The Ministry of Food and Drug Safety (MFDS) said that Aimmed’s Somzz for treating insomnia was the first digital therapeutics (DTx) device to receive domestic marketing approval at a press briefing on Wednesday.

The screenshot shows the application user interface of Aimmed's Sommz insomnia DTx with the login screen, followed by the sleep record diary, the results and confirmation page and lastly the suggestions.(Credit: MFDS)
The screenshot shows the application user interface of Aimmed's Sommz insomnia DTx with the login screen, followed by the sleep record diary, the results and confirmation page and lastly the suggestions.(Credit: MFDS)

Somzz is a software medical device that implements cognitive behavioral treatment (CBT) to treat insomnia patients in the form of a mobile application. It improves insomnia by increasing sleep efficiency through sleep habit training, real-time feedback, and behavioral intervention provided by the mobile app for 6 to 9 weeks. After the patient receives treatment at the hospital, the application is downloaded and used on the patient's smartphone.

The MFDS reviewed the results of six-month clinical trials conducted by Aimmed at three domestic clinical trial institutions for Somzz and confirmed that the DTx device statistically improved the insomnia severity assessment scale before and after its use.

Additionally, a medical device committee consisting of experts such as mental health medicine and family medicine was also included to ensure safety and effectiveness, and the device was approved after scientific and thorough screening, the ministry said.

Professor Kim Jae-jin of the Korean Society for Digital Therapy said, "We expect that the approval of the first digital treatment device in Korea will greatly contribute to expanding treatment opportunities for insomnia patients. Digital treatment devices will bring a change in clinical paradigm as a new treatment tool other than medicine."

Regarding the reimbursement for this insomnia DTx, Minister of Food and Drug Safety Oh Yoo-kyung replied, “We will work closely with related ministries such as the Ministry of Health and Welfare to recognize the appropriate market value for this DTx device based on patient’s use and the prescription value.”

In response to concerns about the leakage of sensitive personal information as it uses an app platform, Oh said that cyber security is being closely monitored by the MFDS and protection software has already been installed by Aimmed in this regard.

According to Allied Market Research, the global market for DTx devices is expected to see an annual growth rate of about 20.6 percent from $3.53729 billion in 2020 to $23.569.38 billion by 2030.

The MFDS was the first in the world to publish the Digital Treatment Device Permission and Review Guidelines in August 2020. Furthermore, in December 2021, they created specialized guidelines for individual digital treatment devices, including Safety and Performance Evaluation of Insomnia Improvement Digital Treatment Devices and guidelines for the preparation of clinical trials.

“With the first digital treatment device licensed domestically, we have opened a new path to use DTx devices in earnest to treat various diseases to improve public health,” said Minister Oh. “We will strengthen support to lead and meet international regulatory standards by additionally developing guidelines for clinical trials and licensing approximately 10 types of customized DTx devices by 2027.”

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