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BrainsWay Ltd. reports developments in noninvasive neurostimulation treatments for mental health disorders. The company markets its proprietary Deep TMS platform, with FDA-cleared indications that include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and derives revenue from leases and sales of Deep TMS systems.
Recurring updates include financial results, operating guidance, system placements, reimbursement and payer coverage for TMS therapy, clinical data for Deep TMS protocols such as SWIFT, and additional regulatory clearances. Company news also covers strategic minority-stake and milestone-based investments in mental health providers and related neurostimulation technologies, along with investor conference participation and operational updates across its U.S. and Israel-based business.
BrainsWay Ltd. (NASDAQ: BWAY) announced a publication revealing impressive results from a post-marketing study on its Deep TMS™ treatment for depression. The study, featured in Psychiatry Research, involved 1,351 patients and demonstrated an 82% response rate and a 65% remission rate among those receiving 30 or more treatments. This data underscores the effectiveness of Deep TMS for patients who have previously failed over seven medication trials. With almost 75% of patients achieving remission based on the Hamilton Depression Rating Scale, the findings reinforce BrainsWay's commitment to advancing neurostimulation therapies for mental health disorders amidst a growing global mental health crisis.
BrainsWay Ltd. (NASDAQ: BWAY) announced its fourth quarter and full-year 2022 results, revealing a 29% revenue decline to $6.0 million compared to Q4 2021. For the full year, revenues decreased 8% to $27.2 million, while the net loss widened to $13.3 million.
Despite these challenges, the installed base of Deep TMS™ systems grew 17% to 884 units. The company holds $47.9 million in cash as of year-end 2022. New CEO Hadar Levy aims for revenue growth and breakeven operating income by Q4 2023, bolstered by improved insurance coverage for Deep TMS treatments.
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BrainsWay Ltd. (NASDAQ: BWAY) announced plans to report its Q4 and full-year 2022 financial results on March 15, 2023, prior to U.S. market opening. The company will host a conference call at 8:30 AM ET to discuss these results and provide business updates. BrainsWay specializes in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its Deep TMS technology, which has received FDA clearance for multiple indications including major depressive disorder and obsessive-compulsive disorder. This announcement aims to inform stakeholders and enhance transparency regarding its operational performance.
Burlington, Mass. and Jerusalem, Feb. 23, 2023 - BrainsWay (NASDAQ: BWAY) announced that Dr. Colleen Hanlon received the 2023 International Brain Stimulation Early Career Award at the 5th International Brain Stimulation Conference in Lisbon, Portugal. This recognition highlights her significant contributions to brain stimulation and neuroscience. Dr. Hanlon, who previously served at Wake Forest University, has secured over $12 million in NIH funding and has authored a consensus paper on noninvasive neuromodulation in addiction. BrainsWay continues to lead in noninvasive neurostimulation treatments for mental health, with FDA-approved indications and ongoing clinical trials.
BrainsWay Ltd. has appointed Hadar Levy as the new Chief Executive Officer, succeeding Christopher R. von Jako, who stepped down to pursue other opportunities. Levy, who has been with the company since 2014, served previously as Chief Financial Officer and COO, bringing extensive operational and financial expertise. The transition aims to leverage Levy's experience to capitalize on growth opportunities in the noninvasive neurostimulation market. BrainsWay is recognized for its innovative Deep TMS technology, targeting mental health disorders, including major depression, OCD, and smoking addiction, with FDA-cleared indications.
BrainsWay Ltd. (NASDAQ & TASE: BWAY) has announced a significant leadership change, with Ami Boehm appointed as Chairman of the Board, succeeding co-founder David Zacut, M.D., who will now serve as a Director. Zacut co-founded the company in 2003 and played a crucial role in its development into a leader in noninvasive neurostimulation treatments for mental health disorders. Boehm, a seasoned professional in capital markets, brings extensive experience, having notably served as a partner at FIMI Opportunity Funds. This transition is expected to enhance shareholder value as BrainsWay pursues growth opportunities in its sector.
BrainsWay announced the publication of a comparative study validating the efficacy of its Deep Transcranial Stimulation (Deep TMS™) H1 and H7 coils for treating depression, published in The Journal of Clinical Investigation (JCI) Insight. The study involved 169 patients with treatment-resistant depression and showed that the H7 Coil demonstrated non-inferiority to the H1 Coil. Additionally, preliminary predictors for treatment optimization were identified. Notably, patients with high symptom severity had a 95% response rate with the H1 Coil. These findings emphasize the potential for personalized treatment approaches in mental health.
BrainsWay Ltd. (BWAY) announced that a major private insurance company in Washington state will extend coverage for its Deep Transcranial Magnetic Stimulation (Deep TMS™) for obsessive-compulsive disorder (OCD) starting February 3, 2023. This expansion affects approximately 2.2 million members and reduces the coverage criteria for major depressive disorder (MDD) from four to three failed medication trials. Since 2021, BrainsWay has significantly expanded its coverage, now reaching 90.5 million lives for OCD treatment, a substantial increase from 52.6 million.
BrainsWay Ltd. (NASDAQ: BWAY) announced the settlement of litigation with Neuronetics, Inc. in the District of Delaware. The settlement terms remain confidential, and BrainsWay did not admit liability. CEO Christopher von Jako emphasized the company's focus on advancing its Deep TMS™ therapy for patients. BrainsWay is recognized for its innovative neurostimulation treatments for various mental health disorders, holding three FDA clearances for its technology. The company remains committed to expanding the use of Deep TMS and conducting further clinical trials.