BrainsWay Receives FDA Clearance for Accelerated Deep TMS Protocol for Non-Invasive Treatment of Major Depressive Disorder (MDD)
BrainsWay (NASDAQ: BWAY) has received FDA clearance for an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) protocol to treat Major Depressive Disorder (MDD). The new protocol significantly reduces treatment time from 4 weeks to just 6 days in the acute phase.
The clearance is based on a multicenter clinical study showing the accelerated protocol achieved comparable results to the standard treatment. Key outcomes include depression score reductions of 19.02 points for accelerated treatment versus 19.79 for standard protocol, with response and remission rates of 87.8% and 78.0% respectively.
The accelerated protocol features 5 sessions per day over 6 days, followed by twice-weekly sessions for 4 weeks. Each session now takes under 10 minutes, compared to 20 minutes in the standard protocol. Notably, the median time to remission decreased to 21 days from 28 days with the standard treatment.
BrainsWay (NASDAQ: BWAY) ha ottenuto l'approvazione FDA per un protocollo accelerato di Stimolazione Magnetica Transcranica Profonda (Deep TMS) per trattare il Disturbo Depressivo Maggiore (MDD). Il nuovo protocollo riduce significativamente il tempo di trattamento da 4 settimane a solo 6 giorni nella fase acuta.
L'approvazione si basa su uno studio multicentrico che ha mostrato che il protocollo accelerato ha raggiunto risultati comparabili al trattamento standard. Gli esiti chiave includono riduzioni del punteggio di depressione di 19,02 punti per il trattamento accelerato rispetto a 19,79 per il protocollo standard, con tassi di risposta e remissione dell'87,8% e del 78,0% rispettivamente.
Il protocollo accelerato prevede 5 sessioni al giorno per 6 giorni, seguite da sessioni due volte al giorno per 4 settimane. Ogni sessione dura ora meno di 10 minuti, rispetto ai 20 minuti del protocollo standard. In particolare, la mediana del tempo alla remissione è scesa a 21 giorni rispetto a 28 giorni con il trattamento standard.
BrainsWay (NASDAQ: BWAY) ha recibido la aprobación de la FDA para un protocolo acelerado de estimulación magnética transcraneal profunda (Deep TMS) para tratar el trastorno depresivo mayor (MDD). El nuevo protocolo reduce significativamente el tiempo de tratamiento de 4 semanas a solo 6 días en la fase aguda.
La aprobación se basa en un estudio clínico multicéntrico que mostró que el protocolo acelerado logró resultados comparables al tratamiento estándar. Los resultados clave incluyen reducciones de la puntuación de depresión de 19,02 puntos para el tratamiento acelerado frente a 19,79 para el protocolo estándar, con tasas de respuesta y remisión del 87,8% y 78,0% respectivamente.
El protocolo acelerado consta de 5 sesiones al día durante 6 días, seguidas de sesiones dos veces por semana durante 4 semanas. Cada sesión dura ahora menos de 10 minutos, en comparación con 20 minutos en el protocolo estándar. En particular, la mediana del tiempo hasta la remisión se redujo a 21 días desde 28 días con el tratamiento estándar.
BrainsWay(NASDAQ: BWAY)가 주요 우울 장애(MDD) 치료를 위한 경량 심층 경두경(Deep TMS) 프로토콜에 대해 FDA 승인을 받았습니다. 새로운 프로토콜은 급성기에 치료 기간을 4주에서 단 6일로 크게 단축합니다.
승인은 다기관 임상 연구를 기반으로 하며, 가속화 프로토콜이 표준 치료와 유사한 결과를 달성했다는 것을 보여줍니다. 주요 결과로는 가속화 치료의 우울 점수 감소가 19.02점, 표준 프로토콜은 19.79점, 반응 및 관해율이 각각 87.8% 및 78.0%입니다.
가속화 프로토콜은 6일 동안 하루에 5회 세션을 거친 뒤 4주 동안 주 2회 세션을 진행합니다. 각 세션은 이제 표준 프로토콜의 20분에서 10분 미만으로 단축됩니다. 특히 관해까지의 중앙값 시간이 21일로 감소했습니다.
BrainsWay (NASDAQ: BWAY) a obtenu l'autorisation de la FDA pour un protocole accéléré de stimulation magnétique transcrânienne profonde (Deep TMS) afin de traiter le trouble dépressif majeur (MDD). Le nouveau protocole réduit considérablement la durée du traitement, passant de 4 semaines à seulement 6 jours dans la phase aiguë.
