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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. 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.
BrainsWay Ltd. (NASDAQ: BWAY) announced that independent Director Yossi Ben Shalom purchased 147,500 ADRs, totaling $277,300, at an average price of $1.88 each. This investment underscores his confidence in BrainsWay's strategic vision and its Deep TMS technology, which has proven effective in treating multiple mental health disorders. Other board members have also made similar open market purchases, reflecting a collective bullish outlook. BrainsWay continues to expand its research and clinical trials to enhance its market position in non-invasive neurostimulation treatments.
BURLINGTON, Mass. and JERUSALEM, Nov. 28, 2022 – BrainsWay Ltd. (NASDAQ: BWAY) reported significant open market stock purchases by its Chairman, Dr. David Zacut, and independent Director, Avner Hagai. Dr. Zacut acquired 431,797 shares for 1,607,676 NIS (approximately 3.72 NIS per share), increasing his stake to 6.71%. Mr. Hagai purchased 403,312 shares for 1,581,048 NIS (approximately 3.92 NIS per share), raising his ownership to 6.49%. Both purchases reflect confidence in the company's growth prospects and favorable industry trends.
BrainsWay (BWAY) reported a 36% revenue decline in Q3 2022, with total revenues of $5.2 million versus $8.1 million in Q3 2021. The company reported a gross margin of 74%, down from 76% the previous year, attributed to rising shipping costs and inventory obsolescence. Operating expenses increased to $8.7 million, leading to an operating loss of $4.9 million compared to a $1.2 million loss in 2021. Despite challenges, BrainsWay acknowledged positive reimbursement developments and a strong balance sheet, with cash reserves of $49.6 million.
BrainsWay Ltd. (NASDAQ: BWAY) announced that Premera Blue Cross will extend coverage for Deep TMS therapy for OCD starting February 3, 2023. This addition will benefit over 2.6 million members in the Pacific Northwest, increasing access to mental health treatments. With this announcement, the total number of insured lives for Deep TMS rises to approximately 90 million. The policy change for major depressive disorder (MDD) requires only three medication trials instead of four, reflecting evolving trends in mental health coverage.
BrainsWay Ltd. (NASDAQ: BWAY) will release its third quarter financial results and operational highlights on November 16, 2022, before U.S. market opening. A conference call scheduled for 8:30 AM ET will provide insights into the company’s performance and updates on business operations. BrainsWay specializes in noninvasive neurostimulation treatments for mental health disorders, with FDA-cleared technologies to treat major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The call will be accessible via dial-in and webcast.