Brainsway Ltd (BWAY)

BrainsWay Announces Minority-Stake Investment in Hopemark Health

Mon, May 18, 2026 at 2:30 PM GMT+3 3 min read

Investment in provider servicing clinics in Illinois is latest in series of similar transactions by BrainsWay with leading North American mental health providers to raise awareness and expand access to transformative care

BURLINGTON, Mass. and JERUSALEM, Israel, May 18, 2026 (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 APS Innovations LLC, the parent company of Advanced Psychiatric Management LLC, a management services organization servicing multiple mental health clinics in the greater Chicago area (collectively, “Hopemark Health” or “Hopemark”). Under the terms of the agreement, BrainsWay will invest $1.5 million initially, with potential for an additional $1.5 million via milestone-based investments, for a minority position in Hopemark in the form of a preferred, annually compounding security. The agreement also provides for a redemption mechanism relating to the shares.


“Our investment in Hopemark represents another step in our strategy to partner with growth-oriented clinical platforms. These investments are in pursuit of BrainsWay’s broader goal of expanding access to and awareness of advanced interventional psychiatry solutions such as Deep TMS. Our minority stake approach allows BrainsWay to continue to be laser-focused on the continuous advancement of its business and technology,” said Hadar Levy, BrainsWay’s Chief Executive Officer.

“We are excited to partner with BrainsWay as we continue to expand access to high-quality mental health care,” said Dr. Abid Nazeer, Hopemark’s Chief Executive Officer. “BrainsWay brings not only growth capital, but a deep understanding of interventional psychiatry and operational best practices that will help us scale efficiently and deliver better outcomes for patients. We see this partnership as a meaningful step in accelerating our growth and impact.”

Advocates Ami Hordes and Sarit Molcho of S. Friedman, Abramson & Co. Law Offices served as lead counsel for BrainsWay on the transaction as well as on the Company’s prior minority stake investments.

BrainsWay shares slip despite first-quarter earnings beat and strong growth (BWAY)May 13, 2026 9:32 AM
IH Market News Shares of BrainsWay (NASDAQ:BWAY) fell more than 2% in premarket trading on Wednesday after investors reacted to the company’s maintained full-year guidance despite stronger-than-expected first-quarter results.The stock declined 2.69% following the earnings release. Revenue and earnings exceed analyst expectations BrainsWay reported adjusted earnings per share of $0.06 for the first quarter of fiscal 2026, beating analyst forecasts of $0.03 per share.Revenue increased 35% year-on-year to $15.5 million, ahead of the consensus estimate of $14.31 million.The company reaffirmed its full-year 2026 revenue guidance of between $66 million and $68 million. The midpoint of the range, at $67 million, came in slightly above analyst expectations of $66.43 million. Deep TMS system shipments hit record level BrainsWay shipped a record 117 Deep TMS systems during the quarter, representing growth of 44% compared with the same period in 2025.Remaining performance obligations rose 25% year-on-year to approximately $75 million.Adjusted EBITDA more than doubled to $2.8 million from $1.3 million a year earlier, while net income climbed to $2.3 million from $1.1 million in the prior-year quarter.“We are off to an excellent start in 2026, delivering 35% revenue growth in the first quarter while generating $2.8 million of Adjusted EBITDA,” said Hadar Levy, chief executive officer of BrainsWay.“Across the board, we are seeing meaningful progress in expanding awareness and access to Deep TMS, driven by broader reimbursement, increasing provider adoption, and continued engagement with leading mental health networks.” Profitability outlook maintained Gross margin remained unchanged at 75% compared with the prior-year period.BrainsWay maintained its forecast for operating income to represent 13% to 14% of revenue in 2026.The company also reiterated adjusted EBITDA guidance of between $12 million and $14 million for the full year, implying expected growth of 86% to 100% compared with 2025. Company advances reimbursement and regulatory efforts BrainsWay said it secured the first insurance coverage approval for its accelerated SWIFT Deep TMS protocol following clearance from the U.S. Food and Drug Administration.The company also plans to submit a regulatory filing during the second quarter seeking FDA clearance for Deep TMS in the treatment of PTSD symptoms.BrainsWay stock price Original: BrainsWay shares slip despite first-quarter earnings beat and strong growth (BWAY)

BrainsWay Reports First Quarter 2026 Financial Results and Operational Highlights

Revenue grew approximately 35% year-over-year to $15.5 million for Q1 2026

Net income increased by over 100% year-over-year to $2.3 million for Q1 2026

Adjusted EBITDA for Q1 of 2026 more than doubled year-over-year to $2.8 million

Remaining performance obligations grew 25% year-over-year to approximately $75 million

Shipped a record total of 117 Deep TMS Systems, indicating significant demand and further strengthening of relationships with enterprise accounts

Reiterates full-year 2026 financial guidance, including revenue of $66 – $68 million, operating income of 13% – 14%, and Adjusted EBITDA of $12 – $14 million

Conference call to be held today at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, May 13, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported first quarter 2026 financial results and provided an operational update.

Recent Financial and Operational Highlights

Revenue in the first quarter of 2026 increased 35% to $15.5 million, compared with the first quarter of 2025.

Remaining performance obligations (RPOs) increased to $75 million as of March 31, 2026, up 25% compared to the prior year period.

Shipped a net total of 117 Deep TMS™ systems during the first quarter of 2026, representing a 44% increase compared to the same period last year. Total installed base reached approximately 1,820 systems.

Gross margin for the first quarter of 2026 was 75%, steady with the prior year period.

Operating income for the first quarter of 2026 was $2.0 million, compared with $0.6 million for the prior year period.

Adjusted EBITDA for the first quarter of 2026 increased 117% to $2.8 million, compared with $1.3 million for the prior year period.

Net income for the first quarter of 2026 increased over 100% to $2.3 million, compared with $1.1 million for the prior year period.

As of March 31, 2026, cash and cash equivalents, and restricted cash totaled $58.9 million.

Secured the first insurer coverage for accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) Deep TMS protocol following FDA clearance.

Growing U.S. payer support for psychiatric mental health nurse practitioners administered TMS, with commercial insurers, Medicare Administrative Contractors, and government payers expanding coverage to include trained nurse practitioners.

Advanced with patient recruitment for the Company’s multicenter study of Deep TMS for alcohol use disorder (AUD), a major unmet need affecting approximately 29 million Americans.

The Company plans to submit an FDA filing in the second quarter of 2026 for the use of Deep TMS in treating PTSD symptoms in patients with MDD, potentially expanding the Company’s clinical pipeline into a large and underserved market with significant unmet need.

Completed a $6 million milestone-based convertible loan to Neurolief following FDA Premarket Approval of ProlivRx system; bringing the Company’s total convertible loan investment in Neurolief to $11 million.

Completed an initial $1 million minority stake investment into BrainStim Health Inc., as well as an additional $1 million revenue milestone-based investment in Axis Management Company, supporting the continued execution and expansion of BrainsWay’s minority position investment strategy.

Reiterates Full-Year 2026 Financial Guidance

The Company expects full-year 2026 revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025.

The Company anticipates continued profitability and positive cash flow, targeting operating income of 13%-14% of revenue and Adjusted EBITDA of $12 million to $14 million, representing anticipated growth of 86% to 100% over 2025.


“We are off to an excellent start in 2026, delivering 35% revenue growth in the first quarter while generating $2.8 million of Adjusted EBITDA,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Across the board, we are seeing meaningful progress in expanding awareness and access to Deep TMS, driven by broader reimbursement, increasing provider adoption, and continued engagement with leading mental health networks. These efforts are translating into growing demand, increased utilization, and strong momentum across our business.”

“With a strong foundation in place and multiple catalysts ahead, we are well positioned to continue expanding access to Deep TMS and driving sustainable long-term growth. Looking ahead, we remain on track to deliver our full-year 2026 guidance of $66 to $68 million in revenues,” concluded Mr. Levy.

BrainsWay Highlights Growing U.S. Payer Support for Nurse Practitioner-Administered Transcranial Magnetic Stimulation (TMS) Therapy

https://finance.yahoo.com/sectors/healthcare/articles/brainsway-highlights-growing-u-payer-113000456.html

Wed, April 15, 2026 at 2:30 PM GMT+3 3 min read

Growing payer acceptance of nurse practitioner administration of Deep TMS is expected to expand access to non-drug mental health treatments

BURLINGTON, Mass. and JERUSALEM, April 15, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today highlighted the growing trend across the U.S. payer landscape of coverage policies that allow appropriately trained nurse practitioners to administer Transcranial Magnetic Stimulation (TMS) therapy. A growing number of commercial insurers, Medicare Administrative Contractors (MACs), and government payers now permit psychiatric mental health nurse practitioners (PMHNPs) to administer TMS therapy, including Deep TMS™, when practicing in accordance with applicable regulations and state scope-of-practice requirements.

Among large U.S. payers, Optum/United Behavioral Health (“Optum Behavioral Health”) updated its TMS clinical policy in late 2025 to explicitly allow PMHNPs to order, supervise, and administer TMS therapy in states that grant them full practice authority, where such services fall within advanced practice registered nurse scope of practice. Previously, this authority had been limited to psychiatrists under the policy. The updated Optum Behavioral Health policy applies to commercial plans covering approximately 34.8 million lives.

In addition to Optum, multiple other U.S. commercial payers, MACs (including First Coast, National Government Services, and Novitas), the U.S. Department of Veterans Affairs, and TRICARE West have all adopted similar coverage approaches increasing the role of nurse practitioners providing TMS care, subject to compliance with applicable policy and regulatory frameworks.

“We believe this continued evolution in payer policy reflects a broader effort to remove structural barriers to proven mental health care options such as Deep TMS,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Expanding the pool of qualified clinicians who can administer Deep TMS – especially in markets experiencing psychiatrist shortages – has the potential to improve access, reduce wait times, and help ensure that more patients can benefit from clinically proven, non-pharmacologic treatment options,” concluded Mr. Levy.

