BrainsWay, a leading company in advanced noninvasive neurostimulation treatments for mental health disorders, has received approval from the US Food and Drug Administration (FDA) for an expanded indication for its Deep Transcranial Magnetic Stimulation system (Deep TMS™).

This expanded indication allows for the treatment of patients with major depressive disorder (MDD) aged 22 to 86, extending the previous upper age limit of 68.

With this approval, Deep TMS becomes the first and only form of TMS indicated for treating MDD patients over the age of 68, including those with comorbid anxiety symptoms.

Vice President of Medical Affairs at BrainsWay, noted the significance of this development, stating, “Depression persists beyond age 68, and anatomical changes in the aging brain can pose challenges in reaching and treating specific brain targets associated with depression.

Believe that the deeper and broader stimulation provided by Deep TMS can effectively address these age-related changes, supported by compelling clinical data presented to the FDA.”

BrainsWay’s application to the FDA included study data indicating promising response and remission rates in MDD patients over 68 years old treated with the H1 Coil.

For instance, using the Hamilton Depression Rating Scale-21 (HDRS-21), response and remission rates were 69% and 62%, respectively, while using the self-administered Patient Health Questionnaire-9 (PHQ-9), response and remission rates were 65% and 35%, respectively.

The business implications of this development, stating, “This significant expansion presents an exciting business opportunity for BrainsWay.

With increasing life expectancies, there is a growing demand among caregivers, assisted living facilities, and families for new and effective therapeutic solutions to alleviate the burden of depression among the elderly population.”

This FDA approval underscores BrainsWay's commitment to advancing mental health treatment options and addressing the needs of diverse patient populations.






Source: globenewswire.com

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