L'autorisation repose sur une étude clinique multicentrique montrant que le protocole accéléré donnait des résultats comparables au traitement standard. Les résultats clés incluent une réduction du score de dépression de 19,02 points pour le traitement accéléré comparé à 19,79 points pour le protocole standard, avec des taux de réponse et de rémission de 87,8 % et 78,0 % respectivement.
Le protocole accéléré prévoit 5 séances par jour pendant 6 jours, suivies de séances deux fois par semaine pendant 4 semaines. Chaque séance dure désormais moins de 10 minutes, contre 20 minutes pour le protocole standard. Notamment, la médiane du temps jusqu'à la rémission est passée à 21 jours.
BrainsWay (NASDAQ: BWAY) hat die FDA-Zulassung für ein beschleunigtes Deep-Transcranial Magnetic Stimulation (Deep TMS) Protokoll zur Behandlung der Major Depressive Disorder (MDD) erhalten. Das neue Protokoll verkürzt die Behandlungszeit in der akuten Phase deutlich von 4 Wochen auf nur 6 Tage.
Die Zulassung basiert auf einer multizentrischen klinischen Studie, die zeigte, dass das beschleunigte Protokoll vergleichbare Ergebnisse wie die Standardbehandlung erzielte. Zu den wichtigsten Ergebnissen gehören Depression-Score-Reduktionen um 19,02 Punkte für die beschleunigte Behandlung gegenüber 19,79 Punkten für das Standardprotokoll, mit Reaktions- und Remissionsraten von 87,8% und 78,0%.
Das beschleunigte Protokoll umfasst 5 Sitzungen pro Tag über 6 Tage, gefolgt von zweimal wöchentlichen Sitzungen über 4 Wochen. Jede Sitzung dauert nun weniger als 10 Minuten, verglichen mit 20 Minuten im Standardprotokoll. Bemerkenswert ist, dass die Medianzeit bis zur Remission auf 21 Tage gesunken ist.
براينزواي (ناسداك: BWAY) حصلت على موافقة إدارة الغذاء والدواء الأمريكية لبروتوكول محسن من التحفيز المغناطيسي العميق فوق الجمجمة (Deep TMS) لعلاج الاضطراب الاكتئابي الشديد (MDD). البروتوكول الجديد يقلل بشكل كبير من وقت العلاج من 4 أسابيع إلى 6 أيام فقط في المرحلة الحادّة.
تعتمد الموافقة على دراسة سريرية متعددة المراكز أظهرت أن البروتوكول المعجّل حقق نتائج مكافئة لعلاج القياسي. النتائج الرئيسية تشمل تقليل درجات الاكتئاب بمقدار 19.02 نقطة للعلاج المعجّل مقابل 19.79 للنظام القياسي، مع معدلات الاستجابة والشفاء بنسبة 87.8% و78.0% على التوالي.
يتألف البروتوكول المعجّل من 5 جلسات يومياً خلال 6 أيام، تليها جلسات مرتين أسبوعياً لمدة 4 أسابيع. كل جلسة الآن تستغرق أقل من 10 دقائق، مقارنة بـ20 دقيقة في البروتوكول القياسي. بشكل خاص، تقلصت الوسيط الزمني للوصول إلى الشفاء إلى 21 يوماً.
BrainsWay（纳斯达克股票代码：BWAY） 已获得FDA批准，用于治疗重度抑郁障碍（MDD）的快速深部经颅磁刺激（Deep TMS）治疗方案。新方案将急性期治疗时间从4周显著缩短至仅6天。
该批准基于多中心临床研究，显示加速方案的疗效可与标准治疗相当。关键结果包括加速治疗抑郁评分下降19.02分，而标准方案为19.79分，反应率和缓解率分别为87.8%和78.0%。
加速方案为6天内每天5次治疗，之后4周每周2次治疗。每次治疗现在少于10分钟，而标准方案为20分钟。值得注意的是，缓解的中位时间从标准治疗的28天降至21天。
- None.
- Current reimbursement limited to two treatments per day, requiring updates for new protocol
- Healthcare provider training needed before implementation
- Treatment adoption dependent on reimbursement updates
Insights
FDA clearance of BrainsWay's accelerated Deep TMS protocol significantly reduces treatment time while maintaining efficacy for depression patients.
The FDA clearance for BrainsWay's accelerated Deep TMS protocol represents a significant advancement in non-invasive depression treatment. The new protocol dramatically reduces the treatment timeline from 4 weeks of daily sessions to just 6 treatment days in the acute phase, while maintaining comparable clinical outcomes. The clinical data demonstrates equivalent efficacy with the accelerated protocol showing depression score reductions of 19.02 points versus 19.79 points with standard treatment, and impressive response and remission rates of 87.8% and 78.0% respectively.
