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What changed in Neuraxis, INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Neuraxis, INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+193 added−182 removedSource: 10-K (2026-03-19) vs 10-K (2025-03-20)

Top changes in Neuraxis, INC's 2025 10-K

193 paragraphs added · 182 removed · 133 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

77 edited+25 added−33 removed239 unchanged
Biggest changeNerve stimulator apparatus; nerve stimulator apparatus for FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co- morbidities, sleep disturbances, psychological disorders, including mood, anxiety, and satiety, pain control, headache control, control of phantom limb pain, stump pain, reflex sympathetic dystrophy (RSD), peripheral neuropathies and other types of sympathetically mediated pain Filed: Allowed US NEURAXIS (STYLIZED) 97/356330 11-Apr-2022 10 Int.
Biggest changeDate Class/Goods Status US NEURAXIS 97/327951 24-Mar-2022 10 Int. nerve stimulator apparatus; nerve stimulator apparatus for FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co- morbidities, sleep disturbances, psychological disorders, including mood, anxiety, and satiety, pain control, headache control, control of phantom limb pain, stump pain, reflex sympathetic dystrophy (RSD), peripheral neuropathies and other types of sympathetically mediated pain Registered US NEURAXIS (STYLIZED) 97/356330 11-Apr-2022 10 Int. nerve stimulator apparatus; nerve stimulator apparatus for FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co- morbidities, sleep disturbances, psychological disorders, including mood, anxiety, and satiety, pain control, headache control, control of phantom limb pain, stump pain, reflex sympathetic dystrophy (RSD), peripheral neuropathies and other types of sympathetically mediated pain Registered US RECTAL EXPULSION DEVICE 99/249573 24-Jun-2025 10 Int. medical devices, namely, devices for measuring pelvic floor dysfunction and rectal hypersensitivity for use in the diagnosis and treatment of chronic constipation; medical diagnostic apparatus for testing pelvic floor dysfunction and rectal hypersensitivity in the field of chronic constipation; medical devices and apparatus for medical screening testing of individuals with chronic constipation; medical apparatus and instrument for diagnostic use, namely, apparatus for medical diagnostic testing in the field of chronic constipation; disposable medical devices for diagnosing and treating constipation Filed US RED – RECTAL EXPULSION DEVICE (word) 99/249859 24-Jun-2025 10 Int. medical devices, namely, devices for measuring pelvic floor dysfunction and rectal hypersensitivity for use in the diagnosis and treatment of chronic constipation; medical diagnostic apparatus for testing pelvic floor dysfunction and rectal hypersensitivity in the field of chronic constipation; medical devices and apparatus for medical screening testing of individuals with chronic constipation; medical apparatus and instrument for diagnostic use, namely, apparatus for medical diagnostic testing in the field of chronic constipation; disposable medical devices for diagnosing and treating constipation Filed US RED & Design 99/249570 24-Jun-2025 10 Int. medical devices, namely, devices for measuring pelvic floor dysfunction and rectal hypersensitivity for use in the diagnosis and treatment of chronic constipation; medical diagnostic apparatus for testing pelvic floor dysfunction and rectal hypersensitivity in the field of chronic constipation; medical devices and apparatus for medical screening testing of individuals with chronic constipation; medical apparatus and instrument for diagnostic use, namely, apparatus for medical diagnostic testing in the field of chronic constipation; disposable medical devices for diagnosing and treating constipation Filed US AXI-STIM 99/507683 20-Nov-2025 10 Int.
The FDA can delay, limit or deny approval of a PMA application for many reasons, including: ● The device may not be shown safe or effective to the FDA’s satisfaction; ● The data from pre-clinical studies and/or clinical trials may be found unreliable or insufficient to support approval; ● The manufacturing process or facilities may not meet applicable requirements; and ● Changes in FDA approval policies or adoption of new regulations may require additional data.
The FDA can delay, limit or deny approval of a PMA application for many reasons, including: ● The device may not be shown safe or effective to the FDA’s satisfaction; 27 ● The data from pre-clinical studies and/or clinical trials may be found unreliable or insufficient to support approval; ● The manufacturing process or facilities may not meet applicable requirements; and ● Changes in FDA approval policies or adoption of new regulations may require additional data.
More recently, in September 2019, the FDA issued revised final guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.
In September 2019, the FDA issued revised final guidance describing an optional “safety and performance based” premarket review pathway for manufacturers of “certain, well-understood device types” to demonstrate substantial equivalence under the 510(k) clearance pathway by showing that such device meets objective safety and performance criteria established by the FDA, thereby obviating the need for manufacturers to compare the safety and performance of their medical devices to specific predicate devices in the clearance process.
The EAD is no longer being manufactured, sold or distributed but reserved only for research purposes. 4 Pediatrics Industry Overview Pediatric providers, as a whole, had expressed concern about the lack of attention given to children with functional abdominal pain disorders (including IBS) and the limited treatment options available for a population that suffers from significant disabilities.
The EAD is no longer being manufactured, sold or distributed but reserved only for research purposes. 4 Pediatrics Industry Overview Pediatric providers, as a whole, expressed concern about the lack of attention given to children with functional abdominal pain disorders (including IBS and FD) and the limited treatment options available for a population that suffers from significant disabilities.
An animal model of IBS demonstrated that the firing of neurons in the amygdala could be reduced by more than 50% in just 15 minutes of stimulation with the IB-Stim technology.
An animal model of IBS demonstrated that the firing of neurons in the amygdala could be reduced by more than 50% in just 15 minutes of stimulation with IB-Stim.
The IB-Stim is intended to be used for 120 hours per week, using one (1) device per week, for four (4) consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS (DEN180057, 2019).
IB-Stim is intended to be used for 120 hours per week, using one (1) device per week, for four (4) consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS (DEN180057, 2019; K252024, 2025).
A recent human study in adults with pain related to fibromyalgia suggested that the IB-Stim technology exerts its effect by modulating emotional and executive control centers related to pain processing, see Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial , Woodbury et.al. , Pain Med. 2021;22:715-726.
A recent human study in adults with pain related to fibromyalgia suggested that IB-Stim exerts its effect by modulating emotional and executive control centers related to pain processing, see Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial , Woodbury et.al. , Pain Med. 2021;22:715-726.
As a PENFS device, it is non-implantable and provides field stimulation to cranial nerves V, VII, IX and X in the ear to access the CNS. It stimulates remotely from the source of pain to modulate central pain regions, such as the limbic system, and relieve functional abdominal pain associated with IBS.
As a PENFS device, it is non-implantable and provides field stimulation to cranial nerves V, VII, IX and X in the ear to access the central nervous system. It stimulates remotely from the source of pain to modulate central pain regions, such as the limbic system, and relieve functional abdominal pain associated with IBS.
Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders. Neurogastroenterol Motil. 2022;34:e14358. We have only submitted one FDA De Novo request and two 510(k) submissions and plan to submit additional 510(k) premarket notifications from our pipeline indications in the future.
Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders. Neurogastroenterol Motil. 2022;34:e14358. We have submitted one FDA De Novo request and three 510(K) submissions and plan to submit additional 510(k) premarket notifications from our pipeline indications in the future.
This dampening of neurons in the CNS likely accounts for the modulation of pain responses in a model of post-inflammatory visceral and somatic hyperalgesia. 11 Clinical Data We have over 700 published patients specific to our first FDA indication which is functional abdominal pain associated with irritable bowel syndrome in patients 8-21 years of age.
This dampening of neurons in the CNS likely accounts for the modulation of pain responses in a model of post-inflammatory visceral and somatic hyperalgesia. 11 Clinical Data There are over 700 published patients specific to our first FDA indication which is functional abdominal pain associated with irritable bowel syndrome in patients 8-21 years of age.
Masimo License and Collaboration Agreement On April 9, 2020, the Company entered into a license and collaboration agreement with Masimo. As consideration, in part, Masimo entered into a Series A Preferred Stock purchase agreement with the Company.
Masimo License and Collaboration Agreemen t On April 9, 2020, the Company entered into a license and collaboration agreement with Masimo. As consideration, in part, Masimo entered into a Series A Preferred Stock purchase agreement with the Company.
Issue Date Anticipated Expiration Date Title Application Status Licensing Status CA Neuraxis, Inc. 3096494 25-Apr-2019 AURICULAR NERVE FIELD STIMULATION DEVICE Applied for JP Neuraxis, Inc. 2021-509961 23-Oct-2020 7252319 27-March-2023 25-April-2039 AURICULAR NERVE FIELD STIMULATION DEVICE Granted US Neuraxis, Inc. 17/040766 23-Sep-2020 11369791 28-Jun-2022 21-Jun-2039 AURICULAR NERVE FIELD STIMULATION DEVICE Granted US Neuraxis, Inc. 17/715121 07-Apr-2022 12097371 24-Sept-2024 04-Jan-2040 AURICULAR NERVE FIELD STIMULATION DEVICE Granted US Neuraxis, Inc. 16/014169 21-Jun-2018 10322062 18-Jun-2019 14-May-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted Out-licensed US Neuraxis, Inc. 16/408004 09-May-2019 11077019 03-Aug-2021 16-July-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted Out-licensed US Neuraxis, Inc. 17/363620 30-Jun-2021 11654082 23-May-2023 29-July-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted Out-licensed US Neuraxis, Inc. 17/830411 02-Jun-2022 DEVICE AND METHOD FOR ERADICATING PATHOGENS IN NASAL PASSAGES Applied for US Neuraxis, Inc. 17/589082 31-Jan-2022 EXTERNAL AUDITORY CANAL PHOTOBIOMODULATION AND AUDIO THERAPY DEVICE Applied for 20 US Neuraxis, Inc. 17/861646 11-Jul-2022 EXTERNAL AUDITORY CANAL THERAPY DEVICE Applied for US Neuraxis, Inc. 17/617364 08-Dec-2021 EXTERNAL AUDITORY CANAL PHOTOBIOMODULATION DEVICE Applied for US Neuraxis, Inc. 15/488416 14-Apr-2017 10413719 17-Sep-2019 14-April-2037 METHODS OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted Out-licensed US Neuraxis, Inc. 16/534159 07-Aug-2019 11331473 17-May-2022 14-April-2037 METHODS OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted US Neuraxis, Inc. 15/595185 15-May-2017 9839577 12-Dec-2017 14-May-2034 SYSTEM AND METHOD FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted Out-licensed US Neuraxis, Inc. 15/811278 13-Nov-2017 10010479 03-Jul-2018 14-May-2034 SYSTEM AND METHOD FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted Out-licensed US Neuraxis, Inc. 14/277158 14-May-2014 9662269 30-May-2017 14-May-2034 SYSTEMS AND METHODS FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted Out-licensed US Neuraxis, Inc. 17/725,761 21-Apr-2022 11813448 14-Nov-2023 14-April-2037 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Granted US Neuraxis, Inc. 18/154,375 13-Jan-2023 12029701 09-July-2024 14-May-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted Out-licensed US Neuraxis, Inc. 18/736,834 07-June-2024 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Applied for Out-licensed US Neuraxis, Inc. 18/173,893 24-Feb-2023 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Applied for US Neuraxis, Inc. 18/377,968 09-Oct-2023 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Applied for CA Neuraxis, Inc. 3243826 07-Aug-2024 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Applied for 21 License Agreements TKBMN Exclusive License Agreement On May 7, 2020, the Company entered into an exclusive license agreement with TKBMN, LLC to obtain an exclusive license under certain patent rights (the “Patent Rights”) owned by TKBMN.
