A Breakthrough for Treating Depression in Older Adults
The U.S. Food and Drug Administration (FDA) has granted an expanded indication for BrainsWay's Deep Transcranial Magnetic Stimulation (Deep TMS) system, now allowing treatment for major depressive disorder (MDD) in patients aged 22 to 86.
This significant approval makes Deep TMS the first and only TMS device indicated for the treatment of depression in patients over the age of 68. However it does not indicate the inefficiency of other TMS devices.
Why This Expansion Matters
Depression does not simply vanish at the age of 68. In fact, older adults often face additional challenges in treatment due to brain atrophy, which increases the distance from the scalp to the brain, making it harder to reach specific brain targets associated with depression. The deeper and broader stimulation provided by Deep TMS is designed to overcome these anatomical changes, ensuring effective treatment for older patients (brainsway) (markets.businessinsider).
Clinical Efficacy and Data
BrainsWay's application to the FDA included compelling clinical data. For example, patients over 68 years treated with the H1 Coil showed a 69% response rate and a 62% remission rate using the Hamilton Depression Rating Scale-21 (HDRS-21). Similar positive outcomes were observed using the Patient Health Questionnaire-9 (PHQ-9), with a 65% response rate and a 35% remission rate (markets.businessinsider) (markets.businessinsider) (Stock Market News Live | Stock Titan).
Impact on the Market and Healthcare
This expanded indication opens up new opportunities for BrainsWay to address a previously underserved segment of the population. As life expectancies rise, the demand for effective depression treatments in older adults is expected to grow. This development not only reinforces BrainsWay's leadership in the neurostimulation market but also provides a competitive edge by being the first to address this age group. The expanded approval is expected to drive increased adoption among healthcare providers and boost market share before competitors can enter this segment (markets.businessinsider) (markets.businessinsider) (Stock Market News Live | Stock Titan).
Looking Ahead
BrainsWay's achievement reflects their robust research and development capabilities, marking their 10th FDA clearance. This milestone underscores the company's commitment to advancing mental health treatments and improving patient outcomes. With ongoing clinical trials and potential future indications, BrainsWay is poised for continued growth and innovation in the field of neurostimulation (brainsway) (markets.businessinsider) (Stock Market News Live | Stock Titan).
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