BrainsWay Ltd. reports developments in noninvasive neurostimulation treatments for mental health disorders. The company markets its proprietary Deep TMS platform, with FDA-cleared indications that include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and derives revenue from leases and sales of Deep TMS systems.
Recurring updates include financial results, operating guidance, system placements, reimbursement and payer coverage for TMS therapy, clinical data for Deep TMS protocols such as SWIFT, and additional regulatory clearances. Company news also covers strategic minority-stake and milestone-based investments in mental health providers and related neurostimulation technologies, along with investor conference participation and operational updates across its U.S. and Israel-based business.
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.
BrainsWay, a leader in non-invasive brain disorder treatments, announced that CEO Dr. Christopher von Jako will present at the H.C. Wainwright 6th Annual Israel Conference on November 12 at 7:00 AM ET. The company will also engage in one-on-one investor meetings at the Oppenheimer Fall MedTech Summit on the same day.
BrainsWay specializes in Deep Transcranial Magnetic Stimulation (Deep TMS) and has received FDA approvals for treating major depressive disorder, obsessive-compulsive disorder, and smoking addiction. They are currently conducting clinical trials for various brain disorders.
BrainsWay Ltd (NASDAQ: BWAY) announced its #TheRealOCD campaign during OCD Awareness Week (October 11-17, 2020), aimed at educating the public on the misrepresentation of Obsessive-Compulsive Disorder (OCD). The campaign features a video with mental health influencers discussing the realities of living with OCD, as well as sharing stories from treated patients. BrainsWay's Deep Transcranial Magnetic Stimulation (Deep TMS) is highlighted as the only FDA-cleared noninvasive treatment for OCD. The initiative underscores the importance of accurate understanding and treatment of this mental health condition.
BrainsWay (NASDAQ: BWAY) announces the presentation of 10 posters at the annual Clinical TMS Poster session, emphasizing the advantages of Deep TMS in treating mental disorders. These presentations showcase a range of topics, including major depressive disorder and obsessive-compulsive disorder, demonstrating real-world applications. The company expressed optimism for future studies and the growing evidence supporting Deep TMS. The session remains accessible until December 31, 2020, enabling ongoing education despite the challenges posed by COVID-19.