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Item 1. Business

2025-03-20 compared with 2024-04-16 · 572 added, 522 removed, 907 unchanged (55% of the section changed)

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.

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.

We believe that superior science and evidence-based

research, are necessary for adoption by the medical and scientific community.

With one FDA indication (functional abdominal pain

associated with IBS in adolescents 11-18 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

(“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.

We believe that superior science and evidence-based research, are necessary for adoption by

the medical and scientific community.

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.

first product, IB-Stim, is a PENFS system intended to be used in patients 8-21 years of age with functional abdominal pain associated

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regulation name of “non-implanted nerve stimulator for functional abdominal pain relief.”

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.

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.

mission is to provide solutions that create value and provide better and safer patient outcomes.

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to 10,800,000.

Furthermore, on September 9, 2021, the board authorized and increase of authorized shares of common stock from 10,800,000

Furthermore, on September 9, 2021, the board authorized an increase of authorized shares of common stock from 10,800,000

to 13,400,000 in anticipation of a capital offering.

part of the conversion to a Delaware corporation, the total number of shares of all classes of stock which the Corporation shall have

authority to issue is 101,120,000 shares, consisting of (i) 100,000,000 shares of common stock, par value $0.001 per share, and (ii) 1,120,000

shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”), 1,000,000 of which is designated as “Series

A Preferred Stock” and 120,000 of which is designated as “Series Seed Preferred Stock”.

authority to issue was 101,120,000 shares, consisting of (i) 100,000,000 shares of common stock, par value $0.001 per share, and (ii)

1,120,000 shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”), 1,000,000 of which was designated as

“Series A Preferred Stock” and 120,000 of which was designated as “Series Seed Preferred Stock”.

on January 10, 2023, the Company’s board of directors authorized a 1-for-2 reverse stock split.

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The reverse split became effective on January 12, 2023.

have developed three FDA cleared products, the IB-Stim (DEN180057, 2019), 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 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome.

The IB-Stim currently is the only product marketed and sold by the Company.

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.

The NSS-2 Bridge

device was licensed to Masimo in April 2020, and we received a one-time licensing fee of $250,000 from Masimo.

Masimo markets and

sells this product as its Masimo Bridge , and we will not receive any further licensing payments or other revenue from

this product.

The original 510(K) device

was the electroacupuncture device (“EAD”), now called NeuroStim .

The EAD is no longer being manufactured,

sold or distributed but reserved only for research purposes.

August 9, 2023, the Company consummated an initial public offering (“IPO”), conducted on a firm commitment basis, pursuant

to which it sold 1,098,667

shares of its common stock at a price of $6.00

per share, resulting in gross proceeds to the

Company of $6,592,002 .

Net proceeds to the Company, after deducting underwriting discounts and commissions and other offering expenses paid by the Company,

were $4,110,721 .

All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File No.

333- 269179), as amended, declared

effective by the SEC on August 9, 2023.

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.

On November 11, 2024, the holders of a majority of the then-outstanding shares of Series B Preferred

Stock authorized (i) an increase in the number of designated Series B Preferred Stock to 5,000,000 shares and (ii) an extension

of the 8.5% cumulative dividend period to December 31, 2026.

The stated value of the Series B Preferred Stock is $2.38 per share.

As of March 13, 2025, there are 4,280,939 shares of Series B Preferred

Stock issued and outstanding, which are convertible (based on the stated value of each share and the conversion price both equalling $2.38)

into 4,280,939 shares of common stock, subject to a maximum ownership cap of between 4.99% and 19.99% of the shares outstanding (following

conversion by the holder) set at the discretion of each holder of Series B Preferred Stock.

holder of Series B Preferred Stock is entitled to cast the number of votes equal to the number of whole shares of common stock into

which the shares of Series B Preferred Stock held by such holder.

Solely for purposes of voting rights, the conversion price is

$3.80 per share.

The 4,280,939 shares of Series B Preferred Stock outstanding therefore represent 2,681,208 votes of common stock,

subject to a maximum voting percentage cap of between 4.99% and 19.99% of the votes outstanding (inclusive of all 2,681,208 votes plus the shares

outstanding on the record date for any particular shareholder meeting) set at the discretion of each holder of Series B Preferred

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.

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.

IB-Stim currently is one of two

products marketed and sold by the Company.

is indicated to evaluate the neuromuscular function and rectal hypersensitivity in patients with chronic constipation.

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.

NSS-2 Bridge is a percutaneous nerve field stimulator, or PNFS, device indicated for use in the reduction of the symptoms of opioid

The NSS-2 Bridge device was licensed to Masimo in April 2020, and we received a one-time licensing fee of $250,000 from

Masimo markets and sells this product as its Masimo Bridge , and we will not receive any further licensing payments

or other revenue from this product.

original 510(K) device was the electroacupuncture device (“EAD”), now called NeuroStim .

The EAD is no longer being

manufactured, sold or distributed but reserved only for research purposes.

Industry Overview

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The following points clearly outline the unmet need in children:

Functional abdominal pain

in children is one of the most common conditions seen by pediatricians and pediatric gastroenterologists.

Children with functional

abdominal pain report lower quality of life compared with their healthy peers and equal to those with inflammatory bowel disease.