Issue Date Anticipated Expiration Date Title Application Status Licensing Status CA Neuraxis, Inc. 3096494 25-Apr-2019 AURICULAR NERVE FIELD STIMULATION DEVICE Applied for JP Neuraxis, Inc. 2021-509961 23-Oct-2020 7252319 27-Mar-2023 25-Apr-2039 AURICULAR NERVE FIELD STIMULATION DEVICE Granted US Neuraxis, Inc. 17/040766 23-Sep-2020 11369791 28-Jun-2022 21-Jun-2039 AURICULAR NERVE FIELD STIMULATION DEVICE Granted US Neuraxis, Inc. 17/715121 07-Apr-2022 12097371 24-Sep-2024 04-Jan-2040 AURICULAR NERVE FIELD STIMULATION DEVICE Granted US Neuraxis, Inc. 16/014169 21-Jun-2018 10322062 18-Jun-2019 14-May-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted US Neuraxis, Inc. 16/408004 09-May-2019 11077019 03-Aug-2021 16-Jul-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted US Neuraxis, Inc. 17/363620 30-Jun-2021 11654082 23-May-2023 29-Jul-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted US Neuraxis, Inc. 17/830411 02-Jun-2022 DEVICE AND METHOD FOR ERADICATING PATHOGENS IN NASAL PASSAGES Applied for US Neuraxis, Inc. 17/589082 31-Jan-2022 EXTERNAL AUDITORY CANAL PHOTOBIOMODULATION AND AUDIO THERAPY DEVICE Applied for 20 US Neuraxis, Inc. 17/861646 11-Jul-2022 EXTERNAL AUDITORY CANAL THERAPY DEVICE Applied for US Neuraxis, Inc. 17/617364 08-Dec-2021 EXTERNAL AUDITORY CANAL PHOTOBIOMODULATION DEVICE Applied for US Neuraxis, Inc. 15/488416 14-Apr-2017 10413719 17-Sep-2019 14-Apr-2037 METHODS OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted US Neuraxis, Inc. 16/534159 07-Aug-2019 11331473 17-May-2022 14-Apr-2037 METHODS OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted US Neuraxis, Inc. 15/595185 15-May-2017 9839577 12-Dec-2017 14-May-2034 SYSTEM AND METHOD FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted US Neuraxis, Inc. 15/811278 13-Nov-2017 10010479 03-Jul-2018 14-May-2034 SYSTEM AND METHOD FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted US Neuraxis, Inc. 14/277158 14-May-2014 9662269 30-May-2017 14-May-2034 SYSTEMS AND METHODS FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION Granted US Neuraxis, Inc. 17/725,761 21-Apr-2022 11813448 14-Nov-2023 14-Apr-2037 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Granted US Neuraxis, Inc. 18/154,375 13-Jan-2023 12029701 09-Jul-2024 14-May-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted US Neuraxis, Inc. 18/736,834 07-June-2024 12383461 12-Aug-2025 14-May-2034 AURICULAR PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME Granted US Neuraxis, Inc. 18/173,893 24-Feb-2023 12447332 21-Oct-2025 01-May-2035 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Granted US Neuraxis, Inc. 18/377,968 09-Oct-2023 12285602 24-Apr-2025 14-Apr-2037 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Granted US Neuraxis, Inc. 19173434 08-Apr-2025 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Applied for CA Neuraxis, Inc. 3243826 07-Aug-2024 AURICULAR NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME Applied for 21 License Agreements TKBMN Exclusive License Agreement On May 7, 2020, the Company entered into an exclusive license agreement with TKBMN, LLC to obtain an exclusive license under certain patent rights (the “Patent Rights”) owned by TKBMN.
We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our shares held by non-affiliates equals or exceeds $250 million as of the prior June 30 th , or (2) our annual revenues equaled or exceeded $100 million during such completed fiscal year and the market value of our shares held by non-affiliates equals or exceeds $700 million as of the prior June 30 th .
We will remain a smaller reporting company until the last day of the fiscal year in which (1) the market value of our shares held by non-affiliates equals or exceeds $250 million as of the prior June 30 th , or (2) our annual revenues equal or exceed $100 million during such completed fiscal year and the market value of our shares held by non-affiliates equals or exceeds $700 million as of the prior June 30 th .
The design of RED allows for it to be used as a self-inflating expulsion device and as a balloon to assess patients who experience rectal hypersensitivity. When it is opened to atmospheric pressure, RED safely self inflates and contains a specially selected foam that mimics the “feel” of stool.
The design of RED allows for it to be used as a self-inflating expulsion device and as a balloon to assess patients who experience rectal hypersensitivity. When it is opened to atmospheric pressure, RED safely self inflates and contains a proprietary foam technology that mimics the “feel” of stool.
With 20% of the United States population under age 18, our Company focus is on opportunities in pediatrics industry. The pediatrics industry has multi-billion-dollar market opportunities.
With 20% of the United States population under age 18, our Company focus began with opportunities in the pediatrics industry. The pediatrics industry has multi-billion-dollar market opportunities.
Medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable neurological pain management generator, with percutaneously-implantable needle arrays; medical system and apparatus consisting of a non-implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical system and apparatus consisting of implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical system and apparatus consisting of a non-implantable modulating frequency generator and implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management, namely, patient stimulators for auricular and peri-auricular peripheral nerve field neuromodulation therapy; medical apparatus, appliances and instruments for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, headache control, control of phantom limb pain, stump pain, reflex sympathetic dystrophy (RSD), peripheral neuropathies and other types of sympathetically mediated pain Registered US IB-STIM 5926831 03-Dec-2019 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered 18 US IB-STIM and Design 5926832 03-Dec-2019 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; Medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered US IB-STIM AURICULAR STIMULATOR 5978411 04-Feb-2020 10 Int. medical apparatus, namely, electrical nerve stimulators; Medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; Medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; Medical device for peripheral nerve and nerve field stimulation; Medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; Medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered US IB-STIM AURICULAR STIMULATOR and Design 5978412 04-Feb-2020 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered 19 Country Trademark App.
Date Class/Goods Status US NEURO-STIM and Design 5105257 20-Dec-2016 10 Int. nerve stimulator apparatus Registered US NSS THE NEUROSTIM SYSTEM and Design 4905470 23-Feb-2016 10 Int. nerve stimulator apparatus Registered US NSS 4852008 10-Nov-2015 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable neurological pain management generator, with percutaneously-implantable needle arrays; medical system and apparatus consisting of a non-implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical system and apparatus consisting of implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical system and apparatus consisting of a non-implantable modulating frequency generator and implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management, namely, patient stimulators for auricular and peri-auricular peripheral nerve field neuromodulation therapy; medical apparatus, appliances and instruments for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, headache control, control of phantom limb pain, stump pain, reflex sympathetic dystrophy (RSD), peripheral neuropathies and other types of sympathetically mediated pain Registered US IB-STIM 5926831 03-Dec-2019 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered 18 US IB-STIM and Design 5926832 03-Dec-2019 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; Medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered US IB-STIM AURICULAR STIMULATOR 5978411 04-Feb-2020 10 Int. medical apparatus, namely, electrical nerve stimulators; Medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; Medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; Medical device for peripheral nerve and nerve field stimulation; Medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; Medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered US IB-STIM AURICULAR STIMULATOR and Design 5978412 04-Feb-2020 10 Int. medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non- implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and peri-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and peri-auricular tissue for use in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve field neuromodulation therapy; medical apparatus, for peripheral nerve field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain Registered 19 Country Trademark App.
IB-Stim is a US FDA Class II medical device that has received one regulatory clearance: IB-Stim (DEN180057, 2019), under the regulation name of “non-implanted nerve stimulator for functional abdominal pain relief.” Our second product, Rectal Expulsion Device (“RED”), is indicated to evaluate the neuromuscular function of a patient’s ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity.
IB-Stim is a US FDA Class II medical device that has received regulatory clearances: IB-Stim (DEN180057, 2019; K252024, 2025), under the regulation name of “non-implanted nerve stimulator for functional abdominal pain relief.” Our second product, RED TM (Rectal Expulsion Device), is indicated to evaluate the neuromuscular function of a patient’s ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity.
To date, we have sold our IB-Stim product to approximately 77 children’s hospitals within our target market. 6 Competition The competitive landscape for therapies includes off-label drugs and drugs with FDA approved only for adults with IBS while there is no FDA indicated treatments for patients 8-21 years of age with functional abdominal pain associated with IBS and prescriptions often contain FDA black box labels.
To date, IB-Stim is established in approximately 80 children’s hospitals within our target market. 6 Competition The competitive landscape for therapies includes off-label drugs and drugs with FDA-approved only for adults with IBS while there is no FDA indicated treatments for patients 8-21 years of age with functional abdominal pain associated with IBS and prescriptions often contain FDA black box labels.
This is based on pre-clinical and clinical studies demonstrating the mechanism of action and efficacy. Based on this new class of devices, the IB-Stim falls under 21 CFR Part 876, Subpart F – Therapeutic Devices, 876.5340, Product Code QHH.
The FDA created a new classification of PENFS for IB-Stim. This is based on pre-clinical and clinical studies demonstrating the mechanism of action and efficacy. Based on this new class of devices, IB-Stim falls under 21 CFR Part 876, Subpart F – Therapeutic Devices, 876.5340, Product Code QHH.
To date, no known gastrointestinal indications. 3. Roo System and Sparrow therapy system: Transcutaneous auricular stimulation devices-cleared for neonatal and adult opioid withdrawal. The neurostimulation market is predominantly comprised of surgically implanted, invasive technologies that are not directly competitive with our technology.
Roo System and Sparrow therapy system: Transcutaneous auricular stimulation devices-cleared for neonatal and adult opioid withdrawal. The neurostimulation market is predominantly comprised of surgically implanted, invasive technologies that are not directly competitive with our technology.
Our Growth Strategies ● List price of our product is $1,195 per device and $4,780 per patient ● Strong gross margin ● Direct sales force ● Target customers are children’s hospitals and pediatric clinics Our Pipeline The IB-Stim device is to be used for the indication of functional abdominal pain associated with IBS and functional nausea in children.
Our Growth Strategies ● List price of our product is $1,195 per device and $4,780 per patient ● Strong gross margin ● Direct sales force ● Target customers are children’s hospitals, adult gastroenterologists in the VA, and adult pain physicians in the VA Our Pipeline IB-Stim is to be used for the indication of functional abdominal pain associated with IBS, functional dyspepsia (FD), and associated FD nausea symptoms.
The absence of conclusive data to support treatments based on scientific evidence, and the fact no drug therapies have been approved by the FDA for the treatment of FAPDs or IBS in children, presents a unique market opportunity for Neuraxis.
The absence of conclusive data to support treatments based on scientific evidence, and the fact no drug therapies have been approved by the FDA for the treatment of FAPDs or IBS in children, presents a unique market opportunity for Neuraxis. Below are the current standard treatments in children with functional abdominal pain and IBS.
The license and collaboration agreement may be terminated by Masimo if there is material breach by the Company that remain uncured for thirty (30) days or without cause by providing thirty (30) days prior written notice. See ”—Our Corporate History ” for more information.
The license and collaboration agreement may be terminated by Masimo if there is material breach by the Company that remain uncured for thirty (30) days or without cause by providing thirty (30) days prior written notice.
The figure below demonstrates how RED can impact clinical decision making. Overall, RED is a point-of-care device designed to be used in the office. Rectal sensation is an important component of evaluating pelvic floor function among patients with chronic constipation. Currently, 98% of clinically appropriate patients do not receive anorectal testing.
Overall, RED is a point-of-care device designed to be used in the office. Rectal sensation is an important component of evaluating pelvic floor function among patients with chronic constipation. Currently, 98% of clinically appropriate patients do not receive anorectal testing.
Timing of FDA review and approval, if ever received, cannot be assured and the process and any approval is within the sole control and discretion of the FDA. 9 Products The IB-Stim is a percutaneous PENFS system intended to be used in patients 8-21 years of age with functional abdominal pain associated with IBS.
Timing of FDA review and approval, if ever received, cannot be assured and the process and any approval is within the sole control and discretion of the FDA. 9 Products IB-Stim is a PENFS technology intended to be used in patients 8 years and older with functional abdominal pain associated with IBS, functional dyspepsia (FD), and associated FD nausea symptoms.
Patents The Company has twelve (12) granted patents in the United States and seven (7) applied for patent applications in the United States and one (1) granted foreign patent and two (2) applied for foreign patent applications. Country Owner Serial No. Actual Filing Date Patent No.
Patents The Company has fifteen (15) granted patents in the United States and one (1) applied for patent application in the United States and one (1) granted foreign patent and two (2) applied for foreign patent applications. Country Owner Serial No. Actual Filing Date Patent No.
To further protect our intellectual property, we enter into confidentiality agreements with our executive officers and directors. 17 Trademarks The Company has seven (7) registered trademarks, and two (2) allowed pending applications for registration: Country Trademark Reg. No. Reg.
To further protect our intellectual property, we enter into confidentiality agreements with our executive officers and directors. 17 Trademarks The Company has nine (9) registered trademarks, and three (3) pending applications for registration: Country Trademark Reg. No. Reg.
To protect our intellectual property, we rely on a combination of laws and regulations, as well as contractual restrictions. Federal trademark law protects our registered trademarks. We also rely on the protection of laws regarding unregistered copyrights for certain content we create and trade secret laws to protect our proprietary technology.
Federal trademark law protects our registered trademarks. We also rely on the protection of laws regarding unregistered copyrights for certain content we create and trade secret laws to protect our proprietary technology.
RED (K242304, 2024) helps identify patients with rectal hypersensitivity who experience a desire or urge to defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations. Our Mission Our mission is to provide solutions that create value and provide better and safer patient outcomes.
RED (K242304, 2024) helps identify patients with rectal hypersensitivity who experience a desire or urge to defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.
The IB-Stim works by sending gentle electrical impulses into cranial nerve bundles located in the ear. This stimulation targets brain areas that process pain and helps reduce functional abdominal pain associated with IBS.
Changes in brain pathways are known to be involved in the pathophysiology of functional bowel disorders and IBS. IB-Stim works by sending gentle electrical impulses into cranial nerve bundles located in the ear. This stimulation targets brain areas that process pain and helps reduce functional abdominal pain associated with IBS.
