[Start! DTx Era] ① "Somz, a Joint Project with the Government... Will Challenge FDA Approval"

Interview with Im Jin-hwan, CEO of AimMed

DTx 'Somz' for 700,000 Sleepless People
Honored as Korea's 'First'

Developing Various Models and Exploring Overseas Expansion

Im Jin-hwan, CEO of AimMed
[Photo by AimMed]

[Asia Economy Reporter Chunhee Lee] "I believe this result was achieved through the combined efforts of Aimmed employees and government agencies such as the Ministry of Food and Drug Safety. We will thoroughly prepare for market entry."

On the 15th, Lim Jin-hwan, CEO of Aimmed, which developed the digital therapeutic device (DTx) for insomnia treatment called 'Somz' and succeeded in obtaining the Ministry of Food and Drug Safety's approval as the 'first DTx,' expressed to Asia Economy his ambition to prepare even more fiercely as this is just the beginning.

He said, "I want to express my gratitude to the company employees who have worked hard so far," and shared his thoughts, "Although we have become the first DTx company, the responsibility is heavy because Aimmed must perform well so that later companies can also share the achievements." He added, "It is not easy to create a new market for emerging industries, especially in the medical industry. Since there were no existing cases, we had to build everything step by step with the authorities, but thanks to the government's firm will and support, we were able to succeed."

AimMed logo [Photo by AimMed]

Lim, who has worked at Aimmed for over 20 years, has been responsible for Somz from its initial development. He explained the development background, saying, "When we started developing DTx in 2019, we reviewed diseases with a broad basic treatment market and the potential to expand into wellness areas beyond prescriptions, and we focused on insomnia treatment." Sleep disorders represent a huge market, with about 700,000 patients visiting hospitals annually in Korea alone, and an estimated 3 million people suffering from sleep disorders when considering those treated for other diseases or hidden patients.

In the early development phase, Aimmed, led by former head of the department and psychiatrist Kim Su-jin (currently director at Kakao Healthcare), benchmarked overseas development cases and continued development and planning. With the prototype completed in early 2022, clinical trials began in earnest. Lim said, "There is a misconception that DTx development involves low costs and risks, but that is incorrect. Many clinical trials fail, but thanks to the efforts of the development team led by Head Kim Su-jin, we were able to verify statistically significant improvements in insomnia severity assessment scales in the experimental group compared to the control group during clinical trials."

After the development reached a certain stage, a DTx business division was established to accelerate the business. Lim explained, "After becoming CEO at the end of 2021, I established a separate business division to properly pursue DTx. We focused on organizing a team led by Head Jung Kyung-ho that could properly handle Somz as well as various pipelines."

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

Somz is now in a state where it can enter the market 30 days after today through the integrated review and evaluation system for innovative medical devices. However, Lim stated, "Since the Health Insurance Review and Assessment Service's guidelines for health insurance coverage have not yet been released, we do not plan to commercialize immediately," adding, "We will continue consultations with the government and related organizations to create a concrete commercialization plan." However, limited market entry to secure real-world data (RWD) is planned to expand to primary medical institutions serving as regional hubs in the second half of this year.

Currently, Somz's development focuses on 'prescription digital therapeutic devices (PDT)' used primarily through doctors' prescriptions, but plans are underway to expand the market further. In addition to developing a 'non-PDT' model that can be used without a prescription, they plan to expand to a wellness version that can be used more broadly. Overseas expansion is also being pursued. Lim explained, "Since domestic approval has been obtained, we plan to actively seek overseas expansion, including immediately applying for a 'pre-submission' consultation with the U.S. Food and Drug Administration (FDA)."

Regarding the Ministry of Food and Drug Safety's mention in the approval and usage precautions that Somz's use by long-distance truck and bus drivers, assembly line workers, etc., may cause drowsiness due to sleep restriction and lead to serious accidents in work and daily life, Lim said they will work on improvements going forward. He said, "This seems to be an issue arising from the inclusion of 'sleep restriction methods' that prevent sleeping at inappropriate times during treatment," adding, "Jobs such as transportation and shift work are vulnerable to sleep disorders and thus have a high demand for insomnia treatment. We will overcome this through additional development related to these areas."

Regarding the socioeconomic significance of DTx, Lim cited addressing unmet needs. He said, "We are considering areas difficult to solve with existing medical care, such as insomnia, intermittent pain, and itching," and added, "By utilizing DTx, continuous real-time data collection is possible, so if accurate feedback can be provided, we ultimately expect personalized medicine that can predict and prevent pain."

This content was produced with the assistance of AI translation services.