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

Rhea-AI Summary

BrainsWay (NASDAQ: BWAY) announced that the U.S. FDA granted Premarket Approval (PMA) to Neurolief's Proliv™Rx neuromodulation system on January 12, 2026, as a Class III adjunctive treatment for adults with major depressive disorder (MDD) who failed to improve after at least one antidepressant.

The approval makes Proliv™Rx the first and only FDA‑labeled at‑home neuromodulation therapy for treatment‑refractory MDD and follows BrainsWay's strategic investment in Neurolief, which includes an option to acquire the company and plans for commercial and research synergies.

Positive

• FDA Premarket Approval awarded for Proliv™Rx on January 12, 2026
• First and only FDA‑labeled at‑home neuromodulation therapy for MDD
• Approval covers adults with MDD who failed ≥1 antidepressant
• BrainsWay holds strategic investment plus an option to acquire Neurolief

Negative

• Indication limited to adjunctive use for treatment‑refractory adult MDD patients
• No commercial rollout timeline or financial terms disclosed in announcement

News Market Reaction – BWAY

+4.67%

7 alerts

+4.67% News Effect

+2.0% Peak in 1 hr

+$20M Valuation Impact

$452M Market Cap

0.1x Rel. Volume

On the day this news was published, BWAY gained 4.67%, reflecting a moderate positive market reaction. Argus tracked a peak move of +2.0% during that session. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $20M to the company's valuation, bringing the market cap to $452M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Device class: Class III Prior antidepressants failed: At least 1

2 metrics

Device class Class III Proliv™Rx system PMA designation for MDD treatment

Prior antidepressants failed At least 1 MDD patients who failed one or more previous antidepressants

Market Reality Check

Price: $12.62 Vol: Volume 100,367 is 5% abov...

normal vol

$12.62 Last Close

Volume Volume 100,367 is 5% above 20-day average 95,257. normal

Technical Price 23.11 is trading above 200-day MA of 13.61, indicating a pre-news uptrend.

Peers on Argus

Peers showed mixed moves: STIM up 4.55%, CATX up 1.07%, VMD slightly up 0.14%, w...

Peers showed mixed moves: STIM up 4.55%, CATX up 1.07%, VMD slightly up 0.14%, while OM fell 3.8% and NNOX dropped 1.98%. This divergence suggests today’s FDA approval is likely a company-specific catalyst rather than a sector-wide move.

Historical Context

5 past events · Latest: Jan 07 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 07	Coverage expansion	Positive	+3.6%	Premera expanded coverage for accelerated SWIFT Deep TMS in MDD.
Dec 22	Coverage expansion	Positive	+10.1%	Optum expanded Deep TMS coverage for adolescents with MDD.
Nov 25	Investor event	Positive	+2.5%	Announced virtual Analyst & Investor Day on growth strategy and Deep TMS.
Nov 17	Clinical trial launch	Positive	-3.7%	Launched first Deep TMS 360 clinical trial in Alcohol Use Disorder.
Nov 13	FDA label expansion	Positive	+1.5%	FDA cleared Deep TMS as adjunct therapy for adolescents with MDD.

Pattern Detected

Recent positive regulatory and coverage news for depression indications has generally aligned with positive price reactions, with only one notable divergence on a clinical trial launch.

Recent Company History

Over the last few months, BrainsWay reported several milestones tied to its Deep TMS™ platform. On Nov 13, 2025, the FDA expanded Deep TMS™ labeling to adolescents, supported by data from 1,120 patients across 35 centers, and the stock rose 1.46%. Subsequent payer coverage expansions on Dec 22, 2025 and Jan 7, 2026 for adolescent and accelerated protocols saw gains of 10.05% and 3.56%. Against this backdrop, today’s FDA PMA for an at-home MDD device adds another regulatory milestone in depression care.

Market Pulse Summary

This announcement details FDA Premarket Approval for Neurolief’s Proliv™Rx, a Class III at-home neur...

Analysis

This announcement details FDA Premarket Approval for Neurolief’s Proliv™Rx, a Class III at-home neuromodulation system for adults with MDD who have failed at least one antidepressant. It follows recent FDA label expansion and coverage wins for Deep TMS™, reinforcing BrainsWay’s focus on treatment-resistant depression across care settings. Investors may watch how BrainsWay leverages its option to acquire Neurolief, commercial synergies, and forthcoming data or payer decisions around home-based neuromodulation.

Key Terms

neuromodulation, class iii premarket approval, premarket approval (pma), major depressive disorder (mdd), +1 more

5 terms

neuromodulation medical

"the first and only FDA approved at-home neuromodulation device with Class III"

Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.

class iii premarket approval regulatory

"at-home neuromodulation device with Class III Premarket Approval labeling for MDD"

The Class III premarket approval is the U.S. regulator’s most stringent authorization for high-risk medical devices, requiring robust clinical evidence that the product is safe and effective before it can be sold. For investors, this approval is a make-or-break milestone: it clears the device for market access but typically involves long timelines, large costs and regulatory risk—like earning a specialized license after rigorous testing and inspection.

premarket approval (pma) regulatory

"the U.S. Food and Drug Administration (FDA) has granted 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

"for adult patients suffering from major depressive disorder (MDD) who have failed"

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.

adjunctive treatment medical

"as an adjunctive treatment for adult patients suffering from major depressive"

An adjunctive treatment is a therapy given in addition to a primary treatment to improve overall effectiveness or manage side effects—think of it as a booster or supportive sidekick to the main medicine. For investors, adjunctive therapies matter because they can expand a product’s market use, create additional revenue streams, affect regulatory pathways and clinical trial design, and influence competitive positioning and pricing in a therapeutic area.

AI-generated analysis. Not financial advice.

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.

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,” “targets,” “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 – especially preliminary data which remains subject to peer-review – 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: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; 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
britchie@lifesciadvisors.com

FAQ

What did BrainsWay (BWAY) announce on January 12, 2026 regarding Neurolief?

BrainsWay announced that the FDA granted PMA to Neurolief's Proliv™Rx Class III system as an adjunctive at‑home treatment for adults with MDD who failed at least one antidepressant.

What patient population does the Proliv™Rx FDA approval cover for BWAY investors?

The approval covers adult patients with major depressive disorder who have not achieved satisfactory improvement after one or more prior antidepressants as an adjunctive treatment.

How does the Proliv™Rx approval affect BrainsWay's strategic position (BWAY)?

The approval validates BrainsWay's strategic investment in Neurolief and supports planned commercial and research synergies, including an option to acquire Neurolief.

Is Proliv™Rx approved for at‑home use and what is its regulatory classification?

Yes. Proliv™Rx received FDA PMA as a Class III device authorized for use at home or in clinic.

Does the FDA approval expand treatment settings for MDD relevant to BWAY shareholders?

Yes. The approval expands clinical care beyond in‑clinic treatment to include at‑home neuromodulation for the specified patient group.