The finalized Category I CPT Code for PENFS, and associated valuations, will be announced publicly in Q4 of 2025. The new code will become effective for utilization on January 1, 2026. Sixteen (16) commercial health insurers, including certain Blue Cross Blue Shield licensees, have instituted formal medical policy coverage for PENFS.
The finalized Category I CPT Code for PENFS, 64567 and associated valuations, was publicly announced in Q4 of 2025. CPT 64567 became effective for utilization and reporting PENFS procedures on January 1, 2026. Twenty-four (24) commercial health insurers, including certain Blue Cross Blue Shield licensees, have instituted formal medical policy coverage for PENFS.
Our IB-Stim® is a non-drug alternative to reduce functional abdominal pain in patients with IBS. In June 2019, the FDA cleared IB-Stim, a non-surgical, neuromodulation device for children and adolescents who suffer from IBS, through a de novo process (DEN180057, 2019). The FDA created a new classification of PENFS for the IB-Stim device.
IB-Stim is a non-drug alternative to reduce functional abdominal pain in patients with IBS. In June 2019, the FDA cleared IB-Stim, a non-surgical, neuromodulation device for children and adolescents who suffer from IBS, through a de novo process (DEN180057, 2019). Most recently, FDA cleared 510(k) 252024, expanding the indications for use.
The primary endpoint will be to measure improvements in validated measures, including the Immediate Post-Concussion Assessment, Post-Concussion Symptom Scale, and Balance Error Scoring Symptom compared to placebo. The study will enroll 100 participants and is being conducted at Children’s Hospital of Orange County. 3. Chemotherapy-induced nausea and vomiting: RCT currently enrolling patients.
The primary endpoint will be to measure improvements in validated measures, including the Immediate Post-Concussion Assessment, Post-Concussion Symptom Scale, and Balance Error Scoring Symptom compared to placebo. The study will enroll 100 participants and is being conducted at Children’s Hospital of Orange County. 3. Cyclic vomiting: Successful pilot study completed and published, Karrento K, et.al..
On August 15, 2024, the Company’s shareholders (i) authorized 5,000,000 shares of preferred stock of which 4,000,000 were designated at $0.001 par value “Series B Preferred Stock” inclusive of cumulative dividends, due and payable quarterly at the Company’s discretion either in cash or common stock when declared, at a rate of 8.5% per annum through June 30, 2025, (ii) retired 1,000,000 shares of Series A Preferred Stock and (iii) retired 120,000 shares of Series Seed Preferred Stock.
In 2024, the Company’s shareholders authorized 5,000,000 shares of preferred stock of which all were designated at $0.001 par value “Series B Preferred Stock” inclusive of cumulative dividends, due and payable quarterly at the Company’s discretion either in cash or common stock when declared, at a rate of 8.5% per annum through December 31, 2026.
Compared to baseline scores, there were significant improvements in the API after 4 weeks of IB-Stim treatment at every time point, including 6 month (p Abdominal Pain Index (API) Time point n Median (IQR) p Value Baseline 288 2.68(1.84, 3.58) N/A 3 weeks 209 1.99 (1.13, 3.27) 3 months 75 1.81 (0.85, 3.20) 6 months 60 1.70 (0.93, 2.72) 9 months 26 1.90 (1.33, 2.82) 0.002 12 months 22 220(0.41, 3.21) An open-label study of 20 patients treated with PENFS in a “real-world” clinical setting at Cincinnati Children’s Hospital demonstrated that after PENFS, abdominal pain (p A clinically meaningful endpoint is the number needed to treat (NNT) used in treatment for abdominal pain-related functional gastrointestinal disorders in adolescents.
Compared to baseline scores, there were significant improvements in the API after 4 weeks of IB-Stim treatment at every time point, including 6 month (p Abdominal Pain Index (API) Time point n Median (IQR) p Value Baseline 288 2.68(1.84, 3.58) N/A 3 weeks 209 1.99 (1.13, 3.27) 3 months 75 1.81 (0.85, 3.20) 6 months 60 1.70 (0.93, 2.72) 9 months 26 1.90 (1.33, 2.82) 0.002 12 months 22 220(0.41, 3.21) An open-label study of 20 patients treated with PENFS in a “real-world” clinical setting at Cincinnati Children’s Hospital demonstrated that after PENFS, abdominal pain (p 14 PENFS Reimbursement Previously, the American Medical Association (AMA) assigned a procedure-specific Category III CPT Code (0720T) to PENFS, which was published on December 30, 2021 and became effective for utilization on July 1, 2022.
Patients who are appropriate clinical candidates may have policy-covered access to PENFS and IB-Stim technology under their specific health plan. We continue to actively leverage clinical evidence and peer-reviewed publications to expand patient access to IB-Stim technology.
The total membership of these health insurers is approaching 100,000,000 covered lives. Patients who are appropriate clinical candidates may have policy-covered access to PENFS and IB-Stim technology under their specific health plan. We continue to actively leverage clinical evidence, peer-reviewed publications, and academic medical society clinical practice guidelines to expand patient access to IB-Stim technology.
The following table presents a summary of IB-STIM studies performed to date: Author DGBI N= Ages # of devices Outcomes Major adverse events Karento et al, 2023 Cyclic Vomiting Syndrome 30 8-18 years 6 Abdominal pain, nausea, FD None Santucci et al., 2023 Functional Dyspepsia 84 11-21 4 Abdominal pain, nausea, anxiety, disability None Bora et.al2,.2023 Irritable bowel syndrome 20 11-18 4 IBS severity scale, Microbiome diversity None Kovacic et.al.,2017 IBS, FD, FAP, abdominal migraine 115 11-18 4 Abdominal pain, disability, global symptoms.
The following table presents a summary of IB-Stim studies performed to date: Author DGBI N= Ages # of devices Outcomes Major adverse events Santucci et al.,2025 Functional Abndominal Pain 219 7-21 4 Abdominal pain, nausea, disability None Dorfman et.al.,2025 Functional Abdominal Pain 22 11-21 4 Abdominal pain, recurrent treatment None Kolacz et.al.,2025 Chronic Nausea 84 11-18 4 Cardiac vagal effeciency None Santucci., et.al., 2024 Functional Dyspepsia 84 11-21 4 Abdominal pain and nausea None Castillo et.al., 2023 Irritable bowel syndrome 27 11-18 4 Abdominal pain, Microbiome Metabolism None Karento et al., 2023 Cyclic Vomiting Syndrome 30 8-18 6 Abdominal pain, nausea, disability None Santucci et.al.,2023 Irritable bowel syndrome, functional dyspepsia, FAP 101 11-21 4 Abdominal pain, nausea, disability None Chogle et.al., 2023 Irritable bowel syndrome, functional dyspepsia 31 11-18 4 Quality of life, disability, anxiety None Chogle et.al., 2023 (Registry) Irritable bowel syndrome, functional dyspepsia 292 8-18 4 Abdominal pain, nausea, disability None Santucci et al., 2023 Functional Dyspepsia 84 11-21 4 Abdominal pain, nausea, anxiety, disability None Bora et.al.,2023 Irritable bowel syndrome 20 11-18 4 IBS severity scale, Microbiome diversity None Santucci et.al.,2021 Functional abdominal pain 20 11-19 4 Abdominal pain, sleep, nausea, anxiety None Krasaelap, et.al., 2020 Irritable bowel syndrome 51 11-18 4 Abdominal pain, global symptoms, disability None Kovacic et.al.,2017 IBS, FD, FAP, abdominal migraine 115 11-18 4 Abdominal pain, disability, global symptoms.
Clinical Background Constipation is one of the most encountered gastrointestinal complaints in clinical practice. A recent systematic review reported that the prevalence of chronic constipation (CC) in North America is between 10-15%. This condition causes significantly reduced quality of life, reduced work-related productivity and billions of dollars in health expenditures.
A recent systematic review reported that the prevalence of chronic constipation (CC) in North America is between 10-15%. This condition causes significantly reduced quality of life, reduced work-related productivity and billions of dollars in health expenditures. Clinical practice guidelines recommend empiric treatment of chronically constipated patients with fiber supplements or laxative therapies.
RED finds people that are willing to try physical therapy but don’t need it. 5. Fits clinical workflow. There is an urgent need to better identify patients with pelvic floor abnormalities and/or rectal hypersensitivity. Making the right diagnosis can impact care and ensure that patients are properly assessed and treated.
Easily integrates with clinical workflow There is an urgent need to better identify patients with pelvic floor abnormalities and/or rectal hypersensitivity. Making the right diagnosis can impact care and ensure that patients are properly assessed and treated. The figure below demonstrates how RED can impact clinical decision making.
Potential patients with other indications are expected to use six (6) or more devices per patient. Technology A maladaptive central nervous system can process pain and emotions differently. This often occurs in children following a traumatic event, viral infections, inflammation or trauma. Changes in brain pathways are known to be involved in the pathophysiology of functional bowel disorders and IBS.
IB-Stim costs $1,195 per device, and each patient will use four (4) devices. Potential patients with other indications are expected to use six (6) or more devices per patient. Technology A maladaptive central nervous system can process pain and emotions differently. This often occurs in children following a traumatic event, viral infections, inflammation or trauma.
The predicate device is re-capped so that the patient must defecate an air-filled balloon with low compliance. The resistance with defecating the predicate is therefore greater than RED, because RED is more compliant than an air-filled balloon.
The resistance with defecating the predicate is therefore greater than RED, because RED is more compliant than an air-filled balloon.
Our first product, IB-Stim, is a PENFS system intended to be used in patients 8-21 years of age with functional abdominal pain associated with IBS.
Our first product, IB-Stim, is a PENFS technology intended to be used in patients 8 years and older with functional abdominal pain associated with irritable bowel syndrome (IBS), functional dyspepsia (FD) and associated FD nausea symptoms.
Eluxadoline: a schedule IV-controlled substance that is a mixed opioid receptor agonist/antagonist in the intestine approved for IBS-diarrhea 7 Devices 1. gammaCore: a transcutaneous, cervical vagal nerve stimulator cleared for cluster and migraine headaches. Recent studies using this device for adults with gastroparesis. 2. Transcranial Magnetic Stimulation: Multiple devices cleared to treat major depressive disorder and obsessive-compulsive disorder.
None 7 Devices 1. gammaCore: a transcutaneous, cervical vagal nerve stimulator cleared for cluster and migraine headaches. Recent studies using this device for adults with gastroparesis. 2. Transcranial Magnetic Stimulation: Multiple devices cleared to treat major depressive disorder and obsessive-compulsive disorder. To date, no known gastrointestinal indications. 3.
The current standard is to refer patients to specialized motility centers for evaluation, resulting in sub-optimal number of patients with constipation undergoing anal-rectal testing.
Current testing methods typically require elaborate volumetric testing equipment to assess sensation and expulsion, which makes them not practical in the clinical setting. The current standard is to refer patients to specialized motility centers for evaluation, resulting in sub-optimal number of patients with constipation undergoing anal-rectal testing.
There is a clinical need for an easy-to-use, office-based, point-of-care, anorectal function test that can measure rectal sensitivity and be used as a rectal expulsion device to assess pelvic floor dysfunction. Current testing methods typically require elaborate volumetric testing equipment to assess sensation and expulsion, which makes them not practical in the clinical setting.
Approximately 40% of patients do not adequately respond to empiric laxative therapy. In these patients, anorectal physiology testing is essential. There is a clinical need for an easy-to-use, office-based, point-of-care, anorectal function test that can measure rectal sensitivity and be used as a rectal expulsion device to assess pelvic floor dysfunction.
Our Competitive Strengths We believe that the following competitive strengths will enable us to compete effectively: ● First to market ● Strong portfolio of device and method patents ● Large Market Opportunities ● Strong pediatric pipeline ● Academic Society Support ● Lower capital expenditures in nurse, trainers, and representatives for first line therapy ● Strong clinical data carried out in leading academic institutions in the U.S.
Our Competitive Strengths We believe that the following competitive strengths will enable us to compete effectively: ● First to market ● Strong portfolio of device and method patents ● Large market opportunities ● Strong pediatric pipeline ● Academic Society guidelines with the only FDA-approved or FDA-cleared recommended treatment ● Category I CPT code (64567) effective January 1, 2026 ● Strong clinical data carried out in leading academic institutions in the U.S.
It is critical to assess rectal sensation and balloon expulsion in patients with constipation and/or fecal incontinence. RED Safety ● The tube for RED remains open to room air as the patient defecates. The pressure is therefore never greater than room air. ● The predicate device uses manual inflation with a syringe against resistance.
RED Safety ● The tube for RED remains open to room air as the patient defecates. The pressure is therefore never greater than room air. ● The predicate device uses manual inflation with a syringe against resistance. The predicate device is re-capped so that the patient must defecate an air-filled balloon with low compliance.
