BrainsWay Reports Promising Feasibility Data Showing Pain Reduction with Deep TMS Therapy
BrainsWay (NASDAQ & TASE: BWAY) announced positive feasibility clinical data for their Deep TMS™ therapy in treating peripheral neuropathic pain. The double-blind, randomized crossover trial involved 17 patients who received either active Deep TMS or sham treatment for five days, followed by a nine-week washout period before switching treatments. Results demonstrated significant reduction in usual pain intensity compared to sham treatment, along with improvements in comorbid anxiety and depression symptoms. The study was published in the Neuromodulation journal, though Deep TMS is not currently FDA-cleared for neuropathic pain treatment.
BrainsWay (NASDAQ & TASE: BWAY) ha annunciato dati clinici positivi sulla fattibilità per la loro terapia Deep TMS™ nel trattamento del dolore neuropatico periferico. Lo studio, in doppio cieco e randomized crossover, ha coinvolto 17 pazienti che hanno ricevuto per cinque giorni o la terapia attiva Deep TMS o un trattamento simulato, seguito da un periodo di washout di nove settimane prima di passare ai trattamenti inversi. I risultati hanno dimostrato una significativa riduzione dell'intensità del dolore abituale rispetto al trattamento simulato, insieme a miglioramenti nei sintomi di ansia e depressione comorbidi. Lo studio è stato pubblicato sulla rivista Neuromodulation, anche se attualmente il Deep TMS non è approvato dalla FDA per il trattamento del dolore neuropatico.
BrainsWay (NASDAQ & TASE: BWAY) anunció datos clínicos positivos de viabilidad para su terapia Deep TMS™ en el tratamiento del dolor neuropático periférico. El estudio, aleatorizado y doble ciego, involucró a 17 pacientes que recibieron o la terapia activa Deep TMS o un tratamiento simulado durante cinco días, seguido de un período de lavado de nueve semanas antes de cambiar de tratamiento. Los resultados demostraron una reducción significativa en la intensidad del dolor habitual en comparación con el tratamiento simulado, junto con mejoras en los síntomas comórbidos de ansiedad y depresión. El estudio fue publicado en la revista Neuromodulation, aunque actualmente el Deep TMS no tiene aprobación de la FDA para el tratamiento del dolor neuropático.
BrainsWay (NASDAQ & TASE: BWAY)는 말초신경병성 통증 치료를 위한 Deep TMS™ 요법의 긍정적인 유효성 임상 데이터를 발표했습니다. 이 이중 맹검, 무작위 교차 시험은 17명의 환자가 5일 동안 활성 Deep TMS 또는 가짜 치료를 받았고, 그 후 치료를 바꾸기 전에 9주간의 세척 기간을 거쳤습니다. 결과는 가짜 치료에 비해 일반적인 통증 강도가 유의미하게 감소함을 보여주었고, 동반된 불안 및 우울증 증상에서도 개선이 있었습니다. 이 연구는 Neuromodulation 저널에 발표되었으나, Deep TMS는 현재 신경병성 통증 치료에 대해 FDA 승인을 받지 않았습니다.
BrainsWay (NASDAQ & TASE: BWAY) a annoncé des données cliniques positives en matière de faisabilité pour sa thérapie Deep TMS™ dans le traitement de la douleur neuropathique périphérique. L'essai en double aveugle, randomisé et croisé a impliqué 17 patients qui ont reçu soit une thérapie active Deep TMS, soit un traitement placebo pendant cinq jours, suivi d'une période de lavage de neuf semaines avant de passer aux traitements inverses. Les résultats ont démontré une réduction significative de l'intensité de la douleur habituelle par rapport au traitement placebo, ainsi que des améliorations des symptômes d'anxiété et de dépression comorbides. L'étude a été publiée dans la revue Neuromodulation, bien que le Deep TMS ne soit actuellement pas approuvé par la FDA pour le traitement de la douleur neuropathique.
