Brainsway

{{Infobox company

| name = BrainsWay Ltd.

| native_name =

| trading_name =

| logo = Brainsway logo.jpg

| type = Public

| traded_as = {{TASE|BRIN}}
{{NASDAQ|BWAY}}

| predecessor =

| successor =

| founder = {{ubl|Avner Hagai (president)|David Zacut (chairman)}}

| defunct =

| fate =

| area_served =

| key_people = {{ubl|Abraham ZangenYiftach Roth|Hadar Levy (CEO}}

| industry = Medical technology

| products = Deep TMS System

| production =

| services = Brain Disorder treatment

| revenue =

| operating_income =

| net_income =

| assets =

| equity =

| owner =

| num_employees =

| parent =

| divisions =

| subsid = Brainsway Inc.

| footnotes =

| intl =

| caption =

| romanized =

| former type =

| foundation = {{Start date and age|2003}}

| location_city = Burlington, Massachusetts

| location_country = United States

| locations =

| homepage = {{URL|brainsway.com}}

| bodystyle =

}}

BrainsWay Ltd. ({{Langx|he|בריינסוויי}}) is an international company that is engaged in the development of a medical device that uses H-coil for deep transcranial magnetic stimulation (Deep TMS) as a non-invasive treatment for depression, OCD, and smoking addiction. The company was founded in 2003 and has offices in the US and Jerusalem.{{Cite web |date=December 2023 |title=REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 |url=https://mayafiles.tase.co.il/rpdf/1564001-1565000/P1564325-00.pdf |access-date=2024-04-25 |website=mayafiles.tase.co.il}}

History

The magnetic coil technology used by BrainsWay's devices, called the "H coil", emerged from research done in the late 1990s and early 2000s at the U.S. National Institutes of Health (NIH) by Abraham Zangen, Roy A. Wise, Mark Hallett, Pedro C. Miranda and Yiftach Roth.{{cite journal|last1=George|first1=Mark S.|title=Stimulating the Brain|journal=Scientific American|date=September 2003|volume=289|issue=3|pages=66–73|doi=10.1038/scientificamerican0903-66|pmid=12951829|bibcode=2003SciAm.289c..66G}}{{cite news|last1=Rapp|first1=David|title=Field of Dreams|url=https://www.haaretz.com/field-of-dreams-1.150597|work=Haaretz|date=17 February 2005|language=en}}{{cite web|last=Blackburn|first=Nicky|title=Israel's BrainsWay stimulates a magnetic remedy for depression|url=http://israel21c.org/health/israels-brainsway-stimulates-a-magnetic-remedy-for-depression/|publisher=Israel21c|access-date=11 January 2013|date=19 February 2006}} Most coils used in transcranial magnetic stimulation (TMS) provide a shallow magnetic field that affects neurons mostly on the surface of the brain, delivered with coil shaped like the number eight. The H coil provided magnetic fields deeper in the brain, and devices using them provide what is called "deep TMS".

The H-coil was patented by the NIH in 2002, and the procedure whereby the H-coil was applied to TMS became known as Deep TMS.{{cite book|title=Neurofeedback and Neuromodulation Techniques and Applications|year=2011|publisher=Academic Press|location=London|isbn=978-0-12-382235-2|pages=278–279|chapter-url=https://books.google.com/books?id=s3p_T2vnro0C&pg=PA278|author1=Spronk, Desirée |author2=Arns, Martijn |author3=Fitzgerald, Paul B. |editor1=Coben, Robert |editor2=Evans, James R. |access-date=11 January 2013|chapter=Chapter 10: Repetitive Transcranial Magnetic Stimulation in Depression: Protocols, Mechanisms, and New Developments}}{{cite news|last=Heller|first=Corinne|title=Scientists in Israel are reaching deeper into the minds of the clinically depressed to try to lift their spirits|url=https://www.reuters.com/article/us-israel-depression-idUSL0557346920061207|access-date=11 January 2013|newspaper=Reuters|date=7 December 2006|archive-date=3 December 2013|archive-url=https://web.archive.org/web/20131203111126/http://www.reuters.com/article/2006/12/07/us-israel-depression-idUSL0557346920061207|url-status=live}}

BrainsWay was founded in 2003 in Delaware by Uzi Sofer and Avner Hagai, together with David Zacut, and they set up a subsidiary in Jerusalem, and obtained an exclusive license from the NIH for the patent it filed on the H coil.{{cite web|title=Magnetic Stimulation Shows Promise as the New Wave for Treating Depression|url=http://www.ott.nih.gov/current_issues/archive_Magnetic_Stimulation.aspx|publisher=NIH Office of Technology Transfer|date=24 July 2007|url-status=dead|archive-url=https://web.archive.org/web/20130330180507/http://www.ott.nih.gov/current_issues/archive_Magnetic_Stimulation.aspx|archive-date=30 March 2013}} By 2006 the company had conducted animal studies at Weizmann Institute of Science and had run its first clinical trial assessing safety, at Tel Aviv University.