We have developed three FDA cleared products, the IB-Stim (DEN180057, 2019), the RED (K242304, 2024), the NSS-2 Bridge (DEN170018, 2017), and the original 510(K) clearance (K140530, 2014), all of which were developed internally by the Company. ● The IB-Stim is a PENFS device that is indicated in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome.
We have developed four FDA cleared products: (i) IB-Stim (DEN180057, 2019), (ii) RED (K242304, 2024), (iii) NSS-2 Bridge (DEN170018, 2017), and (iv) the original 510(k) clearance (K140530, 2014), all of which were developed internally by the Company. ● IB-Stim is a PENFS device that is indicated in patients 8 years and older with functional abdominal pain associated with irritable bowel syndrome, functional dyspepsia, and associated FD nausea symptoms. ● RED is indicated to evaluate the neuromuscular function of a patient’s ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity patients who experience desire or urge to defecate at lower volumes of distention.
Cyclic vomiting syndrome: Pilot study completed, see ClinicalTrials.gov Identifier: NCT03434652. Auricular Neurostimulation for Children with Cyclic Vomiting Syndrome: A randomized, placebo-controlled trial. RCT anticipated to begin enrolling patients in the second half of 2023. This will be a double blind, placebo-controlled trial to evaluate efficacy of IB-Stim in pediatric patients with cyclic vomiting syndrome.
Electrical Nerve Field Stimulation for Drug-Refractory Pediatric Cyclic Vomiting Syndrome. J Pediatr Gastroenterol Nutr. 2023;77:347-353. A new study, Auricular Neurostimulation for Children with Cyclic Vomiting Syndrome: A randomized, placebo-controlled trial. RCT anticipated to begin enrolling patients early in 2026. This will be a double blind, placebo-controlled trial to evaluate efficacy of IB-Stim in pediatric patients with cyclic vomiting syndrome.
Compliance with treatment so far has been outstanding with the four weeks of therapy required to sustain long-term benefits. Compliance has been an issue with non-pharmacological treatment for children, particularly with some of the psychological approaches such as cognitive behavioral therapy or guided imagery, which sometimes requires 8-12 weeks of treatment.
Compliance has been an issue with non-pharmacological treatment for children, particularly with some of the psychological approaches such as cognitive behavioral therapy or guided imagery, which sometimes requires 8-12 weeks of treatment. In fact, in a survey included in the randomised, sham controlled trial (Kovacic, K, Hainsworth, M., et al.
Our method patents also limit other devices from targeting IBS through stimulation of cranial nerve branches in the ear. Approved drugs for Adults with IBS 1. Rifaximin: an intraluminal antibiotic approved for IBS-diarrhea 2. Amitiza: a drug that stimulates fluid secretion from the intestine, approved for IBS-diarrhea 3.
Linzess: a drug that stimulates fluid secretion from the intestine, approved for IBS-constipation in 7 years of age and older Approved drugs for adults with IBS 1. Rifaximin: an intraluminal antibiotic approved for IBS-diarrhea 2. Amitiza: a drug that stimulates fluid secretion from the intestine, approved for IBS-diarrhea 3.
The RED device is therefore safer with regard to patients with decreased compliance. ● Not only is RED safer by design, but there have not been any safety events related to compliance in MAUDE with the predicate in the last 10 years. ● RED is more compliant than air or water based on balloon compression data as demonstrated in the graph below.
RED is therefore safer with regard to patients with decreased compliance. ● There have been no safety events reported to compliance in MAUDE with the predicate in the last 10 years. ● RED is more compliant than air or water based on balloon compression data as demonstrated in the graph below. ● RED CPT coding changed effective January 1, 2026, and we are currently waiting on the AMA CPT Knowledge Base to give an opinion on the coding going forward.
Implications of Being a Smaller Reporting Company We are a “smaller reporting company” as defined in Rule 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
With one FDA indication (functional abdominal pain associated with IBS in adolescents 8-21 years old) on the market, additional clinical trials of PENFS in multiple pediatric conditions are underway focused on unmet healthcare needs in children, see “ Our Pipeline ” for more information.
With one FDA indication—functional abdominal pain associated with IBS, functional dyspepsia (FD), and associated FD nausea symptoms for 8 years and older—on the market, additional clinical trials of PENFS in multiple pediatric conditions are underway focused on unmet healthcare needs in children and adults. These indications consist of post-concussion syndrome, cyclic vomiting syndrome, post-operative pain and fibromyalgia pain.
IB-Stim already has market clearance from FDA for functional abdominal pain associated with IBS in children. FDA has classified the non-implanted nerve stimulator for functional abdominal pain relief as Class II devices.
The FDA has classified the non-implanted nerve stimulator for functional abdominal pain relief as a Class II device.
Digital therapeutics that offer CBT for IBS have been developed for adults with IBS with limited success in terms of reaching large numbers of patients. Virtual reality could potentially be used in the future to also deliver CBT to patients with IBS.
Competition also includes devices that could theoretically be used, but do not have supporting data or FDA clearance for functional bowel disorders or IBS. Digital therapeutics that offer CBT for IBS have been developed for adults with IBS with limited success in terms of reaching large numbers of patients.
RED Reimbursement RED is billable under CPT 91120. The documentation is Rectal Hypersensitivity at 52-60mL: present/absent. Intellectual Property Our intellectual property consists of patents, trademarks, and trade secrets. Our trade secrets consist of product formulas, research, and development, and unpatentable know-how, all of which we seek to protect, in part, by confidentiality agreements.
Intellectual Property Our intellectual property consists of patents, trademarks, and trade secrets. Our trade secrets consist of product formulas, research, and development, and unpatentable know-how, all of which we seek to protect, in part, by confidentiality agreements. To protect our intellectual property, we rely on a combination of laws and regulations, as well as contractual restrictions.
ITEM 1. BUSINESS Overview Neuraxis, Inc. (“we”, “us”, the “Company” or “Neuraxis”) is a medical technology company focused on developing neuromodulation therapies to address chronic and debilitating conditions in children and adults. We are dedicated to advancing science with our proprietary IB-Stim therapy, based on our Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, which was developed internally by the Company.
With several indications in the market and additional clinical trials of Percutaneous Electrical Nerve Field Stimulation (PENFS) in multiple pediatric and adult conditions underway, we are focused on unmet GI healthcare needs in children and adults. We are dedicated to advancing science with our proprietary IB-Stim ® therapy, based on our PENFS technology, which was developed internally by the Company.
Rectal Expulsion Device (RED) The Rectal Expulsion Device (RED) enables comprehensive constipation care for every gastroenterology practice. The mission is to develop the best tool for clinical decision making with the physician and patient in mind. RED was designed to be the most efficient, accurate, and cost-effective diagnostic tool for patients with chronic constipation.
RED TM (Rectal Expulsion Device) RED enables comprehensive constipation for every gastroenterology practice. The mission is for every gastroenterology practice to be able to safely and confidently differentially screen root causes of chronic constipation with the patient and physician in mind.
GMI bears the risk of loss of and damage to the equipment and consigned materials. Performance under the MSA is initiated by orders issued by the Company and accepted by GMI.
The Company’s IB-Stim and RED devices are manufactured in Indiana and Michigan, respectively. The Company provides the necessary equipment to the manufacturers and retains ownership. The manufacturers bear the risk of loss of and damage to the equipment and consigned materials. Performance under the agreement is initiated by orders issued by the Company and accepted by the manufacturers.
These indications consist of chronic nausea, post-concussion syndrome, chemotherapy-induced nausea and vomiting, cyclic vomiting syndrome. The chart below shows our status in the FDA review process for IB-Stim and each of the following pediatric indications: 1. Functional dyspepsia ( nausea ): RCT completed, and data being analyzed. ClinicalTrials.gov Identifier: NCT03675321, Defining Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response.
The chart below shows our status in the FDA review process for IB-Stim and each of the following pediatric indications: 1. Functional dyspepsia ( nausea ): Sub-analysis of the RCT completed, and data was analyzed and presented to FDA.
Psychological treatments such as cognitive behavioral therapy (CBT) or guided imagery have been shown to be some of the most effective treatments for these conditions, however, these are limited by access to trained therapists. It also includes devices that could theoretically be used, but do not have supporting data or FDA clearance for functional bowel disorders or IBS.
Psychological treatments such as cognitive behavioral therapy (CBT) or guided imagery have been shown to be some of the most effective treatments for these conditions, however, these are limited by access to trained therapists. As a result, the Company is addressing this challenge by providing access to guided-imagery audio with IB-Stim at a low associated cost to the patient.
The goal is for every Gastroenterologist practice to be able to safely and confidently perform meaningful anorectal testing without it impacting clinical workflow or requiring a large capital expense. Eight (8) million patients each year present with constipation. Of those eight million patients, 700,000 patients present to the Emergency Room.
RED can be implemented in a GI practice with minimal impact to clinical workflow and does not require a large capital expense. Eight (8) million patients each year present with constipation. Of those eight million patients, 700,000 patients present to the Emergency Room. Clinical Background Constipation is one of the most encountered gastrointestinal complaints in clinical practice.
The study findings demonstrate that RED impacts clinical decision making by identifying patients who would benefit from physical therapy or who would require optimization of laxatives. It is also sufficient to qualitatively assess for rectal hypersensitivity which was evident in almost one-third of patients with chronic constipation failing a trial of fiber/laxatives.
Clin Gastroenterol Hepatol. 2023;21:1082-1090.It is also sufficient to qualitatively assess for rectal hypersensitivity which was evident in almost one-third of patients with chronic constipation failing a trial of fiber/laxatives. It is critical to assess rectal sensation and balloon expulsion in patients with constipation and/or fecal incontinence.
IB-Stim stays on for a total of five-days to allow delivery of gentle electrical pulses to nerves below the skin that access the central nervous system. A study in adolescents showed greater improvement in functional abdominal pain and global symptom improvement with every week of treatment (up to four weeks).
Once the provider is trained, the device can be placed in the outpatient clinic and can be removed by the provider in the clinic or by the patient at home. IB-Stim stays on for a total of five-days to allow delivery of gentle electrical pulses to nerves below the skin that access the central nervous system.
Linzess : a drug that stimulates fluid secretion from the intestine, approved for IBS-constipation 4. Plecanatide: a drug that stimulates fluid secretion from the intestine, approved IBS-constipation 5.
Linzess : a drug that stimulates fluid secretion from the intestine, approved for IBS-constipation 4. Plecanatide: a drug that stimulates fluid secretion from the intestine, approved IBS-constipation 5. Eluxadoline: a schedule IV-controlled substance that is a mixed opioid receptor agonist/antagonist in the intestine approved for IBS-diarrhea Approved drugs for children or adults with functional dyspepsia 1.
The initial term of the MSA was 24 months and automatically renews for terms of twelve months unless either party provides a written termination notice to the other party within 180 days prior to the end of the then-current term.
Manufacturing Services Agreements The Company is party to two separate manufacturing services agreements for the manufacture and supply of the Company’s IB-Stim and RED devices based on the Company’s product specifications that automatically renew annually unless either party provides a written termination notice to the other party within 180 days prior to the end of the then-current term.
The primary endpoint will be to measure decreases in the frequency and severity of cyclic vomiting episodes compared to a placebo device. The study will include a minimum of 120 patients and the site is yet to be finalized. Each step in the FDA review process differs in duration and cannot be predicted with accuracy.
The primary endpoint will be to measure decreases in the frequency and severity of cyclic vomiting episodes compared to a placebo device. The study will include a minimum of 120 patients and is being conducted at Children’s Wisconsin/Medical College of Wisconsin. 4. Post-operative pain (opioid sparing) : RCT currently enrolling patients and plans to include almost 300 patients total.
Syncope=1 in sham group Castillo et.al., 2023 Irritable bowel syndrome 27 11-18 4 Abdominal pain, Microbiome Metabolism None Chogle et.al., 2023 Irritable bowel syndrome, functional dyspepsia 31 11-18 4 Quality of life, disability, anxiety None Krasaelap, et.al., 2020 Irritable bowel syndrome 51 11-18 4 Abdominal pain, global symptoms, disability None Santucci et.al.,2021 Functional abdominal pain 20 11-19 4 Abdominal pain, sleep, nausea, anxiety None Chogle et.al., 2023 (Registry) Irritable bowel syndrome, functional dyspepsia 292 8-18 4 Abdominal pain, nausea, disability None Santucci et.al.,2023 Irritable bowel syndrome, functional dyspepsia, FAP 101 11-21 4 Abdominal pain, nausea, disability None The ability of the IB-Stim to produce systemic effects by modulating the central nervous system has been demonstrated in a pre-clinical animal model of IBS (see Business— Pre-Clinical Data ).
Syncope=1 in sham group The ability of IB-Stim to produce systemic effects by modulating the central nervous system has been demonstrated in a pre-clinical animal model of IBS (see Business— Pre-Clinical Data ).
We believe that superior science and evidence-based research, are necessary for adoption by the medical and scientific community.