Overall, 40-45% of children

with functional abdominal pain disorders continue to have symptoms into adulthood, which impacts quality of life and healthcare spending.

A study published in 2021

demonstrates insufficient evidence for the use of medications in pediatric functional abdominal pain disorders.

This lack of evidence

for drugs has been supported in by the American Academy of Pediatrics and NASPGHAN.

is the only medical therapy that has shown to improve pain, global symptoms, and functional disability in children with FAP and

abdominal pain in children is one of the most common conditions seen by pediatricians and pediatric gastroenterologists.

with functional abdominal pain report lower quality of life compared with their healthy peers and equal to those with inflammatory

bowel disease.

40-45% of children with functional abdominal pain disorders continue to have symptoms into adulthood, which impacts quality of life

and healthcare spending.

study published in 2021 demonstrates insufficient evidence for the use of medications in pediatric functional abdominal pain disorders.

This lack of evidence for drugs has been supported in by the American Academy of Pediatrics and NASPGHAN.

is the only medical therapy that has shown to improve pain, global symptoms, and functional disability in children with FAP and IBS.

is the only currently used medical therapy that is better than placebo in a randomized controlled trial and received FDA clearance

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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.

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.

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.

demonstrated long-term benefits in functional disability, psychological co-morbidities, and pain.

For example, the table below is

from a recently published study of IB-Stim in a population of patients with chronic functional abdominal pain.

The follow-up was

done at 6-12 months post-treatment and shows improvements in validated questionnaires compared to baseline (API), functional

disability index (FDI), pain catastrophizing scale (PCS), Screen for Childhood Anxiety Related Disorders (SCARED) and the Promis

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.

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.

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.

Studies have demonstrated long-term benefits in functional disability, psychological

co-morbidities, and pain.

For example, the table below is from a recently published study of IB-Stim in a population of patients with

chronic functional abdominal pain.

The follow-up was done at 6-12 months post-treatment and shows improvements in validated questionnaires

compared to baseline (API), functional disability index (FDI), pain catastrophizing scale (PCS), Screen for Childhood Anxiety Related

Disorders (SCARED) and the Promis Anxiety.

NR, King C, El-Chammas KI, Wongteerasut A, Damrongmanee A, Graham K, Fei L, Sahay R, Jones C, Cunningham NR, Coghill RC.

of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with

functional abdominal pain disorders.

percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional

abdominal pain disorders.

Neurogastroenterol Motil.

2022;34:e14358.

have only submitted one FDA De Novo request and have not submitted any additional 510(k) premarket notifications for our pipeline indications

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.

with treatment so far has been outstanding with the four weeks of therapy required to sustain long-term benefits.

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product to approximately 77 children’s hospitals within our target market.

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 11-18 years of age with functional abdominal pain associated with IBS and prescriptions often

contain FDA black box labels.

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.

includes devices that could theoretically be used, but do not have supporting data or FDA clearance for functional bowel disorders

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

Our method patents also limit other devices from targeting IBS through stimulation of cranial nerve branches in 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.

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.

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.

reality could potentially be used in the future to also deliver CBT to patients with IBS.

Our method patents also limit other devices

from targeting IBS through stimulation of cranial nerve branches in the ear.

drugs for Adults with IBS

an intraluminal

antibiotic approved for IBS-diarrhea

a drug that stimulates

fluid secretion from the intestine, approved for IBS-diarrhea

drug that stimulates fluid secretion from the intestine, approved for IBS-constipation

stimulates fluid secretion from the intestine, approved IBS-constipation

IV-controlled substance that is a mixed opioid receptor agonist/antagonist in the intestine approved for IBS-diarrhea

a transcutaneous,

cervical vagal nerve stimulator cleared for cluster and migraine headaches.

Recent studies using this device for adults with gastroparesis.

Transcranial Magnetic Stimulation:

an intraluminal antibiotic approved for IBS-diarrhea

a drug that stimulates fluid secretion from the intestine, approved for IBS-diarrhea

a drug that stimulates fluid secretion from the intestine, approved for IBS-constipation

a drug that stimulates fluid secretion from the intestine, approved IBS-constipation

a schedule IV-controlled substance that is a mixed opioid receptor agonist/antagonist in the intestine approved for IBS-diarrhea

a transcutaneous, cervical vagal nerve stimulator cleared for cluster and migraine headaches.

Recent studies using this device for

adults with gastroparesis.

Magnetic Stimulation:

Multiple devices cleared to treat major depressive disorder and obsessive-compulsive disorder.

To date, no known gastrointestinal

Roo System and Sparrow

therapy system:

known gastrointestinal indications.

System and Sparrow therapy system:

Transcutaneous auricular stimulation devices-cleared for neonatal and adult opioid withdrawal.

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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.

portfolio of device and method patents

Market Opportunities

pediatric pipeline

Society Support

capital expenditures in nurse, trainers, and representatives for first line therapy

clinical data carried out in leading academic institutions in the U.S.

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

price of our product is $1,195 per device and $4,780 per patient

customers are children’s hospitals and pediatric clinics

IB-Stim device is to be used for the indication of functional abdominal pain associated with IBS and functional nausea in children.