In early 2007 BrainsWay executed an initial public offering on the Tel Aviv Stock Exchange, raising {{Nowrap|₪33 million}} for a market cap of {{Nowrap|₪110 million}}.{{cite news|last=Weinreb|first=Gali|title=Brainsway IPO four times oversubscribed|url=http://www.globes.co.il/serveen/globes/docview.asp?did=1000168625|access-date=11 January 2013|newspaper=Globes|date=2 January 2007|url-status=dead|archive-url=https://web.archive.org/web/20100121031455/http://www.globes.co.il/serveen/globes/docview.asp?did=1000168625|archive-date=21 January 2010}} In 2010 BrainsWay announced plans to list shares of the company's stock on the Nasdaq exchange but withdrew them in June.{{cite news|last=Habib-Valdhorn|first=Shiri|title=Brainsway looks to Nasdaq offering|url=http://www.globes.co.il/serveen/globes/docview.asp?did=1000580299&fid=1725|archive-url=https://archive.today/20130217203249/http://www.globes.co.il/serveen/globes/docview.asp?did=1000580299&fid=1725|url-status=dead|archive-date=17 February 2013|access-date=11 January 2013|newspaper=Globes|date=8 August 2010}}{{cite web|title=Brainsway withdraws IPO|url=http://www.renaissancecapital.com/ipohome/news/Brainsway-withdraws-IPO-9788.html|publisher=Renaissance Capital|access-date=11 January 2013|date=14 June 2011}}

In January 2013, BrainsWay received clearance from the U.S. Food and Drug Administration and from Health Canada to market its deep TMS device in the United States and in Canada as a treatment for treatment-resistant major depressive disorder.{{cite news|last=Wainer|first=Davic|title=Brainsway Rises as U.S. Allows Depression Device: Tel Aviv Mover|url=https://www.bloomberg.com/news/2013-01-09/brainsway-rises-as-u-s-allows-depression-device-tel-aviv-mover.html|access-date=11 January 2013|newspaper=Bloomberg|date=9 January 2013}}{{cite news|title=Health Canada approves Brainsway depression therapy|url=http://www.globes.co.il/serveen/globes/docview.asp?did=1000814731&fid=1725|archive-url=https://archive.today/20130218045807/http://www.globes.co.il/serveen/globes/docview.asp?did=1000814731&fid=1725|url-status=dead|archive-date=18 February 2013|access-date=26 January 2013|newspaper=Globes|date=15 January 2013}} Evidence to support this use is tentative; as of 2013 no high quality evidence is available.{{cite journal|last1=Bersani|first1=FS|last2=Minichino|first2=A|last3=Enticott|first3=PG|last4=Mazzarini|first4=L|last5=Khan|first5=N|last6=Antonacci|first6=G|last7=Raccah|first7=RN|last8=Salviati|first8=M|last9=Delle Chiaie|first9=R|last10=Bersani|first10=G|last11=Fitzgerald|first11=PB|last12=Biondi|first12=M|title=Deep transcranial magnetic stimulation as a treatment for psychiatric disorders: a comprehensive review.|journal=European Psychiatry|date=January 2013|volume=28|issue=1|pages=30–9|pmid=22559998|doi=10.1016/j.eurpsy.2012.02.006|s2cid=29053871}} {{open access}}

In August 2020, BrainsWay received FDA clearance for its deep TMS device for use in smoking addiction. The device has also previously been cleared by the FDA using an H1-coil for major depressive disorder and H7-coil for OCD.{{Cite web|title=FDA clears first brain stimulation device for smoking cessation|url=https://www.bioworld.com/articles/497063-fda-clears-first-brain-stimulation-device-for-smoking-cessation?v=preview|access-date=2020-08-27|website=www.bioworld.com|language=en}}

Brainsway

History

See also

References

Further reading