Group 1 - Brainsway Ltd. Sponsored ADR (BWAY) shares have increased by 7.4% over the past four weeks, closing at $12.98, with a mean price target of $16.3 indicating a potential upside of 25.6% [1] - The mean estimate consists of four short-term price targets with a standard deviation of $2.15, where the lowest estimate is $14.20 (9.4% increase) and the highest is $19.00 (46.4% increase) [2] - Analysts show strong agreement in revising earnings estimates higher, with the Zacks Consensus Estimate for the current year increasing by 11.5% over the last 30 days [11][12] Group 2 - BWAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While the consensus price target may not be a reliable indicator of the stock's potential gain, it does provide a directional guide for price movement [14]

Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $12,600,000 for Q2 2025, representing a 26% increase compared to $10,000,000 in the same period last year [4][12] - Gross profit for the quarter was $9,500,000, up from $7,500,000 in the prior year, maintaining a strong gross margin of 75% [12][13] - Net profit for the quarter was $2,000,000 compared to $600,000 in the same period of 2024 [14] - Remaining performance obligation grew to $62,000,000, a 25% year-over-year increase, providing strong visibility into future revenue [16] Business Line Data and Key Metrics Changes - The company shipped a total of 88 Deep TMS systems during the quarter, representing a 35% increase compared to the same period last year [4][5] - The total installed base reached 1,522 systems as of June 30, 2025, compared to 1,215 systems a year ago [12] Market Data and Key Metrics Changes - The company has focused on generating recurring revenue streams through multiyear lease agreements, which now account for approximately 70% of recent customer engagements [5] - The backlog of signed agreements with remaining performance obligations totaled approximately $62,000,000, indicating strong future revenue visibility [5][16] Company Strategy and Development Direction - The company aims to elevate market awareness of Deep TMS, advance its R&D roadmap, and broaden patient access through global expansion and health system integration [6] - A new initiative to generate shareholder value through minority interest investments in mental health providers was identified, with a strategic equity investment of $20,000,000 from Valo Equity Partner [10][11] - The company plans to sign at least five contracts for strategic financing arrangements by the end of the year, with a goal of 10 contracts by 2026 [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerated treatment protocol for Deep TMS, expecting FDA clearance by Q4 2025, which could significantly enhance patient convenience [20][21] - The company raised its full-year 2025 revenue guidance to a range of $50,000,000 to $52,000,000, representing 22% to 27% growth over 2024 revenue [17] Other Important Information - The company has engaged in educational initiatives to enhance clinician knowledge and confidence in Deep TMS, including funding new continuing medical education courses [7][8] - Cash position at the end of the quarter was $78,300,000, up $30,200,000 from the same point last year, reflecting strong collections and strategic investments [14][15] Q&A Session Summary Question: Can you discuss the accelerated protocol and its market potential? - Management expects to receive FDA feedback on the accelerated protocol by Q4 2025, which could reduce treatment time significantly, making it more appealing to patients [20][21] Question: What is the size of the commercial organization and its growth? - The current sales team consists of 16 direct sales personnel and 10 practice development staff, totaling 26 individuals supporting sales activities [25] Question: What is the status of the TMS 360 and pilot studies? - The TMS 360 is planned for launch with an alcohol use disorder trial in Q3 2025, alongside feasibility studies for other indications [27] Question: What is the composition of the backlog and OCD placements? - The majority of the backlog comes from enterprise customers, with 30 OCD systems shipped in the second quarter [32] Question: How many strategic financing arrangements are planned for this year? - The company aims to sign at least five new contracts for strategic investments by the end of the year, with potential investments ranging from $2,000,000 to $5,000,000 [36][37] Question: How has the Stella financing arrangement been performing? - The collaboration with Stella MSO has resulted in over a 50% increase in TMS patient utilization, demonstrating the effectiveness of the partnership [38]