The same underlying technology will be used for the remaining pipeline indications, but we may use a name other than

“IB-Stim” for marketing and commercialization purposes.

same underlying technology will be used for the remaining pipeline indications, but we may use a name other than “IB-Stim”

for marketing and commercialization purposes.

one FDA indication—functional abdominal pain associated with IBS in adolescents 8-21 years old—on the market, additional

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chart below shows our status in the FDA review process for IB-Stim and each of the following pediatric indications:

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.

A randomized, double blind,

placebo-controlled trial to evaluate the efficacy of IB-Stim in children with functional nausea.

The primary endpoint was to measure

improvements in nausea using the Nausea Severity Scale after IB-Stim therapy compared to a placebo device.

The study enrolled 110

participants and was conducted at Children’s Wisconsin/Medical College of Wisconsin.

NCT03675321, Defining

Adolescent Nausea Through Brain-Gut Physiology and Non-Invasive Neurostimulation Response.

A randomized, double blind, placebo-controlled

trial to evaluate the efficacy of IB-Stim in children with functional nausea.

The primary endpoint was to measure improvements in nausea

using the Nausea Severity Scale after IB-Stim therapy compared to a placebo device.

The study enrolled 110 participants and was conducted

at Children’s Wisconsin/Medical College of Wisconsin.

Post-concussion:

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ClinicalTrials.gov Identifier:

NCT04978571, A Prospective Study on the

Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients with Post-Concussion Syndrome

A randomized, double blind, placebo-controlled trial to evaluate the efficacy of IB-Stim in children with

post-concussion symptoms.

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.

Chemotherapy-induced

nausea and vomiting:

NCT04978571, A Prospective Study

on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients with Post-Concussion Syndrome (PCS).

A randomized, double blind, placebo-controlled trial to evaluate the efficacy of IB-Stim in children with post-concussion symptoms.

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.

Chemotherapy-induced nausea and vomiting:

RCT currently enrolling patients.

ClinicalTrials.gov Identifier:

NCT05143554, Efficacy of

Auricular Neurostimulation for Children Adolescents and Young Adults with Chemotherapy Induced Nausea and Vomiting.

will be randomized to five days of active vs placebo device during administered chemotherapy known to cause moderate to severe

nausea/vomiting.

With the next scheduled identical chemotherapy cycle, each subject will cross over to the other device (active vs

The primary endpoint will be to measure improvements in validated measures of nausea and vomiting including the Baxter

Retching Faces Scale, Rhodes Index of Nausea, Vomiting and Retching, and also assessment of rescue medication.

The study will enroll

50 participants and is being conducted at Children’s Wisconsin/Medical College of Wisconsin.

vomiting syndrome:

NCT05143554, Efficacy

of Auricular Neurostimulation for Children Adolescents and Young Adults with Chemotherapy Induced Nausea and Vomiting.

be randomized to five days of active vs placebo device during administered chemotherapy known to cause moderate to severe nausea/vomiting.

With the next scheduled identical chemotherapy cycle, each subject will cross over to the other device (active vs placebo).

endpoint will be to measure improvements in validated measures of nausea and vomiting including the Baxter Retching Faces Scale, Rhodes

Index of Nausea, Vomiting and Retching, and also assessment of rescue medication.

The study will enroll 50 participants and is being

conducted at Children’s Wisconsin/Medical College of Wisconsin.

Cyclic vomiting syndrome:

Pilot study completed, see ClinicalTrials.gov Identifier:

Neurostimulation for Children with Cyclic Vomiting Syndrome:

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.

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.

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.

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.

step in the FDA review process differs in duration and cannot be predicted with accuracy.

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the non-implanted nerve stimulator for functional abdominal pain relief as Class II devices.

IB-Stim is intended to be used for 120 hours per week for three (3) consecutive weeks, and not to exceed four (4) weeks, through application

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

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localized skin irritation.

See Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents:

a randomized, double-blind, sham-controlled trial , Kovacic K, et.al., Lancet Gastroenterol Hepatol.

2017;2:727-737;

of Auricular Neurostimulation in Adolescents With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial , Krasaelap A et.al.,

Clin Gastroenterol Hepatol.

2020;18:1987-1994;

Effect of percutaneous electrical nerve field stimulation on mechanosensitivity,

sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders , Santucci et.al., Neurogastroenterol

2022;34:e14358.

The following table presents a summary of IB-STIM studies performed to date:

adverse events

Vomiting Syndrome

pain, nausea, FD

pain, nausea, anxiety, disability

bowel syndrome

severity scale,

FD, FAP, abdominal migraine

pain, disability, global symptoms.

in sham group

bowel syndrome

pain, Microbiome Metabolism

bowel syndrome, functional dyspepsia

of life, disability, anxiety

bowel syndrome

pain, global symptoms, disability

abdominal pain

pain, sleep, nausea, anxiety

et.al., 2023 (Registry)

bowel syndrome, functional dyspepsia

pain, nausea, disability

bowel syndrome, functional dyspepsia, FAP

pain, nausea, disability

ability of the IB-Stim to produce systemic effects by modulating the central nervous system has been demonstrated in a pre-clinical animal

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2021;22:715-726.

field of art pertains to an electrical stimulation device, including a stimulator containing a generator to deliver electrical pulses

with defined parameters, and a power supply for supplying the electrical energy through four separate needles, and at least one of which

is a needle array.

Pre-Clinical Data

an animal model of IBS, extracellular, electrophysiologic recordings were performed from neurons in the rat amygdala before and 15 minutes

after PENFS treatment.

