NeurAxis Receives New FDA 510(K) Clearance for IB-Stim, Expanding its Addressable Market
Rhea-AI Summary
NeurAxis (NYSE American: NRXS) has received a new FDA 510(k) clearance for IB-Stim™, expanding its addressable market by approximately 75%. The clearance extends the age range for use from 11-18 to 8-21 years old and increases the treatment protocol from 3 devices over 4 weeks to 1 device per week for 4 weeks. IB-Stim, a non-surgical neuromodulation device, treats functional abdominal pain associated with IBS by sending gentle electrical impulses to cranial nerve bundles in the ear. The company expects increased revenue and margin growth due to expanded payer coverage and a new CPT Category I code effective January 2026.
Positive
- Addressable market expansion of approximately 75%
- Extended age range approval from 11-18 to 8-21 years old
- Increased treatment protocol from 3 to 4 devices per patient
- New CPT Category I code established, effective January 2026
- Expanded payer coverage
Negative
- None.
News Market Reaction
On the day this news was published, NRXS declined NaN%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Clearance expands indication for use from 11-18 year olds to 8-21 year olds; and from 3 devices, not to exceed 4 weeks, to 1 device per week for 4 weeks
CARMEL, Ind., Nov. 04, 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 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
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:
Company
NeurAxis, Inc.
info@neuraxis.com
Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com
FAQ
What is the new age range approved for NeurAxis (NRXS) IB-Stim device?
How many IB-Stim devices are now approved per patient under the new FDA clearance?
When will the new CPT Category I code for NeurAxis (NRXS) IB-Stim become effective?
By what percentage did the addressable market expand with the new FDA clearance for NRXS?
