BrainsWay Ltd. (BWAY): Business Model Canvas [Dec-2025 Updated]

You're looking to understand the engine behind BrainsWay Ltd. (BWAY) as they push their noninvasive Deep TMS technology into major mental health networks, and honestly, the structure is more recurring than you might think. I've distilled their late 2025 strategy, which centers on locking in value-about $\mathbf{70\%}$ of new engagements are now multi-year leases, supporting their $\mathbf{\$ 51}$ million to $\mathbf{\$ 52}$ million revenue guidance for the year. With $\mathbf{\$ 70.7}$ million in cash on hand as of September 30, 2025, they have the capital to back their proprietary coils and FDA clearances for MDD and OCD. This canvas shows you the nine essential pieces, from their high-margin provider economics to their enterprise sales focus, so you can see exactly how they plan to grow.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Key Partnerships

You're looking at how BrainsWay Ltd. (BWAY) is building out its ecosystem through strategic alliances, which is a critical part of their growth story as of late 2025. This isn't just about selling devices; it's about investing in the delivery network itself. Honestly, these partnerships are what give them visibility into future revenue streams, like the $65 million in remaining performance obligations they reported as of September 30, 2025, largely from multi-year leases.

Strategic Minority Investments in U.S. Mental Health Providers

BrainsWay Ltd. has made a clear push in 2025 to acquire minority stakes in high-performing U.S. mental health providers. As of their Q3 2025 report on November 11, 2025, they announced four such investments in the year, signaling a ramp-up of this strategic initiative.

Here's a breakdown of the disclosed investments in U.S. providers this year:

• The investment in Stella MSO, LLC ("Stella Mental Health") was $5 million for a minority position, announced in June 2025.
• The deal with Axis Integrated Mental Health involved an initial $2.3 million, with another $1 million contingent on milestones, totaling a potential $3.3 million.
• The agreement with Heading Health, which services the Texas-based clinic network, involves an initial $1.5 million, with potential for up to an additional $2.5 million based on milestones.

This strategy is designed to support their core business by accelerating awareness of Deep TMS Therapy with these commercial partners.

Valor Equity Partners for Identifying Clinical Investment Targets

The capital and expertise from Valor Equity Partners are foundational to this expansion strategy. Valor completed a $20 million private investment financing (PIPE) in September 2024, with the potential to reach approximately $34.3 million if all warrants are exercised. BrainsWay Ltd. executives explicitly signaled that the ramp-up of minority equity investments in U.S. mental health providers was made possible via this previous financing from Valor Equity Partners.

Research Collaborations with Institutions like the National Institutes of Health (NIH)

Scientific validation through major grants remains a key partnership focus. BrainsWay Ltd. announced in November 2025 that the U.S. National Institutes of Health (NIH) awarded a new grant to a research team at Stanford University and the Palo Alto Veterans Institute for Research. This grant totals approximately $2.5 million over five years.

The funding supports a clinical study evaluating an accelerated Deep TMS protocol for Alcohol Use Disorder (AUD). This is significant because:

• The study will enroll 100 adults with AUD.
• The protocol involves 30 treatment sessions (three per day for 10 consecutive business days).
• This marks the second major NIH grant awarded to this same research team in two years.

Exclusive Multi-Year Distribution Agreements for International Markets

International expansion is cemented through exclusive agreements. For instance, the exclusive multi-year distribution agreement in Canada, which broadly entered the market in 2024, included minimum quantity orders starting with 11 Deep TMS systems to be ordered in 2024. This structure of minimum, successively increasing orders over several years helps secure a predictable revenue floor outside the U.S.

Convertible Loan Investment in Neurolief Ltd. for At-Home Neuromodulation

To enter the at-home neuromodulation market, BrainsWay Ltd. closed an initial strategic investment via a $5 million convertible loan to Neurolief Ltd. in August 2025. This deal also includes an option for BrainsWay Ltd. to acquire all of Neurolief's equity over time.

The multi-phased transaction structure includes:

• Initial investment: $5 million convertible loan.
• Second tranche: Up to an additional $6 million convertible loan upon U.S. Food and Drug Administration (FDA) approval of Neurolief's Proliv Rx device for major depressive disorder (MDD).
• Third tranche: Up to a $5 million equity investment upon Neurolief achieving an agreed-upon revenue milestone.