BrainsWay believes that broader acceptance of nurse practitioner-delivered TMS care may help address provider capacity constraints and support more timely access to treatment. The Company continues to engage with clinicians, payers, and policymakers to advance awareness of Deep TMS™ and its proprietary noninvasive neurostimulation platform which has received U.S. Food and Drug Administration clearance for multiple indications supported by pivotal clinical studies.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

BrainsWay Completes Additional $6 Million Milestone-Based Investment in Neurolief Ltd. Following FDA Approval of Proliv™Rx System for MDD

https://finance.yahoo.com/sectors/healthcare/articles/brainsway-completes-additional-6-million-113000295.html

BURLINGTON, Mass. and JERUSALEM, March 26, 2026 (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 the completion of an additional $6 million milestone-based convertible loan to Neurolief Ltd. (“Neurolief”). This second tranche investment was triggered by the recent U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for Neurolief's Proliv™Rx system, a milestone defined under the terms of BrainsWay’s August 2025 strategic investment transaction with Neurolief.

“Our strategic investments in Neurolief are part of our long-term mission to help accelerate patient access to innovative mental health treatments,” said Hadar Levy, Chief Executive Officer of BrainsWay. “We believe that Proliv™Rx, a unique, at-home therapy designed for treatment-resistant major depressive disorder (MDD), has the potential to expand our total addressable market and offer synergistic opportunities which complement BrainsWay’s powerful, in-clinic Deep TMS™ technology, by providing a clinically validated neurostimulation option to patients that cannot easily access our clinics,” concluded Mr. Levy.

“We appreciate BrainsWay’s capital investments, which have played an important role in advancing our regulatory and commercial strategy for Proliv™Rx. This is an exciting period in our business, and we look forward to furthering our relationship with BrainsWay as we work toward broader commercial adoption,” stated Scott Drees, Neurolief's Chief Executive Officer. “Since receiving FDA approval for Proliv™Rx for MDD, we have begun scaling our commercial operations. Recently, we expanded provider access across a large segment of the U.S. healthcare system through our authorized reseller’s inclusion in the Veterans Affairs Federal Supply Schedule (FSS). With FSS pricing now established for both Proliv™Rx and Relivion®MG, we have created a clear commercial pathway into the VA health system,” concluded Mr. Drees.

Beyond the $11 million invested by BrainsWay in Neurolief to date, the strategic investment agreement provides for potential additional funding to Neurolief, including a third tranche of up to a $5 million equity investment upon Neurolief achieving a defined revenue-based target. BrainsWay also holds a “call option” to acquire all outstanding equity interests in Neurolief during clearly defined exercise windows, at a price based on the greater of a specified enterprise value or a revenue multiple, with the values varying depending on timing of exercise.

About Neurolief
Neurolief is a pioneering neuromodulation company committed to developing breakthrough therapies for mental health and neurological disorders. The company has developed the world’s first wearable, non-invasive, multi-channel brain neuromodulation system, that is designed for use at home, engineered to simultaneously stimulate key neural pathways in the head in order to modulate brain regions involved in regulation of mood and pain. Neurolief's Proliv™Rx device was granted Premarket Approval by the U.S. Food and Drug Administration (FDA), and is indicated as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic. Its Relivion®MG device is currently FDA-cleared and CE-marked for the treatment of migraine. Learn more at: www.neurolief.com.

BrainsWay Completes Revenue-Based Milestone Investment into Axis Integrated Mental Health

BrainsWay’s investment is part of its ongoing strategy to partner with leading U.S. mental health providers to increase access to care


BURLINGTON, Mass. and JERUSALEM, March 19, 2026 (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 that it has completed a $1 million milestone-based investment in Axis Management Company, Inc. (“Axis Integrated Mental Health” or “Axis”), a management services organization servicing several mental health clinics in Colorado. The investment was made following Axis’s achievement of a predefined revenue performance milestone under the terms of the two companies’ August 2025 strategic equity financing agreement.

“We are excited for the Axis team and their early success in executing a successful growth strategy since our original $2.3 million equity investment. Their rapid achievement of the revenue milestone underscores this program’s ability to identify strong networks such as Axis that can deploy capital effectively to drive growth within the market and increase access to care,” said Hadar Levy, Chief Executive Officer of BrainsWay.

“This is an exciting time for the Axis team, as we continue to meet the goals we set for our growth strategy. The partnership with BrainsWay continues to be a major part of that strategy and is grounded in our shared commitment to delivering the most advanced mental health treatments to the communities we serve,” stated Chris Perez, Chief Executive Officer of Axis.

Under the terms of the agreement, BrainsWay holds a minority position in Axis in the form of a preferred, annually compounding security. The agreement also provides for a redemption mechanism relating to the shares.

Why an early Tesla investor is betting big on Israeli brain technology
BrainsWay’s FDA approvals and clinic expansion strategy are attracting global capital.

https://www.calcalistech.com/ctechnews/article/8kel1holc#google_vignette

BrainsWay Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

Q4 Revenue Grew 27% Year-Over-Year to Record $14.5 Million

Q4 Operating Income of $1.9 Million; Adjusted EBITDA Increased by 53% to $2.3 Million, Reflecting Significant Operating Leverage

Full Year 2025 Revenue Increased by Approximately 27% YoY to $52.2 Million, and Net Income Increased by Approximately 161% YoY to $7.6 Million

Remaining Performance Obligations Increased 43% to Approximately $70 Million

Issuing 2026 Guidance: Expecting Revenue of $66 - $68 million (27% - 30% Growth), Operating Income of 13% - 14%, and Adjusted EBITDA of $12 - $14 Million (86% - 100% Growth)

Conference Call to be Held Today at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, March 11, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported fourth quarter and full year 2025 financial results and provided an operational update.

Recent Financial and Operational Highlights

Revenue in the fourth quarter of 2025 increased 27% to $14.5 million, compared with the fourth quarter of 2024.
Approximately 70% of customer engagements signed in recent quarters are structured as multi-year lease agreements.
Increased remaining performance obligations to approximately $70 million, representing a 43% increase compared with December 31, 2024.
Shipped a net total of 95 Deep TMS™ systems during the fourth quarter of 2025, a 27% increase compared with the same period last year. Total installed base now stands at approximately 1,700 systems.
Gross margin for the fourth quarter of 2025 was 76%, compared with 75% in the prior year period.
Operating income for the fourth quarter of 2025 was $1.9 million, compared with $0.4 million for the prior year period.
Adjusted EBITDA1 for the fourth quarter of 2025 increased 53% to $2.3 million, compared with $1.5 million for the fourth quarter of 2024.
Net income for the fourth quarter of 2025 increased 90% to $2.9 million, compared with $1.5 million for the fourth quarter of 2024.
U.S. Food and Drug Administration (FDA) granted label expansion for the Deep Transcranial Magnetic Stimulation (Deep TMS™) system making the treatment available as an adjunct therapy for adolescents aged 15 to 21 years suffering from major depressive disorder (MDD).
Launched a multicenter clinical trial investigating the use of the new Deep TMS 360™ system in individuals with Alcohol Use Disorder (AUD), which represents a major economic and health burden, affecting about 29 million Americans.
Secured the first insurer coverage for the accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) Deep TMS protocol following FDA clearance.
FDA approved Neurolief’s wearable Proliv™Rx neuromodulation system, a Class III device, as an adjunctive treatment for adult patients suffering from MDD who have failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in the clinic.
Full Year 2025 Financial Highlights

Full year 2025 revenue of $52.2 million, a 27% increase as compared with full year 2024.
Gross margin for the full year 2025 was 75%, flat compared with the prior year.
Operating income for the full year 2025 was $4.3 million, compared with $1.4 million in the prior year.
Net income for the full year 2025 increased by 161% to $7.6 million, compared with $2.9 million for the prior year.
Adjusted EBITDA for the full year 2025 was approximately $7.0 million, compared with $4.5 million for the prior year.
As of December 31, 2025, cash, cash equivalents, and restricted cash totaled $68.0 million.
Full-Year 2026 Financial Guidance

The Company expects full-year 2026 revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025.
The Company anticipates continued profitability and positive cash flow, targeting operating income of 13% to 14% and Adjusted EBITDA of $12 to $14 million.
_____________________

1 See Adjusted EBITDA details and reconciliation table in the appendix below.

“We successfully closed out 2025 with strong momentum across our business, delivering 27% full-year revenue growth while significantly expanding profitability,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Demand for Deep TMS continues to accelerate, supported by expanding customer adoption, additional regulatory clearances, and growing reimbursement coverage. The FDA’s recent clearance expanding Deep TMS MDD treatment to adolescents aged 15 to 21, and its clearance of our accelerated Deep TMS MDD protocol, represent meaningful growth catalysts for 2026 and beyond. In addition, our investment in Neurolief has the potential to significantly expand our addressable market and create new growth opportunities.”

“In parallel with our strong operational execution, we are executing a targeted investment strategy focused on providing growth capital to leading mental health networks. These minority equity positions support clinical expansion while helping accelerate awareness and adoption of innovative therapies. We are seeing real increases in demand for interventional psychiatry solutions like Deep TMS within these networks. As we enter 2026, we have a strong balance sheet and remain focused on extending our reach, strengthening our clinical leadership, and building long-term value for patients, providers, and shareholders,” concluded Mr. Levy.

Call and Webcast

BrainsWay’s management will host a conference call on Wednesday, March 11, 2026, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, March 11, 2026, at 8:30 AM Eastern Time:

United States: 1-877-300-8521
International: 1-412-317-6026
Israel:
Conference ID: 1-80-921-2373
10206784
Webcast: Link
The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.

Non-IFRS Financial Measures

In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating profit and net profit, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net profit adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses.

In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:

Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired.
Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results.
Adjusted EBITDA, however, should not be considered as an alternative to operating profit (loss) or net profit (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net profit (loss) and Adjusted EBITDA is presented in the attached summary financial statements.

Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net profit (loss) and our IFRS financial results.

