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Item 1. Business

2026-03-19 compared with 2025-03-20 · 397 added, 344 removed, 1135 unchanged (39% of the section changed)

(“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

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.”

second product, Rectal Expulsion Device (“RED”), is indicated to evaluate the neuromuscular function of a patient’s

(“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.

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.

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.

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.

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.”

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.

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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.

We believe in improving lives and minimizing

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.

Through innovation and research, we are reimagining the future of patient care.

Company’s product portfolio has achieved several key milestones, including:

Society Guidelines:

In May 2025, the leading pediatric academic society, NASPGHAN (North American Society of Pediatric Gastroenterology,

Hepatology, and Nutrition), published functional abdominal pain guidelines listing PENFS as the ONLY FDA-approved or FDA-cleared

treatment in the guidelines to be recommended.

Category I CPT Code (64567):

In 2024 the AMA confirmed the assignment of a Category I CPT code for PENFS procedures, which takes

effect on January 1, 2026.

This CPT code brings credibility, streamlined reporting, and relative value units (RVUs) for the physician,

allowing credit for their time.

Supply Schedule (FSS) Contract:

In December 2025, NeurAxis was awarded a FSS contract with the United States government which includes

the 01-1020 IB-Stim to be sold for the FDA indications of Functional Abdominal Pain with IBS, Functional Dyspepsia (FD), and associated

FD Nausea Symptoms.

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.

Corporate History

was established in 2011 and incorporated in the state of Indiana on April 17, 2012, under the name of Innovative Health Solutions,

The name was changed to Neuraxis, Inc.

in March of 2022.

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.

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 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.

All per share information has been

adjusted for this reverse stock split.

The reverse split became effective on January 12, 2023.

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.

was established in 2011 and incorporated in the state of Indiana in 2012, under the name of Innovative Health Solutions, Inc.

name was changed to Neuraxis, Inc.

in 2022 when the Company filed a Certificate of Conversion to become a Delaware corporation.

9, 2023, the Company consummated an initial public offering (“IPO”) pursuant to a registration statement on Form S-1 (File

333- 269179), as amended.

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.

The stated value of the Series B

Preferred Stock is $2.38 per share.

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.

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.

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.

RED is intended

to be used in a clinical setting by trained health care providers in adult populations.

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.

1, 2025, The Company terminated the NSS-2 Bridge license with Masimo in exchange for $200,000 of consideration payable of which $100,000

was paid on December 31, 2025 and $100,000 is due on June 30, 2026.

The termination agreement allowed the Company to recapture the

rights to the trademark (U.S.

Registration No.

7,394,465) and two patent applications (Application No.

18/821/255 and Application

29/960.608) that were originally licensed to Masimo on April 9, 2020.

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

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Industry Overview

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.

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.

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.

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.

The following points clearly outline the unmet need in children:

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Below are the current standard treatments in children with functional abdominal pain and IBS.

Pharmacological Treatment Options for Functional Abdominal Pain Disorders

Pain (No Disability)

Pain (With Disability)

antidepressants (amitriptyline)*

serotonin reuptake inhibitors (citalopram)*

suppression with PPIs

Antispasmodics

(hyoscyamine, dicyclomine)*

Cyproheptadine*

Increased risk of dementia based on anticholinergic burden

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.

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.

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.

American Academy of Pediatrics and NASPGHAN supporting our request for insurers to provide coverage for PENFS procedures with IB-Stim.

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).

recently, FDA cleared 510(k) 252024, expanding the indications for use.

The FDA created a new classification of PENFS for IB-Stim.

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.

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

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

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

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.

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2022;34:e14358.

have only submitted one FDA De Novo request and two 510(k) submissions and plan to submit additional 510(k) premarket notifications from

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.

Most recently, FDA cleared 510(k) 252024, expanding the indications for use.

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

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therapy or guided imagery, which sometimes requires 8-12 weeks of treatment.

In fact, 95% of adolescents who used IB-Stim said that they

would recommend this treatment to family and friends.

Many children’s hospitals across the country are already treating children

with IB-Stim successfully since it provides a better alternative for therapy in children with IBS and disability and allows them to treat

them safely and effectively.

In fact, in a survey included in the randomised, sham controlled

trial (Kovacic, K, Hainsworth, M., et al.

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

a randomised, double-blind, sham-controlled trial.

Lancet Gastroenterol Hepatol.

2017 Oct;2(10):727-737), 95% of adolescents who used

IB-Stim said that they would recommend this treatment to family and friends.

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

have concentrated our marketing focus on the 260 children’s hospitals within the United States.

To date, we have sold our IB-Stim

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

To date, IB-Stim is established

in approximately 80 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

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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.

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.

also 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 IBS.

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

drugs for children with IBS

a drug that stimulates fluid secretion from the intestine, approved for IBS-constipation in 7 years of age and older

drugs for adults with IBS

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

drugs for children or adults with functional dyspepsia

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

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pediatric pipeline

Society Support

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

Society guidelines with the only FDA-approved or FDA-cleared recommended treatment

I CPT code (64567) effective January 1, 2026

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

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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.

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

customers are children’s hospitals, adult gastroenterologists in the VA, and adult pain physicians in the VA

is to be used for the indication of functional abdominal pain associated with IBS, functional dyspepsia (FD), and associated FD nausea

The same underlying technology will be used for the remaining pipeline indications, but we may use different branding strategies

for marketing and commercialization purposes.

