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BrainsWay Ltd (BWAY) delivers innovative neurostimulation solutions through its FDA-cleared Deep TMS technology, offering noninvasive treatment for mental health disorders. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and corporate developments.
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Discover updates on BrainsWay's progress in addressing major depressive disorder, OCD, and addiction treatment through its patented magnetic stimulation platform. The resource serves investors monitoring neurotechnology trends and clinicians seeking evidence-based therapeutic innovations.
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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.
BrainsWay Ltd. (NASDAQ: BWAY) announced that it will release its third quarter 2020 financial results on November 18, 2020, before U.S. markets open. A conference call is scheduled for 8:30 AM ET to discuss these results and provide business updates. The Company specializes in non-invasive treatments for brain disorders using its Deep Transcranial Magnetic Stimulation technology, with FDA approvals for conditions like major depressive disorder and smoking addiction. More details will be available via webcast following the call.