Landmark Data Validate BrainsWay’s SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment

https://finance.yahoo.com/news/landmark-data-validate-brainsway-swift-123000119.html

World’s only FDA-cleared Deep TMS™ accelerated treatment reduces the acute phase of treatment by 70%

BURLINGTON, Mass. and JERUSALEM, March 04, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) unveiled new clinical data showing a significantly faster, noninvasive way to treat depression without compromising the efficacy of one of psychiatry’s most impactful treatments. The milestone advances BrainsWay’s brain health vision and sets the stage for a neuromodulation platform that transforms lives.

Two new peer-reviewed manuscripts in Brain Stimulation found that BrainsWay’s exclusive FDA-cleared SWIFT™ accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for the treatment of Major Depressive Disorder (MDD) achieved comparable remission and response rates when compared to the traditional standard protocol. The accelerated protocol reduces the traditional 20-visit acute treatment phase to just 6 half days, followed by weekly maintenance visits for 4 weeks.

Widespread adoption of the SWIFT approach, which reduces the number of clinic visits in the acute phase by ~70%, could alter how interventional psychiatry is delivered, improving patient retention and expanding clinical options at a time when demand for non-drug depression therapies is rising.

In a large, randomized, multisite non-inferiority trial, patients treated with BrainsWay’s accelerated protocol achieved:

87.8% response rate

78.0% remission rates

Median time to remission of 21 days, compared with 28 days under the standard daily protocol

“SWIFT demonstrates that we can substantially reduce treatment burden without compromising on outcomes, which fundamentally changes what access looks like for patients,” said Colleen A. Hanlon, Ph.D., Vice President of Medical Affairs at BrainsWay.

Why SWIFT™ Matters: The Cost of Time

Over 20 million U.S. adults live with MDD, at an estimated $333 billion annual economic burden. Yet logistical barriers – time away from work, caregiving responsibilities, and travel – reduce the number of people who initiate access to this life-saving treatment. SWIFT™ lowers one of the most persistent barriers in interventional psychiatry: Time.

The second published manuscript, focusing on the patients’ own ratings of perceived impact of the treatment on their lives, highlights the human impact of that efficiency. Key secondary outcomes in this study include:

~70% of the participants no longer suffered from severe quality of life impairment

Approximately 60% returned to normal-range functioning after treatment

Patients also reported earlier symptom improvement across a range of measures, consistent with clinician-rated outcomes, suggesting not only statistical success, but lived recovery.

“Patients are reconnecting with work, relationships, and routines,” said Hanlon. “That’s the human outcome that matters most.”

As clinical innovation improves access, payers are also reducing administrative barriers, including the previously announced move by Evernorth® Behavioral Health to eliminate prior authorization requirements for Deep TMS.

“We believe this marks the beginning of a new era for BrainsWay,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Innovation in mental health cannot stop at clinical efficacy – it must address accessibility and scalability. SWIFT demonstrates that we can advance neuroscience while expanding real-world reach. That is the future of interventional psychiatry.”

Study Design and Results

The trial incorporated input from both patients and providers in both urban and rural areas, reflecting a patient-centric approach uncommon in studies of this type. Each manuscript highlights different but complementary findings from the same clinical trial.

Manuscript 1: Accelerated TMS with the H1-coil for Depression: A Multisite, Randomized Non-Inferiority Trial


In the randomized non-inferiority comparison, the accelerated SWIFT protocol achieved an 87.8% response rate and a 78.0% remission rate on the clinician-rated Hamilton Depression Rating Scale (HDRS-21), establishing efficacy comparable to the standard once-daily protocol while requiring substantially fewer treatment days. (The standard protocol consists of an acute phase of 5 daily sessions over 4 weeks, followed by 2 daily sessions per week for 2 weeks.) Median time to remission was 21 days for SWIFT versus 28 days for the standard protocol. Outcomes were consistent across diverse patient subgroups, including individuals with moderate-to-severe depression and comorbid anxiety symptoms.

Manuscript 2: Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS with the H1 coil for Major Depression: A Multisite Randomized Trial


Clinician-rated measures remain the gold standard in depression trials; however, patient-reported outcomes provide critical insight into real-world experiences. Daily patient assessments confirmed substantial improvements in quality of life, functioning, and symptom burden among patients receiving accelerated treatment. By 6 weeks, quality-of-life scores improved by approximately 32 percentage points from those measured at baseline. The proportion of patients reporting severe functional impairment declined from 85–100% at baseline to 15–17% at the end of treatment, and approximately 60% reached normal-range functioning by the end of treatment. Patients receiving SWIFT also reported earlier perceived symptom improvement across a range of symptoms, consistent with clinician-rated findings.

BrainsWay Announces Draft Coverage Policy from Highmark® for Accelerated Deep TMS™

https://finance.yahoo.com/news/brainsway-announces-draft-coverage-policy-123000649.html

New draft policy from Highmark Blue Cross Blue Shield extends to both adolescent and adult depression patients

BURLINGTON, Mass. and JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Highmark Blue Cross Blue Shield®, a company with over seven million covered lives that primarily serves Pennsylvania, Delaware, West Virginia, and parts of New York, has released a draft medical policy which, among other developments, expands coverage to include adolescent and adult patients with major depressive disorder (MDD) treated with the company’s accelerated Deep TMS™ protocol.

The policy, which is anticipated to go into effect in February 2026 after an open comment period, will provide coverage of BrainsWay’s accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) protocol, which consists of an acute phase of five treatment sessions (ten minutes each) per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions. Accelerated Deep TMS does not entail the use of any functional MRI or other expensive neuronavigational equipment.
“We believe this news from Highmark, together with our recently reported adoption by another payer of a medical policy covering our accelerated protocol, will help usher in a new era in Deep TMS depression treatment. This trend affords patients increased flexibility by giving them access to a treatment option requiring considerably fewer visits to the clinic,” stated Scott Blackman, Director of Market Access for BrainsWay.

The Company’s accelerated depression protocol for Deep TMS was cleared by the FDA in September 2025. This clearance followed BrainsWay’s submission of data from a Multisite, Randomized Non-Inferiority Trial demonstrating an 87.8% response rate and 78.0% remission rate for patients treated with the accelerated Deep TMS protocol, which was comparable to outcomes achieved via standard Deep TMS.

Brainsway Ltd. Sponsored ADR (NASDAQ:BWAY) Short Interest Down 21.1% in December

https://www.marketbeat.com/instant-alerts/brainsway-ltd-sponsored-adr-nasdaqbway-short-interest-down-211-in-december-2026-01-18/#google_vignette

Written by MarketBeat

January 18, 2026

Key Points
Short interest fell 21.1% to 60,376 shares as of Dec. 31, representing about 0.4% of the float and a days-to-cover ratio of 0.8 based on average volume.
Analysts turned more positive — HC Wainwright raised its target to $24 (buy), Northland to $23 (outperform), Wall Street Zen upgraded to buy, and the consensus is a "Moderate Buy" with an average price target of $23.50.
Recent results and valuation: the company reported quarterly EPS of $0.08 (miss vs. $0.11) with revenue of $13.51M (beat), and the stock trades around $23.18 with a market cap of roughly $454M and a P/E of ~77.3.

Brainsway Ltd. Sponsored ADR (NASDAQ:BWAY - Get Free Report) was the target of a large decrease in short interest in December. As of December 31st, there was short interest totaling 60,376 shares, a decrease of 21.1% from the December 15th total of 76,503 shares. Based on an average daily trading volume, of 73,199 shares, the days-to-cover ratio is presently 0.8 days. Approximately 0.4% of the shares of the company are short sold. Approximately 0.4% of the shares of the company are short sold. Based on an average daily trading volume, of 73,199 shares, the days-to-cover ratio is presently 0.8 days.

NASDAQ:BWAY traded up $0.08 during trading hours on Friday, reaching $23.18. 55,218 shares of the company's stock were exchanged, compared to its average volume of 110,906. The company has a market capitalization of $453.98 million, a P/E ratio of 77.27 and a beta of 1.19. Brainsway has a 12 month low of $7.84 and a 12 month high of $24.84. The business's 50-day simple moving average is $18.14 and its two-hundred day simple moving average is $15.76.

Brainsway (NASDAQ:BWAY) last posted its quarterly earnings results on Tuesday, November 11th. The company reported $0.08 earnings per share (EPS) for the quarter, missing the consensus estimate of $0.11 by ($0.03). The company had revenue of $13.51 million during the quarter, compared to the consensus estimate of $13.04 million. Brainsway had a net margin of 12.73% and a return on equity of 9.46%. As a group, sell-side analysts anticipate that Brainsway will post 0.08 earnings per share for the current fiscal year.

Analysts Set New Price Targets
A number of brokerages have issued reports on BWAY. HC Wainwright boosted their price target on Brainsway from $18.00 to $24.00 and gave the stock a "buy" rating in a research report on Monday, December 8th. Weiss Ratings restated a "hold (c-)" rating on shares of Brainsway in a research report on Monday, December 29th. Northland Securities upped their price target on shares of Brainsway from $19.00 to $23.00 and gave the stock an "outperform" rating in a research note on Wednesday, November 12th. Finally, Wall Street Zen upgraded shares of Brainsway from a "hold" rating to a "buy" rating in a research note on Saturday, December 13th. Two research analysts have rated the stock with a Buy rating and one has issued a Hold rating to the company. According to data from MarketBeat.com, the stock currently has a consensus rating of "Moderate Buy" and an average price target of $23.50.

Institutional Trading of Brainsway
Several institutional investors and hedge funds have recently bought and sold shares of BWAY. NewEdge Advisors LLC lifted its stake in Brainsway by 7.4% during the third quarter. NewEdge Advisors LLC now owns 28,629 shares of the company's stock valued at $431,000 after buying an additional 1,964 shares in the last quarter. Millennium Management LLC lifted its position in shares of Brainsway by 69.6% in the 3rd quarter. Millennium Management LLC now owns 39,841 shares of the company's stock valued at $600,000 after acquiring an additional 16,354 shares in the last quarter. Centiva Capital LP purchased a new stake in shares of Brainsway in the 3rd quarter valued at approximately $181,000.
Bank of America Corp DE acquired a new position in Brainsway in the 3rd quarter worth approximately $107,000.
Finally, Two Sigma Investments LP grew its position in Brainsway by 25.2% during the 3rd quarter. Two Sigma Investments LP now owns 102,902 shares of the company's stock worth $1,551,000 after purchasing an additional 20,706 shares in the last quarter. Institutional investors and hedge funds own 30.11% of the company's stock.

