Core Insights - BrainsWay Ltd. reported record quarterly revenue of $12.6 million in Q2 2025, marking a 26% increase compared to Q2 2024 [1] - The company raised its full-year 2025 revenue guidance to between $50 million and $52 million, up from the previous range of $49 million to $51 million [4] - Remaining performance obligations increased by 25% year-over-year to $62 million, indicating strong future revenue visibility [1][4] Financial Performance - Operating profit for Q2 2025 totaled $0.6 million, consistent with the prior year [5] - Adjusted EBITDA rose 16% to $1.5 million in Q2 2025, compared to $1.3 million in Q2 2024 [5] - Net profit surged 233% to $2.0 million in Q2 2025, up from $0.6 million in Q2 2024 [5] Operational Highlights - The company shipped a net total of 88 Deep TMS™ systems in Q2 2025, a 35% increase from the same period last year, bringing the total installed base to 1,522 systems [5] - Approximately 70% of recent customer engagements are structured as multi-year lease agreements, contributing to stable revenue streams [5] - The company is actively pursuing minority equity investments in high-performing mental health providers to enhance its strategic initiatives [7] Guidance and Future Outlook - The company expects operating income for full-year 2025 to be between 4% and 5%, with Adjusted EBITDA projected at 12% to 13% [4] - BrainsWay's management expressed confidence in the momentum across its core market and the successful execution of its growth strategy [4][6]

Core Viewpoint - BrainsWay Ltd. is set to report its second quarter 2025 financial results and operational highlights on August 13, 2025, before the U.S. markets open, followed by a conference call to discuss the results and business updates [1]. Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology [3]. - The company has obtained three FDA-cleared indications for its TMS technology, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3]. - Founded in 2003, BrainsWay operates in the United States and Israel, focusing on increasing global awareness and access to Deep TMS [3]. Conference Call Details - The conference call is scheduled for August 13, 2025, at 8:30 AM Eastern Time, with dial-in numbers provided for the United States, international participants, and Israel [2]. - The call will be available for live broadcast and replay for 30 days on the company's website [2].

Core Viewpoint - BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial indicating that the accelerated Deep TMS protocol for treating major depressive disorder is comparable in efficacy to the standard protocol while requiring fewer clinic visits [1][2]. Group 1: Study Overview - The trial involved 104 adult patients diagnosed with depression across eight sites, making it the largest randomized, controlled, blinded, multicenter trial of an accelerated Deep TMS protocol [2]. - Patients were divided into two groups: one receiving standard Deep TMS treatment and the other receiving the accelerated protocol [2]. Group 2: Treatment Protocol - The accelerated group underwent five sessions per day over six treatment days, followed by eight sessions over the next four weeks, significantly reducing the treatment burden [3]. - The primary endpoint was the change in depressive symptoms measured by the HDRS-21 scale, with secondary endpoints including response and remission rates [3]. Group 3: Key Findings - The accelerated Deep TMS group showed comparable efficacy with HDRS depression scores reduced by 18.9 points, while the standard group saw a reduction of 19.9 points [7]. - Response and remission rates were 87.8% and 78.0% for the accelerated group, compared to 87.5% and 87.5% for the standard group [7]. - Sessions for the accelerated protocol lasted less than 10 minutes, compared to 20 minutes for standard sessions [7]. - The median time to remission was 21 days for the accelerated group versus 28 days for the standard group [7]. - The accelerated protocol was well-tolerated with no serious adverse events reported, and side effects were mild [7]. Group 4: Company Commitment - BrainsWay emphasizes that innovation in mental health care involves not only new technology but also improving care delivery methods [5]. - The company is dedicated to expanding access to Deep TMS and advancing the field through scientific research [5]. - The accelerated protocol is investigational and not yet FDA-cleared, with preliminary results subject to further analysis and peer review [5]. Group 5: Company Background - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS platform technology [8]. - The company has obtained three FDA-cleared indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction [8]. - Founded in 2003, BrainsWay operates in the United States and Israel, focusing on increasing global awareness and access to Deep TMS [8].