We believe that superior science and evidence-based research are necessary for adoption by the medical and scientific community. Additional clinical trials of PENFS in multiple pediatric and adult conditions are underway, focused on unmet healthcare needs in children and adults. See “ Our Pipeline ” for more information.
At the end of the four-week study, 95% of adolescents stated they would recommend the treatment to family or friends. Safety of percutaneous electrical nerve field stimulation has also been reported in a separate study of over 1200 adult patients with no serious adverse events and minimal to no side-effects.
Safety of percutaneous electrical nerve field stimulation has also been reported in a separate study of over 1200 adult patients with no serious adverse events and minimal to no side-effects. When wearing IB-Stim and following an easy-to-learn and efficient procedure, patients can still attend school and extracurricular activities, exercise or play non-contact sports, shower, wear earbuds or headphones, and travel.
Below are the current standard treatments in children with functional abdominal pain and IBS. 5 Our Solutions We entered the pediatric market with clinical evidence, key opinion leaders and society endorsement, including a signed letter from the American Academy of Pediatrics and NASPGHAN supporting our request for insurers to pay for our IB-Stim device.
Pharmacological Treatment Options for Functional Abdominal Pain Disorders Mild Pain (No Disability) Pain (With Disability) Peppermint oil Tricyclic antidepressants (amitriptyline)* Rifaximin Iberogast Selective serotonin reuptake inhibitors (citalopram)* Constipation Probiotics Gabapentin Linaclotide Acid suppression with PPIs Antispasmodics (hyoscyamine, dicyclomine)* Lubiprostone Cyproheptadine* Plecanatide * Increased risk of dementia based on anticholinergic burden 5 Our Solutions We entered the pediatric market with clinical evidence, key opinion leaders and society endorsement, including a signed letter from the American Academy of Pediatrics and NASPGHAN supporting our request for insurers to provide coverage for PENFS procedures with IB-Stim.
Nerve stimulator apparatus; nerve stimulator apparatus for FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, changes in FGID co- morbidities, sleep disturbances, psychological disorders, including mood, anxiety, and satiety, pain control, headache control, control of phantom limb pain, stump pain, reflex sympathetic dystrophy (RSD), peripheral neuropathies and other types of sympathetically mediated pain Filed: Allowed The Company has no core trademarks that are currently unregistered.
Medical apparatus, namely, electrical nerve stimulators; medical device, namely, a non-implantable modulating frequency generator, providing neuromodulation therapy to cranial and peripheral nerves; medical apparatus consisting of percutaneously implantable arrays for transmitting current into auricular and per-auricular tissue; medical device for peripheral nerve and nerve field stimulation; medical device consisting of a non-implantable modulating frequency generator and percutaneously implantable needle arrays for transmitting current into auricular and per-auricular tissue for us in pain management and FGID (functional gastrointestinal disorders), namely, patient stimulator for auricular and peri-auricular peripheral nerve filed neuromodulation therapy; medical apparatus, for peripheral never field stimulation in cranial and peripheral nerves and occipital nerve branches, for pain control, FGID, irritable bowel, functional dyspepsia, functional abdominal pain, nausea, functional nausea, abdominal migraine, Crohn’s Disease, visceral hypersensitivity, chronic inflammatory bowel disease, change in FGID co-morbidities, sleep disturbances, psychological disorders, including mood and anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain.
Through innovation and research, we are reimagining the future of patient care. Our Corporate History Neuraxis, Inc. was established in 2011 and incorporated in the state of Indiana on April 17, 2012, under the name of Innovative Health Solutions, Inc. The name was changed to Neuraxis, Inc. in March of 2022.
Our Mission Our mission is to advance drug-free neuromodulation therapies that improve patient outcomes and reduce medication burden in complex disorders, while expanding access to effective care for populations with significant unmet needs. Our Corporate History Neuraxis, Inc. was established in 2011 and incorporated in the state of Indiana in 2012, under the name of Innovative Health Solutions, Inc.
RED is a point-of-care test that helps determine why patients may not respond to conventional laxative therapy and helps identify patients that will respond to pelvic floor therapy. ● The NSS-2 Bridge is a percutaneous nerve field stimulator, or PNFS, device indicated for use in the reduction of the symptoms of opioid withdrawal.
RED is intended to be used in a clinical setting by trained health care providers in adult populations. ● NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device indicated for use in the reduction of the symptoms of opioid withdrawal and was licensed to Masimo Corporation (“Masimo”). Masimo marketed and sold this product as its Masimo Bridge.
We have concentrated our marketing focus on the 260 children’s hospitals within the United States.
Many children’s hospitals and pediatric providers across the country are currently treating children with IB-Stim due to the safety, efficacy, and patient outcomes with this non-drug alternative. We have concentrated our marketing focus on the 260 children’s hospitals within the United States.
We plan to extensively ramp-up our marketing efforts to patients and physicians as we gain additional indications. Patients/Customers Our current patient base is children 8-21 years of age and suffering from functional abdominal pain. Our customers are primarily children’s hospitals who serve these children.
Direct-to-patient marketing efforts will be considered in the future. Patients/Customers IB-Stim is indicated for patients 8 years and older suffering from functional abdominal pain, functional dyspepsia (FD),and associated FD nausea symptoms. Customers are currently primarily children’s hospitals who serve these patients, but is currently expanding to adult gastroenterologists and adult pain physicians.
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We believe in improving lives and minimizing suffering; particularly in the pediatric population, where research and therapeutics are usually lacking. The Company already has market clearance for its IB-Stim ® that targets functional abdominal pain associated with IBS, in children, with a total addressable market of up to 6 million children.
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ITEM 1. BUSINESS Overview Neuraxis, Inc. (“we”, “us”, the “Company” or “Neuraxis”) is a first-to-market growth-stage medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in gastrointestinal (GI) digestive system, specifically from disorders of the gut-brain interaction (DGBIs) in pediatrics and adults.
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Additionally, the Company filed a Certificate of Conversion to become a Delaware corporation on June 23, 2022. The authorized shares were increased, and a par value established. On September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split. They also increased the number of authorized common stock shares from 2,700,000 to 10,800,000.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market trading volume of our common stock could be negatively affected. Any trading market for our common stock may be influenced in part by any research reports that securities industry analysts publish about us.
Biggest changeAny trading market for our common stock may be influenced in part by any research reports that securities industry analysts publish about us. If one or more of security analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage of us, the market price and market trading volume of our common stock could be negatively affected.
Even as we received regulatory clearance to market the IB-Stim, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, and record keeping related to IB-Stim will remain subject to extensive regulatory requirements.
Even as we received regulatory clearance to market IB-Stim, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, and record keeping related to IB-Stim will remain subject to extensive regulatory requirements.
A change in our relationship with our manufacturer could result in a material adverse effect on our business, financial condition and results of operations. A decision to change manufacturers would result in longer times for design and production as we secure any necessary licenses or clearances, develop quality control measures, and implement manufacturing processes.
A change in our relationship with our manufacturers could result in a material adverse effect on our business, financial condition and results of operations. A decision to change manufacturers would result in longer times for design and production as we secure any necessary licenses or clearances, develop quality control measures, and implement manufacturing processes.
Failure to do so could materially harm our business. 43 Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand. We are heavily dependent on customers who use our IB-Stim device to provide good reviews and word-of-mouth recommendations to contribute to our growth.
Failure to do so could materially harm our business. 43 Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand. We are heavily dependent on customers who use IB-Stim to provide good reviews and word-of-mouth recommendations to contribute to our growth.
In particular, our products may not achieve market acceptance for current or future indications because of the following additional factors: ● achieving patient acceptance could be difficult because not all patients are willing to comply with requirements of treatment with our products, and other patients may forego our products for financial, privacy, cosmetic, visibility or mobility reasons; 39 ● achieving patient compliance may be difficult because the recommended use of our products is 120 hours per week for three (3) consecutive weeks, and not to exceed four (4) weeks, which to some extent restricts physical mobility because our products cannot be worn in all circumstances, and the patient or a caregiver must ensure that it remains continuously operable and this may also impact the pool of patients to whom physicians may be willing to prescribe our products; ● there may be certain perceived limitations to our study designs or data obtained from our clinical studies; ● efficacy may also be limited in instances where patients take a break from the device when experiencing skin rashes, or while bathing or swimming (because our products should not be immersed in water); and ● patients may decline therapy or prescribers may be unwilling to prescribe our products due to certain adverse events attributable to the device reported in clinical studies by patients treated with our products.
In particular, our products may not achieve market acceptance for current or future indications because of the following additional factors: ● achieving patient acceptance could be difficult because not all patients are willing to comply with requirements of treatment with our products, and other patients may forego our products for financial, privacy, cosmetic, visibility or mobility reasons; 39 ● achieving patient compliance may be difficult because the recommended use of our products is 120 hours per week for four (4) consecutive weeks, which to some extent restricts physical mobility because our products cannot be worn in all circumstances, and the patient or a caregiver must ensure that it remains continuously operable and this may also impact the pool of patients to whom physicians may be willing to prescribe our products; ● there may be certain perceived limitations to our study designs or data obtained from our clinical studies; ● efficacy may also be limited in instances where patients take a break from the device when experiencing skin rashes, or while bathing or swimming (because our products should not be immersed in water); and ● patients may decline therapy or prescribers may be unwilling to prescribe our products due to certain adverse events attributable to the device reported in clinical studies by patients treated with our products.
Almost all of our revenues have been derived from sales and royalties from sales of IB-Stim, and we expect to develop, market, and sell other neuromodulation therapy devices for the treatment of chronic and debilitating conditions in children.
Almost all of our revenues have been derived from sales and royalties from sales of IB-Stim, and we expect to develop, market, and sell other neuromodulation therapy devices for the treatment of chronic and debilitating conditions in children and adults.
We may experience difficulties in patient enrollment in our clinical studies for a variety of reasons, including: ● the severity of the disease under investigation; ● the limited size and nature of the patient population; ● the patient eligibility criteria defined in our protocol and other clinical study protocols; ● the nature of the study protocol, including the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; ● difficulties and delays in clinical studies that may occur as a result of the COVID-19 pandemic; ● the ability to obtain IRB approval at clinical study locations; ● clinicians’ and patients’ perceptions as to the potential advantages, disadvantages and side effects of our products in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are pursuing; ● availability of other clinical studies that exclude use of our products; ● the possibility or perception that enrolling in a product’s clinical study may limit the patient’s ability to enroll in future clinical studies for other therapies due to protocol restrictions; ● the possibility or perception that our software is not secure enough to maintain patient privacy; ● patient referral practices of physicians; ● the ability to monitor patients adequately during and after treatment; ● the availability of appropriate clinical study investigators, support staff, drugs and other therapeutic supplies and proximity of patients to clinical sites; ● physicians’ or our ability to obtain and maintain patient consents; and ● the risk that when we collaborate with a third-party for research of a product in a particular institution, we can expect to relinquish some or all of the control over the future success of that study to the third-party.
We may experience difficulties in patient enrollment in our clinical studies for a variety of reasons, including: ● the severity of the disease under investigation; ● the limited size and nature of the patient population; ● the patient eligibility criteria defined in our protocol and other clinical study protocols; ● the nature of the study protocol, including the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects; ● the ability to obtain IRB approval at clinical study locations; ● clinicians’ and patients’ perceptions as to the potential advantages, disadvantages and side effects of our products in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are pursuing; ● availability of other clinical studies that exclude use of our products; ● the possibility or perception that enrolling in a product’s clinical study may limit the patient’s ability to enroll in future clinical studies for other therapies due to protocol restrictions; ● the possibility or perception that our software is not secure enough to maintain patient privacy; ● patient referral practices of physicians; ● the ability to monitor patients adequately during and after treatment; ● the availability of appropriate clinical study investigators, support staff, drugs and other therapeutic supplies and proximity of patients to clinical sites; ● physicians’ or our ability to obtain and maintain patient consents; and ● the risk that when we collaborate with a third-party for research of a product in a particular institution, we can expect to relinquish some or all of the control over the future success of that study to the third-party.
We had material weaknesses in our internal control over financing reporting during the years ended December 31, 2024 and 2023, that are unremediated as of December 31, 2024. If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
We had material weaknesses in our internal control over financing reporting during the years ended December 31, 2025 and 2024, that are unremediated as of December 31, 2025. If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
A significant disruption to our manufacturer could have a material adverse effect on our business, financial condition and results of operations. Our reliance on our manufacturer poses a number of risks, including lack of control over the manufacturing process and ultimately over the quality and timing of delivery of our product.
A significant disruption to our manufacturers could have a material adverse effect on our business, financial condition and results of operations. Our reliance on our manufacturers poses a number of risks, including lack of control over the manufacturing process and ultimately over the quality and timing of delivery of our product.
We currently carry cyber and privacy liability insurance with an aggregate limit of $1,000,000, but the amount of insurance coverage that we purchased and may purchase in the future may be inadequate.