There was a 65% decrease in the spontaneous firing of these neurons after 15 minutes of PENFS.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.

of art pertains to an electrical stimulation device, including a stimulator containing a generator to deliver electrical pulses with

defined parameters, and a power supply for supplying the electrical energy through four separate needles, and at least one of which is

a needle array.

an animal model of IBS, extracellular, electrophysiologic recordings were performed from neurons in the rat amygdala before and 15

minutes after PENFS treatment.

There was a 65% decrease in the spontaneous firing of these neurons after 15 minutes of PENFS.

dampening of neurons in the CNS likely accounts for the modulation of pain responses in a model of post-inflammatory visceral and

somatic hyperalgesia.

have over 700 published patients specific to our first FDA indication which is functional abdominal pain associated with irritable bowel

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2017;2:727-737).

secondary endpoint in the same study used the functional disability index (FDI) to assess functional disability in those treated

with PENFS and compared to sham treatment.

Those treated with PENFS changed from moderate disability to minimal at the 2–3-month

follow-up while the sham device group had no change.

secondary endpoint in the same study used the functional disability index (FDI) to assess functional disability in those treated with

PENFS and compared to sham treatment.

Those treated with PENFS changed from moderate disability to minimal at the 2–3-month follow-up

while the sham device group had no change.

separate published paper looked at 51 pediatric patients with IBS and used the symptoms response scale (SRS) to assess global symptoms

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2020;18:1987-1994).

the largest, prospective, multicenter registry for any drug or device in pediatric patients with pain associated DGBIs was

It evaluated outcomes of pediatric patients (8-18 years) following a 4-week course of IB-Stim in a real-world clinical

Overall, 292 patients met Rome IV Diagnostic criteria for any pain associated disorder of the gut-brain interaction

In this cohort, 92% had failed medication therapy and 61% of patients had failed 4 or more medications when they entered

Patients were asked to fill out several validated pediatric measures, including the abdominal pain index (API) and a

validated questionnaire that assesses frequency, duration, and intensity of abdominal pain episodes.

Data were collected weekly for

the first 3 weeks and at 3, 6, 9 and 12 months.

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<0.001) and 12 months (p<0.001).

Although there were many

dropouts by the end of the 12 months, the results were still significant and sustained.

No serious adverse effects were recorded

during the entire 12 month follow-up.

A multicenter registry study on percutaneous electrical nerve field

stimulation for pediatric disorders of gut-brain interaction.

J Pediatr Gastroenterol Nutr.

the largest, prospective, multicenter registry for any drug or device in pediatric patients with pain associated DGBIs was published.

It evaluated outcomes of pediatric patients (8-18 years) following a 4-week course of IB-Stim in a real-world clinical setting.

292 patients met Rome IV Diagnostic criteria for any pain associated disorder of the gut-brain interaction (DGBIs).

In this cohort, 92%

had failed medication therapy and 61% of patients had failed 4 or more medications when they entered the study.

Patients were asked to

fill out several validated pediatric measures, including the abdominal pain index (API) and a validated questionnaire that assesses frequency,

duration, and intensity of abdominal pain episodes.

Data were collected weekly for the first 3 weeks and at 3, 6, 9 and 12 months.

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<0.001) and 12 months (p<0.001).

Although there were many dropouts by the end of the 12 months, the results were still

significant and sustained.

No serious adverse effects were recorded during the entire 12 month follow-up.

A multicenter

registry study on percutaneous electrical nerve field stimulation for pediatric disorders of gut-brain interaction.

J Pediatr Gastroenterol

2024 Mar 7.).

Pain Index (API)

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 < 0.0001), nausea (p=0.001), pain catastrophizing (p = 0.001), functional

disability (p<0.0001), and anxiety (p = 0.03) exhibited significant improvements, and were sustained 6-12 months after treatment (Santucci

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 < 0.0001), nausea (p=0.001), pain catastrophizing (p = 0.001), functional disability

(p<0.0001), and anxiety (p = 0.03) exhibited significant improvements, and were sustained 6-12 months after treatment (Santucci et.al.

Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents

2 unchanged sentences

2022;34:e14358).

Validated questionnairesincluded the abdominal pain

index (API), nausea severity scale (NSS), functional disability index (FDI), as well as psychological measures of catastrophizing (PCS-C)

and anxiety (SCARED).

The table below summarizes the results pre, during and post PENFS results at long-term follow-up (Santucci et.al.

Validated questionnaires included the abdominal

pain index (API), nausea severity scale (NSS), functional disability index (FDI), as well as psychological measures of catastrophizing

(PCS-C) and anxiety (SCARED).

The table below summarizes the results pre, during and post PENFS results at long-term follow-up (Santucci

Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents

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Reimbursement

A PENFS procedure-specific Category III CPT

Code (0720T) was published on December 30, 2021 and became effective for utilization on July 1,2022.

Category III CPT Codes are

temporary codes issued to define and track the utilization of new procedural technology.

In collaboration with the American Medical

Association, we withdrew our initial Category I CPT Code application submitted in 2023.

We continue to work diligently with the

American Academy of Pediatrics and other specialty medical societies on the pursuit of a Category I CPT Code for PENFS procedures.

