Neuronetics® Receives FDA Clearance for Three-Minute TouchStar™ Treatment Protocol
November 23 2020 - 4:05PM
Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical
technology company focused on designing, developing and marketing
products that improve the quality of life for patients who suffer
from psychiatric disorders, announced the U.S. Food and Drug
Administration (FDA) granted clearance for the Company’s TouchStar
treatment, a three-minute intermittent theta burst (iTBS) protocol
with its NeuroStar Advanced Therapy System, administered with
patented Contact Sensing technology.
The new protocol arms physicians with the ability to now offer a
third FDA-cleared treatment protocol with NeuroStar Advanced
Therapy – a non-drug, non-invasive transcranial magnetic
stimulation (TMS) treatment for Major Depressive Disorder (MDD)
that uses magnetic pulses to stimulate areas of the brain that are
underactive in depression. The three-minute TouchStar protocol
allows clinicians to further customize treatments to best suit
patient needs while increasing utilization of the NeuroStar
Advanced Therapy System and expanding its benefits to more
patients.
TouchStar with Contact Sensing provides physicians and their
patients with the option of shorter treatment sessions using higher
frequency pulses while helping ensure that the proper dose is being
given at every session. The Contact Sensing technology monitors
NeuroStar Advanced Therapy’s contoured coil, which is designed with
a curve to fit the head and provides continuous real-time feedback
about the coil’s angle and contact with the head.
“The TouchStar protocol is particularly impactful when paired
with our patented Contact Sensing precision technology that
provides clinicians with the confidence of knowing they are giving
patients the right dose at the exact location,” said Greg Harper,
Vice President of Product Development and Operations at
Neuronetics. “A faster solution to target depression is certainly a
benefit, but when we’re shortening those treatment times it is even
more critical that proper coil position is maintained. With TMS
systems, if coil contact with the head is off by just 1mm, up to 40
percent of the required dosage can be lost1 – Contact Sensing
monitors coil position and helps ensure patients get the full
prescribed treatment dosage every session.”
TouchStar is the latest advancement designed to enhance
treatment options and expand access and availability of NeuroStar
Advanced Therapy for patients. The system now has three treatment
variations: standard, which offers treatments at 37.5 minutes per
session; DASH, which offers treatments as little as 19 minutes per
session; and TouchStar, which offers treatments at three minutes
per session. TouchStar will be available to NeuroStar providers in
the first quarter of 2021.
“TouchStar protocol clearance is an especially relevant
milestone as depression rates continue to rise and providing access
to proven depression treatments remains more critical than ever
before,” said Keith J. Sullivan, President and CEO of Neuronetics.
“Our hope is that this third treatment protocol will mean even more
patients in need will have access to NeuroStar Advanced Therapy to
help them in their battle with this debilitating disease.”
Neuronetics remains committed to gathering real world outcomes
for treatment through the NeuroStar Outcomes Registry and will
include TouchStar data as part of the largest outcomes registry in
the world for MDD. Visit www.neurostar.com for more
information.
About NeuroneticsNeuronetics, Inc. is a
commercial-stage medical technology company focused on designing,
developing, and marketing products that improve the quality of life
for patients who suffer from psychiatric disorders. Its commercial
product, the NeuroStar® Advanced Therapy System, is a non-invasive
and non-systemic office-based treatment that uses transcranial
magnetic stimulation, or TMS, to create a pulsed, MRI-strength
magnetic field that induces electrical currents designed to
stimulate specific areas of the brain associated with mood. The
system is cleared by the United States Food and Drug
Administration, or FDA, for the treatment of major depressive
disorder in adult patients who have failed to achieve satisfactory
improvement from prior antidepressant medication in the current
episode. NeuroStar is also available in other parts of the world,
including Japan, where it is listed under Japan’s national health
insurance. Additional information can be found at
www.neuronetics.com.
Media Contact: Meagan DominickVault
Communications610-455-2779mdominick@vaultcommunications.com
1 Data on file. Neuronetics, Inc.
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