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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 Ltd. (NASDAQ: BWAY) has announced that Christopher von Jako, CEO, will present at the Oppenheimer 31st Annual Healthcare Conference from March 16-18, 2021. The presentation is scheduled for 10:00 AM ET on March 16, 2021. Investors can also participate in one-on-one meetings during the event. BrainsWay specializes in non-invasive neurostimulation products, having received FDA marketing authorization for treatments targeting major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
BrainsWay Ltd. (NASDAQ: BWAY) has successfully closed its underwritten public offering of 5,315,300 American Depositary Shares (ADSs), including 693,300 ADSs from underwriters’ full exercise of their option to purchase additional ADSs, priced at $8.50 per ADS. The offering generated approximately $45.2 million in gross proceeds. Oppenheimer & Co. Inc. led the offering, with Ladenburg Thalmann and Northland Capital Markets as co-managers. The funds will aid in expanding BrainsWay's non-invasive neurostimulation products aimed at treating various brain disorders.
BrainsWay Ltd. (NASDAQ: BWAY) announced a public offering of 4,622,000 American Depositary Shares at $8.50 each, aiming to raise about $39.3 million. The share offering includes a 30-day option for underwriters to purchase an additional 693,300 ADS. Proceeds will support commercial expansion and general corporate purposes, including R&D and marketing. The offering is under SEC registration. Closing is expected on February 25, 2021. Oppenheimer & Co. acts as the sole book-running manager, with Ladenburg Thalmann and Northland Capital as co-managers.
BrainsWay Ltd. (NASDAQ: BWAY) announced plans for an underwritten public offering of American Depositary Shares (ADS), each representing two ordinary shares. The company may grant underwriters a 30-day option for an additional 15% of ADS sold. Proceeds will support commercial expansion and general corporate purposes, including R&D and regulatory matters. The offering is subject to market conditions and is registered under an existing SEC statement. Oppenheimer & Co. Inc. is the sole book-running manager for this offering.
BrainsWay Ltd (NASDAQ & TASE: BWAY) announced the appointment of Fran Hackett as Vice President of North American Sales, effective February 16, 2021. Hackett, a seasoned sales executive with over 30 years of experience, is expected to enhance the company's growth trajectory in the non-invasive treatment of brain disorders. His previous roles include Senior VP of Global Sales at Alter G and CEO of RTI Group. The company aims to expand awareness and access to its Deep Transcranial Magnetic Stimulation (Deep TMS) technology, which has FDA approval for several conditions.
BrainsWay Ltd. (NASDAQ & TASE: BWAY) reported strong preliminary Fourth Quarter Financial Results, with quarterly revenues between $6.8 million and $7.1 million, marking a sequential rise of up to 18.3% and a year-over-year increase of up to 12.7%. Full-year revenues were approximately $21.8 million to $22.1 million, reflecting a decline of 4.3% to 5.6% due to COVID-19 impacts. BrainsWay's installed base of Deep TMS systems grew by 18.7% year-over-year, totaling 629 systems. The company maintains a debt-free status with $17.1 million in cash as of December 31, 2020.
BrainsWay has announced an exclusive distribution agreement with Gaelan Medical Trade LLC to market its Deep TMS treatment in the United Arab Emirates. Following the historic Abraham Accords, this deal allows BrainsWay to expand its reach for treating major depressive disorder and obsessive-compulsive disorder in the UAE. The agreement is a significant step in enhancing access to this innovative non-invasive therapy. BrainsWay's technology has already received FDA approval for various conditions, and clinical trials are ongoing in additional areas.
BrainsWay Ltd. (NASDAQ: BWAY) reported strong third-quarter financial results for 2020, with revenues reaching $6.0 million, a 25% increase from Q2 2020 and a 1% rise year-over-year. The company has installed a total of 593 Deep TMS systems, up 22% from 2019. Recently, it received 510(k) clearance from the FDA for its Deep TMS system to aid smoking cessation. Gross margin stood at 75%, down from 81% in Q3 2019. Operating expenses decreased to $5.1 million from $7.0 million in 2019, leading to an operating loss of $0.6 million, improved from a loss of $2.2 million a year earlier.
BrainsWay Ltd. (NASDAQ: BWAY) announced a KOL call on November 23, 2020, about Deep Transcranial Magnetic Stimulation (Deep TMS) for psychiatric disorders. Dr. Owen Muir from Brooklyn Minds will discuss treatment landscapes for conditions like major depressive disorder (MDD) and obsessive-compulsive disorder (OCD). The management will also update on the company's commercial efforts and Deep TMS technology, authorized by the FDA for various conditions since 2013. This non-invasive treatment activates deep brain structures using electromagnetic fields.
BrainsWay Ltd. (NASDAQ: BWAY) announced positive results from a post-marketing study on its Deep TMS device for obsessive-compulsive disorder (OCD). The study demonstrated that 73% of participants showed a positive response to treatment, with 58% achieving a significant reduction in OCD symptoms after a full course of therapy. Additionally, 52% of patients sustained their improvement for at least one month. The results, published in the Journal of Psychiatric Research, will support reimbursement efforts for Deep TMS in OCD.
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