We currently carry cyber and privacy liability insurance with an aggregate limit of $5,000,000, but the amount of insurance coverage that we purchased and may purchase in the future may be inadequate.
If we experience any delay in the receipt or deficiency in the quality of products supplied to us by third-party suppliers, or if we have to switch to replacement suppliers, we may face additional regulatory delays and the manufacture and delivery of our products would be interrupted for an extended period of time, which would materially adversely affect our business, prospects, financial condition and results of operations. 41 We currently do not own a manufacturing facility and rely on a sole manufacturer for the production of our product .
If we experience any delay in the receipt or deficiency in the quality of products supplied to us by third-party suppliers, or if we have to switch to replacement suppliers, we may face additional regulatory delays and the manufacture and delivery of our products would be interrupted for an extended period of time, which would materially adversely affect our business, prospects, financial condition and results of operations. 41 We currently do not own a manufacturing facility and rely on contract manufacturers for the production of our product s.
In addition, the statements in this prospectus relating to, among other things, the expected growth in the market for our IB-Stim are based on a number of internal and third-party data, estimates and assumptions, and may prove to be inaccurate.
In addition, the statements in this document relating to, among other things, the expected growth in the market for IB-Stim are based on a number of internal and third-party data, estimates and assumptions, and may prove to be inaccurate.
Any significant disruption to the sole manufacturer’s operations or facilities could have a material adverse effect on our business, financial condition and results of operations . We rely on a sole manufacturer for the production of our products. We do not have control over the operations of the facilities of the third-party manufacturer that we use.
Any significant disruption to the contract manufacturer’s operations or facilities could have a material adverse effect on our business, financial condition and results of operations . We rely on two manufacturers for the production of our products. We do not have control over the operations of the facilities of the third-party manufacturers that we use.
In September of 2024, the AMA’s CPT Editorial Panel accepted addition of Category I CPT Code (placeholder 64X11) for PENFS and deletion of Category III CPT Code 0720T. The finalized Category I CPT Code for PENFS, and associated valuations, will be announced publicly in Q4 of 2025. The new code will become effective for utilization on January 1, 2026.
In September of 2024, the AMA’s CPT Editorial Panel accepted the addition of Category I CPT Code (64567) for PENFS and deletion of Category III CPT Code 0720T. The finalized Category I CPT Code for PENFS, and associated valuations, were announced publicly in Q4 of 2025. The new code became effective for utilization on January 1, 2026.
Therefore, holders of our common stock will not receive any return on their investment unless they sell their securities, and holders may be unable to sell their securities on favorable terms or at all.
Therefore, holders of our common stock will not receive any return on their investment unless they sell their securities, and holders may be unable to sell their securities on favorable terms or at all. If securities industry analysts publish unfavorable reports on us, then the market price and market trading volume of our common stock could be negatively affected.
RED is billable under Category I CPT Code 91120. We may not be able to maintain the CPT code for physician services related to our products.
RED CAT I CPT codes changed on January 1, 2026. We may not be able to maintain the CPT code for physician services related to our products.
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We do not currently have and may never obtain research coverage by securities industry analysts. If no securities industry analysts commence coverage of us, the market price and market trading volume of our common stock could be negatively affected.
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Management has developed, documented and implemented controls over each of the Company’s material weaknesses and successfully tested the design and operating effectiveness of three deficiencies during the year ended December 31, 2025.
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In the event we are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage of us, the market price and market trading volume of our common stock could be negatively affected.
Added
However, the material weaknesses were not considered remediated as of December 31, 2025, because the new controls were not operational for a sustained period of a full financial reporting cycle. These remediation efforts are subject to ongoing management evaluation and will continue into fiscal year 2026.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeNeurAxis has a “real time” cybersecurity partner that monitors our servers 24/7/365 for any attempted intrusions. NeurAxis routinely reviews the Office of Civil Right (OCR) audit requirements to assess any gaps within our cybersecurity, privacy and security programs.
Biggest changeNeurAxis has a “real time” cybersecurity partner that monitors our servers 24/7/365 for any attempted intrusions and directs the execution of the Company’s disaster recovery plan. NeurAxis routinely reviews the Office of Civil Right (OCR) audit requirements to assess any gaps within our cybersecurity, privacy and security programs.
The Security Officer collaborates with NeurAxis personnel and our outside IT vendors to identify and analyze cybersecurity risks to NeurAxis, considers industry trends, implement controls, as appropriate and feasible, to mitigate these risks and enables business leaders to make risk-based business decisions that impact cybersecurity considerations.
The Security Officer collaborates with NeurAxis personnel and our outside vendors to identify and analyze cybersecurity risks to NeurAxis, considers industry trends, implement controls, as appropriate and feasible, to mitigate these risks and enables business leaders to make risk-based business decisions that impact cybersecurity considerations.
NeurAxis also seeks contractual commitments from key suppliers to appropriately secure and maintain their information technology systems and protect NeurAxis information that is processed or stored on their systems.
NeurAxis also seeks contractual commitments from key suppliers to appropriately secure and maintain their information technology systems and protect NeurAxis information that is processed or stored on their systems, when applicable.
The Security Officer has over 13 years of experience in managing and leading IT or cybersecurity teams and participates in various cyber security trainings frequently.
The Security Officer has over 15 years of experience in managing and leading IT or cybersecurity teams and participates in various cyber security trainings frequently.
As of the fiscal year ended December 31, 2024, the Company had not experienced any material cybersecurity incidents that have had a significant impact on our operations, data integrity, results of operations, or financial performance. CYBERSECURITY GOVERNANCE. NeurAxis’ Board of Directors is responsible for oversight of cybersecurity risk.
As of the fiscal year ended December 31, 2025, the Company had no t experienced any material cybersecurity incidents that have had a significant impact on our operations, data integrity, results of operations, or financial performance. CYBERSECURITY GOVERNANCE. NeurAxis’ Board of Directors is responsible for oversight of cybersecurity risk.
NeurAxis, through experienced cybersecurity and HIPAA/HITECH counsel, has developed a security manual and a privacy policy. 61 ● Training: We provide security awareness training to help our employees understand their information protection and cybersecurity responsibilities at NeurAxis.
NeurAxis, through experienced cybersecurity and HIPAA/HITECH counsel, has developed a security manual and a privacy policy. These policies and manuals are reviewed and updated annually. 61 ● Training: We provide security awareness training to help our employees understand their information protection and cybersecurity responsibilities at NeurAxis.
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Management continues to enhance the Company’s cybersecurity governance through ongoing improvements to its internal control compliance program. As part of these efforts, the Company has adopted the Control Objectives for Information and Related Technologies (COBIT) 2019 framework to support the design and governance of its Information Technology General Controls (ITGCs).
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During the reporting period, management advanced the identification and implementation of ITGCs within the Company’s risk control matrix as part of the implementation of internal control over financial reporting (“ICFR”).
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While the ITGC controls have been identified and incorporated into the risk control matrix, management expects to conduct the formal assessment and testing of these controls during fiscal year 2026 in alignment with the continued rollout and enhancement of internal controls over financial reporting . In addition, the Company established a dedicated internal control department during fiscal year 2025.
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This function reports directly to the Audit Committee of the Board of Directors regarding the status and progress of the Company’s internal control over financial reporting program, including matters related to ITGCs, to strengthen governance and oversight. 62

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeWe also lease office space in Versailles, Indiana, pursuant to an agreement that commenced January 1, 2022 for a term of one year with automatic one year renewal options, unless 60 day notice of vacating is given. The monthly base rent is $1,800 with an annual 4% escalator upon renewal. 62
Biggest changeWe also lease office space in Batesville, Indiana, pursuant to an agreement that commenced August 1, 2025 for an inital term of three years with automatic one year renewal options subject to an annual 4% rent escalation, unless 60 day notice of vacating is given.
ITEM 2. PROPERTIES Our corporate headquarters are located in Carmel, Indiana, where we lease office space for employees, pursuant to a lease agreement with Zeller-Carmel Property, LLC. The term of this lease commenced on January 1, 2024 and is scheduled to end on May 31, 2029.
ITEM 2. PROPERTIES Our corporate headquarters are located in Carmel, Indiana, where we lease office space for employees. The term of this lease commenced on January 1, 2024 and is scheduled to end on May 31, 2029. Over the term of the lease, the monthly base rent is $6,721 with an annual 2.5% escalator.
Over the term of the lease, the monthly base rent is $6,721 with an annual 2.5% escalator. We received a 50% reduction in our monthly rent for the first 10 months of the lease.
We received a 50% reduction in our monthly rent for the first 10 months of the lease.
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The Company prepaid $25,200 of rent on June 13, 2025 which will be amortized over the initial lease term and thereby reduced the monthly base rent to $1,300.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe remaining claims are still pending, and no trial date has been set for the case. The Court has vacated its Scheduling Order at the parties’ request so that the parties could try to resolve the disputes in both cases through an independent third-party mediator.
Biggest changeThe Court has vacated its Scheduling Order at the parties’ request so that the parties could try to resolve the disputes in both cases through an independent third-party mediator On April 25, 2025, the parties reached a tentative $750,000 settlement payable in 12 equal monthly installments beginning in January of 2026 as filed with the United States District Court for the District of Maryland with the settlement agreement duly executed on May 15, 2025.
While it is too early to predict the ultimate outcome of these matters, we believe the Company has meritorious defenses and intends to defend these matters vigorously. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. PART II
While it is too early to predict the ultimate outcome of these matters, we believe the Company has meritorious defenses and intends to defend these matters vigorously. ITEM 4. MINE SAFETY DISCLOSURES Not applicable. 63 PART II
Mediation has not yet resulted in a resolution of the case. 63 In January 2024, Dr. Arturo Taca served notice to the Company that asserted an interest in its U.S. Patent No. 10,413,719 valued at $2,000,000 based on his own work in neurostimulation. The Company denied both the neurostimulation patent and compensation claims. The case remains unresolved.
In January 2024, Dr. Arturo Taca served notice to the Company that asserted an interest in its U.S. Patent No. 10,413,719 valued at $2,000,000 based on his own work in neurostimulation. The Company denied both the neurostimulation patent and compensation claims. The case remains unresolved.
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The remaining claims are still pending, and no trial date has been set for the case.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures 64 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 64 Item 6. Reserved 64 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 65
Biggest changeItem 4. Mine Safety Disclosures 63 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 64 Item 6. Reserved 64 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 65

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeOn January 17, 2025, the Company issued (i) 39,471 shares of common stock to its independent board members for their service from April 1, 2024 through December 31, 2024 and (ii) 186,166 shares of common stock to an accredited investor upon conversion of 502,647 common stock warrants in a cash less exercise transaction.
Biggest changeAlso on January 22, 2026, the Company issued 86,392 shares of common stock to its independent board members for their 2025 and 2026 service.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information and Holders of Common Stock Our common stock is listed on the NYSE American, under the symbol “NRXS”. As of March 13, 2025, there were approximately 682 record holders of our common stock.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information and Holders of Common Stock Our common stock is listed on the NYSE American, under the symbol “NRXS”. As of March 12, 2026, there were approximately 1,585 record holders of our common stock.
The number of record holders does not include beneficial owners of common stock whose shares are held in the names of banks, brokers, nominees or other fiduciaries and holders of unissued shares common stock. The last reported sales price for our Common Stock as reported on the NYSE American on March 13, 2025 was $2.10.
The number of record holders does not include beneficial owners of common stock whose shares are held in the names of banks, brokers, nominees or other fiduciaries and holders of unissued shares of common stock. The last reported sales price for our Common Stock as reported on the NYSE American on March 12, 2026 was $6.48.
Omnibus Securities and Incentive Plan, as amended on August 15, 2024. The RSUs vest annually over a three-year cliff-vesting period and are payable in shares of the Company’s common stock. The RSUs fully vest upon (i) death or disability or (ii) change of control. Dividend equivalents accrue on RSUs and are paid upon vesting.
The RSUs vest annually pro rata over a three-year period and are payable in shares of the Company’s common stock. The RSUs fully vest upon (i) death or disability or (ii) change of control. Dividend equivalents accrue on RSUs and are paid upon vesting; there were no accrued dividends on unvested RSUs as of the report date.
Removed
Recent Sales of Unregistered Securities On November 14, 2024, the Company entered into security purchase agreements with five accredited investors for the issuance and purchase of 45,653 shares of the Company’s Series B Preferred Stock, par value $0.001 per share, for an aggregate purchase price of $108,664.
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Recent Sales of Unregistered Securities On October 29, 2025, 3,334 restricted stock units (“RSUs”) vested into an equivalent number of shares of common stock. On January 22, 2026, the Company granted 437,431 RSUs pursuant to the Neuraxis, Inc. 2022 Omnibus Securities and Incentive Plan as amended on August 15, 2024.
