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NeurAxis Announces New Medical Policy Coverage For Nearly Six Million Lives in Florida

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NeurAxis announced the expansion of medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) through a Blue Cross Blue Shield (BCBS) licensee in Florida. This new policy covers nearly six million members, increasing the total coverage for IB-Stim to approximately 22.5 million lives. IB-Stim™ is a non-surgical device FDA-cleared for treating functional abdominal pain linked to irritable bowel syndrome (IBS) in adolescents. The expansion aligns with NeurAxis' commercialization strategy and is expected to boost market adoption and revenue growth.

Positive
  • Coverage expansion by BCBS licensee in Florida adds nearly 6 million members.
  • Total IB-Stim coverage now reaches approximately 22.5 million lives.
  • IB-Stim is FDA-cleared for treating IBS-related abdominal pain in adolescents.
  • Increased payer coverage aligns with NeurAxis' commercialization strategy.
  • Expansion expected to drive revenue growth.
Negative
  • Dependency on payer coverage expansion for revenue growth.
  • Current treatments are off-label drugs with serious side effects; lack of FDA-approved drug therapies.

Insights

NeurAxis' recent achievement of expanding medical policy coverage for its PENFS technology to nearly 6 million lives in Florida represents a significant stride towards increasing the market penetration of its IB-Stim device. Given that IB-Stim is designed to address a niche but critical condition—functional abdominal pain in adolescents—this expansion could lead to a substantial boost in demand. Revenue growth is expected as a direct consequence, as more patients gain access to the device through their insurance coverage.

From a financial standpoint, this expanded coverage also solidifies the company's position in the market, potentially reducing the risk of revenue volatility. This is particularly important for a company operating in the medical technology sector, where payer coverage can significantly influence financial performance.

In the short term, investors might expect a positive impact on NeurAxis' stock price, driven by increased sales volumes. In the long term, sustained revenue growth and further policy expansions could solidify NeurAxis' market leadership in pediatric neuromodulation therapies.

The expanded coverage for NeurAxis' IB-Stim device is noteworthy due to its specific application for functional abdominal pain associated with IBS in adolescents. Currently, no FDA-approved drug therapies exist for this condition in children, making IB-Stim a unique non-surgical option. This can potentially lead to fewer side effects and improved patient outcomes compared to off-label drug treatments, which are often associated with significant risks and limited efficacy.

The entry of this technology into a broader market could pave the way for more rigorous clinical studies and data collection, further validating its efficacy and safety. This could have far-reaching implications, not just for the adoption of IB-Stim but for the broader acceptance of neuromodulation therapies in pediatric populations.

CARMEL, Ind., May 16, 2024 (GLOBE NEWSWIRE) -- 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 the publication of medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), with a Blue Cross Blue Shield (BCBS) licensee in Florida. This BCBS licensee has nearly 6 million members, expanding IB-Stim’s policy coverage to roughly 22.5 million total lives.

IB-Stim™ is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. NeurAxis’ PENFS technology is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction. The current medical treatments, which are off-label drugs, can often have serious side effects, and most lack scientific evidence of efficacy.

“I am excited regarding the coverage expansion in the state of Florida, where there are 12 children’s hospitals, many of whom are ready to either expand or launch the use of IB-Stim with this new policy coverage.” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “We continue to make progress on our commercialization strategy goals for IB-Stim by increasing payer coverage to drive market adoption of our technology. The proof of concept of our strategy is becoming apparent, as we are now seeing the expansion of policies and covered lives translating to revenue growth,” Mr. Carrico concluded.

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.

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, the results of the shareholder vote to enable the issuance of the Preferred Stock, 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.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com


FAQ

What is the new medical policy coverage announced by NeurAxis?

NeurAxis announced coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS) by a BCBS licensee in Florida, affecting nearly 6 million members.

How many lives are covered by IB-Stim with the new policy?

With the new policy, IB-Stim's coverage totals approximately 22.5 million lives.

What condition does IB-Stim treat?

IB-Stim treats functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18.

Is IB-Stim FDA-approved?

Yes, IB-Stim is an FDA-cleared device for treating abdominal pain related to IBS in adolescents.

What is the significance of the BCBS coverage expansion for NeurAxis?

The BCBS coverage expansion is expected to drive market adoption and revenue growth for NeurAxis.

What are the current treatment options for abdominal pain-related disorders in children?

Current treatments are off-label drugs, which often have serious side effects and lack scientific evidence of efficacy.

Neuraxis, Inc.

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