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About BrainsWay Ltd. (BWAY)
BrainsWay Ltd. is a global leader in the field of non-invasive neurostimulation, dedicated to advancing mental health care through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology. With headquarters in Jerusalem, Israel, and Burlington, Massachusetts, BrainsWay leverages cutting-edge neuroscience to provide innovative solutions for psychiatric, neurological, and addiction disorders. The company's mission is to improve health and transform lives by offering safe, effective, and clinically validated treatments for conditions that have historically been challenging to manage.
Core Technology and FDA-Cleared Indications
BrainsWay’s Deep TMS platform utilizes a patented coil design to deliver targeted magnetic pulses to specific brain regions involved in mental health disorders. This technology is the first and only TMS system to receive FDA clearance for three distinct indications: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and smoking addiction. The system has also demonstrated efficacy in reducing anxiety symptoms associated with depression, commonly referred to as anxious depression.
Unlike traditional TMS, which offers more superficial stimulation, Deep TMS is designed to penetrate deeper and broader brain regions, making it particularly effective for patients who may not respond to other treatments. The therapy is non-invasive, requires no anesthesia, and is free from systemic side effects, making it a highly convenient option for patients. Treatment protocols typically involve brief daily sessions over several weeks, followed by maintenance phases as needed.
Business Model and Revenue Streams
BrainsWay generates revenue through the sale and leasing of its Deep TMS systems to mental health care providers, hospitals, and clinics worldwide. Additionally, the company benefits from recurring revenue streams through the sale of consumables and maintenance services associated with its systems. This hybrid model ensures both upfront and long-term revenue generation, supporting the company’s growth and operational sustainability.
Clinical Efficacy and Ongoing Research
BrainsWay’s commitment to advancing mental health care is underscored by its robust clinical research program. The company has conducted numerous clinical trials demonstrating the efficacy of Deep TMS in treating a wide range of conditions, including MDD, OCD, and smoking addiction. Recent studies have also explored its potential applications in late-life depression, Parkinson’s disease, and substance use disorders such as alcohol addiction. These efforts aim to expand the indications for Deep TMS, further solidifying its position as a transformative treatment option in mental health care.
Market Context and Competitive Landscape
The global mental health crisis, exacerbated by rising rates of depression, anxiety, and addiction, has created a significant demand for effective, non-invasive treatment options. BrainsWay addresses this unmet need by offering a scientifically validated alternative to traditional pharmacological therapies, which often come with limited efficacy and adverse side effects. Within the competitive landscape, BrainsWay differentiates itself through its patented Deep TMS technology, extensive clinical evidence, and global reach. The company’s focus on underserved populations, such as older adults and veterans, further enhances its market appeal.
Global Reach and Strategic Partnerships
BrainsWay’s international presence spans North America, Europe, South America, and the Middle East, reflecting its commitment to increasing global access to advanced mental health care. The company has established strategic partnerships with mental health networks, hospitals, and specialized care providers, enabling it to expand the reach of its Deep TMS systems. Notable collaborations include initiatives to address the unique mental health challenges faced by veterans and military personnel, as well as efforts to make treatment accessible in underserved regions.
Future Outlook
With ongoing clinical trials, a growing portfolio of FDA-cleared indications, and a strong commitment to innovation, BrainsWay is well-positioned to lead the neurostimulation market. The company’s focus on addressing critical mental health challenges, combined with its scalable business model and global footprint, underscores its potential to transform the landscape of mental health care.
Conclusion
BrainsWay Ltd. represents a unique convergence of advanced neuroscience, innovative technology, and a mission-driven approach to improving mental health. By offering safe, effective, and non-invasive treatment options, the company is redefining the standard of care for mental health disorders and paving the way for a healthier future.
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.
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.
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