Removed
On December 26, 2024, the Company issued 10,000 shares of common stock to an accredited investor for their services in bringing RED to market. On January 3, 2025 and March 6, 2025, the Company granted 360,902 and 373,275 restricted stock units (RSUs), respectively, to certain employees pursuant to the 2022 NeurAxis, Inc.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations Comparison of Year Ended December 31, 2024, and Year Ended December 31, 2023 The following table presents our statements of operations for the years ended December 31, 2024 and 2023: Years Ended December 31, 2024 2023 Net sales $ 2,685,925 $ 2,460,049 Cost of goods sold 362,002 303,345 Gross profit 2,323,923 2,156,704 Selling expenses 324,708 323,569 Research and development 206,107 169,315 General and administrative 8,949,925 8,328,315 Operating loss (7,156,817 ) (6,664,495 ) Other (expense) income, net: Financing charges (230,824 ) (2,772 ) Interest expense, net (174,328 ) (476,416 ) Change in fair value of warrant liability (941 ) 844,854 Change in fair value of derivative financial instruments — 198,551 Amortization of debt discount and issuance costs (126,387 ) (4,881,622 ) Extinguishment of debt liabilities — (3,649,561 ) Other (expense) income, net (552,204 ) 4,778 Total other (expense) income, net (1,084,684 ) (7,962,188 ) Net loss $ (8,241,501 ) $ (14,626,683 ) 66 Net Sales Net sales increased $225,876, or 9.2%, from $2,460,049 for the year ended December 31, 2023, to $2,685,925 for the year ended December 31, 2024, primarily due to volume growth from our financial assistance programs that provide discounts to patients without insurance coverage.
Biggest changeResults of Operations Comparison of Year Ended December 31, 2025, and Year Ended December 31, 2024 The following table presents our statements of operations for the years ended December 31, 2025 and 2024: Years Ended December 31, 2025 2024 Net sales $ 3,569,282 $ 2,685,925 Cost of goods sold 562,916 362,002 Gross profit 3,006,366 2,323,923 Selling expenses 2,279,974 1,468,884 Research and development 493,611 443,614 General and administrative 8,062,689 7,578,242 Operating loss (7,829,908 ) (7,156,817 ) Other income (expense), net: Financing charges (30,240 ) (230,824 ) Interest expense (73,969 ) (174,328 ) Change in fair value of warrant liability (7,634 ) (941 ) Amortization of debt discount and issuance costs -- (126,387 ) Other income (expense), net 141,196 (552,204 ) Total other income (expense), net 29,353 (1,084,684 ) Net loss $ (7,800,555 ) $ (8,241,501 ) 66 Net Sales Net sales increased $883,357, or 32.9%, from $2,685,925 for the year ended December 31, 2024, to $3,569,282 for the year ended December 31, 2025, primarily due to volume growth from (i) both patients with health insurance coverage and those participating our financial assistance programs that provide discounts to patients without health insurance coverage and (ii) device sales from the Company’s launch of the RED product in 2025.
We expect our gross profit to increase for the foreseeable future as our net sales grows, both through broader insurer acceptance of our IB-Stim device in the near term and approval of our technology for the treatment of other indications over the longer term.
We expect our gross profit to increase in the foreseeable future as our net sales grows, both through broader insurer acceptance of IB-Stim in the near term and approval of our technology for the treatment of other indications over the longer term.
The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development efforts, will require significant uses of working capital through the rest of 2025 and beyond.
The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development efforts, will require significant uses of working capital through the rest of 2026 and beyond.
Based on our current operating plans, we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs before the end of 2025. Additionally, we will have to meet all the financial disclosure and reporting requirements associated with being a publicly reporting company.
Based on our current operating plans, we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs before the end of 2026. Additionally, we will have to meet all the financial disclosure and reporting requirements associated with being a publicly reporting company.
Our gross margin has been and will continue to be affected by a variety of factors, primarily the average selling price of our IB-Stim device, production volume, order flows, change in mix of customers, third-party manufacturing costs related to components of our IB-Stim device, and cost-reduction strategies.
Our gross margin has been and will continue to be affected by a variety of factors, primarily the average selling price of IB-Stim, production volume, order flows, change in mix of customers, third-party manufacturing costs related to components of our devices and cost-reduction strategies.
Expenses We have four categories of expenses: cost of goods sold, selling, research and development (“R&D”), and general and administrative (“G&A”). Costs of goods sold consist of costs paid for the IB-Stim device to our contract manufacturer along with shipping and handling costs and expired inventory charges.
Expenses We have four categories of expenses: cost of goods sold, selling, research and development (“R&D”), and general and administrative (“G&A”). Costs of goods sold consist of costs paid for the IB-Stim and RED devices to our contract manufacturers along with shipping and handling costs and expired inventory charges.
We enter into sales agreements with customers for IB-Stim devices based on purchase orders and standard terms, which vary slightly based on the customer’s form, and conditions of sale. Standard payment terms generally are that payment is due within 30 days.
We enter into sales agreements with customers for IB-Stim based on purchase orders and standard terms, which vary slightly based on the customer’s form, and conditions of sale. Standard payment terms generally are net 30 days.
Our largest sales were to three customers representing approximately 40% and 45% of total sales for the years ended December 31, 2024 and 2023, respectively. Inflation did not have a material impact on our operations for any applicable period, and we do not expect inflation to have a material impact on our operations for the foreseeable future.
Our largest sales were to two customers representing approximately 28% and 35% of total sales for the years ended December 31, 2025 and 2024, respectively. Inflation did not have a material impact on our operations for any applicable period, and we do not expect inflation to have a material impact on our operations for the foreseeable future.
Other indications in our pipeline are comprised of functional nausea in children, post-concussion syndrome in children, and cyclic vomiting syndrome in children. Since our inception, we have incurred significant operating losses. Our net loss was $8,241,501 and $14,626,683 for the years ended December 31, 2024 and 2023, respectively.
Other indications in our pipeline are comprised of post-concussion syndrome, cyclic vomiting syndrome, post-operative pain and fibromyalgia pain. Since our inception, we have incurred significant operating losses. Our net loss was $7,800,555 and $8,241,501 for the years ended December 31, 2025 and 2024, respectively.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Overview We are a growth stage company focused on developing neuromodulation therapies to address chronic and debilitating conditions in children. Our mission is to provide solutions that create value and provide better and safer patient outcomes.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Overview We are a growth stage company focused on developing neuromodulation therapies to address chronic and debilitating conditions in children.
Our IB-Stim device sells for $1,195 per device, and each child being treated for functional abdominal pain associated with IBS will use four. Our sales typically are made on a purchase order basis rather than through long-term purchase commitments.
Sales generally are not seasonal and only mildly correlated with economic cycles. IB-Stim sells for $1,195 per device, and each patient being treated for functional abdominal pain associated with IBS, functional dyspepsia (FD), and/or associated FD nausea symptoms will use four devices. Our sales typically are made on a purchase order basis rather than through long-term purchase commitments.
Our auditors have expressed substantial doubt about our ability to continue as a going concern in their audit opinion. We expect to incur significant expenses and operating losses for the foreseeable future as we continue to pursue widespread insurance coverage of our IB-Stim and RED devices and seek FDA clearance of our device for other indications.
We expect to incur significant expenses and operating losses for the foreseeable future as we continue to pursue widespread insurance coverage of our IB-Stim and RED devices and seek FDA clearance of our device for other indications.
There are a number of milestones and conditions that we must satisfy before we will be able to generate sufficient revenue to fund our operations, including FDA clearance of our IB-Stim device to treat future indications.
There are a number of milestones and conditions that we must satisfy before we will be able to generate sufficient revenue to fund our operations, including FDA clearance of IB-Stim to treat future indications. Factors Affecting our Business and Results of Operations Revenue Our revenue is derived from the sale of IB-Stim to healthcare companies, primarily hospitals and clinics.
Liquidity and Capital Resources We had cash on hand of $3,696,870 and $78,560 as of December 31, 2024 and 2023, respectively. We maintained a working capital surplus of $1,832,858 and negative working capital of $1,643,058 as of December 31, 2024 and 2023, respectively.
Liquidity and Capital Resources We had cash on hand of $4,965,072 and $3,696,870 as of December 31, 2025 and 2024, respectively. We maintained a working capital surplus of $2,941,091 and $1,832,858 as of December 31, 2025 and 2024, respectively.
Our gross margin may fluctuate from quarter to quarter due to changes in average selling prices, particularly as we introduce enhancements to our IB-Stim device and new products to address other indications, and as we adopt new manufacturing processes and technologies.
Our gross margin may fluctuate from quarter to quarter due to changes in average selling prices and the mix of patient healthcare coverage (e.g., discounts are provided to lower income patients without healthcare insurance), particularly as we introduce enhancements to IB-Stim and new products to address other indications, and as we adopt new manufacturing processes and technologies.
Despite the increase in sales volume, the decrease in gross margin from 87.7% for the year ended December 31, 2023, to 86.5% for the year ended December 31, 2024, was due to higher growth in the Company’s financial assistance programs that are discounted to patients without insurance coverage compared to the Company’s undiscounted full reimbursement customers.
Despite the increase in sales volume, the decrease in gross margin from 86.5% for the year ended December 31, 2024, to 84.2% for the year ended December 31, 2025, was due to higher discounting in the Company’s financial assistance programs provide to patients without insurance coverage, a higher unit growth rate of the discounted financial assistance programs compared to the full reimbursement health insurance programs and expired RED inventory.
Gross Profit and Gross Margin Gross profit increased $167,219, or 7.8%, from $2,156,704 for the year ended December 31, 2023, to $2,323,923 for the year ended December 31, 2024, due to higher sales volume.
Gross Profit and Gross Margin Gross profit increased $682,443, or 29.4%, from $2,323,923 for the year ended December 31, 2024, to $3,006,366 for the year ended December 31, 2025, due to higher sales volume.
Operating Loss Our operating loss increased $492,322, or 7.4%, from $6,664,495 for the year ended December 31, 2023, to $7,156,817 for the year ended December 31, 2024, primarily due to higher general and administrative expenses partially offset by higher sales volume. 67 Other (Expense) Income Other expense decreased $6,877,504 or 86.4%, from $7,962,188 for the year ended December 31, 2023, to $1,084,684 for the year ended December 31, 2024, due to the full conversion of the convertible notes upon the IPO on August 9, 2023, that eliminated any further debt discount, issuance cost, debt extinguishment and fair value derivative valuation net charges and lower interest expense and issuance cost amortization from a lower debt burden in 2024, partially offset by financing charges incurred to settle a 2023 convertible note dispute and other expense to settle certain claims of pre-IPO Series A Preferred Stock shareholders.
Operating Loss Our operating loss increased $673,091, or 9.4%, from $7,156,817 for the year ended December 31, 2024, to $7,829,908 for the year ended December 31, 2025, primarily due to higher selling and general and administrative expenses partially offset by higher gross profit from sales volume. 67 Other Income (Expense) Other income increased $1,114,037, or 102.7%, from $1,084,684 of expense for the year ended December 31, 2024, to $29,353 of income for the year ended December 31, 2025, due to the absence of one-time, non-recurring 2024 settlements relating to a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholder claims and the conversion of convertible notes into Series B Preferred Stock in 2024 which eliminated any related debt discount and interest charges.
We expect future R&D expenses for other indications, such as functional nausea, post-concussion syndrome and cyclic vomiting syndrome in children. General and administrative expense primarily consists of wages and benefits, professional fees including legal and audit, insurance, investor relations, advertising, facility costs, utilities and travel.
General and administrative expense primarily consists of wages and benefits, professional fees including legal and audit, insurance, investor relations, facility costs, utilities and travel.
This additional corporate governance time required of management could limit the amount of time our management has to implement our business plan and may delay our anticipated growth plans. 68 The following table summarizes our cash flows from operating, investing, and financing activities for the years ended December 31, 2024 and 2023: Years Ended December 31, 2024 2023 Net cash used in operating activities $ (6,098,264 ) $ (6,693,978 ) Net cash used in investing activities (27,776 ) (71,781 ) Net cash provided by financing activities 9,744,350 6,590,620 Net increase (decrease) in cash and cash equivalents 3,618,310 (175,139 ) Cash and cash equivalents at beginning of period 78,560 253,699 Cash and cash equivalents at end of period $ 3,696,870 $ 78,560 Operating Activities – Net cash used in operating activities declined 595,714, or 8.9% from $6,693,978 for the year ended December 31, 2023, to $6,098,264 for the year ended December 31, 2024, primarily due to more issuances of common stock instead of cash for certain services in 2024 than in 2023 and lower interest payments in 2024 due to the conversion of debt in the 2023 IPO, partially offset by payments to past due vendors in 2024 for 2023 services.