BrainsWay (NASDAQ & TASE: BWAY) gab bekannt, dass positive Machbarkeitsdaten aus klinischen Studien für ihre Deep TMS™-Therapie zur Behandlung von peripheren neuropathischen Schmerzen vorliegen. Die doppelblinde, randomisierte Kreuzstudie umfasste 17 Patienten, die entweder aktive Deep TMS oder eine Scheinbehandlung über fünf Tage erhielten, gefolgt von einer neunwöchigen Washout-Periode, bevor sie die Behandlungen wechselten. Die Ergebnisse zeigten eine signifikante Reduzierung der gewohnten Schmerzintensität im Vergleich zur Scheinbehandlung sowie Verbesserungen der komorbiden Angst- und Depressionssymptome. Die Studie wurde in der Zeitschrift Neuromodulation veröffentlicht, obwohl Deep TMS derzeit nicht von der FDA für die Behandlung von neuropathischen Schmerzen zugelassen ist.
- Positive clinical trial results showing significant pain reduction compared to sham treatment
- Additional benefits observed in treating comorbid anxiety and depression symptoms
- Study results published in peer-reviewed journal Neuromodulation
- Product not FDA-cleared for neuropathic pain treatment
- Small study size of only 17 patients
- Additional research needed to confirm results
Insights
This feasibility study demonstrates promising early-stage results for BrainsWay's Deep TMS technology in treating peripheral neuropathic pain. The double-blind, randomized crossover design with 17 patients provides initial scientific validity, though the sample size is relatively small. The dual benefits observed - pain reduction and improvement in anxiety/depression symptoms - could potentially address a significant unmet medical need in chronic pain management.
However, several key considerations temper the immediate impact: 1) This is early-stage data requiring larger confirmatory trials 2) The treatment is not FDA-approved for pain indications 3) The 5-day treatment period is relatively short for chronic pain evaluation.
While the results are scientifically interesting, the commercial implications remain distant given the early stage and regulatory requirements ahead. The market opportunity in neuropathic pain is substantial, but significant development work remains before potential commercialization.
Reductions also seen in comorbid anxiety and depression symptoms
BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 20, 2024 (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 the publication of positive feasibility clinical data evaluating the analgesic effects of deep transcranial magnetic stimulation (Deep TMS™) in patients with peripheral neuropathic pain. The results were published in the Neuromodulation journal, in a peer-reviewed article entitled, “H-Coil Repetitive Transcranial Magnetic Stimulation Relieves Pain and Symptoms of Anxiety and Depression in Patients with Chronic Peripheral Neuropathic Pain: A Randomized Sham-Controlled Crossover Study.”
The double-blind, randomized crossover trial included seventeen (17) patients with chronic neuropathic pain. Participants were assigned to either an active Deep TMS or sham treatment arm for a five-day period, followed by a nine-week washout, before crossing over to the other arm. The study’s primary outcome measure was a comparison between the patterns of the active and sham groups’ self-reported changes in pain levels from baseline. Secondary outcomes included changes in pain ratings at specific time points in the two arms, as well as changes in comorbid symptoms experienced by the patients, including, for example, anxiety and depression.
Results showed that Active deep-TMS therapy significantly reduced "usual pain intensity" in patients with chronic peripheral neuropathic pain compared to sham treatment and improved symptoms of anxiety and depression in the same patient population.
“We are excited to announce the results from this double-blind crossover study of Deep TMS therapy revealing that five active Deep TMS sessions induced significantly stronger analgesic effects compared with sham stimulation over the course of the treatment, as well as statistically significant reductions in anxiety and depression symptoms,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “The results of this study, which we hope to further explore with additional research, are the most recent dataset in a growing portfolio of clinical evidence on the potential efficacy of Deep TMS in treating multiple brain-related indications.”
BrainsWay Deep TMS is not currently cleared by the FDA for the safe or effective treatment of neuropathic pain. Additional outcomes from research conducted on these and other neuropathic pain patients were recently published, lending additional support to the findings of this study on the potential benefits of Deep TMS.
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 offices in Burlington, MA and Jerusalem, 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,” “believes,” “hopes,” “potential” or similar words. 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. In addition, historical results or conclusions from scientific research and clinical studies 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: 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.
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Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com
Investors:
Brian Ritchie
LifeSci Advisors LLC
britchie@lifesciadvisors.com
FAQ
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