[소셜밸류=박완규 기자] A digital medical device for temporomandibular joint disorders developed by Beyond Medicine is gaining attention in the medical device and digital health care industries.
On the 28th, Beyond Medicine announced that ‘Clickless DTx’, its proprietary digital medical device, has been designated by the Ministry of Food and Drug Safety as the first innovative medical device in domestic dental field.
The ‘Clickless DTx’ is an AI-powered digital treatment technology designed for patients with Temporomandibular Disorder (TMD), enabling improvement through hospital-provided solutions that support patient self-management
Rather than relying on traditional drugs or methods, it offers a non-invasive treatment app focused on behavioral regulation and habit modification, gaining industry attention for its technological and market distinctiveness.
The number of TMD patients is expected to be around two million annually. So far, efficiency of clinical trials has been low due to relapse rates over 50% and the difficulty patients face in practicing behavioral regulation and self-management, which are essential principles of treatment. To overcome these challenges, Beyond Medicine conducted exploratory and confirmative clinical research in collaboration with several institutions including Seoul National University Dental Hospital and Hallym University Sacred Heart Hospital.
The results of exploratory clinical research was published in the Journal of Dentistry in 2022, the leading international dental journal. Moreover, confirmatory clinical research was completed to obtain final approval as a medical device by the Ministry Food and Drug Safety. Beyond Medicine has already built system that prescribe its solutions in collaboration with over 1,000 dental clinics and hospitals. In addition, it is expanding its network in the dental industry by participating in major dental medical device exhibitions such as SIDEX and GAMEX.
Since ‘Clickless DTx’ is distributed primarily to private dental clinics under a non-insurance-covered system, unlike other digital medical devices that focus on university hospitals within an insurance-covered system, rapid market expansion is expected.
The global expansion is in its full swing. Beyond Medicine completed the US FDA pre-submission process, demonstrating its innovation as a digital treatment. The Proof of Concept with renowned dental distributors such as Glidewell and Carequest has also been completed. Currently, the US localization project in collaboration with University of Illinois Chicago and Case Western Reserve University is underway, and expansion into major Asian markets including Japan and Singapore is being pursued.
Kim Daehyun, the CEO of Beyond Medicine, said, “We are rapidly expanding network both domestically and internationally with support from Seoul Startup Hub. We will create a new turning point in digital healthcare through global success with dental-based digital medical devices.”
[저작권자ⓒ 사회가치 공유 언론-소셜밸류. 무단전재-재배포 금지]
