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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[INQ. NO. 2604E06] Founded in 2016 as a spin-off from Samsung Electronics, WELT specializes in digital therapeutics, developing digital-healthcare solutions that combine medical expertise with advanced IT technologies based upon the concept of ‘Wellness Technology.’ The company adheres to the core principle of developing clinically validated software medical devices and has expanded its business based on products that have demonstrated safety and efficacy through regulatory approval.
WELT has developed digital therapeutics for insomnia and eating disorders, and is advancing an ‘AI Combo Drug’ strategy that integrates digital treatment with conventional pharmaceutical therapies. By leveraging AI to analyze patient data, the company aims to optimize medication timing and manage treatment adherence, embedding digital technology throughout the entire patient-care journey.
In 2023, WELT obtained approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its insomnia treatment, digital therapeutic SleepQ, establishing a foundation for commercialization in Korea. The company has since collaborated with pharmaceutical firm Handok to expand prescriptions and distribution across domestic medical institutions, promoting a new treatment approach that combines digital therapeutics with conventional medication.

Mobile-based Digital Therapeutic Treatment
SleepQ is a mobile-based digital therapeutic treatment that delivers Cognitive Behavioral Therapy for Insomnia (CBT-I), traditionally administered in person at hospitals. Designed as a six-week treatment program prescribed by medical professionals, SleepQ analyzes patients’ sleep diaries and behavioral data to provide personalized treatment plans.
The platform integrates core CBT-I components such as sleep restriction, stimulus control, cognitive restructuring, relaxation therapy, and sleep-hygiene education. Through a connected system comprising a patient app and a clinician dashboard, healthcare providers can monitor and manage the treatment process efficiently.

Clinical trial results have demonstrated its effectiveness. After seven weeks of treatment, patients using SleepQ showed an average 15.14% improvement in sleep efficiency and a reduction of over 55% in sleep onset latency, confirming meaningful improvements in sleep outcomes.
WELT recently also showcased DrugOS, its AI-powered drug optimization platform. DrugOS analyzes patients’ physiological and behavioral data in order to recommend optimal medication timing and dosage adjustments tailored to changes in the patient’s condition.
DrugOS implements a ‘Just-in-Time’ medication-management model by identifying disease progression patterns and optimizing medication schedules accordingly. An AI agent continuously interacts with patients to collect additional data, refining treatment strategies over time. This approach enables pharmaceutical companies to enhance therapeutic outcomes by integrating digital technology with existing drugs, without altering the drugs themselves.
In recognition of its technological innovation, WELT received a CES Innovation Awards 2026 honor, drawing global attention in the digital healthcare sector.
WELT is actively expanding into global markets. In Europe, the company has established a local subsidiary in Germany, and is conducting clinical trials for adult insomnia patients in collaboration with Charité – Universitätsmedizin Berlin, one of Europe’s largest university hospitals. WELT has also secured CE certification and ISO 27001 certification, thereby reinforcing its data security and medical device quality-management systems.

In the United States, WELT is expanding its partnerships with global pharmaceutical companies through board-level engagement with the American Telemedicine Association (ATA) and is strengthening its digital healthcare ecosystem through joint research with Oura Health.
In the Middle East, the company is exploring market entry opportunities through discussions with regulatory authorities in the UAE and engaging potential partners at global exhibitions such as WHX Dubai.
Looking ahead, WELT plans to enhance SleepQ with expanded AI capabilities in SleepQ 2.0 and broaden its digital therapeutic pipeline beyond insomnia to include eating disorders, migraines, diabetes, hypertension, and other chronic conditions.

 
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