Finance: draft 13-week cash view by Friday.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Key Activities

Deep Transcranial Magnetic Stimulation (Deep TMS) system manufacturing and distribution

BrainsWay Ltd. shipped a net total of 90 Deep TMS systems during the third quarter of 2025, a 43% increase compared to the same period last year. The total installed base reached more than 1,600 systems as of September 30, 2025. Approximately 70% of recent customer engagements are structured as multi-year lease agreements. The company reported a gross margin of 75% for the third quarter of 2025. The company currently has $65 million in remaining performance obligations under multi-year contracts as of September 30, 2025.

Ongoing clinical research and development (R&D) for new indications and protocols

The company secured a $2.5 million NIH grant for a study on Deep TMS for alcohol use disorder. Research and Development Expenses for the second quarter of 2025 were $2.3 million, up from $1.7 million last year.

• Continued progress in the randomized, multicenter U.S. clinical trial evaluating an accelerated treatment protocol for major depressive disorder (MDD) treatment as compared with the current standard-of-care Deep TMS protocol in Q1 2025.

Securing and maintaining regulatory clearances (FDA, CE Mark)

BrainsWay Ltd. received FDA clearance for an accelerated Deep TMS protocol for treating major depressive disorder. The company has received three FDA clearances covering major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction.

Providing comprehensive clinical training and reimbursement support to providers

The company is actively seeking to ramp up its strategic initiative with additional minority equity investments in high-performing mental health providers. BrainsWay entered an equity financing transaction with Stella MSO, LLC, a management services organization servicing more than 20 mental health clinics across US and Israel that have treated over 30,000 patients to date as of Q2 2025.

Sales and marketing focused on enterprise mental health networks

Sales and Marketing Expenses for the second quarter of 2025 were $4.9 million, up from $3.8 million in Q2 2024. The company made strategic investments in Neurolief Ltd. and other mental health providers.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Key Resources

You're looking at the core assets that let BrainsWay Ltd. (BWAY) operate and grow in the neurostimulation space. Honestly, for a medical device company, the intellectual property and regulatory approvals are the bedrock of everything. It all starts with their proprietary Deep TMS (Deep Transcranial Magnetic Stimulation) technology and the unique, patented H-Coils that allow for deeper penetration into brain structures compared to standard figure-8 coils. That's the hardware advantage, the thing that makes their treatment distinct.

The regulatory moat around this technology is significant, built up over years of clinical work. BrainsWay Ltd. is the only TMS company to have secured three distinct FDA-cleared indications based on pivotal studies, which is a huge differentiator when you're talking to payers and providers. Plus, they just expanded that reach in late 2025, which is a big deal for near-term revenue potential.

Here's a quick look at the evidence base that underpins the value of these resources:

The physical assets and financial stability are also critical components of the Key Resources block. You need the installed base to generate recurring revenue, and you need cash to fund ongoing R&D and commercial expansion. The installed base is growing steadily; they shipped a net total of 90 Deep TMS systems in the third quarter of 2025 alone. That growth directly feeds into their financial strength.

You've got to look at the balance sheet to see how well-capitalized BrainsWay Ltd. is to weather any near-term market hiccups. As of September 30, 2025, the company held cash, cash equivalents, and restricted cash totaling $70.7 million. That's a solid cushion for a company of this size. The installed base is the engine for their leasing revenue model, which is a key part of their value proposition now.

Here are the key quantitative operational and financial resources:

• Installed base of over 1,600 Deep TMS systems globally as of Q3 2025.
• Cash and equivalents (including restricted cash) totaling $70.7 million as of September 30, 2025.
• Net total of 90 Deep TMS systems shipped during the third quarter of 2025.
• FDA clearance for MDD (including a recent expansion for adolescents aged 15 to 21), OCD, and Smoking Addiction.

If onboarding takes 14+ days, churn risk rises, but the lease structure helps mitigate that defintely.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Value Propositions

You're looking at the core reasons why providers choose BrainsWay Ltd. (BWAY) technology over alternatives. It boils down to better treatment delivery and proven results for difficult-to-treat conditions.

The fundamental value is offering a noninvasive, medication-free treatment for treatment-resistant mental disorders. This is a key differentiator for patients who have not found success with traditional pharmaceutical routes.

The technology itself offers deep and broad brain stimulation, superior to traditional TMS (Deep TMS). This is because the patented H-coil technology stimulates deeper and broader regions of the brain compared to first-generation devices.

For providers, the unit economics are compelling, showing a high gross margin of 75% for providers, based on Q3 2025 figures. This strong margin indicates healthy per-unit profitability for the installed base.

