BrainsWay Receives FDA Clearance for Three-Minute Theta Burst Treatment Protocol for Major Depressive Disorder
26 Aprile 2021 - 1:30PM
BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the
“Company”), a global leader in advanced noninvasive
neurostimulation treatments for mental health disorders, today
announced that the U.S. Food and Drug Administration (FDA) granted
501(k) clearance for the Company’s Theta Burst three-minute
protocol utilizing its proprietary Deep Transcranial Magnetic
Stimulation (Deep TMS) system for the treatment of major depressive
disorder (MDD).
“Adding our three-minute treatment protocol to
the list of growing solutions available to our provider partners
expands the platform nature of this lifechanging technology,” said
Hadar Levy, Senior Vice President and General Manager of BrainsWay.
“Many patients and providers can benefit from significantly shorter
treatment sessions, and our Theta Burst protocol can provide these
patients with another option to manage their treatment resistant
depression.”
In support of its successful application to the
FDA – the Company’s seventh to date – BrainsWay submitted safety
and efficacy data from 146 subjects who had received either the
standard Deep TMS protocol or the three-minute Deep TMS protocol.
Subjects in both groups demonstrated a statistically and clinically
meaningful reduction in depression scores, and the results met the
equivalence criteria needed for clearance of the shorter
treatment.
“The addition of Theta Burst to the available
protocols further demonstrates BrainsWay’s commitment to expanding
the utility of the BrainsWay Deep TMS system,” said Moria Ankri,
Vice President of Research & Development. “This protocol shows
that innovation need not be revolutionary or radical to have a
positive effect on peoples’ lives. Having a three-minute option for
patients has the potential to expand access to care by providing
patients with added flexibility in selecting courses of treatment
that may fit better with their lifestyle.”
The BrainsWay Theta Burst protocol will be
immediately available on all BrainsWay systems already
installed.
About Major Depressive Disorder
Major depressive disorder (MDD) is a common and debilitating form
of depression characterized by physiological, emotional, and
cognitive symptoms. According to the World Health Organization
(WHO), depression affects approximately 264 million people
worldwide, and the U.S. National Institute of Mental Health (NIMH)
estimates that 17.3 million adults in the United States suffer from
an MDD episode within a given year. Common symptoms of MDD include
loss of interest, depressed mood, reduced energy, disturbed sleep
and appetite, and comorbid anxiety. The ongoing pandemic
continues to exacerbate the incidence of depression globally with
more than a three-fold increase in depression symptoms since the
onset of COVID-19, and more recent research suggests that more than
50% of patients recovering from COVID-19 suffer from symptoms of
MDD.
About BrainsWayBrainsWay 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, and include, but
are not limited to, statements about the expected proceeds, use of
proceeds and closing of the underwritten offering. 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. The following factors, among others,
could cause actual results to differ materially from those
described in the forward-looking statements: 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; 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.
Contacts: BrainsWay:Hadar LevySVP and
General ManagerHadarL@brainsway.com
Media Contact: Will Johnson (201)
465-8019 BrainsWay@antennagroup.com
Grafico Azioni Brainsway (NASDAQ:BWAY)
Storico
Da Set 2024 a Ott 2024
Grafico Azioni Brainsway (NASDAQ:BWAY)
Storico
Da Ott 2023 a Ott 2024