a recurrence rate of over 50%, and the core treatment principles of behavioral control and self-management treatment have not been clinically effective due to difficulties in patient education and practice.
To overcome these limitations, Beyond Medicine conducted exploratory and confirmatory clinical studies with Seoul National University Dental Hospital, Hallym University Sacred Heart Hospital, etc. In 2022, the results of the exploratory clinical study were published in the Journal of Dentistry, a world-renowned journal, and the confirmatory clinical study for final approval of the medical device by the Ministry of Food and Drug Safety was completed, and the goal is to obtain approval and actual clinical prescriptions in the second half of 2025.
In addition, we have already established an environment based on actual prescriptions by collaborating with over 1,000 dental clinics in Korea, and are expanding our contact points with the dental industry by participating in major dental equipment exhibitions such as SIDEX and GAMEX.
Accordingly, while the digital therapeutics field is still confined to a reimbursement system centered on university hospitals, there is analysis that clickless DTx can be distributed to private dental clinics on a non-reimbursement basis, allowing for rapid market expansion.
Overseas expansion is also in full swing. Beyond Medicine has completed the US FDA Pre-submission, proving its innovativeness as a digital therapeutic, and has completed technology verification with dental specialty distributors Glidewell and Carequest. It is currently conducting a localization project in the US with the University of Illinois at Chicago and Case Western University, and is also preparing to enter major Asian countries such as Japan and Singapore.
Beyond Medicine CEO Daehyun Kim said, “With the support of Seoul Startup Hub, we are rapidly expanding our domestic and international networks,” and “We will create a global success story of dental-based digital treatment devices and present a new turning point for digital healthcare.”
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