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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 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.
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.