NeurAxis, Inc. Issues Letter to Shareholders from Brian Carrico, President and Chief Executive Officer
20 Décembre 2023 - 3:00PM
NeurAxis, Inc. (NYSE American: NRXS) (“NeurAxis” or the
“Company”), a medical technology company commercializing
neuromodulation therapies that address chronic and debilitating
conditions in children and adults, today issued a letter to its
shareholders.
Dear Fellow Shareholders,
I am pleased to take this opportunity to share the many
developments that have occurred over the past 4 months and the
future we envision for NRXS as we move into 2024.
As we look back at the first 120 days since our IPO, we are very
pleased with our accomplishments. Highly successful med-tech
companies build success from the foundation of strong data
publications, which leads to broad insurance policy coverage which
results in exponential revenue growth. The primary goal in the 4th
quarter was to make sure the publications were in place to
confidently ask insurance companies for written policy coverage,
and we have succeeded. We have now executed and delivered one of
the strongest med-tech research publication portfolios in the
industry. Our robust portfolio has led to numerous large insurance
policy coverages even sooner than expected which has created an
increase in revenues in the areas written policy coverage exists
such as Massachusetts and Wisconsin.
As we move into 2024, the strength of our publications has
allowed us to schedule 10 major insurance company and policy
decision meetings just in the first quarter. We understand that we
cannot dictate the timing of policy coverage implementation once a
decision is made, but we can prepare the markets and children’s
hospitals for the ability to treat children in need once the policy
coverage is effective.
Regarding future opportunities, we are
anticipating two new revenue opportunities to market in 2024. The
first is for Functional Dyspepsia for children, which has a market
opportunity of $2B and fits strategically with our current vertical
as we are already calling on children’s hospitals. We will be
submitting for FDA clearance in Q1 2024.
The second is for chronic constipation, through
an agreement with the University of Michigan for the exclusive
licensing of its innovative rectal expulsion device (RED) which
also has a $2B market opportunity. This product will fuel the
NeurAxis adult GI focus initiative. RED offers an expeditious
market opportunity for NeurAxis as it has a Category I CPT Code and
established reimbursement in place and targets the same clinical
call points as our current IB-Stim™ product. Working with the
University of Michigan, we plan to submit RED for FDA clearance
under a 510(k) process with commercialization and meaningful
revenues in 2024.
Key 4th Quarter Points of Interest
- As we approach 10M covered lives for our existing product, we
are confident that we will surpass our target of 75M covered lives
by the end of 2024.
- Exceeded our goal of 12 publications by the end of 2023 by
securing a total of 14.
- Having just announced CareFirst BCBS which goes effective
January 1st, 2024, adding 3.5M lives, we continue to have great
visibility into our insurance coverage pipeline which gives us
confidence in realizing a significant revenue increase in
2024.
Our team is laser-focused on continued policy coverage, the
addition of 1 new pediatric IB-Stim indication expected to receive
FDA clearance by the end of 2024 and a new RED product for the
adult GI market expected to generate revenues in 2024, we expect
substantial revenue growth for what is expected to be a great
2024.
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, as well as other 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 PENFSIB-Stim™ device for uses beyond those that are
cleared by the U.S. FDA. See
https://ibstim.com/important-information/.
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.
Contacts:
CompanyNeurAxis,
Inc.info@neuraxis.com
Investor
RelationsGilmartin
GroupIR@neuraxis.com
Neuraxis (AMEX:NRXS)
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