Ybrain's device improves depression symptoms in perinatal women: data

Ybrain is making a case for digital therapeutics in mental health with new clinical data on its MINDD STIM device, which could fill critical gaps in depression treatment.

Early results were unveiled last week at the 6th International Brain Stimulation Conference in Kobe, Japan.

A mid-trial analysis of a clinical study on perinatal depression, led by Professor Cho Hee-young from the Department of Obstetrics and Gynecology at Seoul National University Hospital, found that women using MINDD STIM as a home-based treatment showed significant improvement after six weeks.

The study is tracking 22 women with mild to moderate major depressive disorder (K-BDI-II scores of 18-28), and the latest numbers show notable reductions in both the Korean version of the Beck Depression Inventory-II (K-BDI-II) and the Edinburgh Postnatal Depression Scale (K-EPDS)—with scores dropping by 6.5 and 5.3 points, respectively (p<0.0001).

With limited treatment options during pregnancy and postpartum due to safety concerns with antidepressants, the data suggests MINDD STIM could provide a drug-free alternative that is both accessible and noninvasive.

Ybrain also presented early findings from a six-week study on bipolar disorder, involving 64 patients with bipolar I or II disorder. The device demonstrated a safety profile comparable to placebo, but efficacy was not confirmed. Researchers noted that the study did not strictly control for concurrent medication use, and a larger, more controlled trial is planned to further assess treatment effects.

The device already has a foothold in Korea. Approved by the Ministry of Food and Drug Safety (MFDS) in 2021, MINDD STIM was later designated as a “new medical technology deferment” by the National Evidence-based Healthcare Collaborating Agency (NECA), allowing it to be prescribed as a non-reimbursed treatment. 

Between 2018 and 2022, the device was prescribed 172,536 times to more than 4,800 patients, with no reports of serious adverse effects—a signal that it may have long-term safety advantages over drug-based therapies.

In a 2020 domestic multicenter trial, the device achieved a 62.8 percent remission rate in major depressive disorder when used for 30 minutes daily over six weeks—a figure that outperformed conventional antidepressants, which hover around 50 percent.