Brainsway Company Profile (Get Free Report)
Brainsway Ltd is a medical device company specializing in non-invasive neuromodulation therapies. Publicly traded on the NASDAQ under the symbol BWAY, the company develops and commercializes deep transcranial magnetic stimulation (Deep TMS) systems designed to treat a range of neuropsychiatric and neurological disorders. Brainsway's technology aims to offer an alternative or complement to traditional pharmacological therapies by targeting precise brain regions with its patented coil designs.

The company's flagship Deep TMS platform utilizes proprietary H-coil arrays engineered to reach deeper cortical structures than conventional TMS devices.

PsyCare Inc. hosts clinical trials for new way to treat Alcohol Use Disorder

https://www.coalvalleynews.com/news/psycare-inc-hosts-clinical-trials-for-new-way-to-treat-alcohol-use-disorder/article_e5660d17-3239-5d1d-8fdd-d9bf5e0ad7d6.html

By MAGGIE SUSA msusa@hdmediallc.com
Jan 17, 2026 Updated 3 hrs ago

SOUTH CHARLESTON — Nearly 1 in 10 Americans over the age of 12 has Alcohol Use Disorder, and West Virginia ranks third-highest nationally for alcohol-related deaths due to acute causes, according to the National Center for Drug Abuse Statistics. This includes deaths from DUIs, suicides, organ failure and other causes related to AUD.

Dr. Russ Voltin at PsyCare Inc. in South Charleston is leading a research team working on a new study to treat AUD with Deep Transcranial Magnetic Stimulation, a technology owned by BrainsWay. The current standard to treat AUD is through abstinence with talk therapy and Alcohol Anonymous groups.

BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)

https://finance.yahoo.com/news/brainsway-announces-fda-approval-neurolief-123000248.html

BrainsWay’s strategic investment in Neurolief paved the way for the first and only FDA approved at-home neuromodulation device with Class III Premarket Approval labeling for MDD patients who failed one or more prior antidepressants

BURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for Neurolief's Proliv™Rx system, a Class III device, as an adjunctive treatment for adult patients suffering from major depressive disorder (MDD) who have failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in the clinic.

This approval represents a significant regulatory milestone, making Proliv™Rx the first and only at-home neuromodulation treatment with FDA labeling applicable to treatment refractory MDD patients. The approval expands the clinical landscape beyond traditional in-clinic care and reflects growing regulatory recognition of advanced neuromodulation solutions designed for use in the home setting.

“Our strategic investment in Neurolief, which includes an option to acquire Neurolief, positions us to both enhance our current value proposition to our existing market as well as potentially increase our total addressable market by enabling care for patients who may not be able to easily access the clinic. We are currently working on meaningful synergistic approaches that include the commercial and research infrastructures of both companies,” stated Hadar Levy, Chief Executive Officer of BrainsWay. “This FDA approval represents an exciting early validation of our investment strategy and reinforces our conviction in data-driven, technology-enabled mental health care. Our work with Neurolief, which is singular among TMS manufacturers, further strengthens our leadership position and advances our long-term vision to become the only company in the mental health space offering data-based integration of multiple treatment modalities across multiple care settings,” concluded Mr. Levy.

About Neurolief
Neurolief is a pioneering neuromodulation company committed to developing breakthrough therapies for mental health and neurological disorders. The company has developed the world’s first wearable, non-invasive, multi-channel brain neuromodulation system, that is designed for use at home, engineered to simultaneously stimulate key neural pathways in the head in order to modulate brain regions involved in regulation of mood and pain. Neurolief's Proliv™Rx device was granted Premarket Approval by the U.S. Food and Drug Administration (FDA), and is indicated as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic. Its Relivion® MG device is currently FDA-cleared and CE-marked for the treatment of migraine. Learn more at: www.neurolief.com.

BrainsWay Announces First Coverage Policy for Accelerated Deep TMS™

https://finance.yahoo.com/news/brainsway-announces-first-coverage-policy-123000260.html

New Premera Blue Cross Blue Shield® policy extends to both adolescent and adult depression patients

BURLINGTON, Mass. and JERUSALEM, Jan. 07, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Premera Blue Cross Blue Shield®, a company with over 2.8 million covered lives serving Alaska and Washington state, has adopted a new final medical policy which, among other developments, expands coverage to include patients ages 15 and older with moderate to severe major depressive disorder (MDD) treated with BrainsWay’s accelerated SWIFT™ (Short-course with Intrinsic Field Targeting) Deep TMS™ protocol.

“We are elated at Premera’s decision to formally adopt a policy covering our SWIFT depression protocol, which marks a first among payers. SWIFT entails significantly fewer days spent in the clinic, allowing patients to achieve meaningful improvement more quickly than our standard Deep TMS protocol,” stated Hadar Levy, Chief Executive Officer of BrainsWay.

BrainsWay’s SWIFT depression protocol consists of an acute phase of five treatment sessions (ten minutes each) per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions. There is no need for any functional MRI or other expensive neuronavigational equipment.

“BrainsWay’s clinical trial and real-world evidence demonstrates comparable response and remission outcomes for its SWIFT accelerated depression protocol when compared to the standard Deep TMS protocol. We are committed to continuing our efforts to educate stakeholders within our space on the compelling data supporting additional favorable coverage of this novel protocol,” stated Colleen Hanlon, PhD, Vice President of Medical Affairs for BrainsWay.


BrainsWay continues to lead the field with its proprietary H-coil technology, robust clinical research, and ongoing collaboration with providers and policymakers to expand access to advanced neurostimulation therapies.

BrainsWay Unveils SWIFT, A New FDA-Cleared Treatment for Depressive Disorders

Watch Dr. Richard A. Bermudes, BrainsWay’s Chief Medical Officer, explain how SWIFT, the accelerated Deep TMS protocol, provides rapid, noninvasive relief for patients with depressive disorders.

Watch here: https://ktul.com/living-oklahoma/segments/brainsway-announces-swift-a-new-fda-cleared-option-for-treating-depressive-disorders

Small wonder BWAY breaks 52w/h day in-day out

18.90 +1.79 (+10.46%)
As of 1:40:46 PM EST. Market Open.
Indeed broke 52w/h

$BWAY 18.37 +1.26 (+7.36%)
Just broke 52w/h

BrainsWay Reports Expansion of Adolescent Depression Coverage Applicable to Deep TMS™

https://finance.yahoo.com/news/brainsway-reports-expansion-adolescent-depression-123000653.html

Optum Behavioral Health, a Health Services Company with Over 48 Million Covered Lives, Joins Growing List of Insurers Now Covering Deep TMS Depression Therapy for Adolescents Aged 15 and Older

BURLINGTON, Mass. and JERUSALEM, Dec. 22, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Optum Behavioral Health, a leading health services company with over 48 million covered lives through its network of professionals and a part of UnitedHealth Group, has expanded its medical policy applicable to Deep TMS™ therapy to include coverage for adolescents aged 15 and older with a confirmed diagnosis of major depressive disorder (MDD).

“Optum’s policy expansion marks an important step forward in expanding access to a more effective, clinically proven, and non-drug treatment option for young people affected by MDD,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Deep TMS has already changed the trajectory of care for adults facing depression, and extending access to younger patients reflects a shared commitment to early intervention, innovation, and meaningful clinical impact.”

“Optum’s decision to expand its coverage brings it in line with several other leading insurers that already cover Deep TMS for adolescents with MDD, including Evernorth Health Services, CVS/Aetna, Medi-Cal, PacificSource Health Plans, TRICARE, and several Blue Cross and Blue Shield companies, including Health Care Service Corporation, Highmark, Regence, Florida Blue, Blue Cross Blue Shield of Michigan and Blue Cross Blue Shield of North Carolina, among others. These payers, in the aggregate, cover approximately 180 million lives. We believe this decision reflects a growing recognition of Deep TMS as an essential component of modern mental health care,” concluded Mr. Levy.


An estimated 5 million adolescents aged 15–21 in the United States experience major depression, representing a significant and growing public health challenge. For these young individuals, depression can disrupt critical developmental milestones, affecting academic achievement, family relationships, social functioning and emotional growth during formative years. Treatment options for MDD remain limited, particularly for adolescents who cannot tolerate or do not respond to medication. Those who fail to achieve relief with first-generation treatments face prolonged suffering, higher healthcare costs, and a higher risk of comorbid conditions, such as substance abuse and suicide. Together, these challenges highlight what has historically been a critical gap in access to effective, well-tolerated treatment options for this vulnerable population.

BrainsWay’s Deep TMS is FDA cleared as an adjunct therapy for adolescent patients with depression based on clinical evidence demonstrating meaningful response and remission rates, providing renewed hope at a pivotal stage of life. BrainsWay continues to lead the field with its proprietary H-coil technology, robust clinical research, and ongoing collaboration with providers and policymakers to expand access to advanced neurostimulation therapies.

I forsee todays interest in the Virtual Analyst & Investor Day
drive sp above 52w/h

BrainsWay to Host Virtual Analyst & Investor Day to Discuss the Company’s Growth Strategy and Deep TMS™ Treatment December 1, 2025

https://finance.yahoo.com/news/brainsway-host-virtual-analyst-investor-123000785.html

BURLINGTON, Mass. and JERUSALEM, Nov. 25, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that it will host a virtual Analyst & Investor Day on Monday, December 1, 2025 at 10:00 AM ET, during which company management will highlight various aspects of BrainsWay’s growth strategy. The event will feature Owen Scott Muir, MD, DFAACAP (Co-Founder, Chief Medical Officer, Radial), who will discuss the significant unmet need for various conditions and his clinical experience utilizing Deep TMS™, and Michael Gershenzon, CEO of Stella MSO, a management services organization servicing more than 20 mental health clinics across the U.S. and Israel, who will discuss his experience working with BrainsWay on BrainsWay’s strategic minority-stake investment in Stella. To register, click here.

