Digital Therapeutics

Accelerating Global DTx Market Expansion
[INQ. NO. 2605E03] Beyondmedicine Co., Ltd. is an AI-based Digital Therapeutics (DTx) company founded in 2022, developing prescription-based digital treatment solutions focused on chronic and recurrent Temporomandibular Disorder (TMD).
Recognizing that TMJ disorders are difficult to manage through single, clinic-centered treatments alone, Beyondmedicine has introduced its core product, ClicklessDTx, a digital therapeutic designed to improve patients’ daily behavioral correction and treatment adherence.
By integrating Cognitive Behavioral Therapy (CBT) technology, the platform objectively collects and analyzes patients’ rehabilitation exercise performance and symptom changes ― providing an integrated digital-treatment system that enables clinicians to manage treatment progress beyond the clinic.
Through ClicklessDTx, Beyondmedicine conducted the world’s first Randomized Controlled Trial (RCT) targeting temporomandibular disorder patients and published the results in the SCI-indexed international Journal of Dentistry, thereby demonstrating its clinical efficacy.

It also obtained designation as an Innovative Medical Device from the Korean Ministry of Food and Drug Safety (MFDS), becoming the first digital therapeutic device in the dental field to receive such recognition in Korea. The company has completed domestic medical device approval for its TMJ digital therapeutic device. Overseas, it completed the U.S. FDA Pre-submission process and received recognition as a Novel Technology, thus securing a foundation for global regulatory approval.
Beyondmedicine recently presented a hospital-prescription-based digital-treatment model centered on ClicklessDTx. It emphasized that the solution can operate in conjunction with conventional physical therapy, thereby simultaneously improving hospital-treatment efficiency and revenue structure. Locally, it showcased real clinical data and a clinician-exclusive dashboard to explain product differentiation and practical application, while seeking early-adopter medical institutions and global partners.

ClicklessDTx is a prescription-based digital-treatment system integrating into a single platform home-based rehabilitation, behavior modification, symptom tracking, treatment feedback, and clinical reporting. Patients perform therapeutic programs in daily life while accumulating data, and clinicians can systematically monitor treatment progress and adherence outside the hospital through a dedicated clinician dashboard. The system is designed to complement the limitations of episodic treatment and enhance treatment continuity and management efficiency.
Users are expected to achieve clinically validated improvements through 5–10 minutes of daily program participation over six weeks. The treatment process is visualized through data-based interfaces, allowing both patients and clinicians to intuitively track therapeutic changes.
Beyondmedicine has identified the United States, Japan, and major European countries as key target markets. The United States represents a high-acceptance market with an established regulatory framework for digital therapeutics, and the company is pursuing initial entry based on FDA approval procedures. Japan faces increasing demand for chronic pain and rehabilitation solutions due to population aging, while Europe’s evidence-based healthcare system provides a favorable environment for RCT-based digital therapeutic adoption.
Going forward, Beyondmedicine plans to advance full-scale commercialization of ClicklessDTx in Korean hospitals and gradually expand global market entry in accordance with U.S. FDA regulatory processes. The company will also strengthen global partnerships through participation in international dental and digital health exhibitions and conferences, while expanding its pipeline beyond TMJ digital therapeutics into facial paralysis rehabilitation and broader dental and oral healthcare areas. To support this expansion, the company is preparing for Series-A investment fundraising.

 
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