NeurAxis Announces Publication of Prospective Study Showing IB-Stim™ Improves Quality of Life of Adolescents with IBS
September 12 2023 - 8:00AM
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 announced the publication of Prospective
study of the effect of auricular percutaneous electrical nerve
field stimulation on quality of life in children with pain related
disorders of gut-brain interaction, a randomized, double-blind,
placebo-controlled trial to evaluate the efficacy of IB-Stim™ in
children with post-concussion symptoms, featured in the September
2023 Frontiers in Pain Research.
The publication, led by investigators from
Children’s Hospital of Orange County, investigated changes in
gastrointestinal symptoms and quality of life in 31 adolescent
patients aged 11 – 18 years with functional abdominal pain
disorders (FAPDs) before and after treatment with IB-Stim. The
patients were treated for 4 weeks and data were collected
prospectively from both the patient and the parents using validated
questionnaires. Following IB-Stim™ treatment, the study noted
that:
- patients
reported significant reductions in abdominal pain, nausea,
disability, and anxiety from baseline to week 4 (p < 0.05);
- parent
assessments reported significant improvement in the child’s quality
of life based on physical function, psychosocial function, and
generic core scale scores (p < 0.05); and
- parents also
reported reduced abdominal pain, functional disability, and
somatization in their child. The global health scores also
significantly improved based on both patient and parent reports (p
< 0.05).
Dr. Adrian Miranda, Chief Medical Officer of
NeurAxis said, “We are pleased that outcomes post IB-Stim treatment
continue to be replicated at centers of excellence across the
country. Further, this study is unique in that it not only found
improvements in gastrointestinal symptoms, but also in the child’s
quality of life based on the parent’s report.” Dr. Miranda added,
“The ability to improve a child’s quality of life is something that
NeurAxis is extremely proud of and we will continue to work
tirelessly towards our goal to ensure that every child has access
to necessary treatment.”
Brian Carrico, President and Chief Executive
Officer of NeurAxis, said, “We are pleased to highlight the 10th
peer reviewed publication, focused on our PENFS technology, as the
body of clinical evidence supporting our IB-Stim™ therapy grows. We
are actively leveraging IB-Stim™ publications to expand written
policy coverage with a goal to drive guideline changes that support
IB-Stim as the standard of care for FAPDs.”
Forward-Looking Statements
Certain 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
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