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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, Aug. 30, 2021 – BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation for mental health, will have its CEO, Christopher von Jako, present and hold investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. The company is recognized for its Deep TMS™ technology, with three FDA-clearances for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. With ongoing clinical trials, BrainsWay aims to expand global access to its innovative treatments.
BrainsWay Ltd. announced on August 18, 2021, that it received 510(k) clearance from the FDA for its Deep Transcranial Magnetic Stimulation (Deep TMS™) System. This allows BrainsWay to market its system for reducing anxiety symptoms in adults with depression, enhancing its existing depression indication. The company presented data from 573 patients across 11 studies, showing clinically meaningful treatment effects. This clearance broadens its reach in the mental health market, potentially impacting millions suffering from anxious depression, as 60-90% of depressed patients exhibit anxiety symptoms.
BrainsWay Ltd. reported a strong Q2 2021 performance, achieving total revenues of $7.0 million, a 45% increase year-over-year. The installed base of Deep TMS™ systems rose to 682, marking a 20% growth. The company is gaining traction in OCD reimbursement, with key coverage policies from Centene and HCSC impacting 42 million covered lives. Operating loss was $1.5 million, up from $215 thousand in Q2 2020, while cash reserves increased to $55.9 million.
BrainsWay Ltd. (NASDAQ: BWAY) announced it will report its second quarter 2021 financial results and operational highlights on August 11, 2021, before U.S. markets open. A conference call will follow at 8:30 AM ET to discuss these results and business updates. BrainsWay is recognized for its advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology. The company has achieved FDA clearance for three indications, including major depressive disorder, and continues expanding clinical trials for additional disorders.
On July 13, 2021, MindPath Care Centers announced an open house on July 15 to showcase BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) treatment for major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) in Charlotte, NC. The event will allow local mental health clinicians to witness live demonstrations of the Deep TMS device, which administers magnetic waves via a helmet. It is FDA-cleared for MDD since 2013 and OCD since 2018. Patients can return to normal activities post-treatment, enhancing access to care for those with treatment-resistant conditions.
BrainsWay Ltd. (NASDAQ: BWAY) announced that Christopher von Jako, Ph.D., President and CEO, will present at the Ladenburg Thalmann 2021 Healthcare Conference on July 14, 2021, at 2:30 PM ET. The company will also facilitate one-on-one investor meetings during the conference. BrainsWay specializes in advanced noninvasive neurostimulation treatments for mental health disorders and is recognized for its FDA-cleared indications including major depressive disorder and obsessive-compulsive disorder.
BrainsWay (NASDAQ: BWAY), a leader in noninvasive neurostimulation, announced CEO Christopher von Jako will present at the Raymond James Human Health Innovation Conference on June 21, 2021, at 10:00 AM ET. The event will include one-on-one investor meetings. BrainsWay is recognized for its proprietary Deep TMS technology, with FDA clearance for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company aims to expand awareness and access to its innovative treatments, leveraging clinical evidence to advance mental health care.
BrainsWay (NASDAQ: BWAY) announced participation in two significant global medical conferences: the Clinical TMS Society Annual Meeting from June 10-12 and the Psych Congress Elevate from June 11-13, 2021. At the Clinical TMS Society event, BrainsWay will present seven posters showcasing the benefits of Deep TMS™ for mental health disorders, along with two showcase presentations. Dr. David Feifel will present at the Psych Congress discussing evidence for Deep TMS in OCD and smoking cessation. The company is focused on advancing innovative treatments for mental health issues.
BrainsWay Ltd. (NASDAQ: BWAY) announced a positive coverage policy from Health Care Service Corporation (HCSC) for its Deep TMS™ system, effective June 15, 2021, for treating obsessive-compulsive disorder (OCD). HCSC, covering approximately 17 million members, is a significant health insurer in the U.S. This coverage marks a milestone for BrainsWay, following other recent coverage announcements for OCD. The company aims to expand positive coverage from additional systems. OCD affects 2.3% of the U.S. population, resulting in a healthcare burden exceeding $7 billion annually.
BrainsWay Ltd. announced the publication of a draft Local Coverage Determination (LCD) by Palmetto GBA for its Deep TMS™ system, aimed at treating obsessive-compulsive disorder (OCD). This coverage proposal affects over 9 million Medicare patients across seven states. BrainsWay's management expressed optimism about improved access to treatment for patients unresponsive to standard therapies. The draft LCD aligns with clinical guidelines and follows a recent positive coverage decision from Centene. A formal meeting for public comments will take place before a final policy is issued.
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