Core Insights - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, showcasing its Deep TMS technology at the Clinical TMS Society's 2025 Annual Meeting [1][4] - The company will present preliminary results from a multicenter randomized non-inferiority trial comparing its standard Deep TMS protocol to a novel accelerated protocol [2] - BrainsWay is the first and only TMS company to obtain three FDA-cleared indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [4] Company Overview - BrainsWay was founded in 2003 and operates in the United States and Israel, focusing on improving health through its proprietary Deep TMS platform technology [4] - The company is dedicated to advancing neuroscience and increasing global awareness and access to Deep TMS treatments [4] Clinical Research Highlights - The latest Deep TMS research will be featured in poster presentations at the conference, emphasizing the technology's advantages over first-generation TMS systems [3] - A Phase IV Registry Study demonstrated that 49% of patients successfully quit smoking after 15 treatment sessions using the Deep TMS H4 Coil [5] - A post-marketing surveillance study involving over 1,200 adolescent patients showed the efficacy and safety of Deep TMS for adolescent depression [5]

Core Insights - BrainsWay has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to mental health care and raise awareness of innovative treatments [1][2] - The investment in Stella is part of a broader strategy to make minority-stake investments in high-performing mental health providers across the U.S. [2] - BrainsWay will invest $5 million in Stella, acquiring a minority position in the company through preferred, annually compounding securities [4] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5] - BrainsWay aims to increase global awareness and access to Deep TMS through ongoing clinical trials and scientific advancements [5] Stella Overview - Stella is an interventional psychiatry practice focused on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients across more than 20 clinics [1][6] - Stella's partnership with BrainsWay is expected to accelerate its growth and enhance patient care [3][5]

Core Insights - BrainsWay Ltd. achieved record quarterly sales of $11.5 million in Q1 2025, marking a 27% increase compared to Q1 2024 [1][8] - The company reported an operating profit of $0.6 million, a significant increase of 519% year-over-year, and Adjusted EBITDA rose to $1.3 million, up 81% from the previous year [1][8] - The demand for Deep TMS Systems is strong, with a record shipment of 81 systems in Q1 2025, representing a 42% increase from 57 systems shipped in the same period last year [1][8] Financial Performance - Revenue for Q1 2025 was $11.5 million, up 27% from $9.1 million in Q1 2024 [8][21] - Gross margin remained stable at 75% compared to the prior year [8] - Net profit surged by 897% to $1.1 million in Q1 2025, compared to $0.1 million in Q1 2024 [1][8] Operational Highlights - The company is reiterating its full-year 2025 financial guidance, projecting revenue between $49 million to $51 million, with an operating profit margin of 3% to 4% and Adjusted EBITDA of 11% to 12% [5][8] - BrainsWay's CEO highlighted the growing demand for their technology in treating various mental health disorders, including OCD and anxious depression, and emphasized the importance of relationships with large enterprise customers [5][6] Market Expansion - The company is expanding its global market presence, now operating in key markets including Canada, Asia, India, and Europe [6] - Upcoming catalysts for growth include the next-generation Deep TMS 360™ system and the expansion into new indications supported by additional clinical data [6]

Company Overview - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, specifically through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology [4] - The company has obtained three FDA-cleared indications for Deep TMS, which include Major Depressive Disorder (MDD), Anxious Depression, Obsessive-Compulsive Disorder (OCD), and Smoking Addiction [4] - Founded in 2003, BrainsWay operates in both Israel and the U.S. and is committed to increasing global awareness and access to Deep TMS [4] Industry Participation - BrainsWay will participate in the American Psychiatric Association (APA) Annual Meeting from May 17–21, 2025, in Los Angeles, California, showcasing its role in psychiatric care [1] - The company will host live demonstrations of its Deep TMS system at its exhibit booth, providing hands-on interaction with this innovative treatment modality [3] Educational Initiatives - A master course titled "Clinical Applications for Psychiatric Practice: Ketamine and TMS" will be held on May 18, 2025, focusing on integrating novel treatments into clinical psychiatric practice [2] - The course will feature prominent clinician-researchers, including BrainsWay's Chief Medical Officer Dr. Richard Bermudes and Vice President of Medical Affairs Dr. Colleen Hanlon, discussing innovative therapeutic approaches [2][3]

Core Insights - BrainsWay Ltd. will report its first quarter 2025 financial results and operational highlights on May 13, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30 AM Eastern Time on the same day to discuss the results and business operations [1][2] Company Overview - BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [3] - The company has obtained three FDA-cleared indications for its TMS technology, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3] - Founded in 2003, BrainsWay operates in Israel and the U.S. and is focused on increasing global awareness and access to Deep TMS [3]