This additional corporate governance time required of management could limit the amount of time our management has to implement our business plan and may delay our anticipated growth plans. 68 The following table summarizes our cash flows from operating, investing, and financing activities for the years ended December 31, 2025 and 2024: Years Ended December 31, 2025 2024 Net cash used in operating activities $ (6,432,843 ) $ (6,098,264 ) Net cash used in investing activities (131,150 ) (27,776 ) Net cash provided by financing activities 7,832,195 9,744,350 Net increase in cash and cash equivalents 1,268,202 3,618,310 Cash and cash equivalents at beginning of period 3,696,870 78,560 Cash and cash equivalents at end of period $ 4,965,072 $ 3,696,870 Operating Activities – Net cash used in operating activities increased $334,579, or 5.5% from $6,098,264 for the year ended December 31, 2024, to $6,432,843 for the year ended December 31, 2025, primarily due to the payment of the 2024 short-term incentive program in 2025 (no program existed previously) and higher inventory purchases as the Company prepared for the January 1, 2026 effective date of the Category I CPT code for the IB-Stim device, partially offset by better receivable collections.
Net Loss Our net loss decreased $6,385,182, or 43.7%, from $14,626,683 for the year ended December 31, 2023, to $8,241,501 for the year ended December 31, 2024, primarily due to (i) higher sales volume, (ii) the elimination of debt discount, issuance cost and fair value derivative valuation net charges as a result of the conversion of notes upon the 2023 IPO and (iii) lower interest expense and issuance cost amortization from a lower debt burden in 2024, partially offset by (iv) financing charges incurred to settle a 2023 convertible note dispute and other expense to settle certain claims of pre-IPO Series A Preferred Stock shareholders and (v) higher general and administrative expenses due to the absence of 2023 post-IPO consulting and recruiting services and the payment of incentive bonuses relating to the 2023 IPO.
Net Loss Our net loss decreased $440,946, or 5.4%, from $8,241,501 for the year ended December 31, 2024, to $7,800,555 for the year ended December 31, 2025, primarily due to higher sales volume and the absence of one-time, non-recurring 2024 settlements relating to a 2023 convertible note dispute and certain pre-IPO Series A Preferred Stock shareholder claims, partially offset by higher selling expenses and the one-time non-recurring settlement of a lawsuit in 2025.
We expect production costs to remain relatively constant and only nominal inventory expirations in the foreseeable future. 65 Our core selling expenses primarily consist of commissions. Research and development expense is attributable to our clinical trials and related efforts to have our IB-Stim device cleared by the FDA for other indications.
Research and development expenses consist primarily of clinical research studies, new product development, costs of materials and supplies used in research and development activities and salaries and other related personnel costs for employees engaged in research and development activities to have our IB-Stim and RED devices cleared by the FDA for other indications.
Our IB-Stim device is a PENFS system intended to be used in patients 8-21 years of age with functional abdominal pain associated with IBS. Our device already has market clearance from FDA for functional abdominal pain associated with IBS in children.
Our IB-Stim device is a PENFS system with FDA indications for patients 8 years and older with functional abdominal pain associated with IBS, functional dyspepsia (FD), and associated FD nausea symptoms. Our RED device is an easy-to-use, office-based, point-of-care test that identifies patients with chronic constipation due to pelvic floor dyssnergia and has FDA for adults.
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Factors Affecting our Business and Results of Operations Revenue Our revenue is derived from the sale of our IB-Stim device to healthcare companies, primarily hospitals and clinics. Sales generally are not seasonal and only mildly correlated with economic cycles.
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Our mission is to advance drug-free neuromodulation therapies that improve patient outcomes and reduce medication burden in complex disorders, while expanding access to effective care for populations with significant unmet needs.
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Expired inventory expense is related to our FDA clearance for our device in the treatment of functional abdominal pain associated with IBS in children.
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Although we had stockholders’ equity of $3,399,372, our auditors have expressed substantial doubt about our ability to continue as a going concern in their audit opinion.
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Specifically, a certain component of our IB-Stim device is cleared for a two-year period after the date the device is manufactured, and if the device is not sold in such period, we must take the device out of inventory and write it off.
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Expired inventory expense is related to the FDA clearance period from the date our devices are manufactured, and if the device is not sold in such period, a reserve is recorded. Expired inventory charges totaled $19,973 and $0 for the years ended December 31, 2025 and 2024.
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The cost of expired inventory was $25,008 for the year ended December 31, 2023, representing 8.2% of our costs of goods sold. The Company did not have any expired inventory in the year ended December 31, 2024. We have a fixed-price contract with the manufacturer of our IB-Stim device to produce the device.
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We have fixed-price contracts with the manufacturers of our devices. 65 Our selling expenses primarily consist of advertising, marketing and promotion of the Company’s products including salaries, commissions and other related personnel costs including travel expenses.
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Selling Expenses Selling expenses increased $1,139, or 0.4%, from $323,569 for the year ended December 31, 2023, to $324,708 for the year ended December 31, 2024, due to higher sales volume.
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The Company reclassified $1,144,176 of general and administrative expenses to selling expenses in the Consolidated Statements of Operations for the year ended December 31, 2024, to conform to current year presentation.
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Research and Development Research and development expenses increased $36,792, or 21.7%, from $169,315 for the year ended December 31, 2023, to $206,107 for the year ended December 31, 2024, due to costs to bring the RED product to market and higher costs on a medical research project.
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The Company reclassified $227,507 of general and administrative expenses to research and development expenses in the Consolidated Statements of Operations for the year ended December 31, 2024, to conform to current year presentation. We expect future R&D expenses for other indications, such as post-concussion syndrome, cyclic vomiting syndrome, post-operative pain and fibromyalgia pain.
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General and Administrative General and administrative expenses increased $621,610, or 7.5%, from $8,328,315 for the year ended December 31, 2023, to $8,949,925 for the year ended December 31, 2024, due to (i) higher legal, insurance, investor relations, board of directors and stock exchange listing costs as a publicly held entity that the Company did not incur prior to its 2023 IPO, (ii) incremental headcount to build out the market access, sales and finance teams, (iii) severance charges related to the Company’s prior Chief Operating Officer, (iv) one-time advisory costs, (v) expenses related to the introduction of an annual short-term incentive program and (vi) higher advertising costs in order to expand market awareness, partially offset by the non-recurrence of 2023 post-IPO consulting and recruiting services and the payment of incentive bonuses contingent upon the 2023 IPO.
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Although unit growth from the discounted financial assistance programs outpaced the full health insurance reimbursement programs, the Company’s overall growth was function of new customers (both hospitals and private physical practices), new insurance carrier coverage in certain locations across the United States and higher prior authorization approval rates of the Company’s Category III CPT Code.
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The increase in working capital was primarily due to the issuance of $5,000,000 of Convertible Series B Preferred Stock in November 2024 that significantly improved the Company’s liquidity position. We have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital stock.
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Selling Expenses Selling expenses increased $811,090, or 55.2%, from $1,468,884 for the year ended December 31, 2024, to $2,279,974 for the year ended December 31, 2025, due to higher commissions from higher sales volume, a higher temporary commission structure to facilitate growth and adoption in new states, incremental sales and marketing headcount and increased advertising and marketing costs focused on health insurance carriers due to the January 1, 2026 effective date of IB’Stim’s new Category I CPT Code Research and Development Research and development expenses increased $59,997, or 13.8%, from $433,614 for the year ended December 31, 2024, to $493,611 for the year ended December 31, 2025, due to costs to higher year-over-year spending on a medical research project, improved IB-Stim design features and costs to develop the RED device.
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As of December 31, 2024, we had stockholders’ equity of $2,067,748, short-term outstanding borrowings of $154,152 and no long-term debt.
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General and Administrative General and administrative expenses increased $484,447, or 6.4%, from $7,578,242 for the year ended December 31, 2024, to $8,062,689 for the year ended December 31, 2025, primarily due to a $630,568 one-time, non-recurring charge to settle a lawsuit, headcount and related costs incurred to improve and enhance the Company’s internal control environment and the introduction of annual short-term and long-term incentive plans in 2024 that were not outstanding for the full fiscal year, partially offset by the absence of certain one-time non-recurring severance, hiring, consulting and advisory costs incurred in 2024 and lower legal, accounting and insurance costs as new hires in 2024 have internally absorbed certain services.
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Investing Activities – Net cash used in investing activities decreased $44,005, or 61.3%, from $71,781 for the year ended December 31, 2023, to $27,776 for the year ended December 31, 2024, primarily due to the purchase of the Company’s trademark in 2023 that did not recur in 2024.
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The increase in working capital was primarily due to the sale and issuance of 3,108,170 shares of common stock pursuant to the shelf registration statement and warrant exercises for gross proceeds of $8,826,615 offset by cash used in operations of $6,432,843 for the year ended December 31, 2025 which improved the Company’s liquidity position.
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Financing Activities – Net cash provided by financing activities increased $3,153,730, or 47.9%, from $6,590,620 for the year ended December 31, 2023, to $9,744,350 for the year ended December 31, 2024, primarily due to principal repayments on notes payable in 2023 that did not recur in 2024 and the Company subsequently raised capital from the IPO in 2023 to retire the notes payable and issued Convertible Series B Preferred Stock in 2024.
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We have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, the exercises of warrants and the sale of capital stock. As of December 31, 2025, we had stockholders’ equity of $3,399,372, short-term outstanding borrowings of $148,293 and long-term debt of $9,999.
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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.
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Investing Activities – Net cash used in investing activities increased $103,374, or 372.2%, from $27,776 for the year ended December 31, 2024, to $131,150 for the year ended December 31, 2025, primarily due to the $100,000 installment payment to Masimo pursuant to the July 1, 2025 NSS-2 Bridge license termination agreement that allowed the Company to recapture the rights to a trademark and two patent applications.
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Financing Activities – Net cash provided by financing activities decreased $1,912,155, or 19.6%, from $9,744,350 for the year ended December 31, 2024, to $7,832,195 for the year ended December 31, 2025, primarily due to (i) gross financing proceeds of $10,214,846 for the year ended December 31, 2024 from the issuance of Series B preferred stock and convertible notes in addition to the exercise of warrants compared to gross financing proceeds of $8,826,615 for the year ended December 31, 2025 through the issuance of common stock and the exercise of warrants and (ii) higher financing fees, offering costs and legal fees paid in 2025 versus 2024.
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Critical Accounting Estimates Management considers its allowance for credit losses, reserve for sales returns and reserve for excess and expired inventory to be the most critical accounting estimates and assumptions in understanding our financial statements because they involve significant judgments and uncertainties. Actual results could differ from management’s estimates.
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See Note 2 for further information on our most significant accounting policies. Allowance for Credit Losses The Company sells its IB-Stim and RED devices primarily to hospitals and private physician practices with payment generally due within 30 days. The Company does not offer discounts if the customer pays some or all of an invoiced amount prior to the due date.
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We maintain an allowance for credit losses to reflect our estimate of expected losses on accounts receivable from the sale of our medical devices. The estimate of expected credit losses is a considered a critical accounting estimate because it requires significant judgment and the use of assumptions about future customer payment behavior and economic conditions.
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In estimating the allowance for credit losses, management regularly reviews its past due account receivable balances and evaluates many factors including, but not limited to, creditworthiness, past transaction and payment history, historical loss experience, current economic industry trends and payment terms. The Company performs that review by utilizing an aging schedule to assess the collectability of accounts.
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Actual credit losses may differ from estimated amounts. Differences between estimated and actual credit losses are recognized in earnings in the period in which such changes are identified.
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A change in the past due account balance by 10 percentage points as of December 31, 2025, would increase or decrease the allowance for credit losses by $558. 69 Allowance for Sales Returns We recognize revenue net of estimated product returns upon customer receipt under FOB destination terms.
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Customers may return devices if the goods are found to be defective, nonconforming or otherwise do not meet the technical specifications. Historically, the Company has also allowed returns at the request of physicians, on a case-by-case basis, as long as the devices are returned in their original, unopened packaging.
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As a result, we record an allowance for sales returns which is considered a critical accounting estimate because it requires significant judgment and is sensitive to changes in assumptions. In establishing the allowance for sales returns, management evaluates historical return rates by product and adjusts those rates to reflect current trends and conditions.
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Estimates are reassessed each reporting period based on actual return activity and updated information. Actual product returns may differ from estimated amounts. Differences between estimated and actual returns are recognized as adjustments to revenue in the period in which they become known.
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A change in the return rate of one percentage point as of December 31, 2025, would have increased or decreased the allowance by $5,593. Allowance for Excess and Expired Inventory Inventories are valued at the lower of cost or net realizable value.
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An allowance for excess and expired inventory is recorded to reflect inventory quantities that are not expected to be sold or that are expected to be sold below cost. The determination of this allowance is considered a critical accounting estimate because it requires significant judgment regarding future product demand and the timing of orders.
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In estimating the allowance for excess and expired inventory, management considered a number of factors including, but not limited to, historical sales trends, product shelf life and expiration dates, regulatory and clinical requirements, backlog and anticipated demand and future orders. Actual inventory usage and obsolescence may differ from management’s estimates.
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Differences between estimated and actual inventory usage are recognized as adjustments to earnings in the period in which they become known. A change in the forecasted demand of 20 percentage points as of December 31, 2025, would have increased or decreased the allowance by $758. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.

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