BrainsWay Announces 100,000 Patients Treated with Deep Transcranial Magnetic Stimulation (Deep TMS)
April 14 2021 - 8:03AM
BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the
“Company”), a global leader in advanced noninvasive
neurostimulation treatments for mental health disorders, announced
today that 100,000 patients have been treated globally with Deep
transcranial magnetic stimulation (Deep TMS).
The noninvasive therapy administers magnetic
pulses through a proprietary H-coil to target structures of the
brain associated with mental health conditions. The technology
received FDA clearance for the treatment of major depressive
disorder (MDD) in 2013 and for the treatment of
obsessive-compulsive disorder (OCD) in 2018. Most recently, the
technology was FDA cleared as an aid for short-term smoking
cessation.
"As scientific founders of BrainsWay, it is
rewarding to see the Company achieve this milestone and to witness
the positive impact this groundbreaking technology has had on so
many patients and families,” said Prof. Abraham Zangen, Co-Founder
and Board Director of BrainsWay, and Yiftach Roth, Ph.D.,
Co-Founder and Chief Scientific Officer of BrainsWay. “This novel
technology can help millions of patients in the coming years, and
we are honored to be part of providing successful and noninvasive
mental health solutions to those who need them most.”
BrainsWay's Deep TMS has been investigated in
more than 30 randomized clinical trials worldwide, with additional
studies ongoing or planned. Conducted primarily in the outpatient
setting, patients can return to normal activities immediately
following the treatment session. By penetrating deeper and broader
than traditional figure-8 TMS devices, Deep TMS has demonstrated
versatility in addressing a range of disorders by safely targeting
and stimulating deeper and broader brain regions.
“When I first had the opportunity to evaluate
this technology, it was clear that this was a unique solution with
the ability to transform lives,” said David Zacut, MD, Founder and
Chairman of BrainsWay. “At that time, TMS technology had not yet
been widely adopted clinically, but it showed substantial promise
to advance the field of neuroscience. It has been a pleasure seeing
how far the Company has grown and progressed the field over the
past two decades."
There are more than 600 BrainsWay Deep TMS
Systems installed in private clinics, outpatient facilities, and
hospitals globally. For more information around provider locations
visit brainsway.com/find-a-provider.
About BrainsWay
BrainsWay is a global leader in advanced
noninvasive neurostimulation treatments for mental health
disorders. The Company is boldly advancing neuroscience with its
proprietary Deep Transcranial Magnetic Stimulation (Deep TMS)
platform technology to improve health and transform lives.
BrainsWay is the first and only TMS company to obtain three
FDA-cleared indications backed by pivotal studies demonstrating
clinically proven efficacy. Current indications include major
depressive disorder, obsessive-compulsive disorder, and smoking
addiction. The Company is dedicated to leading through superior
science and building on its unparalleled body of clinical evidence.
Additional clinical trials of Deep TMS in various psychiatric,
neurological, and addiction disorders are underway. Founded in
2003, with offices in Cresskill, NJ and Jerusalem, Israel,
BrainsWay is committed to increasing global awareness and broad
access to Deep TMS. For the latest news and information about
BrainsWay, please visit www.brainsway.com.
Forward Looking Statements
This press release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. These forward-looking
statements and their implications are based on the current
expectations of the management of the Company only and are subject
to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the
forward-looking statements. Additionally, the claims contained
herein are based on various internal data and assumptions which may
be subject to differing interpretation, analysis, and further
assessment. The following factors, among others, could cause actual
results to differ materially from those described herein:
inadequacy of financial resources to meet future capital
requirements; changes in technology and market requirements; delays
or obstacles in launching and/or successfully completing planned
studies and clinical trials; failure to obtain approvals by
regulatory agencies on the Company’s anticipated timeframe, or at
all; inability to retain or attract key employees whose knowledge
is essential to the development of Deep TMS products; unforeseen
difficulties with Deep TMS products and processes, and/or inability
to develop necessary enhancements; inadequacy and/or inconsistency
between different tracking processes; unexpected costs related to
Deep TMS products; failure to obtain and maintain adequate
protection of the Company’s intellectual property, including
intellectual property licensed to the Company; the potential for
product liability; changes in legislation and applicable rules and
regulations; unfavorable market perception and acceptance of Deep
TMS technology; inadequate or delays in reimbursement from
third-party payers, including insurance companies and Medicare;
inability to commercialize Deep TMS, including internationally, by
the Company or through third-party distributors; product
development by competitors; inability to timely develop and
introduce new technologies, products and applications, and the
effect of the global COVID-19 health pandemic on our business and
continued uncertainty and market impact relating thereto.
Any forward-looking statement in this press
release speaks only as of the date of this press release. The
Company undertakes no obligation to publicly update or review any
forward- looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading “Risk Factors” in the Company’s filings with the U.S.
Securities and Exchange Commission, including the Company's Annual
Report on Form 20-F. Investors and security holders are urged to
read these documents free of charge on the SEC’s web site at
http://www.sec.gov.
Contact: BrainsWay: Hadar LevySVP and General
ManagerHadarL@brainsway.com
Media Contact:Will Johnson(201)
465-8019BrainsWay@antennagroup.com
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