To expand patient access to PENFS procedures and IB-Stim technology, we launched our internal Prior Authorization team under our

Guidance & Patient Support function in 2023.

This continues to address the Prior Authorization process barriers for providers

and children’s hospitals and streamlines a patient’s access to our Patient Advocacy and Financial Assistance offerings,

Six (6) commercial health insurers, including certain Blue Cross Blue Shield licensees, have instituted formal medical

policy coverage for PENFS.

The total membership of these health insurers is approximately 9,000,000 covered lives;

an additional

health insurer, with approximately 7,000,000 members, will institute formal medical policy coverage for PENFS in the second quarter

of 2024 bringing the total number of covered lives to approximately 16,000,000 over seven (7) commercial health insurers.

who are appropriate clinical candidates may have policy-covered access to PENFS and IB-Stim technology under their specific health

We continue to actively leverage clinical evidence and peer-reviewed publications to expand patient access to IB-Stim

In addition, we anticipate academic medical society support in the form of a position paper and an update to treatment

guidelines to support the use of PENFS as a potential standard of care.

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.

Category III CPT Codes are temporary codes issued to define and track

the utilization of new procedural technology.

To expand patient access to PENFS procedures and IB-Stim technology, we launched our internal

Prior Authorization team under our Guidance & Patient Support function in 2023.

This continues to address the Prior Authorization

process barriers for providers and children’s hospitals and streamlines a patient’s access to our Patient Advocacy and Financial

Assistance offerings, if needed.

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.

Sixteen (16) commercial

health insurers, including certain Blue Cross Blue Shield licensees, have instituted formal medical policy coverage for PENFS.

membership of these health insurers is approximately 45,000,000 covered lives.

An additional health insurer, with approximately 6,000,000

members, will institute formal medical policy coverage for PENFS beginning the second quarter of 2025, bringing the total number of covered

lives to approximately 51,000,000 across seventeen (17) commercial health insurers.

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.

In addition, we anticipate academic medical society

support in the form of a position paper and an update to treatment guidelines to support the use of PENFS as a potential standard of

market our products through search engine optimization, or SEO, internet channels and to physicians via the academic society.

4 unchanged sentences

hospitals who serve these children.

Expulsion Device (RED)

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.

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

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.

Clinical practice guidelines recommend empiric treatment of

chronically constipated patients with fiber supplements or laxative therapies.

Approximately 40% of patients do not adequately respond

to empiric laxative therapy.

In these patients, anorectal physiology testing is essential.

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.

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.

In the current clinical setting, only about 2% of all patients with constipation are referred for anal-rectal testing

and thus, a large number with pelvic floor dysfunction and rectal hypersensitivity are missed and/or fail to get proper treatment.

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.

This provides an alternative to sensation and expulsion testing in the office without affecting clinical

Sensation Testing

sensation is an important metric to guide clinical care, particularly rectal hypersensitivity.

For example, a patient that reports an

immediate perceived immediate need to defecate or discomfort (max tolerated) to low volumes of distension would have rectal hypersensitivity.

This diagnosis is important because it would impact how a patient is treated.

Rectal hypersensitivity is addressed by pelvic floor physical

therapists who deliver education and re-training to help the patient align the desire to defecate according to the actual volume of stool

contained within the rectal vault.

The basis of sensory re-training during physical therapy involves inflating a balloon in the rectum

until urge threshold is reached.

With repeated inflations, the patient learns to associate a given sensory intensity with the inflated

Over time, the balloon is inflated with decreasing volumes and the patient is asked to closely monitor and attend to sensations

Eventually, new sensory thresholds are established.

Unfortunately, because of the difficulty in performing hypersensitivity

testing in routine clinical care, only a small percentage of all patients with constipation undergo anorectal testing in the clinical

a recent study, 60 adult patients (mean±standard deviation age of 46.4±17.6 years;

93.3% women) that underwent evaluation

with RED and answered the questions were included in the analysis.

One patient did not undergo rectal sensation testing due to suspected

anal fissure and overall, 58 patients were included in the analysis.

outlined in the figure below, 18 of 58 patients, or 31.%, had rectal hypersensitivity on RED when defined on a single yes/no question

of “do you feel you have to poop right now” that evaluates the patient perception to defecate.

data suggest that approximately 31% of patients with chronic constipation reported urge to defecate with RED baseline distension volume,

thus meeting the London criteria for hypersensitivity.

Expulsion Testing

can be used as a rectal expulsion device and in a recent prospective trial of 60 adults with functional constipation (defined by Rome

IV criteria), it was demonstrated to be safe in a clinical setting.

It can be quickly performed in the left lateral position (i.e., the

patient lying on their left side) immediately after a rectal examination.

Further, it proved to be effective for patients who fail a

trial of laxative therapy.

In those patients with constipation who failed laxative treatment, RED was able to reliably identify patients

for whom pelvic floor physical therapy was unlikely to provide substantial benefit (i.e, patients who might be more likely to benefit

from intensifying medical therapy).

Patients with an abnormal RED in the left lateral position or commode were likely to respond to pelvic

floor therapy (48.8% to 71.4%, respectively).

Also, RED showed very high sensitivity (>95%) to broadly detect evacuation disorders

as a simple screening tool as noted in the table below.

