Improvement in depression scores, response and remission were all found to be comparable with standard Deep TMS in non-inferiority trialBURLINGTON, Mass. and JERUSALEM, June 11, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced preliminary results from a multicenter, randomized controlled trial titled, “Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inf ...

-Aetna authorizes claim for PoNS Device at out-of-network negotiated price of $18,350, becoming the third payer to join Anthem and United in providing PoNS reimbursement- -Out of Network reimbursement is only the first step towards expanding third-party paid access to PoNS- NEWTOWN, Pa., June 11, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) ("Helius" or the "Company"), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait def ...

Deep TMS Takes Center Stage with Compelling Research BURLINGTON, Mass. and JERUSALEM, June 10, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, proudly announces its Gold Sponsorship of the Clinical TMS Society's 2025 Annual Meeting, taking place June 12–14 in San Diego, CA. BrainsWay's participation will spotlight its industry-leading Deep Transcranial Magnetic Stimulation (Deep TMS™) technology, ...

Core Insights - BrainsWay has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to mental health care and raise awareness of innovative treatments [1][2] - The investment in Stella is part of a broader strategy to make minority-stake investments in high-performing mental health providers across the U.S. [2] - BrainsWay will invest $5 million in Stella, acquiring a minority position in the company through preferred, annually compounding securities [4] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5] - BrainsWay aims to increase global awareness and access to Deep TMS through ongoing clinical trials and scientific advancements [5] Stella Overview - Stella is an interventional psychiatry practice focused on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients across more than 20 clinics [1][6] - Stella's partnership with BrainsWay is expected to accelerate its growth and enhance patient care [3][5]

BURLINGTON, Mass. and JERUSALEM, June 04, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced it has entered into a strategic equity financing agreement with Stella MSO, LLC (“Stella Mental Health” or “Stella”), a management services organization servicing more than 20 mental health clinics across the U.S. and Israel that have treated over 30,000 patients ...

Core Viewpoint - Vivani Medical, Inc. plans to spin off its subsidiary Cortigent, Inc. into an independent publicly traded company on Nasdaq by the third quarter of 2025, aiming to enhance value for both Vivani and Cortigent stockholders [1][3][6] Company Developments - Cortigent is developing the Orion Visual Cortical Prosthesis System to provide visual perception for the blind and a Stroke Recovery System to aid recovery of arm and hand movement post-stroke [1][8] - The Orion system has received FDA Breakthrough Device designation and completed a six-year Early Feasibility Study with promising results [2][8] - Cortigent's previous product, the Argus II, was the first FDA-authorized artificial vision device, successfully implanted in hundreds of patients [2][8] Strategic Focus - The spin-off will allow Vivani to concentrate on its proprietary NanoPortal drug implant technology, specifically for chronic weight management and type 2 diabetes [1][2][3] - Vivani's lead program includes a six-month subdermal GLP-1 implant for chronic weight management, with additional products in development for type 2 diabetes [9][11] Financial and Operational Structure - The spin-off is expected to provide clearer visibility into the financial and operational structures of both companies, enhancing understanding of their respective strategies and risks [5][10] - The transaction is subject to various conditions, including board approval and SEC and Nasdaq compliance [6] Management and Leadership - Cortigent's CEO, Jonathan Adams, has extensive experience in the biopharmaceutical field and aims to accelerate the development of Cortigent's technologies post-spin-off [2][8]

Core Insights - Nexalin Technology, Inc. is hosting a webinar on June 3, 2025, to discuss its innovative approach to mental healthcare using its proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology [1][2] - The company is positioned in a $537 billion mental health market, with international regulatory approvals and U.S. expansion plans underway [2] - Nexalin's technology includes real-time AI-driven patient monitoring and aims to provide scalable, at-home treatment options [2] Company Overview - Nexalin designs and develops non-invasive neurostimulation products aimed at addressing the global mental health epidemic [4] - The company's devices are believed to penetrate deep brain structures associated with mental health disorders, enhancing patient response without adverse side effects [4] - The Nexalin Gen-2 15 milliamp neurostimulation device has received approval in China, Brazil, and Oman [4]

HOUSTON, May 06, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the closing of its previously announced underwritten public offering of 3,850,000 shares of its common stock at a public offering price of $1.30 per share. The gross proceeds from the offering to Nexalin were approximately $5.0 million, before deducting underwriting discounts and commissions and othe ...

Company Overview - Nexalin Technology, Inc. is a leader in Deep Intracranial Frequency Stimulation (DIFS™) technology aimed at addressing mental health issues through innovative neurostimulation products [5] - The company's products are designed to be non-invasive and are believed to provide relief for individuals suffering from mental health disorders [5] Public Offering Details - Nexalin announced a public offering of 3,850,000 shares of common stock priced at $1.30 per share, with expected gross proceeds of approximately $5.0 million [1] - The offering is set to close on or about May 6, 2025, subject to customary closing conditions [1] - An additional 577,500 shares may be purchased by underwriters within a 45-day option period at the public offering price [1] Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes, including sales and marketing, product development, and capital expenditures [2] Regulatory Compliance - A shelf registration statement for the shares was filed with the SEC on April 23, 2025, and was declared effective on April 29, 2025 [3] - The offering is being conducted through a written prospectus and prospectus supplement available on the SEC's website [3]

Core Viewpoint - Nexalin Technology, Inc. is initiating formal regulatory engagement with the FDA for its Gen-2 SYNC system, aimed at treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI) [1][2]. Regulatory Engagement - The company plans to submit a Q-Submission ("Q-Sub") to the FDA to facilitate structured dialogue regarding clinical trial design [1][2]. - This decision follows recent publications, encouraging internal data, and preliminary feedback from the FDA, marking a critical step in advancing Gen-2 SYNC as a non-invasive therapeutic option [2]. Product Development - The Gen-2 SYNC system features technical enhancements over prior generations, including a redesigned enclosure and a proprietary 15 milliamp advanced waveform [3]. - The company is rebranding the device to clearly differentiate it from earlier versions, marketing it as "Gen-2 SYNC" [3]. Company Focus - Nexalin is committed to progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative for cognitive and neuropsychiatric disorders [3]. - The company designs and develops innovative neurostimulation products aimed at addressing the global mental health epidemic, utilizing bioelectronic medical technology [5].