Brainsway Ltd. Stock Price, News & Analysis

BrainsWay (NASDAQ & TASE: BWAY) has announced a US$20 million private placement with Valor Equity Partners. The deal includes issuing 2,103,745 American Depositary Shares (ADSs) at US$9.51 per ADS, a 20% premium over the 30-day VWAP, and warrants to purchase up to 1,500,000 additional ADSs. If fully exercised, the warrants could increase total proceeds to US$34.3 million.

Valor will gain board representation and BrainsWay will use the funds for strategic initiatives including expanding market awareness, enhancing data analysis capabilities, developing R&D roadmap, and expanding access to Deep TMS™ technology. The transaction is subject to shareholder approval and customary closing conditions.

BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has announced a significant expansion on the U.S. East Coast. A large and growing enterprise network has placed an order for 14 new Deep TMS™ systems, following other recent multisystem orders. This expansion aligns with BrainsWay's strategic goal of fostering relationships with various mental health groups and networks to drive long-term profitable growth.

CEO Hadar Levy expressed satisfaction with the company's continued expansion and support for the growth of this large enterprise network. As of June 30, 2024, BrainsWay had an installed base of 1,215 Deep TMS systems, solidifying its position as a preferred choice for many mental health providers.

BrainsWay (NASDAQ & TASE: BWAY) has received approval from the Israel Ministry of Defense's Rehabilitation Department for reimbursement of Deep TMS™ therapy for qualifying PTSD patients at Israeli public hospitals. This decision comes in response to growing concerns about PTSD in Israel, especially following recent conflicts. CEO Hadar Levy emphasized the importance of addressing this expanding patient population.

A recent study estimates that over 5% of Israel's population could develop PTSD. Additionally, a retrospective cohort study of 99 military veterans showed significant symptom reductions after Deep TMS treatment: 44.1% for PTSD, 43.5% for depression, and 54% for suicidal ideation at six-month follow-up. BrainsWay aims to expand reimbursement to more medical centers and private clinics in Israel.

BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has appointed Richard A. Bermudes, M.D. as Chief Medical Officer (CMO), effective September 1, 2024. Dr. Bermudes, with over 20 years of experience in brain stimulation therapies, is considered a preeminent clinician in the TMS field. He replaces Dr. Aron Tendler, who will continue collaborating on strategic research projects.

Dr. Bermudes brings extensive experience as a practicing physician, researcher, and entrepreneur. He co-founded a behavioral health care network with 24 outpatient clinics, pioneered new therapies, and launched successful telehealth programs. He is also an Associate Physician at UC Davis Department of Psychiatry and Behavioral Sciences and the lead editor of a renowned book on Transcranial Magnetic Stimulation.

BrainsWay (NASDAQ & TASE: BWAY) reported strong Q2 2024 financial results, with 28% year-over-year revenue growth to $10 million. The company achieved positive net income for the third consecutive quarter and positive Adjusted EBITDA for the fourth consecutive quarter. Key highlights include:

- Gross margin increased to 75% from 73% in Q2 2023
- Operating income of $0.6 million, compared to a $1.3 million loss in Q2 2023
- Net income of $0.6 million, compared to a $1.7 million loss in Q2 2023
- Adjusted EBITDA of $1.2 million, compared to a $0.6 million loss in Q2 2023
- Cash and equivalents of $48.1 million as of June 30, 2024

BrainsWay raised its full-year 2024 revenue guidance to $38.5-$40 million, representing 21-25% growth over 2023. The company expects continued profitability and positive cash generation in H2 2024.

BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has announced its plan to report second quarter 2024 financial results on August 6, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss results and provide operational updates.

Investors can access the call via phone or webcast. The webcast will be available for replay for 30 days on BrainsWay's investor relations website. This announcement provides shareholders and analysts with a scheduled opportunity to review the company's financial performance and engage with management about recent developments and future prospects.

BrainsWay has announced an exclusive multi-year distribution agreement to market its Deep Transcranial Magnetic Stimulation (Deep TMS) system in Canada. The agreement involves a specialty distributor serving acute and non-acute healthcare sectors, and includes minimum quantity orders, starting with 11 systems in 2024. BrainsWay’s CEO, Hadar Levy, emphasized the significance of expanding into Canada to address the country's mental health crisis. The Deep TMS system, which uses a patented coil design to stimulate brain neural networks, is currently approved in Canada for treating major depressive disorder and obsessive-compulsive disorder.

BrainsWay has launched a new clinical trial to evaluate an accelerated treatment protocol for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, targeting major depressive disorder (MDD). This multicenter, randomized, controlled trial will compare a novel accelerated protocol to the FDA-cleared standard-of-care protocol. Over 100 patients will participate, with one group receiving an acute treatment phase over several days and the other over several weeks. The trial aims to determine if the accelerated protocol is as effective as the traditional method. Recruitment is ongoing across multiple U.S. sites.

BrainsWay has announced that the FDA has expanded the indication for its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to treat major depressive disorder (MDD) in patients aged 22 to 86, extending beyond the previous age limit of 68. This marks the company's 10th FDA clearance, making their Deep TMS the only TMS device approved for depression treatment in patients over 68. The expanded labeling is supported by clinical data showing significant response and remission rates in older patients. BrainsWay sees this as a promising business opportunity, given the rising life expectancy and the need for effective depression treatments in the elderly.