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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.
BURLINGTON, Mass. and JERUSALEM, Oct. 11, 2022 – BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation treatments, announced a collaboration with NOCD, which specializes in online therapy for obsessive-compulsive disorder (OCD). This partnership aims to enhance awareness and access to effective OCD treatment options. BrainsWay's Deep TMS, FDA-cleared for OCD, will be emphasized alongside NOCD's extensive telehealth platform, ensuring that patients can find suitable treatments more easily. Recently, Cigna expanded coverage for Deep TMS, increasing access for over 86 million adults.
BrainsWay Ltd. (NASDAQ: BWAY) announced President and CEO Christopher von Jako has been named honorary cochair of NAMIWalks Silicon Valley, an event aimed at raising mental health awareness, occurring on October 1, 2022. Dr. von Jako emphasized the importance of community engagement in mental health issues. NAMI Santa Clara County highlighted the walk as a major fundraiser after two challenging years for mental health. BrainsWay, a leader in noninvasive treatments for brain disorders, is committed to increasing access to mental health care through its innovative Deep TMS technology.
BrainsWay Ltd. (NASDAQ: BWAY) announced that Cigna has issued a favorable policy for Deep Transcranial Magnetic Stimulation (TMS) to treat medication-resistant obsessive-compulsive disorder (OCD), effective September 15, 2022. This policy provides access to Deep TMS for patients aged 18 and older after failing multiple medication trials. With Cigna's endorsement, over 86 million adults can now access this innovative treatment. BrainsWay aims to improve healthcare for OCD patients, highlighting that nearly 50% of those with OCD are treatment-resistant.
BrainsWay, a leader in advanced non-invasive treatments for brain disorders, announced that CEO Christopher von Jako will participate in a virtual fireside chat at the H.C. Wainwright Annual Global Investment Conference on September 12, 2022. The event will take place at the Lotte Palace Hotel in New York City. The fireside chat is scheduled for 7:00 a.m. ET. BrainsWay is known for its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology, which is FDA cleared for major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
BrainsWay Ltd. has received FDA 510(k) clearance for its Deep TMS™ H7 Coil, marking the company’s 9th FDA approval. This new clearance allows treatment of adults with major depressive disorder and anxious depression, enhancing options for treatment-resistant patients. A multicenter trial with 144 subjects demonstrated the H7 Coil’s efficacy similar to the existing H1 Coil. This advancement solidifies BrainsWay's commitment to personalized medicine and expands its non-pharmaceutical treatment arsenal.
BrainsWay Ltd. (NASDAQ: BWAY) reported a 14% revenue increase in Q2 2022, totaling $8.0 million, marking its eighth consecutive quarter of growth. The installed base for Deep TMS™ systems rose 22% year-over-year to 829 units. Reimbursement progress included a positive coverage policy from Highmark BCBS for OCD treatment, enhancing eligibility to nearly 70 million lives. However, gross margin decreased to 73% from 81% due to inventory costs and increased international sales. Operating loss widened to $2.0 million compared to $1.5 million in the prior year.
Burlington, Mass. and Jerusalem, July 27, 2022 - BrainsWay Ltd. (BWAY) will report its second quarter financial results before U.S. markets open on August 10, 2022. A conference call will follow at 8:30 AM ET to discuss these results and update on business operations. BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, with FDA-cleared indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. For further details and to access the call, visit their official website.
BrainsWay Ltd. (NASDAQ: BWAY) has achieved a significant milestone with the Israeli Ministry of Health approving its Deep TMS™ treatment for depression, now included in Israel's health basket of essential medical services. This means qualifying patients over 21, who have not responded to prior antidepressants, can receive up to 40 sessions free of charge. Dr. Christopher von Jako emphasized the importance of access to this Israeli innovation, as the company aims to expand insurance coverage globally, focusing on improving mental health treatment accessibility.
BrainsWay Ltd. announces positive coverage from Highmark BCBS for its Deep TMS™ treatment of obsessive-compulsive disorder (OCD), effective May 2, 2022. This coverage benefits 6.8 million members across New York, Pennsylvania, West Virginia, and Delaware. With existing coverage from Health Care Service Corporation, nearly 70 million lives are now eligible for Deep TMS OCD treatment. BrainsWay remains the only TMS company with FDA clearance for OCD, backed by positive clinical data. The firm aims to enhance reimbursement for Deep TMS through continued engagement with major payors.
BrainsWay Ltd. (NASDAQ: BWAY) reported a 30% year-over-year revenue growth in Q1 2022, achieving total revenues of $8.0 million, up from $6.1 million in Q1 2021. The company's gross margin improved to 77%, while operating expenses increased to $7.6 million, leading to an operating loss of $1.5 million. Despite operational challenges due to the Omicron surge, the firm saw a 21% increase in its Deep TMS installed base, totaling 790 systems as of March 31, 2022. Leadership changes were also made to support long-term growth.
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