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Brainsway

Brainsway, founded by Abraham Zangen, commercializes FDA-cleared deep TMS for depression and OCD from Jerusalem, with 1,000+ systems deployed globally.

Brainsway

Founded in 2003 by neuroscientist Abraham Zangen, Brainsway is a Jerusalem-based medical device company focused on non-invasive neuromodulation. The company commercializes its proprietary deep TMS technology, which uses a patented H-coil to stimulate deeper and broader brain regions than conventional TMS. The initial and largest clinical application is treatment-resistant major depressive disorder (MDD). The system received FDA clearance in 2013 for MDD and has since expanded into obsessive-compulsive disorder (OCD) and smoking cessation. Brainsway sells its systems directly to psychiatrists, hospitals, and outpatient clinics, and the installed base now exceeds 1,000 units across more than 30 countries. The company's core strategy centers on deepening clinical evidence and expanding coverage and reimbursement for its indications. Brainsway allocates significant resources to post-market clinical trials and investigator-sponsored studies, building a published evidence library in peer-reviewed journals such as the American Journal of Psychiatry and JAMA Psychiatry. Beyond depression, the company pursues additional FDA-cleared indications: it received FDA clearance for OCD in 2018 and for cigarette smoking addiction in 2020. It also generates recurring revenue from service contracts and proprietary disposable helmets used per-treatment. Brainsway trades on the Nasdaq and Tel Aviv Stock Exchange under ticker BWAY. As of May 2024, the company reported trailing twelve-month revenue of $33.2 million, with gross margins consistently above 70%. The company has periodically attracted strategic attention; in 2022, Brainsway launched a multi-year collaboration with a major U.S. managed care organization to study the economic impact of TMS on MDD treatment pathways. The leadership team is led by President and CEO Yaacov Michlin, who assumed the role in 2022 and previously held executive positions at medical device firms including Lumenis. Brainsway's structural differentiator is its patented H-coil technology, which enables stimulation of cortical targets up to 6 cm beneath the skull without increasing electric field intensity at the surface. This depth separates it from standard figure-8 TMS coils and allows access to subcortical limbic structures implicated in mood regulation — a design constraint that effectively defines the company's clinical differentiation and its incremental FDA claims.

General information

Firm type

other

Year founded

2003

AUM

Undisclosed

Location

Region

Middle East

Country

Israel

City

Jerusalem

Corporate office

Jerusalem, Israel

Principals

Yaacov Michlin

President and CEO

Abraham Zangen

Founder and Scientific Consultant

Sector focus

Digital Health

Frequently asked questions

What clinical indications has Brainsway received FDA clearance for?

Brainsway has received FDA 510(k) clearance for three main indications: treatment-resistant major depressive disorder (MDD, 2013), obsessive-compulsive disorder (OCD, 2018), and cigarette smoking addiction (2020). The company also holds CE marking in Europe for several additional neuropsychiatric conditions. Each clearance covers the specific H-coil model and treatment protocol validated in pivotal trials.

How does Brainsway's deep TMS technology differ from standard TMS?

Standard figure-8 TMS coils typically stimulate cortical tissue at depths of 1.5 to 2 cm below the skull. Brainsway's patented H-coil is designed to generate magnetic fields that stimulate deeper brain regions, reaching approximately 4 to 6 cm in depth, without requiring a higher surface electrical field. This allows non-invasive activation of limbic and reward-system structures that are inaccessible with conventional coils — a critical distinction in treating mood and addiction disorders.

Who runs investment decisions at Brainsway?

Brainsway operates as a publicly traded medical device company, not an investment firm. Capital allocation decisions — including R&D spending, clinical trial funding, manufacturing expansion, and potential M&A — are made by CEO Yaacov Michlin and the executive leadership team, overseen by a board of directors chaired by David Zacut. As a commercial-stage company, Brainsway reinvests operating cash flow rather than deploying third-party investor capital.

Does Brainsway participate in fund commitments or only direct deals?

Brainsway does not make fund commitments or direct investments as an allocator — it is an operating company that designs, manufactures, and sells medical devices. The question is misapplied; Brainsway is a Nasdaq-listed issuer, not an institutional LP. Its counterparties are hospitals, clinics, group purchasing organizations, and distributors rather than general partners or fund managers.

What is Brainsway's known posture on co-investments alongside external GPs?

Brainsway does not have a posture on co-investments alongside GPs because it is not a capital allocator. The firm occasionally partners with academic medical centers and managed care organizations on investigator-sponsored clinical studies, which involve cost-sharing or grant funding, but these are operating partnerships rather than investment co-underwritings.

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