[Q2 2025 Earnings Release Overview](index=1&type=section&id=Q2%202025%20Earnings%20Release%20Overview) [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) BrainsWay achieved record quarterly revenue of $12.6 million in Q2 2025, an increase of 26% compared to Q2 2024, alongside positive operating profit and increased Adjusted EBITDA Key Financial Highlights (Millions) | Metric | Q2 2025 (Millions) | | :---------------- | :----------------- | | Revenue | $12.6 | | Operating Profit | $0.6 | | Adjusted EBITDA | $1.5 | - Achieved record quarterly revenue of **$12.6 million** in Q2 2025, an increase of **26%** compared to Q2 2024[1](index=1&type=chunk) [Key Operational Highlights](index=1&type=section&id=Key%20Operational%20Highlights) The company reported a significant year-over-year increase in remaining performance obligations, indicating strong future revenue streams from multi-year agreements - Remaining performance obligations increased by **25%** year-over-year to **$62 million**[1](index=1&type=chunk) [Updated Full-Year 2025 Guidance](index=1&type=section&id=Updated%20Full-Year%202025%20Guidance) BrainsWay raised its full-year 2025 revenue and EBITDA guidance, reflecting improved visibility and business momentum - Raised full-year 2025 Revenue and EBITDA guidance[1](index=1&type=chunk) [Recent Financial and Operational Highlights](index=1&type=section&id=Recent%20Financial%20and%20Operational%20Highlights) [Q2 2025 Financial Performance](index=1&type=section&id=Q2%202025%20Financial%20Performance) BrainsWay reported strong Q2 2025 financial results, with significant year-over-year growth in revenue, net profit, and Adjusted EBITDA, while maintaining a high gross margin Q2 2025 Financial Performance (Millions) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :------------------------------------------------------- | :------ | :------ | :--------- | | Revenue | $12.6M | $10.0M | +26% | | Gross Margin | 75% | 75% | 0% | | Operating Income | $0.6M | $0.6M | 0% | | Adjusted EBITDA | $1.5M | $1.3M | +16% | | Net Profit | $2.0M | $0.6M | +233% | | Cash, Cash Equivalents, Restricted Cash, and Short-term Deposits (as of June 30, 2025) | $78.3M | N/A | N/A | [Q2 2025 Operational Achievements](index=1&type=section&id=Q2%202025%20Operational%20Achievements) The company significantly increased its Deep TMS system shipments and expanded its installed base, with a majority of new customer engagements structured as multi-year lease agreements - Shipped a net total of **88 Deep TMS™ systems** in the second quarter of 2025, a **35% increase** compared to the same period last year, bringing the total installed base to **1,522 systems**[6](index=6&type=chunk) - Approximately **70%** of recent customer engagements are structured as multi-year lease agreements, contributing to **$62 million** in remaining performance obligations[6](index=6&type=chunk) [Strategic Initiatives and Business Momentum](index=1&type=section&id=Strategic%20Initiatives%20and%20Business%20Momentum) BrainsWay is actively pursuing strategic minority equity investments in high-performing mental health providers and made progress with regulatory submissions and clinical programs - Entered an equity financing transaction with Stella MSO, LLC, a management services organization servicing over **20 mental health clinics**[6](index=6&type=chunk) - Actively seeking to ramp up strategic initiative with additional minority equity investments in high-performing mental health providers, partnering with Valor Equity Partners[6](index=6&type=chunk) - Submitted data to the FDA from its randomized, multicenter U.S. clinical trial evaluating an accelerated Deep TMS treatment protocol[6](index=6&type=chunk) - Continued progress with Israel Ministry of Defense's Rehabilitation Department in qualifying patients with post-traumatic stress disorder (PTSD) for Deep TMS[6](index=6&type=chunk) [Full-Year 2025 Financial Guidance](index=1&type=section&id=Full-Year%202025%20Financial%20Guidance) BrainsWay raised its full-year 2025 financial guidance, projecting higher revenue, operating income, and Adjusted EBITDA, driven by strong Q2 results and improved business momentum Full-Year 2025 Financial Guidance | Metric | New Guidance (2025) | Previous Guidance (2025) | | :---------------- | :---------------------- | :----------------------- | | Revenue | $50M - $52M | $49M - $51M | | Operating Income | 4% - 5% | 3% - 4% | | Adjusted EBITDA | 12% - 13% | 11% - 12% | [Management Commentary](index=1&type=section&id=Management%20Commentary) [Q2 Performance and Growth Strategy](index=1&type=section&id=Q2%20Performance%20and%20Growth%20Strategy) CEO Hadar Levy highlighted strong Q2 results, attributing success to momentum in the core market, successful execution of the growth strategy, and stable recurring revenue streams from multi-year agreements - BrainsWay's second quarter