The event will provide an overview of BrainsWay’s patented breakthrough treatment, Deep TMS, and the potential impact of its accelerated protocol. Deep TMS is a clinically proven, noninvasive in-office brain stimulation treatment that uses magnetic fields to activate neural networks in the brain to improve symptoms of certain mental health and addiction conditions, including depression, obsessive-compulsive disorder, and smoking addiction.

A live question and answer session will follow the formal presentations.

About Owen Scott Muir, MD, DFAACAP
Owen Scott Muir, MD, DFAACAP, is a dual-board-certified child, adolescent, and adult psychiatrist and the Chief Medical Officer of Radial Health and Neurolief. He is a leading investigator in advanced neuromodulation, with work spanning deep-TMS (H-coil platforms), accelerated protocols, vocal, video, language, and oculomotor biomarkers, and multimodal precision psychiatry. Dr. Muir has served as principal or co-investigator on trials involving BrainsWay, Magnus, Ampa, Psyrin, Videra, iRxReminder, Mind Medicine, and other cutting-edge technologies. His clinical programs have pioneered real-world deployment of accelerated neuromodulation for adolescents and adults with severe depression, OCD, suicidality, and treatment-resistant conditions. He is also the author of The Frontier Psychiatrists newsletter (2.5m reads), TikTok (8m views/year), LinkedIn (1m impressions/year with 7.7.% engagement rate) and the popular press Inessential Pharmacology, and continues to publish on the integration of AI-augmented neurotherapeutics into routine care.

BrainsWay Launches First Clinical Trial of Deep TMS 360™ System for Alcohol Use Disorder

https://finance.yahoo.com/news/brainsway-launches-first-clinical-trial-123000060.html

Multicenter, randomized, controlled study will evaluate Company’s next-generation multichannel TMS technology in reducing heavy drinking and cravings

BURLINGTON, Mass. and JERUSALEM, Nov. 17, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced the launch of a multicenter clinical trial investigating the use of its novel Deep TMS 360™ system in individuals with Alcohol Use Disorder (AUD). AUD represents a major economic and health burden, affecting about 29 million Americans (10% of those aged 12+) and, despite available treatments, up to 60% of patients relapse within 3-6 months. This study will mark the first multicenter clinical trial utilizing BrainsWay’s next-generation multichannel TMS platform, representing a major milestone in advancing the company’s innovation pipeline.

The Company’s new Deep TMS 360 technology has been designed to provide more comprehensive and uniform stimulation of the neurons in the targeted brain regions. BrainsWay believes that the multichannel architecture of this new system may be better suited for complex clinical populations such as those suffering from chronic AUD, where there may be greater difficulty in achieving desired stimulation levels due to cortical atrophy (i.e. brain shrinkage).

“The launch of this trial represents a pivotal step in expanding our quest to advance into new and highly important therapeutic areas,” said Hadar Levy, CEO of BrainsWay. “Alcoholism is one of the most pressing public health challenges worldwide, and we believe our new 360 technology has the potential to make a meaningful difference for patients seeking to reduce or overcome alcohol dependence.”

The study will be a randomized, double-blind, sham-controlled clinical trial, and will enroll over 200 patients aged 18–86 with moderate to severe AUD as determined using the DSM-5 criteria. Participants will receive either active or sham Deep TMS 360 treatments for approximately six months, including an intensive treatment phase during the first 3–5 weeks, followed by weekly maintenance sessions until the 6-month follow-up visit. Each visit comprises two sessions per day. The trial’s primary endpoint is the proportion of participants who experience no heavy drinking days (NHDD) during the initial four-month treatment period – an endpoint recognized by the FDA as clinically meaningful in AUD research. Subjects will also undergo educational and behavioral sessions focused on coping strategies and alcohol use reduction.

“BrainsWay’s new Deep TMS 360 system is an exciting evolution of our platform, designed to deliver more robust stimulation patterns,” said Dr. Colleen Hanlon, Vice President of Medical Affairs BrainsWay. “We anticipate this study will advance our understanding of how noninvasive neuromodulation can help reduce alcohol cravings and promote long-term recovery.”

The study will be conducted at multiple research sites across the US – including Alabama, California, Florida, Illinois, New York, and West Virginia – as well as several select international sites in Israel and Sweden. The study follows previous studies investigating BrainsWay’s current Deep TMS system in AUD which resulted in promising data.

Individuals wishing to learn more about potentially enrolling in this study may visit https://www.go.brainsway.com/brainsway-aud-trial-participants.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

BrainsWay Receives FDA Clearance of Deep TMS™ as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21

https://finance.yahoo.com/news/brainsway-receives-fda-clearance-deep-110000205.html

BWAY, new 52 week high

BWAY, new 52 week high

BWAY, new 52 week high

BWAY , new 52 week high

dear midastouch, what do you see here?
I believe it can help those depressed or suffering from OCD without toxic drugs. Plus FDA/Medicare shifting to covering 2 TMS treatments per day instead of 1 suggests they like it too. If the stigma shifts the government should start taking on more of the costs.

Robust 26% Year-over-Year Revenue Growth in Q3 2024

Raising Full-Year 2024 Revenue Guidance to $40-41 Million and Initiating Profitability Guidance
With this data, it is quite strange that sp is declining in PM

BrainsWay Reports Third Quarter 2024 Financial Results and Operational Highlights

https://finance.yahoo.com/news/brainsway-reports-third-quarter-2024-123000415.html


Robust 26% Year-over-Year Revenue Growth in Q3 2024

Raising Full-Year 2024 Revenue Guidance to $40-41 Million and Initiating Profitability Guidance

Conference Call to be Held Today at 8:30 AM ET

BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported third quarter 2024 financial results and provided an operational update.

Recent Financial and Operational Highlights

For the three months ended September 30, 2024, revenues were $10.5 million, a 26% increase compared to the same period in 2023.

Gross margin for the third quarter of 2024 was 74%, steady from the same period in 2023.

Operating income for the third quarter of 2024 was $0.3 million, compared to a loss of $0.1 million for the same period in 2023.

Net income for the third quarter of 2024 was $0.7 million, compared to a net loss of $0.2 million for the third quarter of 2023.

Adjusted EBITDA1 for the third quarter of 2024 was approximately $1.1 million, compared to $0.3 million for the third quarter of 2023.

As of September 30, 2024, cash and cash equivalents and short-term deposits totaled $48.4 million, reflecting a $0.3 million increase from June 30, 2024.

Following the end of the third quarter, the Company closed on an equity financing by Valor Equity Partners, receiving gross proceeds of approximately $20 million to date, before deducting offering expenses and before any potential exercise of warrant rights by Valor. BrainsWay intends to leverage this new capital and Valor’s expertise for strategic initiatives aimed at building market awareness, its R&D roadmap, and expanding access to Deep TMS™.

Through the first nine months of 2024, BrainsWay shipped a total of 177 Deep TMS systems, representing a 12% increase from the same period last year.

Israel Ministry of Defense’s Rehabilitation Department approved reimbursement for Deep TMS therapy for qualifying PTSD patients in public hospitals.

Appointed Dr. Richard Bermudes, who is widely considered one of the preeminent U.S. clinicians in the TMS field, as BrainsWay’s new Chief Medical Officer (CMO), effective September 1, 2024.

Expanded U.S. East Coast access to Deep TMS with order of 14 new systems by large enterprise mental health treatment network.

Expanded the presence of Deep TMS in East Asia through the placement of 15 new systems in Taiwan and South Korea.

Continued progress in the Company’s randomized, multicenter U.S. clinical trial evaluating an accelerated treatment protocol for the Deep TMS system for major depressive disorder (MDD) treatment as compared to the current standard-of-care Deep TMS protocol.

________________________
1 See Adjusted EBITDA details and reconciliation table in the appendix below.

Full Year 2024 Financial Guidance

Increasing full-year 2024 revenue guidance to between $40 million to $41 million, which represents 25% to 29% growth over 2023 revenue.

Anticipating continued profitability and positive cash flow, and expecting operating income of 3-4% and Adjusted EBITDA of 10-11% for the full year.

"Global demand for our Deep TMS system continued to grow throughout the first nine months of 2024, strengthening our leadership position in the market. Our focus remains on building sustainable growth by investing strategically in our long-term vision. Our commitment to driving innovation and expanding treatment possibilities is stronger than ever, with key investments across three core areas, including the development of our next-generation Deep TMS 360™ system, conducting clinical trials to broaden and enhance treatment capabilities, and expanding our commercial presence through targeted sales and marketing efforts. These critical investments reflect our dedication to leading the industry in mental health and neurological care, providing impactful and accessible solutions for patients worldwide," said Hadar Levy, BrainsWay’s Chief Executive Officer.

"Our recent private financing with Valor Equity Partners will enable us to explore new markets and revenue channels, including different customer types and commercial partnerships. This will further strengthen our potential for accelerated growth and enhance access to Deep TMS," concluded Mr. Levy.

Call and Webcast

BrainsWay’s management will host a conference call on Tuesday, November 12, 2024, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Tuesday, November 12, 2024, at 8:30 AM Eastern Time:

United States:

1-877-300-8521

International:

1-412-317-6026

Israel:
Conference ID:

1-80-921-2373
10193781

Webcast:

https://viavid.webcasts.com/starthere.jsp?ei=1693565&tp_key=866e8470ea





The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register.

Non-IFRS Financial Measures

In addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating income and net income, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net income adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses.

In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:

Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired.

Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results.

Adjusted EBITDA, however, should not be considered as an alternative to operating income (loss) or net income (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company’s net income (loss) and Adjusted EBITDA is presented in the attached summary financial statements.

Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net income (loss) and our IFRS financial results.

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.

Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors LLC
britchie@lifesciadvisors.com




BRAINSWAY LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

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September 30,



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2023



ASSETS



(Unaudited)



(Audited)

Current Assets









Cash and cash equivalents



$

48,127





$

10,520



Short-term deposits





-







35,465



Restricted cash





271







271



Trade receivables, net





3,521







3,780



Inventory





3,690







3,717



Other current assets





1,720







1,712









57,329







55,465



Non-Current Assets









System components





1,745







1,273



Leased systems, net





3,962







3,700



Other property and equipment





6,795







817



Other long-term assets





2,269







1,717









14,771







7,507







$

72,100





$

62,972













LIABILITIES AND EQUITY









Current Liabilities









Trade payables



$

1,269





$

758



Deferred revenues





4,824







2,504



Liability in respect of research and development grants





600







1,008



Other accounts payable





5,994







5,491









12,687







9,761



Non-Current Liabilities









Deferred revenues and other liabilities





9,038







5,553



Liability in respect of research and development grants





6,347







6,077









15,385







11,630













Equity









Share capital





367







367



Share premium





140,662







140,344



Share-based payment reserve





5,116







4,360



Currency Translation Adjustments





(2,188

)





(2,188

)

Accumulated deficit





(99,929

)





(101,302

)







44,028







41,581

















$

72,100





$

62,972
















BRAINSWAY LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

U.S. dollars in thousands (except per share data)

























For the three months ended
September 30,





For the nine months ended
September 30,







2024





2023









2024





2023







(Unaudited)





(Unaudited)

Revenues



$

10,502



$

8,302







$

29,602



$

22,756



Cost of revenues





2,781





2,131









7,532





6,018



Gross income





7,721





6,171









22,070





16,738











































Research and development expenses, net





1,809





1,544









5,146





5,231



Selling and marketing expenses





4,108





3,602









11,731





12,497



General and administrative expenses





1,523





1,158









4,233





4,153



Total operating expenses





7,440





6,304









21,110





21,881























Operating income (loss)





281





(133

)







960





(5,143

)





















Finance income





830





175









1,945





1,583



Finance expenses





374





213









1,182





349



Income (loss) before income taxes





737





(171

)







1,723





(3,909

)

Taxes on income





75





59









350





415



Net income (loss) and total comprehensive income (loss)



$

662



$

(230

)





$

1,373



$

(4,324

)





















Basic and diluted net income (loss) per share



$

0.02



$

(0.01

)





$

0.04



$

(0.13

)
























BRAINSWAY LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands























For the three months ended
September 30,



For the nine months ended
September 30,







2024







2023







2024







2023







(Unaudited)



(Unaudited)

Cash flows from operating activities:

















Total comprehensive income (loss)



$

662





$

(230

)



$

1,373





$

(4,324

)

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:















Adjustments to profit or loss items:

















Depreciation and amortization





188







85







308







279



Depreciation of leased systems





260







247







755







719



Impairments and disposals





600







481







1,242







938



Finance expenses (income), net





(456

)





38







(763

)





(1,234

)

Cost of share based payment





388







95







1,057







147



Income taxes





75







59







350







415



Total adjustments to reconcile income (loss)





1,055







1,005







2,949







1,264



Changes in asset and liability items:

















Decrease (increase) in trade receivables





415







(31

)





295







1,404



Increase in inventory





(465

)





(373

)





(572

)





(6

)

Decrease (increase) in other current assets





41







369







72







(243

)

Increase (decrease) in trade payables





(366

)





(58

)





514







(639

)

Increase (decrease) in other accounts payable





456







401







(74

)





(356

)

Increase (decrease) in deferred revenues and other liabilities





(52

)





(173

)





1,151







238



Total changes in asset and liability





29







135







1,386







398



Cash paid and received during the period for:

















Interest paid





(81

)





(100

)





(104

)





(103

)

Interest received





613







546







2,194







1,586



Income taxes paid





-







-







(994

)





(11

)

Total cash paid and received during the period





532







446







1,096







1,472



Net cash provided by (used in) operating activities:





2,278







1,356







6,804







(1,190

)



















Cash flows from investing activities:

















Purchase of property and equipment and system components, net





(1,300

)





(514

)





(2,871

)





(1,945

)

Proceeds from sub-lease asset





-







-







40







-



Withdrawal of (investment in) deposits, net





(34

)





8







34,985







(8

)

Net cash provided by (used in) investing activities





(1,334

)





(506

)





32,154







(1,953

)



















Cash flows from financing activities:

















Repayment of liability in respect of research and development grants





(572

)





-







(1,104

)





(345

)

Exercise of share options





-







-







19







-



Receipt of government grants





-







-







-







32



Repayment of lease liability





(126

)





(56

)





(237

)





(186

)

Net cash used in financing activities





(698

)





(56

)





(1,322

)





(499

)

Exchange rate differences on cash and cash equivalents





17







(69

)





(29

)





(46

)



















Increase (decrease) in cash and cash equivalents





263







725







37,607







(3,688

)

Cash and cash equivalents at the beginning of the period





47,864







43,168







10,520







47,581



Cash and cash equivalents at the end of the period



$

48,127





$

43,893





$

48,127





$

43,893





















(a) Significant non cash transactions:

















Recognition of new lease liability and right-of-use



$

5,469





$

-





$

5,650





$

207



Termination of lease liability and right-of-use



$

-





$

-





$

17





$

70























BRAINSWAY LTD.

A reconciliation of Adjusted EBITDA to net income (loss), the most directly comparable IFRS measure, is set forth below:

U.S. dollars in thousands (except share and per share data)























For the three months ended September 30,



For the nine months ended September 30,







2024







2023







2024







2023







(Unaudited)



(Unaudited)

Net income (loss) and total comprehensive income (loss)



$

662





$

(230

)



$

1,373





$

(4,324

)



















Finance expense (income), net





(456

)





38







(763

)





(1,234

)

Income taxes





75







59







350







415



Depreciation and amortization





188







85







308







279



Depreciation of leased systems





260







247







755







719



Cost of share based payment





388







95







1,057







147



Restructuring and litigation Cost





-







50







-







852



Adjusted EBITDA



$

1,117





$

344





$

3,080





$

(3,146

)






















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BWAY, new 52 week high

BWAY (own it) new 52 week high

great israeli company....... not one of those.
likely going to be acquired at one point.

BrainsWay Further Penetrates East Asia with Placement of 15 Additional Deep TMS™ Systems in Taiwan and South Korea

https://finance.yahoo.com/news/brainsway-further-penetrates-east-asia-113000596.html

BURLINGTON, Mass. and JERUSALEM, Israel, Oct. 09, 2024 (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 the further expansion of its Deep Transcranial Magnetic Stimulation (Deep TMS™) platform in East Asia through the placement of 15 new systems in Taiwan and South Korea.

“The recent orders for 15 additional Deep TMS systems to be used by mental health centers in Taiwan and South Korea are indicative of the continued commercial success we are experiencing in penetrating this strategically important region. These countries each play an important role in our international growth strategy, and we are pleased to report the expanding demand from the East Asia region,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “The BrainsWay team and our international distribution partners continue to focus on expanding access to our innovative Deep TMS platform among patients and healthcare providers globally.”

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

BrainsWay Announces US$20 Million Private Placement with Valor Equity Partners

https://finance.yahoo.com/news/brainsway-announces-us-20-million-113000437.html

Company to leverage capital and Valor’s expertise for strategic initiatives building market awareness, R&D roadmap, data analysis capabilities, and expanding access to Deep TMS™

Purchase price of US$9.51 represents a 20% premium over 30-day VWAP of BrainsWay’s American Depositary Shares

Valor provides growth equity to technology-enabled companies and currently has $18.9B in assets under management

BURLINGTON, Mass. and JERUSALEM, Sept. 30, 2024 (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 that it has entered into a securities purchase agreement with an affiliate of Valor Equity Partners (“Valor”) for a private investment financing (the "PIPE") expected to result in gross proceeds of approximately US$20 million. Valor is an operational growth investment firm focused on investing in high-growth companies across various stages of development. The firm partners with leading companies and entrepreneurs who are committed to the highest standards of excellence and the courage to transform their industries. For decades, Valor has served companies such as SpaceX, Tesla, Neuralink, Harmony Biosciences, and K Health with unique expertise to solve the challenges of growth and scale.

“The equity financing strengthens the Company’s balance sheet, further advances strategic initiatives, and expands access to its Deep TMS™ technology, while aligning BrainsWay with a premier U.S. tech investor,” Ami Boehm, the Company’s Chairman of the Board, notes. “With this transaction, we will be better positioned to accelerate the growth of our business by tapping into new markets and new revenue channels, including customer types and commercial partnerships. During the past year, we have received several inbound requests from leading investment groups interested in investing in BrainsWay. We elected to move forward with Valor given its exceptional track record and our belief that it is ideally suited to support us in executing our growth plans in the U.S. We are pleased to welcome Valor to our board of directors.”

“We are grateful for the opportunity to provide this important strategic growth capital to BrainsWay at a pivotal point in its corporate evolution,” said Jonathan Shulkin, Partner and Co-President at Valor. “BrainsWay’s transformative TMS technology has the opportunity to capture significant market share in the growing global TMS industry. Our investment in BrainsWay reflects our focus on disruptive technologies and businesses, as well as our strong belief in the Company’s mission and leadership.”

In the PIPE, BrainsWay has agreed to issue to Valor (i) an aggregate of 2,103,745 American Depositary Shares (ADSs) (representing 4,207,490 ordinary shares), at a purchase price of US$9.51 per ADS, a 20% premium above the 30-day volume-weighted average price (VWAP) of the ADSs, and (ii) warrants (the "Warrants") to purchase up to an additional 1,500,000 ADSs (representing up to 3,000,000 ordinary shares) at the same price (the “Exercise Price”), which may further increase the proceeds from the PIPE up to a total of approximately US$34.3 million if the Warrants are fully exercised in cash. The Warrants will become exercisable upon issuance thereof at the closing of the PIPE and will remain exercisable for 18 months following their initial issuance date, provided, however, that during such 18-month period, if the Company’s ADS closing price for any thirty (30) consecutive trading days exceeds the Exercise Price by 40% or more, the holder of the Warrants shall be required to fully exercise the Warrants in accordance with the terms therein within five (5) trading days.

