NeurAxis Announces Geisinger Health Plan Medical Policy Coverage for PENFS, Effective September 15 2024

Rhea-AI Summary

NeurAxis (NYSE American: NRXS) has announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology by Geisinger Health Plan, effective September 15, 2024. This coverage will bring the national total for PENFS to approximately 24 million insured lives. NeurAxis' FDA-cleared IB-Stim™ device is designed for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. The company aims to achieve medical policy coverage for at least 50 million lives by the end of 2024, setting the stage for significant revenue and margin growth in late 2024 and 2025.

Positive

• Medical policy coverage secured from Geisinger Health Plan, serving 600,000+ enrollees
• National coverage for PENFS technology increased to approximately 24 million insured lives
• On track to achieve coverage for 50 million lives by end of 2024
• Potential for significant revenue and margin growth in late 2024 and 2025

Negative

• None.

Medical Technology Analyst

This coverage expansion for NeurAxis's PENFS technology is a significant milestone in the commercialization of IB-Stim. The addition of 600,000+ insured lives through Geisinger Health Plan brings their total coverage to approximately 24 million lives, demonstrating growing acceptance of this innovative treatment.

The lack of FDA-approved drug therapies for children with abdominal pain-related disorders presents a substantial market opportunity for NeurAxis. Their non-surgical, low-risk approach could potentially disrupt the current treatment paradigm, which relies on off-label drugs with questionable efficacy and side effects.

Investors should note the company's ambitious goal of reaching 50 million covered lives by end of 2024. If achieved, this could indeed set the stage for significant revenue growth in late 2024 and 2025. However, it's important to monitor the pace of additional coverage decisions and actual adoption rates among healthcare providers to gauge the potential financial impact.

Pediatric Gastroenterologist

The coverage of PENFS by Geisinger Health Plan is a welcome development for pediatric patients suffering from functional abdominal pain associated with IBS. Traditional treatments often fall short, leaving many young patients with options.

NeurAxis's IB-Stim offers a novel, non-pharmacological approach that could significantly improve quality of life for these patients. The gentle electrical stimulation of cranial nerve bundles represents a paradigm shift in treating gut-brain interaction disorders.

However, it's important to note that while promising, long-term efficacy data and comparisons with other treatment modalities are still needed. As more insurers cover this technology, we may see increased adoption and, consequently, more real-world data to support its use. This could potentially lead to expanded indications and broader acceptance in the medical community.

Healthcare Policy Analyst

The decision by Geisinger Health Plan to cover PENFS reflects a growing trend in healthcare towards value-based care and innovative treatment options. This move suggests that payers are recognizing the potential cost-effectiveness and improved patient outcomes associated with neuromodulation therapies.

NeurAxis's progress in securing coverage is commendable, but investors should be aware that the healthcare policy landscape is complex and ever-changing. While the company aims for 50 million covered lives by the end of 2024, achieving this goal will depend on various factors, including continued clinical evidence, cost-effectiveness data and competition from emerging therapies.

The lack of FDA-approved drug therapies for this indication could expedite adoption, but it also means that any new drug approvals could significantly impact NeurAxis's market position. Monitoring the regulatory environment and potential competing therapies will be important for assessing the long-term prospects of IB-Stim.

CARMEL, Ind., Aug. 27, 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 medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), for Geisinger Health Plan, serving 600,000+ enrollees in central Pennsylvania. This medical policy will bring our national total coverage for PENFS to roughly 24 million insured lives, with more decisions from major payers still pending.

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.

“We are excited about the coverage expansion with Geisinger Health, an affiliate of the Geisinger Janet Weis Children's Hospital, located in central Pennsylvania,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “We continue to make progress in our commercialization of IB-Stim by increasing payer coverage to drive market adoption of our technology. Payers' acceptance of our PENFS technology is the result of the robust body of published research. We are on track to achieve our stated goal of having medical policy coverage for at least 50 million lives by the end of 2024, which will set the stage for a significant revenue and margin ramp in late 2024 and into 2025,” 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.

For IFU, Precautions, Warnings, Risks, See https://ibstim.com/important-information/.

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 effective date for Geisinger Health Plan's coverage of NeurAxis' PENFS technology?

Geisinger Health Plan's coverage for NeurAxis' Percutaneous Electrical Nerve Field Stimulation (PENFS) technology will be effective September 15, 2024.

How many insured lives does NeurAxis' PENFS technology cover after the Geisinger Health Plan inclusion?

After the inclusion of Geisinger Health Plan, NeurAxis' PENFS technology covers approximately 24 million insured lives nationally.

What is NeurAxis' (NRXS) coverage goal for PENFS technology by the end of 2024?

NeurAxis (NRXS) aims to achieve medical policy coverage for at least 50 million lives by the end of 2024 for its PENFS technology.

What condition is NeurAxis' IB-Stim device FDA-cleared to treat?

NeurAxis' IB-Stim device is FDA-cleared to treat functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18 years old.