BrainsWay (BWAY) Receives FDA Approval for Proliv™Rx System for Depression Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 12 2026
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Source: Globenewswire
- Regulatory Milestone: BrainsWay's Proliv™Rx system has received FDA Premarket Approval, becoming the first home-use neuromodulation device for treatment-resistant major depressive disorder, underscoring the company's leadership in non-invasive brain stimulation technologies.
- Market Expansion Opportunity: This approval not only allows BrainsWay to enter the home care market but also significantly broadens its potential customer base by providing more accessible treatment options, enhancing the company's market share in mental health.
- Strategic Investment: BrainsWay's investment in Neurolief includes an acquisition option, aimed at leveraging the synergies between both companies' commercial and research infrastructures to enhance its value proposition and increase overall market coverage.
- Technological Innovation: The launch of the Proliv™Rx device reflects BrainsWay's commitment to data-driven mental health care, further solidifying its leadership in integrating multiple treatment modalities and advancing the realization of the company's long-term vision.
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Analyst Views on BWAY
Wall Street analysts forecast BWAY stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for BWAY is 22.00 USD with a low forecast of 19.00 USD and a high forecast of 24.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 24.710
Low
19.00
Averages
22.00
High
24.00
Current: 24.710
Low
19.00
Averages
22.00
High
24.00
About BWAY
Brainsway Ltd is an Israel-based company engaged in the development and marketing of medical devices for the treatment of various neurological and psychopathological disorders. The Company primarily offers Transcranial Magnetic Stimulation (TMS) system, a medical device that enables direct non-invasive activation of deep brain structures. Its TMS system uses magnetic pulses to stimulate neurons and consequently modulates the physiological activity of the brain. TMS system is used in various clinical applications including: major depressive disorders, obsessive-compulsive disorder, smoking addiction and others various psychiatric, neurological, and addiction disorders.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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BrainsWay Secures Expanded Coverage for Depression Treatment from Highmark
- Policy Expansion: Highmark Blue Cross Blue Shield has released a draft policy expanding coverage to include adolescent and adult patients with major depressive disorder, expected to take effect in February 2026, marking a significant advancement for BrainsWay in depression treatment.
- Accelerated Treatment Protocol: The new policy includes BrainsWay's accelerated SWIFT™ protocol, which consists of five treatment sessions per day for six days, significantly reducing patient clinic visits and enhancing treatment accessibility and flexibility.
- Clinical Efficacy: BrainsWay's accelerated Deep TMS protocol received FDA clearance in September 2025, with clinical trials demonstrating an 87.8% response rate and a 78.0% remission rate, indicating comparable efficacy to standard Deep TMS and strengthening its market competitiveness.
- Market Outlook: With the implementation of this policy, BrainsWay is poised to attract more insurers to adopt its treatment protocols, further promoting the acceptance and accessibility of Deep TMS technology, thereby enhancing the company's leadership position in the mental health sector.
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