What's particularly noteworthy is the median time to remission of 21 days for accelerated treatment versus 28 days for standard protocol, representing a potential 25% reduction in time to clinical benefit. Additionally, each accelerated session lasts under 10 minutes compared to 20 minutes for standard sessions, further reducing the treatment burden. This protocol efficiency could significantly improve clinical workflow, allowing treatment centers to help more patients within the same operational capacity.
The accelerated protocol's safety profile showing no severe adverse events is equally important for clinical adoption. However, the company faces implementation challenges, including the need for provider training and securing updated reimbursement approvals, as current coverage allows only two treatments per day while the new protocol requires five daily sessions during the acute phase. The successful navigation of these reimbursement hurdles will be crucial for full commercial realization of this innovation.
This FDA clearance for BrainsWay's accelerated Deep TMS protocol introduces a reimbursement challenge that warrants close attention. The company explicitly acknowledges that "current reimbursement for Deep TMS therapy only allows for up to two treatments per day," while the newly cleared protocol requires five sessions per day during the acute treatment phase. This creates a significant temporary barrier to commercialization until payer policies can be updated.
The clinical data showing comparable efficacy with fewer total clinic visits provides a strong economic argument for payers. The accelerated protocol could potentially reduce the total treatment burden and associated costs (fewer clinic visits, less provider time, faster return to productivity for patients). From a health economics perspective, the accelerated protocol requiring 6 treatment days versus 28 days of standard treatment represents significant efficiency gains that should appeal to payers focused on value-based care.
The company will likely need to engage in negotiations with Medicare, Medicaid, and commercial payers to update coverage policies. The process of securing updated reimbursement approvals typically takes 3-6 months following FDA clearance for novel treatment protocols. Until those reimbursement updates are secured, adoption will likely be limited to cash-pay patients or those with flexible insurance benefits. This creates a temporary commercialization hurdle that investors should monitor in upcoming quarterly results.
Clinical data shows that BrainsWay’s new accelerated stimulation protocol is comparable to standard Deep TMS in depression score improvement, response and remission
The accelerated protocol is now commercially available in the United States, expanding patient and provider access
BURLINGTON, Mass. and JERUSALEM, Sept. 16, 2025 (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 U.S. Food and Drug Administration (FDA) has granted an expansion of the cleared treatment protocols for the Company’s Deep Transcranial Magnetic Stimulation system (Deep TMS™) to include an accelerated protocol for the treatment of patients with major depressive disorder (MDD) including those with comorbid anxiety symptoms.
“We are excited to announce this important FDA clearance of an accelerated treatment protocol for our Deep TMS system, which we are confident will empower providers to treat more patients,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “More than just another clearance, this marks a pivotal advancement in the treatment of depression with Deep TMS because it expands the ways in which we can use Deep TMS to treat depression. While previously, treatment involved 4 weeks of daily treatment sessions before follow up visits, this newly cleared accelerated protocol includes an acute phase of just 6 treatment days.”
“As we look toward introducing the accelerated protocol to patients, we will be providing training to healthcare providers over the coming months. In addition, we are actively seeking updates to reimbursement to match the new accelerated protocol, which will help with patient adoption. As a reminder, the current reimbursement for Deep TMS therapy only allows for up to two treatments per day,” continued Mr. Levy.
The expanded clearance protocol was based on clinical data from a multicenter, randomized, blinded, controlled study titled, “Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial,” showing that the accelerated Deep TMS protocol using iTBS to treat patients with MDD resulted in outcomes that were comparable to the standard protocol - while requiring considerably fewer visits to the clinic. For example, HDRS-21 depression scores, after statistical adjustment, were reduced by 19.02 and 19.79 points in the accelerated and standard Deep TMS groups, respectively; and response and remission rates were
The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from MDD and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. MDD is a leading cause of disability globally, with millions of people affected. The situation is especially dire for those patients who fail to respond to traditional treatments, facing prolonged suffering, higher healthcare costs, and a heightened risk of comorbid conditions such as substance abuse and suicide. Despite the global impact of MDD, there is a critical gap in accessible, effective therapies, particularly for these patients.
About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “targets,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. While the clinical study described in this release found a higher incidence of certain adverse events such as headaches and application site discomfort/pain in the accelerated group when compared to the standard of care group, none of these events was classified as severe, and they were comparable to previous TMS clinical studies. In addition, historical results or conclusions from scientific research and clinical studies – especially preliminary data which remains subject to peer-review – do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com
Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
FAQ
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