BWAY Shares Gain on FDA Nod for Accelerated Deep TMS Depression Care

BrainsWay Ltd. BWAY recently secured FDA clearance for an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (TMS) system. The approval allows providers to treat patients with major depressive disorder, including those with comorbid anxiety. This advancement marks a meaningful step forward in improving patient access while giving providers greater flexibility in care delivery.

The protocol has shown outcomes comparable to the standard approach while requiring fewer visits, which may support stronger adoption. BrainsWay is preparing provider training and working on reimbursement updates, positioning the clearance as a meaningful growth opportunity in the mental health market.

Likely Trend of BWAY Stock Following the News

Following the announcement, the company's shares gained 11.9% at yesterday’s market closing. Shares of the company have surged 79.2% in the year-to-date period compared with the industry’s 5.5% growth. The S&P 500 has gained 13.6% in the same time frame.

This FDA clearance positions BWAY to capture a larger share of the mental health market by offering a faster, more convenient treatment option for depression, which could drive stronger patient adoption and provider uptake over time. By expanding its clinical footprint and aligning reimbursement with the new protocol, the company has the potential to accelerate revenue growth, enhance competitive differentiation, and strengthen its long-term leadership in non-invasive neurostimulation therapies.

BWAY currently has a market capitalization of $285.3 million. The company projects an earnings growth of 94.4% for the current year.

More on BWAY's Accelerated Deep TMS for Depression

BrainsWay’s newly cleared accelerated Deep TMS protocol is designed to significantly shorten the treatment timeline for major depressive disorder. Instead of four weeks of daily sessions under the standard approach, the accelerated protocol delivers an acute phase of five sessions per day over just six days, followed by weekly maintenance. Each session takes less than 10 minutes, compared to 20 minutes with the traditional method. This structure enables patients to complete treatment more quickly while alleviating the logistical burden of frequent clinic visits.

Clinical data from a multicenter, randomized, controlled trial demonstrated that the accelerated protocol delivered results comparable to the standard approach. Depression scores on the HDRS-21 scale dropped by roughly the same degree in both groups, and response and remission rates were in line, with the accelerated group reaching remission in a median of 21 days versus 28 days for the standard protocol. Importantly, no severe adverse events were reported, reinforcing the safety and tolerability of this new treatment option.

For BrainsWay, this clearance not only validates the strength of its clinical research but also enhances its market proposition. By offering a treatment that is both effective and less time-intensive, the company is addressing a key barrier to care for patients and providers alike. BrainsWay is now rolling out provider training and pursuing reimbursement updates to align with the accelerated protocol, steps that could help support adoption and fuel long-term growth in the competitive mental health treatment landscape.

Favorable Industry Prospects for BWAY

Per a report by Grand View Research, the global neuromodulation devices market size was estimated at $5.80 billion in 2024 and is projected to reach $10.39 billion by 2030, registering a CAGR of 8.51% from 2025 to 2030. 

The increasing incidence of chronic pain, neurological disorders, and mental health conditions is expected to drive the demand for effective and innovative treatment solutions.

BWAY’s Zacks Rank & Key Picks

Currently, BWAY carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are West Pharmaceutical Services, Inc. WST, Medpace Holdings, Inc. MEDP and Envista NVST.

West Pharmaceutical reported second-quarter 2025 adjusted earnings per share (EPS) of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the Zacks Consensus Estimate by 5.4%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.

Medpace Holdings, sporting a Zacks Rank of 1, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.

Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.9%.

Envista reported second-quarter 2025 adjusted EPS of 26 cents, which beat the Zacks Consensus Estimate by 8.3%. Revenues of $682 million surpassed the Zacks Consensus Estimate by 6.3%. It currently carries a Zacks Rank #2 (Buy).

Envista has a long-term estimated growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.50%.

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This article originally published on Zacks Investment Research (zacks.com).

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