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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, a leader in non-invasive brain disorder treatments, announced that CEO Christopher von Jako will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 1:40 PM ET. The company specializes in Deep Transcranial Magnetic Stimulation (Deep TMS) technology, which has received FDA approval for various disorders, including major depressive disorder in 2013, obsessive-compulsive disorder in 2018, and smoking addiction in 2020. BrainsWay is actively conducting clinical trials across multiple psychiatric and neurological conditions.
BrainsWay, a leader in non-invasive brain disorder treatments, announced that CEO Christopher von Jako will present at two key conferences on September 15, 2020. The H.C. Wainwright 22nd Annual Global Investment Conference will take place at 2:00 PM ET, followed by the Cantor Fitzgerald Virtual Global Healthcare Conference at 10:00 AM ET on the same day. BrainsWay specializes in Deep Transcranial Magnetic Stimulation technology, with FDA approvals for conditions like major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
BrainsWay Ltd. (NASDAQ: BWAY) achieved a significant milestone by receiving FDA 510(k) clearance for its Deep TMS system to assist in short-term smoking cessation in adults. This clearance marks the first FDA approval for a TMS device in the addiction sector. Based on a randomized study of 262 subjects, the Deep TMS group demonstrated a 17.1%-28.4% continuous quit rate compared to a 7.9%-11.7% rate in the sham group. With plans for a controlled U.S. market launch in early 2021, this advancement solidifies BrainsWay's leadership in the non-invasive treatment of brain disorders.
BrainsWay Ltd. (NASDAQ: BWAY) reported Q2 2020 revenues of $4.8 million, down 15% from Q2 2019 due to COVID-19-related disruptions. The installed base of Deep TMS systems rose 24% year-over-year to 567 systems, with significant reimbursement progress made for major depressive disorder treatments. The company achieved a 79% gross margin and reduced operating expenses to $4.0 million, down from $7.0 million in the previous year, leading to a smaller operating loss of $0.2 million compared to $2.7 million in 2019.
BrainsWay Ltd. (NASDAQ: BWAY) will announce its Q2 2020 financial results on August 12, 2020, before U.S. markets open. A conference call will take place at 8:30 AM ET to discuss the results and business updates. BrainsWay specializes in non-invasive treatments for brain disorders through its Deep TMS technology, which has FDA approval for treating major depressive disorder and obsessive-compulsive disorder. The company is currently conducting clinical trials for various neurological and psychiatric disorders. Forward-looking statements involve risks and uncertainties.