Benefits Over Predicates

point of care test allows assessment of patients and potentially changes clinical management.

those who would benefit from physical therapy or who would require optimization of laxatives

or addition of secretagogues.

many patients with rectal hypersensitivity that otherwise would never get tested.

finds people that are willing to try physical therapy but don’t need it.

clinical workflow.

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.

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.

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.

It is critical to assess rectal sensation

and balloon expulsion in patients with constipation and/or fecal incontinence.

tube for RED remains open to room air as the patient defecates.

The pressure is therefore

never greater than room air.

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.

The resistance with defecating the predicate is therefore greater than RED, because RED is

more compliant than an air-filled balloon.

The RED device is therefore safer with regard

to patients with decreased compliance.

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.

is more compliant than air or water based on balloon compression data as demonstrated in

the graph below.

Reimbursement

is billable under CPT 91120.

The documentation is Rectal Hypersensitivity at 52-60mL:

present/absent.

intellectual property consists of patents, trademarks, and trade secrets.

8 unchanged sentences

executive officers and directors.

Company has 10 registered trademarks, eight (8) of which are being used in commerce:

NEURO-STIM and Design

nerve stimulator

NSS THE NEUROSTIM SYSTEM

nerve stimulator

THE NEURO-STIM SYSTEM and

nerve stimulator

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

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;

Company has seven (7) registered trademarks, and two (2) allowed pending applications for registration:

nerve stimulator apparatus

THE NEUROSTIM SYSTEM and Design

nerve stimulator apparatus

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

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

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,

1 unchanged sentence

anxiety, satiety and changes in autonomic nervous system and other types of sympathetically mediated pain

IB-STIM and Design

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 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

IB-STIM AURICULAR STIMULATOR

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 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

AURICULAR STIMULATOR

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

IB-STIM AURICULAR STIMULATOR

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 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

AURICULAR STIMULATOR and Design

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

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

NEURAXIS (STYLIZED)

Nerve stimulator

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

Company has no unregistered trademarks.

Company has eight (8) granted patents and nine (9) applied for patent applications in the United States and nine (9) applied for foreign

patent applications.

Expiration Date

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

201980027574.9

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

10-2020-7034010

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

DEVICE AND METHODS FOR USING THE SAME

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

DEVICE AND METHODS FOR USING THE SAME

Neuraxis, Inc.

AURICULAR PERIPHERAL NERVE

FIELD STIMULATOR AND METHOD OF OPERATING SAME

Neuraxis, Inc.

AURICULAR PERIPHERAL NERVE

FIELD STIMULATOR AND METHOD OF OPERATING SAME

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

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

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

Company has no core trademarks that are currently unregistered.

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.

Expiration Date

Neuraxis, Inc.

AURICULAR PERIPHERAL NERVE

FIELD STIMULATOR AND METHOD OF OPERATING SAME

Neuraxis, Inc.

DEVICE AND METHOD FOR ERADICATING

PATHOGENS IN NASAL PASSAGES

Neuraxis, Inc.

EXTERNAL AUDITORY

CANAL PHOTOBIOMODULATION AND AUDIO THERAPY DEVICE

Neuraxis, Inc.

EXTERNAL AUDITORY CANAL

THERAPY DEVICE

Neuraxis, Inc.

EXTERNAL AUDITORY CANAL

PHOTOBIOMODULATION DEVICE

Neuraxis, Inc.

202080060202.9

EXTERNAL AUDITORY CANAL

PHOTOBIOMODULATION DEVICE

Neuraxis, Inc.

EXTERNAL AUDITORY CANAL

PHOTOBIOMODULATION DEVICE

Neuraxis, Inc.

EXTERNAL AUDITORY CANAL

PHOTOBIOMODULATION DEVICE

Neuraxis, Inc.

EXTERNAL AUDITORY CANAL

PHOTOBIOMODULATION DEVICE

Neuraxis, Inc.

NERVE FIELD STIMULATION DEVICE

27-March-2023

25-April-2039

METHODS OF TREATING DISEASE

USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION

Neuraxis, Inc.

NERVE FIELD STIMULATION DEVICE

PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME

AND METHOD FOR ERADICATING PATHOGENS IN NASAL PASSAGES

AUDITORY CANAL PHOTOBIOMODULATION AND AUDIO THERAPY DEVICE

AUDITORY CANAL THERAPY DEVICE

AUDITORY CANAL PHOTOBIOMODULATION DEVICE

14-April-2037

METHODS OF TREATING DISEASE

USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION

Neuraxis, Inc.

SYSTEM AND METHOD FOR AURICULAR

PERIPHERAL NERVE FIELD STIMULATION

Neuraxis, Inc.

SYSTEM AND METHOD FOR AURICULAR

PERIPHERAL NERVE FIELD STIMULATION

Neuraxis, Inc.

SYSTEMS AND METHODS FOR

AURICULAR PERIPHERAL NERVE FIELD STIMULATION

Neuraxis, Inc.

AURICULAR NERVE FIELD STIMULATION

DEVICE AND METHODS FOR USING THE SAME

OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION

14-April-2037

OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION

AND METHOD FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION

AND METHODS FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION

14-April-2037

NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME

PERIPHERAL NERVE FIELD STIMULATOR AND METHOD OF OPERATING SAME

NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME

Exclusive License Agreement

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.