In connection with the PIPE, the Company is granting Valor the right to nominate (i) at least one member to its board of directors so long as Valor holds, directly or indirectly, at least 10% of the outstanding voting rights of the Company and (ii) two members to its board of directors so long as Valor holds, directly or indirectly, at least 20% of the issued and outstanding share capital of the Company. Valor has notified the Company that the initial director it designates for nomination as a member to the board of directors will be Mr. Shulkin.

The closing of the PIPE and the issuance of the ADSs and Warrants to Valor is subject to customary closing conditions as well as the Company obtaining shareholder approval of the transaction. The Company agreed to (i) file a notice and proxy statement for its extraordinary general meeting of its shareholders for the purpose of obtaining such shareholder approval by no later than ten (10) days following the signing of the securities purchase agreement and (ii) hold such meeting within thirty-five (35) days following such filing. The Company intends to use the proceeds from the PIPE for strategic initiatives including to expand market awareness, enhance data analysis capabilities, develop its R&D roadmap, evaluate other potential opportunities in the TMS industry and expand access to Deep TMS.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the securities purchase agreement, BrainsWay and Valor entered into a registration rights agreement pursuant to which the Company has agreed to file within 10 days following receipt of the shareholder approval noted above a registration statement with the Securities and Exchange Commission to register the resale of the ADSs sold in the PIPE financing, as well as the securities underlying the Warrants sold in the PIPE financing.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Valor Equity Partners

Valor, founded and led by Antonio J. Gracias, Valor’s Chief Executive Officer and Chief Investment Officer, is an operational growth investment firm focused on investing in, and partnering with, high-growth companies and entrepreneurs with the courage to transform their industries. For decades, Valor has served companies such as SpaceX, Tesla, Neuralink, Harmony Biosciences, and K Health with unique expertise to solve the challenges of growth and scale. Valor Siren Ventures II L.P. (together with its parallel funds, “VSV”) is a venture fund managed by Valor and the primary fund investing in the PIPE. VSV is differentiated by anchor investments from Starbucks, Nestlé, and a suite of Fortune 500 food and retail organizations. VSV seeks to add value to portfolio companies by applying the intellectual capital of Valor and accelerating growth through its operations team and network of strategic investors. Valor’s mission is to serve exceptional founders, entrepreneurs, and companies that are making the world a better place. For more information on Valor Equity Partners, please visit www.valorep.com.

BWAY under $10

BWAY10Q due March 6

BWAY new 52 week high

BWAY new 52 week high

BWAY new 52 week high

BrainsWay Broadens Access to Deep TMS™ for U.S. Military Service Members Through Expanded Partnership with Katie’s Way Plus

https://finance.yahoo.com/news/brainsway-broadens-access-deep-tms-113000032.html

Provider of Mental Health Services with Focus on Military Community Orders 10 New Deep TMS™ Systems

BURLINGTON, Mass. and JERUSALEM, Sept. 20, 2023 (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 that its longstanding partner, Katie’s Way Plus, which provides comprehensive mental health services tailored to the unique needs of active duty military members, veterans, and their families, has ordered an additional 10 Deep Transcranial Magnetic Stimulation (Deep TMS™) systems, which will more than double its existing offering.

“This is yet another demonstration of our strategic focus on larger enterprise customers across the U.S.,” said Eric Hirt, VP U.S. Sales of BrainsWay. “The strategic collaboration between BrainsWay and Katie's Way Plus is poised to make a substantial impact on addressing the critical and unique mental health issues faced by military personnel by providing world-class care to those who have served their country and are in need of advanced solutions to address their specialized conditions.”

“We are thrilled to support Katie's Way Plus in its vital mission to provide focused care to U.S. service members, veterans, and their families,” said Hadar Levy, Chief Executive Officer of BrainsWay. “BrainsWay's advanced Deep TMS technology has demonstrated remarkable clinical efficacy in treating depression, and we are confident that this expansion will bring hope and healing to many U.S. service members.”

“Katie's Way was founded in memory of my daughter, Katie, who tragically lost her battle with depression,” said Jeff Mathis, Founder of Katie’s Way. “Our goal is to ensure that no other family needs to endure such pain. These additional BrainsWay systems will allow us to extend our reach, offer hope, and ultimately save lives.”

Depression is a contributing factor to suicide, which is a particularly pressing concern within the military community. September is Suicide Prevention Month, which helps raise awareness to the fact that 22 U.S. military veterans take their lives each dayi.

BrainsWay Deep TMS is delivered via a unique treatment coil housed in a cushioned, patient and provider-friendly helmet. The patient is awake, alert, and engaged during the treatment session, and each session only takes less than 30 minutes from start to finish. For some patients, a shorter three-minute intermittent theta burst (iTBS) protocol is also an option. Most candidates for Deep TMS depression treatment have already failed multiple courses of medication and talk therapy, and in a recently published post-marketing analysis of close to 1,400 patients, those patients who had received 30 or more treatments of Deep TMS demonstrated an 82% response rate and a 65% remission rateii.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

About Katie’s Way
Katie's Way TMS is a trailblazing mental health care provider with a heartfelt commitment to improving the lives of active duty military service members, veterans, and their families. Founded by Jeff Mathis, our mission is deeply rooted in a profound personal loss. Jeff's daughter, Katie, tragically lost her battle with depression, inspiring him to establish Katie's Way with a resolute determination to prevent others from experiencing a similar tragedy. At Katie's Way TMS, our focus is clear: to provide specialized care, hope, and healing to those who have selflessly served our nation. We understand the unique challenges that military members, veterans, and their families face when it comes to mental health, and we are dedicated to addressing these challenges head-on. With unwavering commitment, Katie's Way TMS strives to make a meaningful impact by providing accessible, evidence-based care to individuals who have sacrificed so much for our country. Our journey is driven by the memory of Katie and the hope that no other family will have to endure the pain of losing a loved one to depression. Katie’s Way currently operates 5 treatment facilities in the United States, and will expand to 12-15 clinics by early 2024. To learn more, please visit www.katieswayplus.com.

Year to date

4.7200+0.3900 (+9.0069%)
As of 11:17AM EDT. Market open.
Momentum continues:
Volume 378,206
Avg. Volume 51,124

BWAY new 52 week high

BrainsWay Forges Strategic Partnership with Treatment Provider in Northeast U.S.

https://finance.yahoo.com/news/brainsway-forges-strategic-partnership-treatment-113000648.html


10 Deep TMS™ Systems to be Installed in 2023 Alone

BURLINGTON, Mass. and JERUSALEM, Sept. 05, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced non-invasive neurostimulation treatments, today announced the formation of a strategic partnership with a prominent mental health clinical treatment provider with an increasingly expanding footprint in the Northeast region of the United States. As a result of this partnership and a series of successive orders, a total of 10 Deep Transcranial Magnetic Stimulation (Deep TMS™) systems will be installed by this provider in 2023 alone, with the potential for additional systems thereafter.

"We are thrilled to strengthen our relationship with this esteemed and rapidly growing mental health services provider,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Their order of 10 systems this year alone, with interest in additional systems in the future, is a testament to this customer’s confidence in BrainsWay’s status as the premier TMS technology platform in the industry.”

The announcement is the latest demonstration of the Company’s increasing traction with a variety of new institutional and enterprise customers in the U.S and internationally.

“We remain steadfast in our mission to redefine mental health treatment by leveraging our advanced and unique Deep TMS technology to address the alarming global increase in the prevalence of mental health conditions and the corresponding rise in demand for innovative and effective treatment modalities,” concluded Mr. Levy.

$BWAY - 🚀Up 10% Pre-Market/Current Price $2.58
👉Reports Q2 '23 Financial Results and Operational Highlights
👉For the 3 months ended June 30 '23, revenues were $7.8m, an 18% increase as compared to the Q1 '23. Gross margin for the Q2 '23 was 73%

BrainsWay Announces Publication of Three New Deep TMS Research Publications

https://finance.yahoo.com/news/brainsway-announces-publication-three-deep-120000767.html

New Articles Enhance Understanding of Deep TMS Safety Profile and Survey Addiction Research

BURLINGTON, Mass. and JERUSALEM, Aug. 03, 2023 (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 three recent publications highlighting its Deep Transcranial Magnetic Stimulation (Deep TMS™) in leading peer-reviewed medical journals.

Two of the publications enhance understanding of the safety profile of TMS. The first, published in Brain Stimulation, provides a concise overview of the adverse event profile of the H1, H4, and H7 Coils as studied in five (5) large, multicenter, randomized controlled trials (RCTs). It is the most transparent review on the safety record of a TMS device, and the only one of its kind published by a TMS manufacturer. The second, published in the Journal of Clinical Psychiatry and on Psychiatrist.com, provides practical recommendations on performing TMS on patients having metallic implants, a common contraindication for all forms of TMS.

The third, published in Brain Sciences, is a comprehensive review on the use of TMS to address smoking addiction, an existing indication supported by clinically proven efficacy, and potential indications including alcohol use disorder (AUD) and other substance use disorders (SUDs). BrainsWay Deep TMS™ for smoking addiction represents the only FDA-cleared TMS solution for any addiction. The publication highlights preliminary research of Deep TMS in various other addictions, and underscores the need for further randomized controlled clinical trials in these difficult-to-treat conditions.

“One of BrainsWay’s three pillars is ‘superior evidence,’ and we are committed to advancing the field of neuroscience through a greater understanding of this life-changing technology for mental health patients, their caregivers, and providers,” said Colleen Hanlon, Ph.D., BrainsWay’s Vice President of Medical Affairs and Director of Innovation. “The body of evidence supporting Deep TMS is unparalleled in depth and breadth, and we are excited to continue conducting research and analyzing existing datasets to provide our customer partners with informed science to best treat their patients.”

