Brainsway

Brainsway is an Israeli medical-device company focused on non-invasive brain stimulation. Its principal technology is Deep Transcranial Magnetic Stimulation, commonly called Deep TMS, which uses proprietary H-coil designs to deliver magnetic stimulation to broader and deeper regions of the brain than conventional figure-eight TMS coils. The company develops, manufactures, and commercializes systems intended for use in psychiatric and addiction-treatment settings. The technology underlying Brainsway’s products originated in research conducted in the late 1990s and early 2000s by researchers associated with the U.S. National Institutes of Health, including Abraham Zangen, Roy A. Wise, Mark Hallett, Pedro C. Miranda, and Yiftach Roth. Conventional TMS systems generally concentrate stimulation near the cortical surface. The H-coil concept was designed to produce a deeper magnetic field, leading to the clinical approach known as Deep TMS. The H-coil was patented through the NIH in 2002. Brainsway was established in Delaware in 2003 by Uzi Sofer, Avner Hagai, and David Zacut. The founders established a Jerusalem subsidiary and obtained an exclusive NIH license related to the H-coil patent. Early development included animal research conducted with the Weizmann Institute of Science and a first safety-oriented clinical study at Tel Aviv University. These activities helped move the technology from laboratory research toward regulated medical-device development. The company’s main commercial platform is the Brainsway Deep TMS system, used with different coil configurations for different clinical indications. The H1 coil has been associated with treatment-resistant major depressive disorder, while the H7 coil has been used for obsessive-compulsive disorder. Brainsway has also pursued applications in smoking addiction. Regulatory clearances do not mean that every clinical use is universally accepted or that treatment is effective for every patient; clinical outcomes depend on the indication, protocol, patient population, and treating provider. Brainsway became a public company through an initial public offering on the Tel Aviv Stock Exchange in early 2007. It later explored a Nasdaq listing but withdrew that plan in 2010. In January 2013, the company received U.S. Food and Drug Administration and Health Canada clearance to market its Deep TMS device for treatment-resistant major depressive disorder. The FDA subsequently cleared additional uses, including an indication related to obsessive-compulsive disorder and, in 2020, smoking addiction. In September 2025, the company reported FDA clearance for an accelerated major-depressive-disorder protocol intended to reduce the initial treatment phase from approximately four weeks to six days. Brainsway’s positioning is centered on expanding access to non-invasive neuromodulation through dedicated clinical systems rather than pharmaceuticals or invasive surgery. Its business depends on regulatory authorization, clinical adoption, treatment-center economics, reimbursement conditions, provider training, and evidence supporting each indication. The company has offices in Jerusalem and the United States and markets its systems internationally.

Brainsway’s origins lie in research on magnetic brain stimulation conducted during the late 1990s and early 2000s. Researchers including Abraham Zangen, Roy A. Wise, Mark Hallett, Pedro C. Miranda, and Yiftach Roth investigated coil geometries capable of producing a deeper and more distributed magnetic field than the figure-eight coils commonly used in conventional TMS. Their work led to the H-coil concept, which was patented through the U.S. National Institutes of Health in 2002. The approach became known as Deep Transcranial Magnetic Stimulation, or Deep TMS. Brainsway was founded in Delaware in 2003 by Uzi Sofer, Avner Hagai, and David Zacut. The company established a subsidiary in Jerusalem and obtained an exclusive license from the NIH relating to the H-coil patent. Its early development program included animal studies conducted at the Weizmann Institute of Science and a first clinical safety study at Tel Aviv University by 2006. These studies formed part of the transition from experimental technology to a regulated medical-device platform. The company entered the public markets in early 2007 through an initial public offering on the Tel Aviv Stock Exchange. The offering reportedly raised 33 million Israeli new shekels and gave the company a market capitalization of approximately 110 million shekels at the time. Brainsway later announced an intention to list on Nasdaq, but withdrew that plan in June 2010. A major regulatory milestone came in January 2013, when Brainsway obtained clearance from the U.S. Food and Drug Administration and Health Canada to market its Deep TMS device for treatment-resistant major depressive disorder. The company’s platform uses interchangeable or indication-specific coil configurations. The H1 coil has been associated with major depressive disorder, while the H7 coil has been cleared for obsessive-compulsive disorder. In 2020, the FDA also cleared the device for use in smoking addiction. Brainsway’s development model has therefore combined proprietary hardware, licensed intellectual property, clinical protocols, and regulatory submissions for specific indications. The company’s commercial opportunity depends on whether mental-health providers adopt Deep TMS as an alternative or complement to medication, psychotherapy, electroconvulsive therapy, and conventional TMS. Evidence and regulatory status vary by indication; the existence of clearance for a particular use does not establish uniform effectiveness across all conditions or patients. In September 2025, Brainsway received FDA clearance for an accelerated major-depressive-disorder protocol. The protocol was described as reducing the initial treatment period from approximately four weeks to six days, a change intended to make treatment more compatible with patient schedules and clinical operations. Brainsway operates from Jerusalem and the United States and serves international markets through its medical-device business.

• 2025

  FDA clearance for accelerated depression protocol

  [1]Brainswayen.wikipedia.org

  The FDA cleared an accelerated major-depressive-disorder protocol intended to reduce the initial treatment phase to six days.