Thomas Carrico, our Chief Regulatory Officer, is the manager of

Brian Carrico, our Chief Executive Officer, and Matt Carrico, our National Sales Director, are members of TKBMN.

the Patent Rights set forth in the patents listed in the following table (the “TKBMN Patents”) by virtue of an

assignment from Dr.

Carrico, who is the sole inventor listed on the TKBMN Patents.

TKBMN has assigned the auricular portion of the

TKBMN Patent Rights to the Company.

Licensed TKBMN Patents

Application No.

October 2, 2020

October 18, 2037

Systems and methods for electro-therapy treatment

October 18, 2037

Systems and methods for electro-therapy treatment

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.

Thomas Carrico, our Chief Regulatory Officer, is the manager of TKBMN.

Carrico, our Chief Executive Officer, and Matt Carrico, our National Sales Director, are members of TKBMN.

TKBMN owns the Patent Rights

set forth in the patents listed in the following table (the “TKBMN Patents”) by virtue of an assignment from Dr.

who is the sole inventor listed on the TKBMN Patents.

TKBMN has assigned the auricular portion of the TKBMN Patent Rights to the Company.

TKBMN Patents

and methods for electro-therapy treatment

If all maintenance fees remain paid

35 unchanged sentences

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

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 .

Such reduced disclosure and corporate governance obligations may make it more challenging for investors

to analyze our results of operations and financial prospects.

Smaller reporting companies may take advantage

of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

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

Such reduced disclosure and corporate governance obligations may make it more challenging for investors to analyze our

results of operations and financial prospects.

additional information, see “ Risk Factors – Because the Company is a ‘smaller reporting company,’ we may take

8 unchanged sentences

(3) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under

the Securities Exchange Act of 1934, as amended, or the Exchange Act, which would occur on the date on which we have issued

more than $1.0 billion in non-convertible debt securities during the prior three-year period.

An emerging growth company may take advantage

of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable

the Securities Exchange Act of 1934, as amended, or the Exchange Act, which would occur on the date on which we have issued more than

$1.0 billion in non-convertible debt securities during the prior three-year period.

An emerging growth company may take advantage of

specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable

to public companies.

As an emerging growth company, we may:

present only two years

of audited financial statements, plus unaudited condensed financial statements for any interim period, and related management’s

discussion and analysis of financial condition and results of operations in this prospectus;

avail ourselves of the

exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over

financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

provide reduced disclosure

about our executive compensation arrangements;

not require stockholder

non-binding advisory votes on executive compensation or golden parachute arrangements.

only two years of audited financial statements, plus unaudited condensed financial statements for any interim period, and related

management’s discussion and analysis of financial condition and results of operations in this prospectus;

ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal

control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

reduced disclosure about our executive compensation arrangements;

require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

addition, under the JOBS Act, an emerging growth company can delay the adoption of certain accounting standards until those standards

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including the following:

The FDA or other regulatory

authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;

Patients do not enroll

in clinical trials at the rate expected;

Patients do not comply

with trial protocols;

Patient follow-up is not

at the rate expected;

Patients experience serious

adverse events;

Patients die during a clinical

trial, even though their death may not be related to the products that are part of the trial;

Device malfunctions occur

with unexpected frequency or potential adverse consequences;

Side effects or device

malfunctions of similar products already in the market that change the FDA’s view toward approval of result in the imposition

of new requirements or testing;

Institutional review boards

and third-party clinical investigators may delay or reject the trial protocol;

Third-party clinical investigators

decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with the clinical trial protocol,

investigator agreement, investigational plan, good clinical practices, the IDE regulations, or other FDA or IRB requirements;

Third-party investigators

are disqualified by the FDA;

We or third-party organizations

do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent with the clinical trial protocol

or investigational or statistical plans, or otherwise fail to comply with the IDE regulations governing responsibilities, records,

and reports of sponsors of clinical investigations;

Third-party clinical investigators

have significant financial interests related to us or our study such that the FDA deems the study results unreliable, or the company

or investigators fail to disclose such interests;

Regulatory inspections

of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective action or suspend

or terminate our clinical trials;

Changes in government regulations

or administrative actions;

The interim or final results

of the clinical trial are inconclusive or unfavorable as to safety or effectiveness;

The FDA concludes that

our trial design is unreliable or inadequate to demonstrate safety and effectiveness.

FDA or other regulatory authorities do not approve a clinical trial protocol or a clinical trial, or place a clinical trial on hold;

do not enroll in clinical trials at the rate expected;

do not comply with trial protocols;

follow-up is not at the rate expected;

experience serious adverse events;

die during a clinical trial, even though their death may not be related to the products that are part of the trial;

malfunctions occur with unexpected frequency or potential adverse consequences;

effects or device malfunctions of similar products already in the market that change the FDA’s view toward approval of result

in the imposition of new requirements or testing;

Institutional

review boards and third-party clinical investigators may delay or reject the trial protocol;

clinical investigators decline to participate in a trial or do not perform a trial on the anticipated schedule or consistent with

the clinical trial protocol, investigator agreement, investigational plan, good clinical practices, the IDE regulations, or other

FDA or IRB requirements;

investigators are disqualified by the FDA;

or third-party organizations do not perform data collection, monitoring and analysis in a timely or accurate manner or consistent

with the clinical trial protocol or investigational or statistical plans, or otherwise fail to comply with the IDE regulations governing

responsibilities, records, and reports of sponsors of clinical investigations;

clinical investigators have significant financial interests related to us or our study such that the FDA deems the study results

unreliable, or the company or investigators fail to disclose such interests;

inspections of our clinical trials or manufacturing facilities, which may, among other things, require us to undertake corrective

action or suspend or terminate our clinical trials;

in government regulations or administrative actions;

interim or final results of the clinical trial are inconclusive or unfavorable as to safety or effectiveness;

FDA concludes that our trial design is unreliable or inadequate to demonstrate safety and effectiveness.