BrainsWay Reports First Quarter 2023 Financial Results and Operational Highlights

https://finance.yahoo.com/news/brainsway-reports-first-quarter-2023-113000884.html

BURLINGTON, Mass. and JERUSALEM, May 17, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported first quarter 2023 financial results and provided an operational update.

Recent Financial and Operational Highlights

For the three months ended March 31, 2023, revenues were $6.6 million, a 10% increase as compared to the fourth quarter of 2022.

The Company shipped a net total of 48 Deep TMS™ new systems during the first quarter of 2023, bringing BrainsWay’s total Deep TMS installed base to 932 total systems as of March 31, 2023, an 18% increase from the installed base at the same point in the prior year.

As of March 31, 2023, the Company had shipped 453 obsessive-compulsive disorder (OCD) coils as add-on helmets to certain of BrainsWay’s new and existing systems, representing OCD treatment capability on nearly 50% of its total installed base.

Cash, cash equivalents, and short-term deposits as of March 31, 2023, amounted to $44.3 million, compared to $47.9 million as of December 31, 2022.

Recently published compelling data in Psychiatry Research demonstrating high response and remission rates for depression and anxious depression patients undergoing Deep TMS™ treatment.

Data from the expansive post-marketing study demonstrated that patients who had received 30 or more treatments achieved an 82% response rate and a 65% remission rate in depression symptoms. Outcomes data from 1,351 patients evaluated in the study showed that average sustained response was achieved at 16 sessions, or 21 days after beginning treatment with Deep TMS.

Continued to achieve reimbursement progress, increasing access for patients to the Deep TMS system.

BlueCross BlueShield of Mississippi issued a healthcare policy update that allows TMS trained healthcare professionals to order and provide TMS treatment to their patients with major depressive disorder (MDD).

United HealthCare has updated their Medicare Advantage policy in states covered by National Government Services Medicare to allow non-physician practitioners, like nurse practitioners, to order and administer TMS Therapy to their patients with MDD in states where they have scope of practice to do so.

“We remain focused on implementing key initiatives aimed at growing the Company’s top-line while simultaneously advancing toward profitability,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “Importantly, we are gaining strong interest from our international business which increased significantly during the first quarter and helped facilitate our shipment of a net total of 48 systems during the quarter.”

“We also executed a number of cost optimization measures late in the first quarter that we expect to begin seeing the benefits of in the second quarter, and more meaningfully in the second half of this year,” continued Mr. Levy. “We continue to target breakeven operating income in the fourth quarter of 2023, while demonstrating full-year revenue growth over 2022.”

First Quarter 2023 Financial Results

Total revenues for the first quarter of 2023 were $6.6 million, compared to $8.0 million in the first quarter of 2022, a decrease of 17%.

Gross margin for the first quarter of 2023 was 73%, compared to 77% for the first quarter 2022.

Operating expenses for the first quarter of 2023 totaled $8.5 million, compared to $7.6 million for the first quarter of 2022.

Operating loss for the first quarter of 2023 was $3.7 million, compared to a loss of $1.5 million for the same period in 2022.

Net loss for the first quarter of 2023 was $2.4 million, compared to a loss of $2.0 million for the same period in 2022.

Conference Call and Webcast

BrainsWay’s management will host a conference call on Wednesday, May 17, 2023, at 8:30 a.m. Eastern Time to discuss these results and answer questions.

Wednesday, May 17, 2023, at 8:30 AM Eastern Time:

United States:

1-877-407-3982

International:

1-201-493-6780

Israel:

1-809-406-247

Conference ID:

13738617

Webcast:

https://viavid.webcasts.com/starthere.jsp?ei=1613817&tp_key=17843474e5

To listen to a live webcast, please visit the Investors section of the BrainsWay website at www.BrainsWay.com. Please access the Company’s website at least 10 minutes ahead of the conference call to register. The webcast replay will be available on the website for two weeks following the completion of the call.

Publication Analyzes Clinical Efficacy of Deep TMS™ in Treating Different Brain Regions Associated with Major Depressive Disorder

https://finance.yahoo.com/news/publication-analyzes-clinical-efficacy-deep-130000866.html


Study Results Outline a Potential Path to More Personalized Medicine in Noninvasive Brain Stimulation

BURLINGTON, Mass. and JERUSALEM, Jan. 31, 2023 (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 the publication of a comparative study of BrainsWay’s Deep Transcranial Stimulation (Deep TMS™) H1 Coil, which targets the lateral prefrontal cortex, and the Company’s H7 Coil, which targets the medial prefrontal cortex. Published in The Journal of Clinical Investigation (JCI) Insight, the study, which enrolled 169 treatment-resistant depression patients, validates the efficacy of both BrainsWay coils for depression, and also identifies preliminary predictors that could help optimize treatment based on individual patients’ attributes.

The primary endpoint of the study – non-inferiority of the H7 Coil in reducing depressive scores when compared to the H1 Coil – was successfully demonstrated among the overall patient population. This study served as the basis for BrainsWay’s August 2022 H7 Coil FDA clearance for depression. This publication of the study also includes a new retrospective analysis of the clinician rating scales and EEG data, revealing intriguing differences between the patient treatment of the two coils. Categorizing patients according to “clusters” of clinical depressive and anxiety baseline symptoms derived from a subset of the Hamilton Depression Rating Scale (HDRS-21) resulted in two subject groups: One with higher severity of the cluster, which on average responded better to the H1 Coil, and another with lower severity of the cluster, which on average responded better to the H7 Coil. This retrospective analysis was referred to in the publication as the “Clinical Differential Predictor” for TMS H-Coils.

Another interesting finding involved retrospective EEG analysis, which showed that brain activity measured during the first treatment session correlated with the clinical outcomes ultimately achieved after the full course of treatment. This finding suggests that specific brain patterns observed in an individual’s response to either coil during the early stages of treatment might be predictive of the longer-term outcome of treatment with that coil.

“This study is a significant milestone for depression and anxious depression patients and reinforces our commitment to bring mental health within reach for all,” said Christopher von Jako, Ph.D., President and CEO of BrainsWay.

“This study is an important scientific step forward toward personalized psychiatry,” said Prof. Abraham Zangen, Head of the Brain Stimulation and Behavior Lab and the Chair of the PsychoBiology Brain Program at Ben-Gurion University and a scientific consultant for and member of the board of directors of BrainsWay. “Previously published case series had indicated that the H7 Coil was potentially effective in treating depression in patients that did not achieve response or remission after undergoing treatment with TMS coils which target the lateral prefrontal cortex. While the similar reduction in depression scores notably validated the non-inferiority between the H1 and H7 Coils, we were truly inspired by the subsequent retrospective analyses of the clinician rating scales and EEG data. Once we apply the categorization technique employed in this study, the potential exists to increase depression response rates even further. For example, patients categorized as having high cluster severity demonstrated response rates of 95%. We look forward to further validating these preliminary predictors in subsequent research as we continue our quest to optimize patient outcomes.”

The paper, “Pursuing personalized medicine for depression by targeting lateral or medial prefrontal cortex with Deep TMS,” was published in The Journal of Clinical Investigation (JCI) Insight. For more information, please visit: https://insight.jci.org/articles/view/165271

About Major Depressive Disorder and Anxious Depression
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.

Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts:
Scott Areglado
SVP and Chief Financial Officer
617-771-2287
SAreglado@BrainsWay.com

Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com

Media Contact:
Meghan Laska
(610) 212-0125
Meghan.Laska@BrainsWay.com

BrainsWay Announces Extended Private Insurance Coverage in Washington State for the Treatment of OCD and Depression Utilizing Deep TMS™

https://finance.yahoo.com/news/brainsway-announces-extended-private-insurance-130000484.html

BURLINGTON, Mass. and JERUSALEM, Jan. 11, 2023 (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 that a major private insurance company in Washington state will extend positive coverage applicable to Deep Transcranial Magnetic Stimulation (Deep TMS™) for the treatment of obsessive-compulsive disorder (OCD) as of February 3, 2023. This policy extension provides coverage of Deep TMS for OCD to approximately 2.2 million members.

The policy change also reduces major depressive disorder (MDD) TMS coverage criteria from four failed medication trials to only three. OCD coverage criteria is also three failed medication trials.

“Over the past two years, BrainsWay has seen significant coverage expansion of Deep TMS, including reduced patient selection criteria and earlier access to treatment for both MDD and OCD patients,” said Scott Blackman, Director of Market Access of BrainsWay. “This has been especially evident in the Medicare population where all Medicare administrative contractors now cover depression with only one or two failed medication trials.”

BrainsWay continues to focus on informing and providing payers with its growing body of published clinical and real-world evidence to facilitate up-to-date evidence-based coverage determinations. In 2021, only 52.6 million U.S. lives were covered for OCD treatment with TMS. Last year, insurers such as Cigna, Highmark BCBS, and Palmetto GBA Medicare extended coverage, increasing the total covered lives to 90.5 million.

BrainsWay’s patented H-Coil technology was first FDA-cleared for treating MDD in 2013 and OCD in 2018, and is designed to penetrate deeper and broader structures of the brain than traditional TMS coils.

BrainsWay Resolves Neuronetics Litigation

https://finance.yahoo.com/news/brainsway-resolves-neuronetics-litigation-130000356.html

BURLINGTON, Mass. and JERUSALEM, Jan. 10, 2023 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported that it has settled litigation filed by Neuronetics, Inc. (“Neuronetics”) in the District of Delaware.

BrainsWay had filed a motion to dismiss the case, and, while that motion was pending, agreed to settle the case on mutually agreeable terms and without any admission of liability or wrongdoing, including the release of certain potential counterclaims, to avoid the time, expense and uncertainty of litigation. “We are pleased to have resolved this litigation so that we can focus our full attention on our technology and bringing our Deep TMS™ therapy to patients,” said Christopher von Jako, P.h.D., President and CEO of BrainsWay.

Except as set forth in this press release, and a corresponding announcement from Neuronetics, the parties have agreed to keep the terms of the settlement agreement confidential.