• 2020

  FDA clearance for smoking addiction

  [1]Brainswayen.wikipedia.org

  The FDA cleared Brainsway’s Deep TMS system for use in smoking addiction treatment.

• 2013

  North American clearance for treatment-resistant depression

  [1]Brainswayen.wikipedia.org

  The FDA and Health Canada cleared Brainsway’s Deep TMS system for treatment-resistant major depressive disorder.

• 2007

  Initial public offering on the Tel Aviv Stock Exchange

  [1]Brainswayen.wikipedia.org

  Brainsway completed an initial public offering on the Tel Aviv Stock Exchange.

• 2006

  Early preclinical and clinical work completed

  [1]Brainswayen.wikipedia.org

  Brainsway conducted animal studies with the Weizmann Institute of Science and a first clinical safety study at Tel Aviv University.

• 2003

  Brainsway founded

  [1]Brainswayen.wikipedia.org

  Uzi Sofer, Avner Hagai, and David Zacut founded Brainsway in Delaware and established a Jerusalem subsidiary.

• 2002

  H-coil patent filed through the NIH

  [1]Brainswayen.wikipedia.org

  The H-coil technology underlying Deep TMS was patented through the U.S. National Institutes of Health.

A specialist neuromodulation company using proprietary H-coil technology to provide non-invasive treatment systems for psychiatric and addiction-related conditions.

• Medical neuromodulation system

  Brainsway Deep TMS

  Brainsway Deep TMS is the company’s core clinical platform. It uses an H-coil mounted in a helmet-like applicator to deliver non-invasive electromagnetic stimulation to deeper and broader brain regions than conventional figure-eight TMS designs. The system is used with indication-specific treatment protocols and coil configurations. Regulatory clearances have covered treatment-resistant major depressive disorder, obsessive-compulsive disorder, and smoking addiction in specified markets and settings.

• TMS coil configuration

  H1 coil

  The H1 coil is a Brainsway coil configuration associated with Deep TMS treatment for major depressive disorder, including treatment-resistant cases. It is designed to produce a deeper stimulation field than traditional superficial TMS coil arrangements. Its use is governed by the applicable regulatory clearance, clinical protocol, patient selection criteria, and treatment-provider practices in each market.

• TMS coil configuration

  H7 coil

  The H7 coil is a Deep TMS configuration associated with obsessive-compulsive-disorder treatment. It is intended to target neural regions relevant to the approved clinical protocol while retaining the non-invasive nature of TMS. The device’s use and indication are subject to jurisdiction-specific regulatory authorization and clinical guidelines.

• 2025

  Accelerated major-depressive-disorder treatment protocolGeneration change

  Background

  Brainsway pursued a shorter treatment schedule intended to reduce the time burden associated with the initial Deep TMS treatment phase.

  Action taken

  The FDA cleared an accelerated protocol that shortens the initial phase from approximately four weeks to six days.

  Aftermath

  The clearance created a shorter authorized treatment pathway for the specified major-depressive-disorder use.

  Source

• 2020

  Expansion into smoking-addiction treatmentProduct launch

  Background

  Brainsway pursued an additional application of Deep TMS beyond psychiatric mood and obsessive-compulsive indications.

  Action taken

  The FDA cleared the device for use in smoking addiction treatment.

  Aftermath

  The clearance broadened the company’s authorized clinical application area in the United States.

  Source

• 2013

  North American regulatory expansion for major depressive disorderProduct launch

  Background

  Brainsway sought authorization to commercialize Deep TMS for treatment-resistant major depressive disorder.

  Action taken

  The FDA and Health Canada cleared the company’s Deep TMS device for the specified indication.

  Aftermath

  The clearances enabled marketing of the system for treatment-resistant major depressive disorder in the United States and Canada.

  Source

• 2010

  Withdrawal of planned Nasdaq listingStrategy

  Background

  Brainsway had announced plans to pursue a Nasdaq listing after becoming publicly traded in Israel.

  Action taken

  The company withdrew the planned Nasdaq listing in June 2010.

  Aftermath

  Brainsway remained listed on the Tel Aviv Stock Exchange rather than proceeding with the proposed U.S. listing.

  Source

• 2007

  Public-market financing through the Tel Aviv Stock ExchangeOther

  Background

  After several years of technology development and early clinical work, Brainsway pursued public financing to support its medical-device program.

  Action taken

  The company completed an initial public offering on the Tel Aviv Stock Exchange.

  Aftermath

  The transaction made Brainsway a publicly traded company and supplied capital for continued development and commercialization.

  IPO proceeds and reported market capitalization. 33 million Israeli new shekels raised; approximately 110 million Israeli new shekels market capitalization (Early 2007)

  Source

• 2026.11.02

  Reported2026.11.02

  BrainsWay and Mindful Health Solutions announce strategic collaboration[3]BrainsWay与Mindful Health Solutions宣布战略合作manilatimes.net

  BrainsWay announced a strategic collaboration with Mindful Health Solutions to expand access to noninvasive mental health treatments and pursue joint physician education, clinical-awareness and research initiatives.

Read more

1. 1Brainswayen.wikipedia.org
2. 2Brainsway official websitebrainsway.com
3. 3BrainsWay与Mindful Health Solutions宣布战略合作manilatimes.net