BrainsWay () 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.

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 The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1 ...

(NIH) by Abraham Zangen, Roy A. Wise, Mark Hallett, Pedro C. Miranda and Yiftach Roth. 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. 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. 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 Tel Aviv University (TAU) ( he, אוּנִיבֶרְסִיטַת תֵּל אָבִיב, ''Universitat Tel Aviv'') is a public research university in Tel Aviv, Israel. With over 30,000 students, it is the largest university in the country. Locate ...

. In early 2007 BrainsWay executed an

initial public offering An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investment ...

on the Tel Aviv Stock Exchange, raising for a market cap of . In 2010 BrainsWay announced plans to list shares of the company's stock on the Nasdaq exchange but withdrew them in June. In January 2013, BrainsWay received clearance from the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...

and from

Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary unit ...

to market its deep TMS device in the United States and in Canada as a treatment for treatment-resistant major depressive disorder. Evidence to support this use is tentative as of 2013 no high quality evidence is available. 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 Major depressive disorder (MDD), also known as clinical depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Introdu ...

and H7-coil for OCD.

History

See also

References

Further reading