The company has clinically proven efficacy for MDD, OCD, and Smoking Addiction. Specifically for smoking cessation using the H4 Coil in a Phase IV Registry Study after 15 sessions, data demonstrated 49% of patients successfully quit smoking and reduced nicotine cravings. In the pivotal study for smoking addiction, the continuous quit rate (four consecutive weeks of abstinence) was 28.0% in the active Deep TMS group versus 11.7% in the sham group.

For Major Depressive Disorder (MDD), BrainsWay Ltd. (BWAY) achieved an accelerated treatment protocol now FDA-cleared in September 2025. This clearance drastically cuts the time commitment for the acute phase of treatment.

Here's the quick math comparing the standard and the newly cleared accelerated MDD protocols based on the pivotal study data:

Beyond the controlled trial, real-world data for MDD patients who completed at least 30 sessions showed even higher rates:

• 82% response rate.
• 65% remission rate.
• Approximately 4 in 5 achieved a response (50+% symptom reduction).
• Approximately 2 in 3 achieved remission.

For OCD, clinical data of over 200 patients in real usage showed that greater than 1 in 2 patients who received 29 sessions achieved response, defined as a 30+% symptom reduction on the Y-BOCS scale.

The total installed base stood at more than 1,600 systems as of the end of Q3 2025.

Finance: draft 13-week cash view by Friday.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit... wait, BrainsWay Ltd. (BWAY) is well past that, focusing instead on locking in long-term value from its growing installed base. The relationship strategy centers on deep integration with enterprise-level mental health providers, which is clearly reflected in their financial commitments.

High-touch, long-term relationships with enterprise mental health networks are the bedrock of BrainsWay Ltd. (BWAY)'s recurring revenue model. This commitment to long-term partnership is quantified by the significant contracted revenue visibility. As of the third quarter of 2025, the Company reported $65 million in remaining performance obligations from customers under multi-year contracts. Furthermore, approximately 70% of recent customer engagements are structured as multi-year lease agreements, showing a clear preference for deep, sustained relationships over one-time sales. This strategy supports a total installed base that grew to over 1,600 Deep TMS systems by the end of Q3 2025.

The focus on enterprise traction is concrete. For instance, in Q2 2025, BrainsWay Ltd. (BWAY) entered an equity financing transaction with Stella MSO, LLC, an organization servicing more than 20 mental health clinics across the US and Israel that have treated over 30,000 patients to date. The Company also announced four new minority equity investments in 2025, signaling a deliberate effort to embed itself within the broader mental health treatment ecosystem.

The structure supporting these relationships involves a direct sales team and clinical specialists for defintely personalized support, which is necessary to manage the growing fleet of devices. The commercial expansion is supported by targeted investment, as Sales and Marketing expenses totaled $4.7 million in Q3 2025, up from $4.1 million in Q3 2024. This team is responsible for driving system placements, with 90 Deep TMS systems shipped in Q3 2025 alone, representing a 43% year-over-year increase for the quarter.

For ongoing operational support, the MyBrainsWay customer portal for accessories, marketing, and reimbursement tools is a key touchpoint, though specific usage metrics aren't public. Similarly, the commitment to HIPAA-compliant reimbursement support services for clinics is implied by the focus on enterprise adoption and the need to secure recurring revenue streams, which requires seamless operational integration for the customer. The structure for initial engagement involves dedicated Practice Development Consultants for a 90-day onboarding program, designed to ensure these high-value enterprise partners achieve rapid utilization and success with the technology.

Here's a quick look at the key customer-related financial and operational metrics as of late 2025:

The ongoing customer engagement is supported by these operational trends:

• Total installed base grew by 43% year-over-year in Q3 2025 system shipments.
• Q3 2025 Sales and Marketing spend was $4.7 million.
• RPO increased by 37% year-over-year as of September 30, 2025.
• The Company made an initial $5 million strategic investment in Neurolief Ltd. as part of its ecosystem expansion.

Finance: draft 13-week cash view by Friday.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Channels

You're looking at how BrainsWay Ltd. gets its Deep TMS (Deep Transcranial Magnetic Stimulation) systems and service contracts into the hands of clinicians and patients as of late 2025. The channel strategy is clearly multi-pronged, mixing direct sales muscle with financial engineering via equity stakes.

