Neofect "Ybrain Applies for Korea's First Electronic Drug Approval for Depression... Aiming for Sales Next Year"

[Asia Economy Reporter Hyunseok Yoo] NeoFact affiliate Ybrain has completed the application for domestic marketing approval of an electronic medicine for depression treatment, becoming the first Korean company to do so. The commercialization of an electronic medicine platform capable of simultaneous application to hundreds of patients as a standalone treatment for depression is the world's first.

On the 25th, Ybrain announced that it had completed the application for marketing approval of the electronic medicine for depression treatment from the Ministry of Food and Drug Safety, as well as integrated review applications for new medical technology evaluation by the Korea Health Industry Development Institute and insurance listing by the Health Insurance Review and Assessment Service. If the review proceeds as scheduled, sales are expected to begin next year.

This Ministry of Food and Drug Safety marketing approval application was submitted based on the Phase 3 clinical trial data for the world's first home-based standalone treatment indication for depression, completed last September.

The Phase 3 clinical trial was conducted on 65 patients diagnosed with mild to moderate major depressive disorder. The tDCS (transcranial direct current stimulation) module installed on Ybrain’s electronic medicine platform was used alone. Most patients who self-administered 30 minutes daily for six weeks showed improvement in depressive symptoms, and over 50% of patients recovered to the normal range.

In the 2020 international tDCS guidelines published by the International Journal under the Collegium Internationale Neuro-Psychopharmacologicum (CINP), Ybrain’s Phase 3 clinical trial was cited as a successful case, highlighting safety and portability as representative advantages of the technology. The efficacy of ‘improvement of depressive symptoms in patients with major depressive disorder’ was recommended at ‘Level A evidence (definitely effective).’

A Ybrain official stated, “Ybrain’s electronic medicine platform is the industry’s smallest wearable electronic medicine that can be self-administered anywhere, including at home, and can fundamentally prevent misuse through electronic prescriptions by medical professionals.” He added, “After approval of sales authorization, we will proceed with service contracts for the electronic medicine platform targeting major domestic hospitals, clinics, and public medical institutions.”

He continued, “If successful in new medical technology registration, prescriptions will be possible during hospital visits, and it is expected to be actively introduced in public medical institutions and public health centers, where there has been existing waiting demand.”