BURLINGTON, Mass. and JERUSALEM - BrainsWay Ltd. (NASDAQ & TASE: BWAY), a company specializing in noninvasive neurostimulation treatments, announced today that the US Food and Drug Administration (FDA) has approved an expanded age indication for its Deep Transcranial Magnetic Stimulation (Deep TMS) system. The treatment can now be administered to patients with major depressive disorder (MDD) aged 22 to 86, extending the previous age limit of 68.
This clearance is the 10th FDA approval for BrainsWay and marks the first time a TMS treatment has been indicated for MDD patients over 68, including those with comorbid anxiety symptoms. The decision was influenced by clinical data demonstrating the effectiveness of Deep TMS in older patients.
Studies showed response and remission rates of 69% and 62%, respectively, using the Hamilton Depression Rating Scale-21 (HDRS-21), and 65% and 35%, respectively, using the Patient Health Questionnaire-9 (PHQ-9).
Colleen A. Hanlon, Ph.D., Vice President of Medical Affairs at BrainsWay, stated that brain atrophy, which increases with age, can pose challenges in reaching and treating brain targets associated with depression. The company believes that the deeper and broader stimulation of Deep TMS can overcome these anatomical changes in the elderly.
Hadar Levy, CEO of BrainsWay, views this development as a significant business opportunity, citing the growing demand for effective depression treatments in the elderly population, which is expanding due to increased life expectancies.
MDD is a debilitating mental health disorder affecting millions globally and is often accompanied by severe anxiety. It has a substantial economic impact, with the cost in the United States estimated at $326 billion before the COVID-19 pandemic.
BrainsWay's Deep TMS technology is the only one with three FDA-cleared indications, including MDD, obsessive-compulsive disorder, and smoking addiction. The company is currently conducting additional clinical trials for various psychiatric, neurological, and addiction disorders.
The information in this article is based on a press release statement from BrainsWay.
InvestingPro Insights
BrainsWay's recent FDA approval for an expanded age indication of its Deep TMS system presents a noteworthy development for the company, potentially impacting its financial health and attractiveness to investors. In light of this, let's delve into some key metrics and tips for BrainsWay (NASDAQ: BWAY) from InvestingPro.
InvestingPro Data shows that BrainsWay holds a market capitalization of $104.48 million, reflecting its size and market value within the healthcare sector. Despite the company's innovative strides, analysts have taken note of its financial figures, with a Price/Earnings (P/E) ratio of -62.97, indicating that the company is not currently profitable. Furthermore, revenue growth was robust in the last twelve months as of Q1 2024, with an increase of 32.61%, signaling potential for future business expansion.
As for performance, BrainsWay has experienced a significant return over the last week, with a 16.48% increase in its stock price. This short-term surge is complemented by a remarkable 265.49% return over the past year, which could be a sign of strong investor confidence or reaction to positive developments within the company, such as the recent FDA approval.
InvestingPro Tips highlight the company's strong liquidity position, as it holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. These factors could provide BrainsWay with financial flexibility to invest in further research and development or to weather economic downturns.
However, it is important to note that, according to additional InvestingPro Tips, BrainsWay is not expected to be profitable this year, and it does not pay a dividend to shareholders, which might be a consideration for income-focused investors.
For those interested in a deeper dive into BrainsWay's financials and future prospects, InvestingPro offers numerous additional tips. Utilize coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription and gain access to valuable insights that could inform your investment decisions.
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