Core Insights - BrainsWay Ltd. has received FDA approval for an expanded indication of its Deep Transcranial Magnetic Stimulation (Deep TMS™) system, now allowing treatment for major depressive disorder (MDD) in patients aged 22 to 86, up from the previous limit of 68 years [1][2]. Company Developments - This marks the 10th FDA clearance for BrainsWay, making its Deep TMS the first and only TMS treatment approved for patients over 68 with MDD, including those with comorbid anxiety symptoms [2]. - Clinical data presented to the FDA showed that MDD patients over 68 treated with the H1 Coil had response and remission rates of 69% and 62% respectively, based on the Hamilton Depression Rating Scale-21 (HDRS-21), and 65% and 35% respectively using the Patient Health Questionnaire-9 (PHQ-9) [4]. Market Opportunity - The CEO of BrainsWay highlighted the significant business opportunity presented by this development, noting the increasing life expectancy and the demand for effective therapeutic solutions for the elderly suffering from depression [5]. - The economic burden of major depressive disorder in the U.S. was estimated at $326 billion prior to the COVID pandemic, indicating a substantial market for effective treatments [6]. Company Background - BrainsWay is recognized as a leader in noninvasive neurostimulation treatments for mental health disorders, with a focus on advancing neuroscience through its proprietary Deep TMS™ technology [7]. - The company has multiple FDA-cleared indications, including MDD, obsessive-compulsive disorder, and smoking addiction, and is committed to expanding clinical trials for various psychiatric and neurological disorders [7].

BURLINGTON, Mass. and JERUSALEM, June 03, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the p ...

Shares of Brainsway Ltd. Sponsored ADR (BWAY) have gained 3.5% over the past four weeks to close the last trading session at $5.33, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $11.75 indicates a potential upside of 120.5%. While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wise at a ...

BrainsWay Ltd. (NASDAQ:BWAY) Q1 2024 Earnings Conference Call May 8, 2024 8:30 AM ET Troy Williams – Investor Relations, Life Science Advisors Hadar Levy – Chief Executive Officer Ido Marom – Chief Financial Officer Jeff Cohen – Ladenburg Steve Lichtman – Oppenheimer Ram Selvaraju – H.C. Wainwright Good morning, everyone. My name is Julie, and I will be your conference operator today. At this time, I would like to welcome everyone to BrainsWayÂ's First Quarter 2024 Financial Results Conference Call. All lin ...

Generated Significant 37% Year-over-Year Revenue Growth in Q1 2024 Recorded Positive Quarterly Net Income for Second Consecutive Quarter, and Positive Adjusted EBITDA and Cash Flow from Operations for Third Consecutive Quarter Conference Call to be Held Today at 8:30 AM ET BURLINGTON, Mass. and JERUSALEM, May 08, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a world leader in advanced and non-invasive treatment for brain disorders, today reported first quarter ...

JERUSALEM and BURLINGTON, Mass., April 04, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced results published in a review article exploring the potential efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS™) as a novel therapeutic approach for Parkinson's Disease (PD). The paper was published in Frontiers of Human Neuroscience, a leading peer-review ...

D. Risk Factors · Clinical trials involve a lengthy and expensive process with an uncertain outcome, which may delay or cause us to abandon the development of Deep TMS for additional indications. · Our collaboration arrangements may not be successful, which could adversely affect our ability to develop and commercialize our products. Government Regulatory Risks · Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to ...

Brainsway Ltd. Sponsored ADR (BWAY) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the syste ...

BURLINGTON, Mass. and JERUSALEM, March 18, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) ("BrainsWay" or the "Company"), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced today that its significant existing partner, Katie's Way Plus, which provides comprehensive mental health services tailored to the unique needs of active duty military members, veterans, and their families, has ordered an additional 18 Deep Transcranial Magnetic Stimu ...

Generally speaking, you want to minimize your exposure to cheap stocks under $10. Yes, smaller companies have the potential to rise dramatically higher than their larger counterparts. In part, that’s because they’re unpredictable – and this ambiguity cuts both ways.Sure, cheap stocks under $10 have the benefit of the law of small numbers working in their favor during upswings. Basically, it doesn’t take as much energy to push a pebble up the mountain. However, if you climb too high up that mountain and you ...