results were strong, demonstrating momentum across the core market and successful execution of the growth strategy[4](index=4&type=chunk) - The stable growth reflects recurring revenue streams built over the past few years through multi-year agreements, which now make up approximately **70%** of the new installed base[4](index=4&type=chunk) - Achieved an extensive order of systems with a multi-phased delivery plan through the end of the year by a fast-growing U.S. mental health network[4](index=4&type=chunk) [Strategic Equity Investments](index=1&type=section&id=Strategic%20Equity%20Investments) Mr. Levy emphasized the strategic initiative to secure minority equity investments in high-performing mental health providers, aiming to significantly increase patient awareness of Deep TMS technology - Successes have given rise to exciting new opportunities, including a strategic initiative aimed at securing minority equity investments in high-performing mental health providers[5](index=5&type=chunk) - This program has already led to several opportunities being explored and is expected to significantly increase awareness among patients of the benefits of transformative care, including Deep TMS technology[5](index=5&type=chunk) [Conference Call and Webcast](index=1&type=section&id=Conference%20Call%20and%20Webcast) BrainsWay's management hosted a conference call on August 13, 2025, to discuss the Q2 results, with details provided for accessing the call via phone and webcast - BrainsWay's management hosted a conference call on **Wednesday, August 13, 2025, at 8:30 a.m. Eastern Time** to discuss results and answer questions[6](index=6&type=chunk) - Dial-in numbers were provided for the United States, International, and Israel, along with a Conference ID[7](index=7&type=chunk) - The conference call was broadcast live and made available for replay for **30 days** on the Company's investor relations website[7](index=7&type=chunk) [Non-IFRS Financial Measures](index=2&type=section&id=Non-IFRS%20Financial%20Measures) [Definition and Purpose of Adjusted EBITDA](index=2&type=section&id=Definition%20and%20Purpose%20of%20Adjusted%20EBITDA) Adjusted EBITDA is presented as a non-IFRS measure to evaluate operating performance, defined as net profit adjusted for specific non-operating and non-cash items, providing a clearer view of operational efficiency and comparability - Adjusted EBITDA is a non-IFRS measure defined as net profit adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses[8](index=8&type=chunk) - It is used by management and investors for period-to-period comparisons, understanding operating results, and assessing operational efficiency, as it excludes items that can vary substantially between companies[9](index=9&type=chunk)[13](index=13&type=chunk) - Adjusted EBITDA should not be considered an alternative to operating profit or net profit under IFRS and may not be comparable to similarly titled measures from other companies[9](index=9&type=chunk)[10](index=10&type=chunk) [About BrainsWay](index=2&type=section&id=About%20BrainsWay) BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology with three FDA-cleared indications, and is committed to advancing neuroscience through clinical evidence and global access - 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[11](index=11&type=chunk) - The company is the first and only TMS company to obtain **three FDA-cleared indications** backed by pivotal clinical studies: major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction[11](index=11&type=chunk) - BrainsWay is dedicated to leading through superior science, building on its clinical evidence, and conducting additional clinical trials for Deep TMS in various psychiatric, neurological, and addiction disorders[11](index=11&type=chunk) [Forward-Looking Statement](index=2&type=section&id=Forward-Looking%20Statement) This section contains standard forward-looking statements, which are subject to various factors and uncertainties that could cause actual results to differ materially from projections, and the company undertakes no obligation to update them - This press release contains "forward-looking statements" under the Private Securities Litigation Reform Act of 1995, including financial guidance and projections[12](index=12&type=chunk) - These statements are based on current management expectations and are subject to numerous factors and uncertainties that could cause actual results to differ materially from those described[12](index=12&type=chunk) - The company undertakes no obligation to publicly update or review any forward-looking statement, except as may be required by applicable securities laws[15](index=15&type=chunk) [Contacts](index=3&type=section&id=Contacts) Contact information for