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

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BrainsWay's strategic investment in Neurolief paved the way for the first and only FDA approved at-h...

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BrainsWay's recent FDA approval for Neurolief's Proliv™Rx device positions it uniquely in the mental health market. As the first at-home treatment for patients with major depressive disorder, this milestone could significantly expand their market reach and treatment capabilities, potentially leading to higher revenues and a strengthened competitive position.

Sentiment Rationale

The approval of a unique product enhances revenue streams and reduces competition risks. Historically, similar FDA milestones have led to positive market reactions for biopharmaceutical companies, driving share prices higher.

Trading Thesis

Invest in BWAY as FDA approval may enhance market valuation and growth prospects in Q1 2026.

Market-Moving

  • FDA approval enhances BWAY's market position in mental health treatments.
  • Increased addressable market could lead to higher revenues and stock valuation.
  • Strategic plans for Neurolief acquisition indicate potential growth synergies.
  • Positive regulatory moves may boost investor confidence and stock price.

Key Facts

  • BrainsWay receives FDA approval for Neurolief's Proliv™Rx system.
  • Proliv™Rx is the first FDA-approved at-home device for MDD.
  • Approval expands BrainsWay's market reach and treatment offerings.
  • Strategic investment in Neurolief enhances BrainsWay's market proposition.
  • Proliv™Rx targets patients not responding to standard antidepressants.

Companies Mentioned

  • Neurolief (N/A): Acquisition and regulatory success boosts BWAY's market potential.

Corporate Developments

This falls under 'Corporate Developments' due to BrainsWay's strategic investment and regulatory milestone. The FDA approval significantly impacts BWAY's product offerings and potential market growth.

BrainsWay Receives FDA Approval for Neurolief's Proliv™Rx Neuromodulation System for MDD

Published: January 12, 2026 | Source: GlobeNewsWire

Announcement of Significant Regulatory Milestone

BURLINGTON, Mass. and JERUSALEM – BrainsWay Ltd. (NASDAQ & TASE: BWAY), a pioneer in noninvasive brain stimulation technologies, has announced that the U.S. Food and Drug Administration (FDA) granted Premarket Approval (PMA) for the Proliv™Rx system developed by Neurolief. This Class III device is aimed at treating adult patients with major depressive disorder (MDD) who have not responded positively to at least one prior antidepressant medication, allowing treatment at home or in clinical settings.

This FDA approval is a major breakthrough, marking the Proliv™Rx as the first and only FDA-approved at-home neuromodulation device specifically designed for patients with treatment-resistant MDD.

Implications of the FDA Approval

The approval of Proliv™Rx not only expands the treatment options for MDD patients but also signifies a growing regulatory endorsement for home-use neuromodulation technologies. This shift in the clinical landscape offers potential for enhancing patient access to advanced treatment methods.

Hadar Levy, Chief Executive Officer of BrainsWay, stated, “Our strategic investment in Neurolief, which includes an option to acquire the company, positions us to enhance our value proposition while potentially increasing our market reach. We are currently developing synergistic strategies that leverage the capabilities of both companies.”

Strategic Vision and Future Outlook

Mr. Levy emphasized that this FDA approval validates BrainsWay's investment approach and reinforces their commitment to technology-driven mental health care. He noted that their collaboration with Neurolief distinguishes them in the market, enhancing their goal of integrating diverse treatment methods across various healthcare environments.

About Neurolief and BrainsWay

Neurolief is an innovative neuromodulation company dedicated to developing transformative therapies for mental health and neurological disorders. Their flagship Proliv™Rx device is designed to stimulate critical neural pathways and is indicated for MDD treatment in adults who show insufficient improvement from previous medications.

BrainsWay continues to lead the field of advanced neurostimulation treatments. The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology to address multiple mental health disorders, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction. BrainsWay is the only TMS entity to have secured three FDA-cleared indications supported by robust clinical study outcomes.

Forward-Looking Statements

This announcement contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which may include terms such as “intends,” “plans,” “expects,” and similar terminology. These statements reflect BrainsWay's management expectations and are subject to multiple risks and uncertainties that could cause actual results to differ significantly.

Factors that may impact the company's future results include potential integration challenges, regulatory approval timelines, technological developments, and market acceptance of *Deep TMS* technology.

For more information about BrainsWay, please visit their website at www.brainsway.com.

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