Direct sales force targeting U.S. mental health clinics and hospitals

The core of the U.S. channel relies on direct engagement, evidenced by system shipment growth and the structure of customer contracts. The company has been focusing its attention on selling to large enterprise customers for approximately two years as of late 2025. The recurring revenue model is key here, with approximately 70% of recent customer engagements structured as multi-year lease agreements. This leasing approach secures long-term revenue visibility.

Here's a look at the system deployment metrics through the first three quarters of 2025:

The total installed base grew from 1,522 systems at the end of Q2 2025 to more than 1,600 systems by the end of Q3 2025.

Strategic minority investments to accelerate adoption within partner networks

BrainsWay Ltd. is actively using its cash position to take minority stakes in providers to accelerate adoption. As of October 27, 2025, the company had completed four such strategic minority investments during 2025. One specific example is an equity financing agreement with Tangient ATX Inc., which services the "Heading Health" mental health clinic network across Texas. The terms for this specific deal included an initial investment of $1.5 million, with potential for up to an additional $2.5 million based on milestones. Another transaction involved a management services organization, Stella MSO, LLC, which services more than 20 mental health clinics across the US and Israel.

Specialty distributors for international market penetration (e.g., East Asia, Canada)

While specific international revenue breakdowns aren't detailed in the latest reports, the company maintains operations in Israel besides the United States. The overall strategy includes building on its unparalleled body of clinical evidence to increase global awareness. The growth in the total installed base, which now exceeds 1,600 systems as of September 30, 2025, reflects this global reach beyond the US market.

Online and offline marketing campaigns to drive patient awareness and referrals

Driving patient awareness is supported by regulatory milestones that widen the addressable market. The FDA clearance for adolescent MDD adjunct therapy in November 2025, for instance, materially widens the labeled age range. The company is dedicated to increasing global awareness of Deep TMS.

Academic and clinical trial sites for technology validation and exposure

Clinical validation is a core channel for establishing credibility and securing broader indications. The FDA clearance for adolescent MDD adjunct therapy followed real-world data collected from 1,120 adolescents treated across 35 U.S. centers between 2012 and 2024. Furthermore, a new multicenter clinical trial for Alcohol Use Disorder (AUD) is set to enroll over 200 patients aged 18-86. The company is also running a trial in Israel related to PTSD.

Key clinical validation points include:

• FDA clearance for three indications: MDD, OCD, and Smoking Addiction.
• Adolescent MDD data involved 1,120 patients across 35 centers.
• New AUD trial enrollment target: over 200 patients.
• The company is testing use cases for Alzheimer's and post-stroke treatment.

Finance: draft 13-week cash view by Friday.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Customer Segments

Enterprise mental health clinic networks and large hospital systems represent a key segment, evidenced by the strategic investment in Stella MSO, LLC, a management services organization servicing more than 20 mental health clinics across US and Israel that have treated over 30,000 patients to date as of Q2 2025. BrainsWay Ltd. (BWAY) also secured an extensive order with a multi-phased delivery plan through the end of the year by a fast-growing U.S. mental health network in the western and southeastern U.S. in Q2 2025.

Private psychiatric practices and specialized TMS treatment centers form the core base for system placement. As of the third quarter of 2025, the total installed base reached over 1,600 systems globally. The company shipped a net total of 90 Deep TMS systems in Q3 2025. Of recent customer engagements, approximately 70% are structured as multi-year lease agreements.

Patients with treatment-resistant Major Depressive Disorder (MDD) or Obsessive-Compulsive Disorder (OCD) are the end-users driving utilization. BrainsWay Ltd. (BWAY) has FDA clearances for MDD, OCD, and Smoking Cessation, with the MDD indication now expanded to adolescents aged 15 - 21 years, in addition to adults aged 22-86. The supporting study for the adolescent clearance involved data from over 1,200 adolescent patients across 56 sites.

Healthcare providers seek noninvasive, high-margin treatment modalities. The company's gross margin for Q3 2025 was maintained at 75%. The leasing model provides stability, with the company holding $65 million in remaining performance obligations from customers under multi-year contracts as of Q3 2025. The overall TMS market is projected to reach $3 billion by 2033.

Research institutions and academic medical centers contribute to clinical validation and protocol development. A multicenter randomized controlled trial for an accelerated Deep TMS protocol for MDD enrolled 104 adult patients across eight sites. This trial tested a protocol where patients completed five sessions per day over six treatment days.

