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BrainsWay Ltd. (NASDAQ & TASE: BWAY) is a leading global neurostimulation company headquartered in Jerusalem and the U.S., specializing in advanced noninvasive treatments for mental health disorders. With its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology, BrainsWay has revolutionized the field of brain disorder treatment, offering hope to millions of patients worldwide.
The company's innovative solutions target major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. BrainsWay's Deep TMS is FDA-cleared for its efficacy in treating these conditions. Clinical trials are ongoing for additional indications, including various psychiatric, neurological, and addiction disorders, aiming to expand the reach of this cutting-edge technology.
BrainsWay's treatments are non-invasive, safe, and convenient, typically requiring only brief daily sessions over a few weeks. This approach has already treated over 10,000 patients, delivering significant improvements without long-term side effects. The company leases and sells its Deep TMS systems, generating revenue while expanding its global footprint.
Recent collaborations, such as the partnership with Katie’s Way for providing mental health care to U.S. servicemembers, veterans, and their families, highlight BrainsWay's commitment to addressing critical mental health needs. This partnership underscores the transformative impact of Deep TMS technology in treating depression, particularly within the military community, where mental health issues are on the rise.
BrainsWay has also achieved significant milestones, such as being the first TMS company to receive three FDA-clearances for different indications, backed by pivotal clinical studies. The company's financial health is robust, with a reported 37% year-over-year revenue growth in the first quarter of 2024 and positive net income for consecutive quarters.
Looking ahead, BrainsWay continues to pursue innovations, including a clinical trial comparing accelerated Deep TMS protocols with standard treatments. This trial aims to enhance the convenience and appeal of Deep TMS, potentially broadening its market reach.
For more information about BrainsWay and its latest news, visit the company's website or follow their updates on StockTitan.
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.
BrainsWay Ltd. has appointed Colleen A. Hanlon, Ph.D., a seasoned expert in brain stimulation research, as Vice President of Medical Affairs. Dr. Hanlon, with nearly 20 years of experience, will enhance the integration of medical intelligence for TMS providers and advance patient safety protocols. Previously a professor at Wake Forest University, she has secured over $12 million in NIH funding and published extensively in her field. BrainsWay is a leader in noninvasive neurostimulation treatments, focusing on major depressive disorder, OCD, and addiction.
BrainsWay Ltd. (NASDAQ: BWAY) has launched the Don’t Miss Another Moment sweepstakes to promote the awareness of Deep TMS™ for mental health treatment during Depression Awareness Month. Participants can enter from Oct. 14 to win a $2,000 Airbnb gift card. The campaign targets individuals dealing with mental health disorders, encouraging them to seek help. BrainsWay emphasizes its commitment to advancing neuroscience and supporting those affected by mental illness.
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