NeurAxis announces insurance coverage for PENFS, expanding access to its FDA-cleared therapy for abdominal pain in children.
Quiver AI Summary
NeurAxis, Inc. has announced new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, specifically the IB-Stim device, by two health insurers in Connecticut and Massachusetts, benefiting approximately 700,000 members. This expands the total national coverage for PENFS to around 53 million, with additional decisions from other insurers still expected. The IB-Stim device is FDA-cleared for treating functional abdominal pain related to irritable bowel syndrome (IBS) and pediatric functional dyspepsia in adolescents aged 8-21. NeurAxis aims to improve access to this non-surgical treatment, especially given the lack of FDA-approved drug therapies for such conditions in children. CEO Brian Carrico highlighted the importance of expanding insurance coverage and noted the upcoming activation of a Category I CPT code for PENFS, which will enhance reimbursement and encourage its broader use.
Potential Positives
- Medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS) has been announced, expanding access to the therapy for approximately 700,000 members in Connecticut and Massachusetts.
- The total national coverage for PENFS now reaches roughly 53 million, indicating significant growth in access to the treatment.
- The incorporation of NeurAxis' IB-Stim technology into leading pediatric academic society treatment guidelines marks a key milestone that may drive broader policy coverage and reimbursement.
- The upcoming activation of a Category I CPT code for PENFS is expected to improve reimbursement and incentivize adoption across children's hospitals.
Potential Negatives
- The company may face challenges in achieving broader insurance coverage for its PENFS technology, as major payers' decisions are still pending, highlighting uncertainty in market access.
- The reliance on forward-looking statements without guarantees of fulfillment presents a risk to investors regarding the company's future performance and growth prospects.
- While IB-Stim is FDA-cleared, there remains a lack of FDA-approved drug therapies for children with abdominal pain-related disorders, indicating a gap in treatment options that could reflect poorly on the company's product's competitiveness.
FAQ
What is Percutaneous Electrical Nerve Field Stimulation (PENFS)?
PENFS is a neuromodulation therapy designed to treat chronic abdominal pain associated with IBS and functional dyspepsia.
Who is eligible for the IB-Stim therapy?
The IB-Stim device is FDA-cleared for adolescents aged 8-21 experiencing functional abdominal pain related to IBS.
What recent insurance coverage updates have occurred for PENFS?
NeurAxis announced medical policy coverage for PENFS by two health insurers, extending coverage to approximately 700,000 members.
What is the significance of the new CPT code for PENFS?
The Category I CPT code for PENFS, effective January 1, 2026, aims to improve reimbursement and boost adoption in healthcare facilities.
How does NeurAxis plan to expand access to IB-Stim therapy?
NeurAxis is focused on increasing insurance coverage and reinforcing its approval in pediatric treatment guidelines to ensure wider accessibility.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$NRXS Hedge Fund Activity
We have seen 5 institutional investors add shares of $NRXS stock to their portfolio, and 5 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CREATIVE PLANNING added 551,668 shares (+inf%) to their portfolio in Q1 2025, for an estimated $1,186,086
- BANK OF MONTREAL /CAN/ removed 32,541 shares (-23.4%) from their portfolio in Q1 2025, for an estimated $69,963
- CITADEL ADVISORS LLC removed 20,273 shares (-43.0%) from their portfolio in Q1 2025, for an estimated $43,586
- AIGH CAPITAL MANAGEMENT LLC added 19,869 shares (+inf%) to their portfolio in Q1 2025, for an estimated $42,718
- GEODE CAPITAL MANAGEMENT, LLC added 2,266 shares (+10.0%) to their portfolio in Q1 2025, for an estimated $4,871
- BLACKROCK, INC. removed 2,100 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $4,515
- UBS GROUP AG added 1,225 shares (+106.9%) to their portfolio in Q1 2025, for an estimated $2,633
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
CARMEL, Ind., June 17, 2025 (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), covering two health insurers, with approximately 700,000 total members in Connecticut and Massachusetts. This medical policy will bring our national total coverage for PENFS to roughly 53 million, with more decisions from major payers still pending.
NeurAxis’ PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia (Nausea Symptoms) 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. Off-label, prescription drugs are often used to treat children despite poor evidence of efficacy and the potential for serious side effects.
“As we continue to execute, we remain focused on expanding insurance coverage for IB-Stim, which will make this much-needed therapy for abdominal pain associated with IBS and Pediatric Functional Dyspepsia more accessible and affordable to patients,” said Brian Carrico, CEO of NeurAxis. “This is an exciting inflection point for NeurAxis. Our proprietary PENFS technology was recently incorporated into the leading pediatric academic society’s treatment guidelines for Functional Abdominal Pain in IBS—a key milestone we expect will drive broad policy coverage and reimbursement. Additionally, the upcoming activation of the Category I CPT code for PENFS, effective January 1, 2026, will assign value to the PENFS procedure, improve reimbursement, and incentivize broader adoption across children’s hospitals. With a recently strengthened balance sheet, we are well-positioned to capitalize on the accelerating demand we see ahead.”
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) and functional dyspepsia 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.
Contacts:
Company
NeurAxis, Inc.
info@neuraxis.com
For contraindications, precautions, warnings, and IFU, please see:
https://ibstim.com/important-information/
.
Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com
This article was originally published on Quiver News, read the full story.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