BrainsWay's Chief Financial Officer and Investor Relations is provided for inquiries - BrainsWay Contact: Ido Marom, Chief Financial Officer (Ido.Marom@BrainsWay.com)[16](index=16&type=chunk) - Investors Contact: Brian Ritchie, LifeSci Advisors LLC (britchie@lifesciadvisors.com)[16](index=16&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statements of Financial Position (Balance Sheet)](index=4&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) The balance sheet shows an increase in total assets to $111.56 million as of June 30, 2025, primarily driven by an increase in current assets and investments in financial assets, with a corresponding increase in deferred revenues and equity Consolidated Statements of Financial Position (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | Change | | :--------------------------------- | :------------------------ | :-------------------------- | :----- | | **ASSETS** | | | | | Current Assets | $89,490 | $79,670 | +$9,820 | | Non-Current Assets | $22,074 | $14,646 | +$7,428 | | **Total Assets** | **$111,564** | **$94,316** | **+$17,248** | | **LIABILITIES AND EQUITY** | | | | | Current Liabilities | $25,508 | $15,346 | +$10,162 | | Non-Current Liabilities | $17,924 | $16,657 | +$1,267 | | Equity | $68,132 | $62,313 | +$5,819 | | **Total Liabilities and Equity** | **$111,564** | **$94,316** | **+$17,248** | [Consolidated Statements of Comprehensive Profit (Loss) (Income Statement)](index=5&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Profit%20(Loss)) For Q2 2025, BrainsWay reported significant revenue growth and a substantial increase in net profit compared to the prior year, primarily driven by higher finance income Consolidated Statements of Comprehensive Profit (Loss) (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | YoY Change | H1 2025 (Unaudited) | H1 2024 (Unaudited) | YoY Change | | :--------------------------------- | :------------------ | :------------------ | :--------- | :------------------ | :------------------ | :--------- | | Revenues | $12,632 | $10,005 | +26.3% | $24,168 | $19,100 | +26.5% | | Gross profit | $9,499 | $7,537 | +26.0% | $18,109 | $14,349 | +26.2% | | Operating profit | $578 | $586 | -1.4% | $1,154 | $679 | +69.9% | | Finance income | $2,303 | $518 | +344.6% | $3,414 | $1,115 | +206.2% | | Finance Expense | $784 | $401 | +95.5% | $1,207 | $808 | +49.4% | | Net profit and total comprehensive profit | $2,027 | $600 | +237.8% | $3,134 | $711 | +340.8% | | Basic net income per share | $0.05 | $0.02 | +150.0% | $0.08 | $0.02 | +300.0% | | Diluted net income per share | $0.05 | $0.02 | +150.0% | $0.07 | $0.02 | +250.0% | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In Q2 2025, net cash provided by operating activities significantly increased, while investing activities resulted in a net cash outflow due to purchases of financial assets and short-term deposits Consolidated Statements of Cash Flows (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--------------------------------- | :------------------ | :------------------ | :------------------ | :------------------ | | Net cash provided by operating activities | $12,383 | $1,348 | $17,393 | $4,526 | | Net cash provided by (used in) investing activities | $(15,859) | $34,198 | $(17,825) | $33,488 | | Net cash used in financing activities | $(264) | $(35) | $(1,019) | $(624) | | Increase (decrease) in cash and cash equivalents | $(3,689) | $35,482 | $(1,433) | $37,344 | | Cash and cash equivalents at the end of the period | $67,912 | $47,864 | $67,912 | $47,864 | [Reconciliation of Adjusted EBITDA to Net Profit](index=8&type=section&id=Reconciliation%20of%20Adjusted%20EBITDA%20to%20Net%20Profit) The reconciliation shows that Adjusted EBITDA for Q2 2025 was $1.45 million, an increase from $1.25 million in Q2 2024, after adjusting net profit for non-cash and non-operating items Reconciliation of Adjusted EBITDA to Net Profit (U.S. dollars in thousands) | Metric (U.S. dollars in thousands) | Q2 2025 (Unaudited) | Q2 2024 (Unaudited) | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--------------------------------- | :------------------ | :------------------ | :------------------ | :------------------ | | Net profit and total comprehensive profit | $2,027 | $600 | $3,134 | $711 | | Finance income, net | $(1,519) | $(117) | $(2,207) | $(307) | | Income taxes | $70 | $103 | $227 | $275 | | Depreciation and amortization | $180 | $58 | $371 | $120 | | Depreciation of leased systems | $208 | $240 | $411 | $495 | | Cost of share based payment | $227 | $364 | $552 | $669 | | Restructuring and litigation Cost | $258 | $0 | $258 | $0 | | **Adjusted EBITDA** | **$1,451** | **$1,248** | **$2,746** | **$1,963** |

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].

