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

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) completed a $6 million milestone-based convertible loan to Neurolief after the FDA granted Premarket Approval for Neurolief's Proliv™Rx system for treatment-resistant major depressive disorder (MDD).

BrainsWay has invested $11 million to date and may provide further funding, including up to $5 million in a third tranche tied to revenue milestones; BrainsWay also holds a call option to acquire Neurolief equity under defined pricing formulas.

Neurolief reported commercial scaling, including inclusion on the Veterans Affairs Federal Supply Schedule with FSS pricing for Proliv™Rx and Relivion®MG.

Positive

• FDA PMA received for Proliv™Rx for MDD
• Completed $6 million second tranche convertible loan
• Total invested by BrainsWay to date: $11 million
• VA FSS inclusion and FSS pricing established for devices

Negative

• Additional funding and third tranche of up to $5 million are contingent on revenue targets

Key Figures

Second tranche investment: $6 million Total invested to date: $11 million Potential third tranche: Up to $5 million

3 metrics

Second tranche investment $6 million Milestone-based convertible loan to Neurolief triggered by FDA PMA

Total invested to date $11 million BrainsWay’s cumulative investment in Neurolief so far

Potential third tranche Up to $5 million Equity investment contingent on Neurolief reaching revenue target

Market Reality Check

Price: $13.86 Vol: Volume 157,812 is below 2...

normal vol

$13.86 Last Close

Volume Volume 157,812 is below 20-day average 197,699 ahead of this FDA-linked update. normal

Technical Trading above 200-day MA at 8.74, with price at 13.86 and 5.39% below 52-week high.

Peers on Argus

BWAY gained 2.67% while scanner peers were mixed: two names down and one up. Thi...

1 Up 2 Down

BWAY gained 2.67% while scanner peers were mixed: two names down and one up. This pattern points to a more stock-specific reaction versus a uniform medical device move.

Previous Fda approval Reports

2 past events · Latest: Jan 12 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	FDA approval	Positive	+4.7%	FDA PMA for Neurolief’s Proliv™Rx neuromodulation system in MDD.
Jun 03	FDA label expansion	Positive	+5.3%	FDA expanded Deep TMS label to treat late life depression.

Pattern Detected

Prior FDA approval headlines for BWAY produced mid-single-digit positive moves, suggesting historically constructive reactions to regulatory milestones.

Recent Company History

Recent news for BrainsWay highlights regulatory and commercial progress in neuromodulation. Two prior FDA approval events on Jan 12, 2026 and Jun 03, 2024 each saw positive single-digit gains. Today’s milestone-based funding into Neurolief following Proliv™Rx approval fits this pattern of leveraging FDA decisions into strategic growth steps around depression-focused therapies.

Historical Comparison

+5.0% avg move · Past FDA-approval headlines for BrainsWay led to average moves of 4.96%, indicating that regulatory ...

fda approval

+5.0%

Average Historical Move fda approval

Past FDA-approval headlines for BrainsWay led to average moves of 4.96%, indicating that regulatory milestones have historically coincided with constructive share reactions.

These FDA approval events show a progression from gaining neuromodulation indications in depression to deepening the Neurolief partnership, now reinforced by milestone-based funding tied to Proliv™Rx.

Market Pulse Summary

This announcement ties BrainsWay’s capital deployment directly to Neurolief’s FDA-approved Proliv™Rx...

Analysis

This announcement ties BrainsWay’s capital deployment directly to Neurolief’s FDA-approved Proliv™Rx platform, adding an additional $6 million and taking total funding to $11 million with potential for a further $5 million. Investors may track how revenue-based milestones, VA system access via FSS, and the structured call option translate into commercial traction and strategic flexibility over time.

Key Terms

premarket approval (pma), major depressive disorder (mdd), call option, enterprise value

4 terms

premarket approval (pma) regulatory

"triggered by the recent U.S. Food and Drug Administration (FDA) Premarket Approval (PMA)"

Premarket Approval (PMA) is the strict regulatory review process used by the U.S. authority for high-risk medical devices to prove they are safe and effective before they can be sold. For investors, a granted PMA is like receiving a key to a locked market: it can open exclusive sales opportunities, reduce near-term competition, and justify higher valuations, while also signaling that the company has cleared a costly, time-consuming hurdle.

major depressive disorder (mdd) medical

"Proliv™Rx, a unique, at-home therapy designed for treatment-resistant major depressive disorder (MDD)"

Major depressive disorder (MDD) is a clinical mental-health condition characterized by persistent low mood, loss of interest in usual activities, and changes in sleep, appetite, energy, and concentration that significantly impair daily functioning for weeks or longer. It matters to investors because MDD drives healthcare spending, shapes demand for treatments, affects workforce productivity and absenteeism, and influences the commercial and regulatory prospects of companies developing therapies—like a chronic engine problem that reduces output and raises repair costs.

call option financial

"BrainsWay also holds a “call option” to acquire all outstanding equity interests"

A call option is a contract that gives its buyer the right, but not the obligation, to buy a specific number of shares at a predetermined price within a set time period. Think of it as a refundable reservation to buy an item later at today’s price: you pay a fee up front and can profit if the stock rises, while your downside is limited to that fee; investors use calls to gain leverage, speculate on upside, or hedge positions without owning the shares.

enterprise value financial

"at a price based on the greater of a specified enterprise value or a revenue multiple"

Enterprise value is the total worth of a company, reflecting what it would cost to buy the entire business. It includes the company's market value plus any debts, minus its cash holdings, offering a comprehensive picture of its true value. Investors use it to compare companies regardless of their capital structures, helping them assess how much they would need to pay to acquire the business.

AI-generated analysis. Not financial advice.

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.

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.

Forward-Looking Statements
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, and also includes any financial guidance and projections contained herein. 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: risks relating to the Company’s ability to consummate, finance and close proposed or potential investments, 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

FAQ

What did BrainsWay (BWAY) announce on March 26, 2026 regarding Neurolief funding?

BrainsWay announced completion of a $6 million milestone-based convertible loan to Neurolief. According to the company, this tranche followed FDA PMA for Proliv™Rx and raises BrainsWay's total invested to $11 million to date.

How does the FDA Premarket Approval for Proliv™Rx affect Neurolief's commercial plans and BWAY investment?

FDA PMA enabled Neurolief to scale commercial operations and trigger BrainsWay's $6 million tranche. According to the company, Neurolief expanded provider access and secured VA Federal Supply Schedule pricing for Proliv™Rx and Relivion®MG.

Does BrainsWay have options to increase its ownership in Neurolief after the March 26, 2026 deal?

Yes. BrainsWay holds a call option to acquire all outstanding Neurolief equity during defined windows at formula-based prices. According to the company, pricing depends on specified enterprise value or revenue multiples tied to timing.

Is there additional funding available from BrainsWay to Neurolief beyond the $11 million invested?

Potential additional funding exists, including a third tranche up to $5 million contingent on Neurolief meeting a defined revenue target. According to the company, that third tranche is not automatic and depends on revenue milestones.

What commercial milestone did Neurolief achieve after FDA approval mentioned on March 26, 2026?

Neurolief obtained inclusion on the Veterans Affairs Federal Supply Schedule with established FSS pricing. According to the company, FSS pricing covers both Proliv™Rx and Relivion®MG, creating a pathway into the VA health system.

How much has BrainsWay invested in Neurolief and what triggered the recent $6 million payment?

BrainsWay has invested $11 million in Neurolief to date; the recent $6 million tranche was triggered by Neurolief receiving FDA PMA for Proliv™Rx. According to the company, the investment follows their August 2025 strategic agreement.