NeurAxis Receives New FDA 510(K) Clearance for IB-Stim, Expanding its Addressable Market
04 November 2024 - 3:00PM
NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American:
NRXS), a medical technology company commercializing neuromodulation
therapies addressing chronic and debilitating conditions in
children and adults, today announced that it received a new 510(k)
clearance for IB-Stim™ Nonimplanted Nerve Stimulator for functional
abdominal pain relief. The new indication expands IB-Stim’s
addressable market and overall devices per patient. NeurAxis
leveraged its robust published data to receive this new indication.
“We are excited to receive this new 510(k)
clearance for IB-Stim, which expands the IB-Stim addressable market
by roughly 75%,” said Brian Carrico, President and Chief Executive
Officer of NeurAxis. “Furthermore, we expect devices per patient to
increase, as this new FDA clearance states on label use of four
devices per patient. All of this has been achieved due to the
strong body of published research, which has resulted in the
increased acceptance of our PENFS technology. This includes ongoing
expansion of payer coverage, as well as the recent establishment of
a new CPT Category I code by the American Medical Association,
effective January 2026. Our recent achievements in our
commercialization strategy have set the stage for increased revenue
and margin growth in the upcoming quarters.” Mr. Carrico
concluded.
NeurAxis’ PENFS technology, IB-Stim, is
FDA-cleared for functional abdominal pain associated with irritable
bowel syndrome (IBS) in adolescents 8-21 years old. IB-Stim is a
non-surgical device that sends gentle electrical impulses into
cranial nerve bundles in the ear. There are currently no
FDA-approved drug therapies for children with abdominal
pain-related disorders of the gut-brain interaction. Pharmacologic
treatments that use drugs off-label can often have serious side
effects, and most lack scientific evidence of efficacy.
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 the 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 8-21
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.
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, the results of submissions to the FDA, and
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.
For contraindications, precaution, warnings, and IFU, please
see:
https://ibstim.com/important-information/.
Contacts:
CompanyNeurAxis,
Inc.info@neuraxis.com
Investor Relations Lytham PartnersBen
Shamsian646-829-9701shamsian@lythampartners.com
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