BrainsWay reports promising results for accelerated depression treatment

BURLINGTON, Mass. and JERUSALEM - BrainsWay Ltd. (NASDAQ & TASE: BWAY) announced preliminary results from a multicenter trial suggesting its accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) protocol for major depressive disorder shows comparable efficacy to standard treatment while requiring fewer clinic visits.

The randomized controlled trial enrolled 104 adult depression patients across eight sites, comparing standard Deep TMS treatment to an accelerated protocol where patients received five sessions daily over six days, followed by eight continuation sessions over four weeks.

Results showed the accelerated protocol reduced depression scores by 18.9 points compared to 19.9 points with standard treatment. Response rates were nearly identical at 87.8% for accelerated treatment versus 87.5% for standard treatment, while remission rates were 78.0% and 87.5% respectively. This clinical progress has contributed to BrainsWay’s strong market performance, with the stock delivering a 74% return over the past year and currently trading near its 52-week high of $11.79. InvestingPro subscribers have access to 13 additional key insights about BWAY’s valuation and growth prospects.

The accelerated sessions lasted under 10 minutes compared to 20 minutes for standard sessions, and patients reached remission in a median of 21 days versus 28 days with standard treatment. No serious adverse events were reported.

"Throughout psychiatry, we see patients who are motivated to get better but simply cannot make it to a clinic five days a week for six weeks straight," said Dr. Russ Voltin, a board-certified psychiatrist at PsyCare, a participating site in the study.

The accelerated protocol remains investigational and is not yet FDA-cleared. The preliminary results are subject to additional analysis and peer review, according to the company’s press release statement.

BrainsWay currently has three FDA-cleared indications for its Deep TMS technology: major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company maintains a healthy balance sheet with more cash than debt and a strong current ratio of 5.03, positioning it well for future growth. For detailed analysis and comprehensive financial metrics, investors can access the full BWAY Research Report on InvestingPro, part of their coverage of over 1,400 US stocks.

In other recent news, BrainsWay has reported its first-quarter earnings for 2025, with revenues reaching $11.5 million, closely aligning with H.C. Wainwright’s projection of $11.3 million. The company achieved net earnings of $0.03 per share, consistent with initial estimates. H.C. Wainwright has adjusted its full-year 2025 revenue forecast to $51.6 million, up from the previous $50.8 million, while maintaining a Buy rating and a $16.00 price target on BrainsWay stock. The firm’s analyst has also revised the 2026 revenue estimate to $60.8 million from an earlier $60 million.

In a strategic move, BrainsWay has invested $5 million in Stella MSO, LLC, gaining a minority stake in the management services organization that operates over 20 clinics in the U.S. and Israel. This investment is part of BrainsWay’s broader strategy to enhance the reach of its Deep Transcranial Magnetic Stimulation (Deep TMS) Therapy. The company plans to make additional minority-stake investments to support interventional psychiatry. BrainsWay’s management has maintained their revenue guidance for the year within the range of $49-51 million, and the company ended the first quarter with $71.6 million in cash, cash equivalents, and short-term deposits.

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