'Electronic Medicine' Ybrain Collaborates to Establish International Standards for Electrical Stimulation

Electronic medicine platform company Ybrain announced on the 1st that it participated as a leading domestic company in the update of 'LOTES,' the global industry standard guideline related to transcranial direct current stimulation (tDCS).

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LOTES, which stands for Limited Output Transcranial Electrical Stimulation, is an international standard used worldwide in the brain stimulation field, serving as a guideline to ensure the safety and efficacy of tDCS technology. The updated version, LOTES-2023, was released last month following the initial LOTES-2017 published in 2017.

The LOTES-2023 update includes the latest international consensus on standards and regulations for tDCS from the United States, Europe, and South Korea. Engineering principles, regulatory requirements, and industry standards for low-risk wellness, general, and prescription medical devices have been newly updated to reflect current trends. Based on this, the latest criteria for warnings and precautions when using transcranial electrical stimulation (TES) therapy for children, pregnant women, and nursing mothers have been established.

The update was also published last month in Brain Stimulation, an international leading journal in the field of neurostimulation, under the title “Update of Engineering Principles, Regulatory Requirements, and Industry Standards for Low-Risk Wellness, Non-Prescription, and Prescription Medical Devices.”

Ybrain participated as the leading domestic company in the LOTES-2023 update following LOTES-2017. In this update, information on the approval of tDCS treatment in South Korea was presented for reference in other countries' approval processes, along with the latest treatment data analyzing the real-world use of the tDCS-based electronic medicine 'Mindsteem' in Korea from 2018 to 2022. Through this data, LOTES-2023 reported that no serious adverse reactions occurred after analyzing 170,000 tDCS treatment sessions conducted under physician supervision on 4,866 patients both in hospitals and at home during that period. This included 141 infants under 10 years old, 786 adolescents under 20, and 1,388 women of childbearing age between 20 and 49, demonstrating that tDCS is a safe treatment option for depression patients seeking alternatives to drug therapy.

Lee Gi-won, CEO of Ybrain, stated, “It is highly significant that Ybrain was the first in the world to establish real-world data through the approval and commercialization of tDCS in Korea. The safety evidence of tDCS created through Mindsteem in Korea will act as a catalyst for the global commercialization of tDCS treatment.”