Cogthera, Korea’s 1st mild cognitive impairment DTx, now prescribed in hospitals

Emocog said Tuesday Cogthera, Korea's first digital therapeutic device for mild cognitive impairment (MCI) approved by the Ministry of Food and Drug Safety (MFDS), has begun prescriptions at major university hospitals, including Yongin Severance Hospital and Ewha Womans University Mokdong Hospital.

Cogthera is a digital therapeutic device developed to mitigate cognitive decline in patients with mild cognitive impairment. Delivered as a mobile app, it provides 15-minute, twice-daily cognitive training as directed by a doctor and automatically adjusts difficulty based on patient performance to deliver personalized training.

Medical professionals can review patient participation patterns and adherence rates through Cogthera training reports, enabling personalized clinical feedback based on this data.

Cogthera obtained Korea's first approval for a digital therapeutic device for MCI from the MFDS in May. It has also secured the European CE mark and is currently undergoing clinical trials for health insurance coverage in Germany.

MCI represents the initial stage where cognitive changes become apparent, making early assessment and cognitive management critical. During this period, strengthening cognitive reserve through training and slowing the rate of cognitive decline are known to be vital.

Cogthera is a digital therapeutic device designed to mitigate cognitive decline by enabling consistent, medically prescribed training anytime, anywhere. This increases patient adherence and naturally integrates cognitive activities into daily life.

In clinical trials, the Cogthera treatment group showed a trend toward greater improvement than the control group, suggesting that digital cognitive training may have clinically meaningful effects in patients with mild cognitive impairment.

Professor Kim Woo-jung of the Department of Psychiatry at Yongin Severance Hospital commented on the clinical impact, stating, “I believe the ability to prescribe digital therapeutic devices in the clinical setting for patients with mild cognitive impairment represents a significant change in healthcare practice. The significance lies in establishing a foundation for more systematic, patient-tailored cognitive management through digital therapeutic devices like Cogthera.”

Adding further perspective, Professor Kim Geon-ha of the Department of Neurology at Ewha Womans University Mokdong Hospital remarked, “The actual application of digital therapeutic devices at the prescription stage for patients with mild cognitive impairment is seen as an opportunity to expand the clinical approach of medical professionals.”

It is significant that Cogthera has created an environment where patients can continue cognitive training in their daily lives, as prescribed by the medical team, Kim added.

Additionally, Emocog operates the “Happy Call” program to support patients' initial adaptation and sustained use. The program is a systematic management service that guides patients on usage after prescription and encourages continued training. It serves as a core support system that enhances the device's usability and supports consistent training.

Kim Joo-hye, leader of Emocog's Customer Service (CS) Team, emphasized the program's role, saying, “The Happy Call program goes beyond simple guidance procedures; it is a systematic support process that manages motivation and usage experience to ensure patients consistently use Cogthera. This management system plays a crucial role in enhancing the actual utility of digital therapeutic devices.”

Reflecting on the device’s broader impact, Emocog CEO Lee Jun-young stated, “Cogthera's first prescription marks a turning point where digital therapeutic devices are now being actively used in actual patient treatment. Digital therapy is no longer a ‘technology of the future’ but a ‘treatment method of the present.’ We will continue to collaborate with hospitals and clinics nationwide to expand access, enabling more patients to experience digital therapy easily and safely.”

Emocog plans to expand Cogthera prescriptions to over 20 major hospitals nationwide by the end of this year. Currently starting with a non-covered fee application, it is preparing for a new medical technology evaluation to enter the covered benefits track.

Furthermore, based on German clinical results, it aims for European market health insurance listing and official launch in the first quarter of next year.