[Start! DTx Era] ① Finally the 'No.1'... Can It Become a 'Medical Revolution'?

AimMed's 'Somz' Receives First MFDS Approval
Enhancing Patient Convenience While Reducing Development Burden
Expected to Form an 11 Trillion KRW Market by 2025

Active Support from Regulatory Authorities
"Korea is Leading Global DTx Regulation"

[Image source=Getty Images]

[Asia Economy Reporter Chunhee Lee] The country's first digital therapeutic device (DTx) has finally been released. The protagonist is 'Somz,' an insomnia cognitive therapy software developed by digital health company AimMed. With active institutional reforms and support from authorities such as the Ministry of Food and Drug Safety (MFDS), this approval is drawing attention as it may trigger the introduction of a new medical system.

On the 15th, MFDS Commissioner Oh Yu-kyung announced, "Today, we have decided to approve the product Somz, developed by a domestic manufacturer to improve insomnia symptoms." Somz is a software medical device (SaMD) that implements insomnia cognitive behavioral therapy (CBT) for insomnia patients through a mobile application (app).

The app provides sleep habit education, real-time feedback, and behavioral interventions over 6 to 9 weeks to improve sleep efficiency and alleviate patients' insomnia. For example, when patients keep a daily sleep diary, the app helps them maintain a fixed sleep schedule and advises them to avoid naps as much as possible, correcting lifestyle habits to improve insomnia symptoms. Commissioner Oh explained, "We thoroughly reviewed domestic clinical trial results and confirmed that insomnia symptoms significantly improved after using the product compared to before use."

According to the MFDS definition, DTx is "SaMD that provides evidence-based therapeutic interventions to patients to prevent, manage, or treat medical disorders or diseases." It can be installed and used on general-purpose devices such as smartphones and tablets without special equipment, and is used not only for treatment but also for prevention and management of diseases classified in actual disease classifications, making it a medical device with clinical evidence of its mechanism of action.

DTx is gaining attention recently because it greatly enhances patient convenience by allowing treatment anytime and anywhere, and from a development perspective, it can be developed faster than conventional new drugs. Professor Jae-yong Shin of Yonsei University’s Department of Preventive Medicine (CEO of Evertry) emphasized, "Face-to-face psychological counseling costs 100,000 KRW per week with an effectiveness of 100, while DTx costs 10,000 KRW per week with an effectiveness of 30. Although conventional treatment is superior in effectiveness, DTx offers 24-hour specialized treatment and better cost-effectiveness."

Since it can overcome spatial and temporal limitations, medical professionals and existing pharmaceutical companies also expect DTx to be a new innovation opportunity. A pharmaceutical company official who invested in a DTx company said, "If conventional treatments and DTx are combined for prescriptions, not only efficacy but also side effects can be monitored in real time," adding, "We expect it to pioneer a new area beyond the limitations of existing treatments."

Thanks to these factors, the DTx market has recently shown rapid growth. Global market research firm Statista forecasts the global DTx market size to grow from $1.67 billion in 2016 to $8.94 billion (approximately 11 trillion KRW) in 2025, with an average annual growth rate of 20.5%. The Electronics and Telecommunications Research Institute (ETRI) of Korea also projects the domestic market to continue growing steadily, increasing from 124.7 billion KRW in 2019 to 528.8 billion KRW in 2025. With the birth of the first DTx today, this trend is expected to accelerate further.

Behind the 'Good Approval' is 'Good Regulation'

This approval came about five years after the U.S. Food and Drug Administration (FDA) first approved Pear Therapeutics' drug addiction treatment DTx 'reSET' in September 2017, and about four years after confirmatory clinical trials for DTx approval began in Korea in 2019. For AimMed, it succeeded in obtaining product approval just one and a half years after starting clinical trials in September 2021.

Although the start was somewhat late, the rapid development was attributed to AimMed's efforts and the authorities' significant role. Thanks to the government's active support and world-class DTx regulations, fast approval was possible. Megan Coder, Vice President of Policy at the Digital Therapeutics Alliance (DTA), said, "The Korean MFDS was the first in the world to create guidelines related to DTx," and added, "Many countries refer to these, making Korea a leader in global DTx regulation."

The basis for this evaluation is the world's first 'DTx Approval and Review Guidelines' issued by the MFDS. In August 2020, the MFDS created guidelines defining DTx, criteria and cases for judgment, how to prepare technical documents for approval, and the scope of submission materials. Unlike other countries that fit approvals into existing SaMD regulations, this was the world's first government-level dedicated approval guideline for DTx. Since then, the MFDS has continued tailored regulations by creating 'DTx Safety and Performance Evaluation and Clinical Trial Protocol Preparation Guidelines' for five indications including insomnia, alcohol and nicotine use disorders, panic disorder, and depressive disorder. The MFDS plans to develop guidelines for attention deficit hyperactivity disorder (ADHD) and eating disorders within this year and add guidelines for eight indications by 2027.

Aimed's Chronic Insomnia Improvement DTx 'Somz'
[Photo by Aimed]

Im Jin-hwan, CEO of AimMed, said, "The government and MFDS showed an active and open attitude toward approving DTx, which had never been approved domestically before," adding, "The MFDS proactively presented clinical and approval standards for DTx, reducing trial and error, and provided great help through new systems such as integrated review and evaluation."

MFDS Commissioner Oh Yu-kyung stated, "We will do our best to ensure digital therapeutic devices are rapidly commercialized," and added, "We will transform domestic regulations into global standards and firmly build regulatory support bridges to increase the success rate of product development and accelerate the launch of innovative new technology products so that domestic companies can lead the global market."