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NeurAxis' IB-Stim Receives FDA Clearance for Functional Abdominal Pain, Expanding Market

• NeurAxis received FDA 510(k) clearance for IB-Stim, a non-implanted nerve stimulator, for functional abdominal pain relief, expanding its market by approximately 75%. • The new clearance allows for the use of four IB-Stim devices per patient, potentially increasing device utilization and revenue for NeurAxis. • IB-Stim is a Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, already FDA-cleared for IBS-related abdominal pain in adolescents aged 8-21. • This clearance, supported by published research, may lead to increased payer coverage and a new CPT Category I code by the AMA in 2026, boosting revenue growth.

NeurAxis, Inc. (NYSE American: NRXS) announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its IB-Stim device for the relief of functional abdominal pain. This new indication significantly broadens the addressable market for IB-Stim, a non-implanted nerve stimulator, and is expected to increase the number of devices used per patient.

Expanding the IB-Stim Market

The recent FDA clearance is projected to expand the IB-Stim market by roughly 75%, according to Brian Carrico, President and CEO of NeurAxis. The clearance also specifies the use of up to four devices per patient, potentially increasing device utilization. This approval is based on a strong foundation of published research supporting the efficacy of NeurAxis' Percutaneous Electrical Nerve Field Stimulation (PENFS) technology.

IB-Stim Technology and Its Applications

IB-Stim is a non-surgical device that delivers gentle electrical impulses to cranial nerve bundles in the ear. It is already FDA-cleared for managing functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21. With limited FDA-approved drug therapies available for children with abdominal pain-related disorders, IB-Stim offers a non-pharmacological alternative.

Commercialization and Future Prospects

NeurAxis anticipates that this new clearance will further drive the adoption of IB-Stim, supported by ongoing expansion of payer coverage and the establishment of a new CPT Category I code by the American Medical Association, set to take effect in January 2026. These advancements are expected to contribute to increased revenue and margin growth for NeurAxis in the coming quarters.
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Reference News

[1]
NeurAxis Receives New FDA 510(K) Clearance for IB-Stim, Expanding its Addressable Market
morningstar.com · Nov 4, 2024

NeurAxis received 510(k) clearance for IB-Stim Nonimplanted Nerve Stimulator for functional abdominal pain relief, expan...

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