BURLINGTON, Mass. and JERUSALEM - BrainsWay Ltd. (NASDAQ & TASE: BWAY), a developer of brain disorder treatments, reported positive results from a Stanford University pilot study on treating alcohol use disorder (AUD) with its Deep Transcranial Magnetic Stimulation (TMS) technology. The study, published in the Brain Stimulation journal, indicates that an accelerated Deep TMS protocol might improve treatment outcomes for AUD patients.
The research compared a small group of AUD patients treated with BrainsWay's H7-Coil (n=5) against a historical control group from the same residential program (n=39) who did not receive Deep TMS treatment. Results showed that the Deep TMS group had fewer heavy drinking days (3% vs. 22%) and regular drinking days (15% vs. 28%), as well as lower relapse rates (60% vs. 74%). Neuroimaging also revealed changes in brain activity and connectivity in areas associated with addiction disorders.
Following the study, the U.S. National Institutes of Health awarded approximately $1.5 million to the research team to further explore Deep TMS in treating substance addictions. This grant underscores the potential of Deep TMS as a noninvasive treatment option within the addiction space. The market has recognized this potential, with BrainsWay's stock delivering a remarkable 64% return over the past year. For deeper insights into BrainsWay's growth potential and comprehensive analysis, investors can access the full Pro Research Report on InvestingPro, which covers over 1,400 US equities.
BrainsWay's CEO, Hadar Levy, expressed optimism about the preliminary results, suggesting they could lead to broader research into Deep TMS for treating AUD and other addictions. However, it's important to note that BrainsWay's Deep TMS is not currently FDA-cleared for treating AUD.
BrainsWay is known for its FDA-cleared Deep TMS treatments for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company continues to investigate Deep TMS applications in various psychiatric, neurological, and addiction disorders.
This announcement is based on a press release statement and does not imply FDA approval for the treatment of AUD with Deep TMS. The efficacy of this treatment for AUD will require further research and regulatory review. While current market valuation suggests the stock is trading above its Fair Value based on InvestingPro analysis, the company's strong balance sheet and expected net income growth this year could support its ambitious expansion plans.
In other recent news, BrainsWay has reported a significant increase in its revenue for the third quarter of 2024. The company's revenue rose by 26% year-over-year, reaching $10.5 million. This marks the fourth consecutive quarter of positive net income and adjusted EBITDA for BrainsWay. Additionally, Valor Equity Partners provided $20 million in equity financing, which increased the company's pro forma cash to $68.4 million.
These recent developments also include an increase in the company's full-year 2024 revenue guidance to $40-41 million, with an expected operating income of 3-4%. BrainsWay has also shipped 177 systems year-to-date, indicating a 12% increase from the previous year. The company is also in the midst of an ongoing clinical trial for an accelerated treatment for major depressive disorder, with FDA clearance expected in 2025.
BrainsWay is actively pursuing additional clinical indications for its Deep TMS technology and is focusing on expanding its global distribution network, including new agreements in Asia Pacific and Europe. Despite geopolitical concerns, the company's operations in Israel remain uninterrupted, and it has a continuity plan to ensure production for the upcoming six months.
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