Brainsway

BrainsWay Ltd. 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.[1]

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.[2][3][4] 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.[4][5][6]

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,[4] and obtained an exclusive license from the NIH for the patent it filed on the H coil.[7] 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.[4]

In early 2007 BrainsWay executed an initial public offering on the Tel Aviv Stock Exchange, raising ₪33 million for a market cap of ₪110 million.[8] In 2010 BrainsWay announced plans to list shares of the company's stock on the Nasdaq exchange but withdrew them in June.[9][10]

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.[11][12] Evidence to support this use is tentative; as of 2013 no high quality evidence is available.[13]

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.[14]

In September 2025, BrainsWay received FDA clearance for an Accelerated MDD Protocol that shortens the initial treatment phase from 4 weeks down to just 6 days. This protocol has been trademarked the SWIFTTM protocol. [15]

See also

Further reading

References

  1. REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 mayafiles.tase.co.il, December 2023, retrieved 2024-04-25^
  2. Mark S. George. Stimulating the Brain Scientific American, September 2003^
  3. David Rapp. Field of Dreams Haaretz, 17 February 2005^
  4. Nicky Blackburn. Israel's BrainsWay stimulates a magnetic remedy for depression Israel21c, 19 February 2006, retrieved 11 January 2013^
  5. Neurofeedback and Neuromodulation Techniques and Applications Academic Press, 2011, retrieved 11 January 2013^
  6. Corinne Heller. Scientists in Israel are reaching deeper into the minds of the clinically depressed to try to lift their spirits Reuters, 7 December 2006, retrieved 11 January 2013^
  7. Magnetic Stimulation Shows Promise as the New Wave for Treating Depression NIH Office of Technology Transfer, 24 July 2007^
  8. Gali Weinreb. Brainsway IPO four times oversubscribed Globes, 2 January 2007, retrieved 11 January 2013^
  9. Shiri Habib-Valdhorn. Brainsway looks to Nasdaq offering Globes, 8 August 2010, retrieved 11 January 2013^
  10. Brainsway withdraws IPO Renaissance Capital, 14 June 2011, retrieved 11 January 2013^
  11. Davic Wainer. Brainsway Rises as U.S. Allows Depression Device: Tel Aviv Mover Bloomberg, 9 January 2013, retrieved 11 January 2013^
  12. Health Canada approves Brainsway depression therapy Globes, 15 January 2013, retrieved 26 January 2013^
  13. FS Bersani, A Minichino, PG Enticott, L Mazzarini, N Khan, G Antonacci, RN Raccah, M Salviati. Deep transcranial magnetic stimulation as a treatment for psychiatric disorders: a comprehensive review. European Psychiatry, January 2013^
  14. FDA clears first brain stimulation device for smoking cessation www.bioworld.com, retrieved 2020-08-27^
  15. Landmark Data Validate BrainsWay’s SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment BrainsWay, retrieved 2026-03-31^