Here's a quick look at the operational scale supporting these segments as of late 2025:

The customer base is segmented by the indications they treat, which directly impacts system utilization:

• FDA-cleared indications include Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), and Smoking Cessation.
• MDD clearance now includes adolescents aged 15 - 21 years.
• The accelerated MDD protocol uses sessions of less than 10 minutes compared to the standard 20 minutes.
• A Phase IV Registry Study for Smoking Cessation involved 15 treatment sessions.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Cost Structure

You're looking at the core expenses that drive BrainsWay Ltd.'s operations as we head into the end of 2025. Honestly, the structure shows a company scaling revenue while managing its fixed costs to improve profitability, which is what you want to see.

The cost of revenues, which covers manufacturing the Deep TMS systems and the ongoing maintenance/service components of the business, is kept relatively lean due to the high-margin nature of the recurring revenue stream. For the third quarter of 2025, the gross margin stood at a strong 75%. This means that for every dollar of revenue, only about 25 cents went to the direct costs of goods sold and services rendered.

Investment in the future, specifically Research and Development (R&D), remains a significant line item as BrainsWay Ltd. pushes for new indications and next-generation devices. R&D expenses for the third quarter of 2025 totaled $2.4 million, up from $1.8 million in the third quarter of 2024. That's a clear signal of commitment to innovation.

Driving system adoption and utilization requires a dedicated commercial team, reflected in the Selling and Marketing expenses. In Q3 2025, these costs were $4.7 million, an increase from $4.1 million in the same period last year, showing targeted investment in expansion efforts. Also, as a public company trading on both NASDAQ and TASE, there are necessary overheads for General and Administrative (G&A) functions. G&A costs were $1.8 million for the third quarter of 2025, compared to $1.5 million the prior year period, partly due to costs related to new investments.

Here's the quick math on the operating expense profile for the third quarter of 2025, based on the reported figures:

The disciplined cost management, coupled with revenue growth, is translating directly to the bottom line. BrainsWay Ltd. has officially raised its full-year 2025 guidance for profitability. You should expect the operating income for the full year 2025 to be in the range of 6% to 7% of revenue. This improvement reflects the operating leverage gained as the installed base grows and recurring revenue stabilizes the cost base.

The key cost drivers that influence this margin profile include:

• Cost of Revenues, maintaining a 75% gross margin in Q3 2025.
• Targeted investment in Sales and Marketing, reaching $4.7 million in Q3 2025.
• Increased R&D spend to $2.4 million in Q3 2025 for clinical trials.
• G&A costs reflecting public company compliance and new investment diligence.

Finance: draft 13-week cash view by Friday.

BrainsWay Ltd. (BWAY) - Canvas Business Model: Revenue Streams

You're looking at how BrainsWay Ltd. (BWAY) brings in money, which is heavily leaning on long-term commitments now. This structure gives them a solid, predictable base, which is smart for a medical device company scaling up.

The core of the revenue generation is clearly shifting toward recurring streams. Of recent customer engagements, approximately 70% are structured as multi-year lease agreements. This focus on leasing over outright sales helps secure future cash flow and deepens the relationship with the customer base.

This strategy is reflected in the significant backlog of committed revenue. BrainsWay Ltd. currently holds $65 million in remaining performance obligations from customers under multi-year contracts. This figure provides concrete visibility into future recognized revenue.

The other side of the coin is the direct system sales component. BrainsWay Ltd. derives revenue from both the lease and sale of its Deep TMS devices. To support the lease model and expand the installed base, the company shipped a net total of 90 Deep TMS systems in the third quarter of 2025, a 43% increase compared to the same period last year. The total installed base now stands at more than 1,600 systems as of September 30, 2025.

Utilization fees and service contract revenue come from servicing this growing installed base. The company made a strategic decision to focus on large enterprise customers who value the high level of customer service to support their Deep TMS systems, which naturally feeds into service contract revenue.

Here's a quick look at the latest financial outlook and recent performance that underpins these revenue assumptions:

The company raised its full-year 2025 revenue guidance midpoint to the range of $51 million to $52 million, up from the previous guidance of $50 million to $52 million. This reflects the strong momentum seen in the third quarter, where revenue grew 29% year-over-year to $13.5 million.

The revenue streams can be broken down into key components:

• Recurring revenue from multi-year lease agreements, representing about 70% of new deals.
• Upfront payments from system sales, evidenced by 90 systems shipped in Q3 2025.
• Service contract revenue tied to the installed base of over 1,600 systems.

The strength of the recurring model is also visible in the improved profitability guidance, with Adjusted EBITDA expected in the range of 13% to 14% for the year.