Clearance Process

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in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo reclassification.

The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo request

or a PMA in the first instance, but the FDA may review this determination to evaluate the regulatory status of the modified product at

any time and may require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing

clearance or PMA approval is obtained or a de novo request is granted.

Also, in these circumstances, the manufacturer

may be subject to significant regulatory fines or penalties.

The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo request or

a PMA in the first instance, but the FDA may review this determination to evaluate the regulatory status of the modified product at any

time and may require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance

or PMA approval is obtained or a de novo request is granted.

Also, in these circumstances, the manufacturer may be subject to

significant regulatory fines or penalties.

the last several years, the FDA has proposed reforms to its 510(k) clearance process, and such proposals could include increased requirements

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also subject to the payment of user fees, which for fiscal year 2021 includes a standard application fee of $365,657.

Overall, the FDA review

of a PMA application generally takes between one and three years, but may take significantly longer.

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;

Changes in FDA approval

policies or adoption of new regulations may require additional data.

the FDA review of a PMA application generally takes between one and three years, but may take significantly longer.

The FDA can delay,

limit or deny approval of a PMA application for many reasons, including:

device may not be shown safe or effective to the FDA’s satisfaction;

data from pre-clinical studies and/or clinical trials may be found unreliable or insufficient to support approval;

manufacturing process or facilities may not meet applicable requirements;

in FDA approval policies or adoption of new regulations may require additional data.

the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter, or an approvable letter, the latter of which

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These include:

Establishment registration

and device listing with the FDA;

QSR requirements, which

require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, supplier/contractor selection,

compliant handling, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

Labeling regulations, advertising

and promotion requirements, restrictions on sale, distribution or sale of a device, each including the FDA prohibition against the

promotion of products for any uses other than those authorized by the FDA, which are commonly known as “off-label” uses;

The Medical Device Reporting,

or MDR, regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to

a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute

to a death or serious injury, if the malfunction were to recur;

Medical device correction

and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken

to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

Recall requirements, including

a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death;

An order of repair, replacement,

Device tracking requirements;

Post-market study and surveillance

requirements.

Establishment

registration and device listing with the FDA;

requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, supplier/contractor

selection, compliant handling, documentation and other quality assurance procedures during all aspects of the design and manufacturing

regulations, advertising and promotion requirements, restrictions on sale, distribution or sale of a device, each including the FDA

prohibition against the promotion of products for any uses other than those authorized by the FDA, which are commonly known as “off-label”

Medical Device Reporting, or MDR, regulations, which require that a manufacturer report to the FDA if a device it markets may have

caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would

be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

device correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals

if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health

consequences or death;

order of repair, replacement, or refund;

tracking requirements;

study and surveillance requirements.

a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute

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regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

Warning letters, untitled

letters, fines, injunctions, consent decrees and civil penalties;

Recalls, withdrawals, or

administrative detention or seizure of our products;

Operating restrictions

or partial suspension or total shutdown of production;

Refusing or delays in processing,

clearing, or approving submissions or applications for new products or modifications to existing products;

Suspension or withdrawal

of 510(k) clearances or PMA approvals that have already been granted;

FDA refusal to issue certification

to foreign governments needed to export our products for sale in other countries;

Criminal prosecution.

letters, untitled letters, fines, injunctions, consent decrees and civil penalties;

withdrawals, or administrative detention or seizure of our products;

restrictions or partial suspension or total shutdown of production;

or delays in processing, clearing, or approving submissions or applications for new products or modifications to existing products;

or withdrawal of 510(k) clearances or PMA approvals that have already been granted;

refusal to issue certification to foreign governments needed to export our products for sale in other countries;

facilities, records and manufacturing processes are subject to periodic unscheduled inspections by the FDA.

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will among other things:

Strengthen the rules on

placing devices on the market and reinforce surveillance once they are available;

Establish explicit provisions

on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

Improve the traceability

of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

Set up a central database

to provide patients, healthcare professionals and the public with comprehensive information on products available in the European

Union, or EU;

Strengthen the rules for

the assessment of certain high-risk devices, which may have to undergo an additional check by experts before they are placed on the

the rules on placing devices on the market and reinforce surveillance once they are available;

explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices

placed on the market;

the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available

in the European Union, or EU;

the rules for the assessment of certain high-risk devices, which may have to undergo an additional check by experts before they are

placed on the market.

aforementioned EU rules are generally applicable in the European Economic Area, or EEA, which consists of the 27 EU member states plus

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There is a new, dedicated, environmentally controlled build room built in 2022 for our equipment and production.

All of our material

All of our materials

are now maintained in this room.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business