NeurAxis Highlights Pediatric Post-Concussion Clinical Study
29 8월 2023 - 10:00PM
NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American:
NRXS), a medical technology company commercializing neuromodulation
therapies that address chronic and debilitating conditions in
children and adults, today highlighted A Prospective Study on the
Effect of Auricular Percutaneous Electrical Nerve Field Stimulation
(PENFS™) in Patients with Post-Concussion Syndrome (PCS), a
randomized, double-blind, placebo-controlled trial to evaluate the
efficacy of IB-Stim™ in children with post-concussion symptoms.
Brian Carrico, President and Chief Executive
Officer of NeurAxis, said, “We are thrilled to support this
research because if the data is positive and the FDA gives
clearance, this would be a groundbreaking therapeutic option for
post-concussion syndrome. According to literature, the majority of
concussions occur in children, mainly due to sports and
unstructured play with or without helmets. While symptoms generally
resolve in a few weeks, others persist, including ongoing
headaches, nausea, and dizziness, as well as mood and behavioral
disorders. Medications are primarily used for off-label in the
treatment, despite the lack of evidence to support efficacy or
safety.”
“We support the ongoing pediatric
post-concussion clinical research and it reinforces our commitment
to evidence-based research to drive adoption for our PENFS™
technology, a minimally invasive device alternative, to meet the
needs of this $2 billion market. We look forward to working with
the FDA to continue expanding pediatric indications on our PENFS™
technology, currently FDA cleared for functional abdominal pain
with IBS in adolescents, to also potentially include
post-concussion syndrome in children,” concluded Mr. Carrico.
Currently enrolling up to 100 patients, the
clinical trial’s primary endpoint is improvements in validated
measures, including the Immediate Post-Concussion Assessment,
Post-Concussion Symptom Scale, and Balance Error Scoring Symptom
compared to placebo. The trial is being conducted at Children’s
Hospital of Orange County, CA.
Forward-Looking
StatementsCertain statements in this press release are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements other
than statements of historical fact are forward-looking statements.
Forward-looking statements are based on management’s current
assumptions and expectations of future events and trends, which
affect or may affect the Company’s business, strategy, operations
or financial performance, and actual results and other events may
differ materially from those expressed or implied in such
statements due to numerous risks and uncertainties. Forward-looking
statements are inherently subject to risks and uncertainties, some
of which cannot be predicted or quantified. There are a number of
important factors that could cause actual results, developments,
business decisions or other events to differ materially from those
contemplated by the forward-looking statements in this press
release. These factors include, among other things, the conditions
in the U.S. and global economy, the trading price and volatility of
the Company’s stock, public health issues or other events, the
Company’s compliance with applicable laws, the results of the
Company’s clinical trials and perceptions thereof, as well as
factors described in the Risk Factors section of NeurAxis’s public
filings with the Securities and Exchange Commission (SEC). Because
forward-looking statements are inherently subject to risks and
uncertainties, you should not rely on these forward-looking
statements as predictions of future events. These forward-looking
statements speak only as of the date of this press release and,
except to the extent required by applicable law, the Company
undertakes no obligation to update or revise these statements,
whether as a result of any new information, future events and
developments or otherwise.
About NeurAxis, Inc.NeurAxis,
Inc., is a medical technology company focused on neuromodulation
therapies to address chronic and debilitating conditions in
children and adults. NeurAxis is dedicated to advancing science and
leveraging evidence-based medicine to drive adoption of its
IB-Stim™ therapy, which is its proprietary Percutaneous Electrical
Nerve Field Stimulation (PENFS) technology, by the medical,
scientific, and patient communities. IB-Stim™ is FDA cleared for
functional abdominal pain associated with irritable bowel syndrome
(IBS) in adolescents 11-18 years old. Additional clinical trials of
PENFS in multiple pediatric and adult conditions with large unmet
healthcare needs are underway. For more information, please visit
http://neuraxis.com/.
This page discusses ongoing research activities
with percutaneous electrical nerve field stimulator (PENFS)
technology. Please note, the research being described includes
information about technology and intended uses of that technology
which have not been reviewed or approved/cleared by the U.S. FDA,
and is being provided for informational purposes only. NeurAxis
does not recommend or suggest the use of its PENFS™ IB-Stim™ device
for uses beyond those that are cleared by the U.S. FDA.
See https://ibstim.com/important-information/ .
Contacts:
CompanyNeurAxis,
Inc.info@neuraxis.com
Investor
RelationsGilmartin
GroupIR@neuraxis.com
Neuraxis (AMEX:NRXS)
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