Ybrain said on Thursday that it participated in the update of the global industry standard guidelines for limited output transcranial electrical stimulation (LOTES).

LOTES-2023 is an updated version of LOTES-2017 which is an international standard used in the field of brain stimulation worldwide and is a guideline to ensure the safety and effectiveness of transcranial electrical stimulation technology.

Notably, LOTES-2023 consolidates standards and regulations for transcranial electrical stimulation in the United States, Europe, and South Korea into the latest international standards. The guidelines inform trial design and regulatory decisions, and manufacturer activities for LOTES-based devices whether obtained over-the-counter (OTC) or by prescription.

This also includes warnings and precautions for the use of transcranial electrical stimulation (TES) therapy in children, pregnant women, and lactating women.

In particular, Ybrain provided information on the licensing of transcranial direct-current stimulation (tDCS) therapy in Korea, which can be used as a reference for licensing in each country. The company also provided the latest treatment data analyzing the real-world data of Ybrain’s MINDD STIM electroceutical n Korea from 2018 to 2022.

Accordingly, Ybrain shared that there were no serious adverse events after analyzing data from approximately 170,000 physician-supervised in-office and at-home tDCS treatments administered to 4,866 patients.

This includes data from 141 infants under the age of 10, 786 adolescents under the age of 20, and 1,388 women of childbearing age between the ages of 20 and 49, demonstrating that tDCS is a safe treatment for patients with depression seeking an alternative to medication.

"We are pleased to be the first company in the world to provide real-world data through the licensing and commercialization of tDCS in Korea," said Ybrain CEO Lee Ki-won. "We hope that the safety evidence of tDCS generated through MINDD STIM in Korea will help catalyze the commercialization of other tDCS-based treatments globally.”

The guidelines were published in the Brain Stimulation journal on May 15.