Key Takeaways Net profit, also referred to as the bottom line, is one of the key tools to determine the financial health of an enterprise. The metric demonstrates a company's ability to convert per-dollar sales into profits. A low profit margin indicates higher risks, implying that a revenue drop might dampen profits, pushing a company into the red. However, Catalyst Pharmaceuticals, Inc. (CPRX) , Gambling.com Group Limited (GAMB) , Orion Group Holdings, Inc. (ORN) and BrainsWay Ltd. (BWAY) boast solid net ...

Group 1 - The stock of Brainsway Ltd. (BWAY) is experiencing significant attention due to high implied volatility in the options market, particularly for the Jan 16, 2026 $12.50 Call option [1] - Implied volatility indicates the market's expectation of future movement, suggesting that investors anticipate a significant price change or an upcoming event that could impact the stock [2] - Brainsway currently holds a Zacks Rank 3 (Hold) in the Medical - Products Industry, which is in the bottom 34% of the Zacks Industry Rank, indicating a relatively weak position in the market [3] Group 2 - Over the past 60 days, two analysts have raised their earnings estimates for Brainsway for the current quarter, while one has lowered theirs, resulting in a net increase in the Zacks Consensus Estimate from three cents to four cents per share [3] - The high implied volatility may present a trading opportunity, as options traders often seek to sell premium on options with elevated implied volatility, aiming to benefit from the decay of options value [4]

Group 1 - Brainsway Ltd. Sponsored ADR (BWAY) shares have increased by 7.1% over the past four weeks, closing at $11.49, with a mean price target of $15.05 indicating a potential upside of 31% [1] - The average price targets range from a low of $14.20 to a high of $16.00, with a standard deviation of $0.74, suggesting a relatively high agreement among analysts regarding the stock's potential movement [2] - Analysts show strong agreement on the company's ability to report better earnings than previously predicted, which supports the expectation of an upside [4][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 1.7% over the last 30 days, with one estimate moving higher and no negative revisions [12] - BWAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential upside [13] - While consensus price targets may not be entirely reliable, the direction they imply appears to be a good guide for potential price movement [14]

Company Overview - Brainsway Ltd. shares (BWAY) experienced a 5.3% increase, closing at $11.49, with notable trading volume compared to typical sessions [1] - The company is expected to report quarterly earnings of $0.04 per share, unchanged from the previous year, with revenues projected at $12.39 million, reflecting a 23.8% increase year-over-year [3] Clinical Trial Results - The recent rise in BWAY shares is linked to positive market sentiment following successful clinical trial results for BrainsWay's accelerated Deep TMS therapy for Major Depressive Disorder (MDD) [2] - The multicenter, randomized study showed statistically significant improvements in depression symptoms, a favorable safety profile, and rapid onset of effect, positioning BrainsWay's technology as a leading non-invasive treatment option for MDD [2] Earnings Estimates and Market Sentiment - The consensus EPS estimate for Brainsway has been revised 10% higher in the last 30 days, indicating a positive trend that typically correlates with price appreciation [4] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook in the market [5] Industry Comparison - Brainsway operates within the Zacks Medical - Products industry, where Boston Scientific (BSX) also competes, having closed 1.1% higher at $102.36, but with a -3.1% return over the past month [5] - Boston Scientific's consensus EPS estimate has increased by 0.1% to $0.72, representing a 16.1% change compared to the previous year [6]

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].