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.

These indications

consist of chronic nausea, post-concussion syndrome, chemotherapy-induced nausea and vomiting, cyclic vomiting syndrome.

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.

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.

Sub-analysis of the RCT completed, and data was analyzed and presented to FDA.

looked only at those patients who met criteria for functional dyspepsia and those that improved in abdominal pain scores by 30% or more

as well as improvements in a validated measure of nausea.

The sub-analysis was used for FDA purposes and there is no plan to publish

in peer reviewed journal since the entire cohort of patients with DGBIs was already published in 2017.

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 (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.

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:

Auricular Neurostimulation

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.

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.

Cyclic vomiting:

Successful pilot study completed and published, Karrento K, et.al..

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 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 early

This will be a double blind, placebo-controlled trial to evaluate efficacy of IB-Stim in pediatric patients with cyclic vomiting

The primary endpoint will be to measure decreases in the frequency and severity of cyclic vomiting episodes compared to a placebo

The study will include a minimum of 120 patients and is being conducted at Children’s Wisconsin/Medical College of Wisconsin.

Post-operative pain (opioid sparing) :

RCT currently enrolling patients and plans to include almost 300 patients total.

ClinicalTrials.gov

Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery.

outcome measure is opioid consumption.

Assess how the use of the NSS-2 BRIDGE Device over a 5 day stimulation period affects the participant’s

total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.

Other measures will include post-operative

pain ratings, sleep, somatization, as well as length of hospital stay.

The study is being conducted at University of Pittsburgh Medical

Fibromyalgia in adults :

RCT currently enrolling patients.

ClinicalTrials.gov Identifier:

Auricular Neuromodulation

in Veterans with Fibromyalgia:

The proposed Merit, a randomized, sham-controlled trial of auricular

PENFS, evaluates the clinical utility of PENFS for fibromyalgia as compared to sham placebo control, acute and longitudinal PENFS-related

neural changes visualized on rs-fcMRI and effects of PENFS on HRV as a potential vagal mechanism of pain relief.

For Aim 1, 240 total

participants meeting 2016 diagnostic criteria for fibromyalgia (male and female, age 18-60 years old) will be randomized to either true

(n=120) or sham (n=120) auricular PENFS.

The study is being conducted at Emory University and VA medical center.

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

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received, cannot be assured and the process and any approval is within the sole control and discretion of the FDA.

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

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.

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).

In published studies, patients treated with IB-Stim demonstrated

significant improvement in pain, disability and global symptoms with no serious adverse events, and minimal to no side effects, including

localized skin irritation.

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.

The FDA has classified the non-implanted nerve stimulator for functional abdominal

pain relief as a Class II device.

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).

In published studies, patients treated with IB-Stim

demonstrated significant improvement in pain, disability and global symptoms with no serious adverse events, and minimal to no side effects,

including localized skin irritation.

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

Abndominal Pain

pain, nausea, disability

Abdominal Pain

pain, recurrent treatment

vagal effeciency

pain and nausea

bowel syndrome

pain, Microbiome Metabolism

Vomiting Syndrome

pain, nausea, disability

bowel syndrome, functional dyspepsia, FAP

pain, nausea, disability

bowel syndrome, functional dyspepsia

of life, disability, anxiety

bowel syndrome

pain, global symptoms, disability

abdominal pain

pain, sleep, nausea, anxiety

et.al., 2023 (Registry)

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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

pain, nausea, anxiety, disability

bowel syndrome

severity scale, Microbiome diversity

abdominal pain

pain, sleep, nausea, anxiety

bowel syndrome

pain, global symptoms, disability

FD, FAP, abdominal migraine

pain, disability, global symptoms.

in sham group

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 ).

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There were no serious adverse events.

providers are trained to place the IB-Stim through IB-Stim Training and Certification.

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 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.

adolescents showed greater improvement in functional abdominal pain and global symptom improvement with every week of treatment (up to

At the end of the four-week study, 95% of adolescents stated they would recommend the treatment to family or friends.

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.

wearing our IB-Stim device 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 ear buds or headphones, and travel.

IB-Stim device 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.

Since that study, numerous other studies have confirmed the

safety and efficacy in children with chronic DGBIs (see table above).

providers are trained to place IB-Stim through NeurAxis’ IB-Stim Training and Certification process.

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.

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

A study in adolescents showed greater improvement in functional abdominal pain and global symptom improvement with every week

of treatment (up to four weeks).

At the end of the four-week study, 95% of adolescents stated they would recommend the treatment to family

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.

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.

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.

maladaptive central nervous system can process pain and emotions differently.

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disorders and IBS.

The IB-Stim works by sending gentle electrical impulses into cranial nerve bundles located in the ear.

IB-Stim works by sending gentle electrical impulses into cranial nerve bundles located in the ear.

This stimulation

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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.

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.

that the firing of neurons in the amygdala could be reduced by more than 50% in just 15 minutes of stimulation with IB-Stim.

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.

2021;22:715-726.

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.

The 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.

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

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.

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.

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2022;34:e14358).

clinically meaningful endpoint is the number needed to treat (NNT) used in treatment for abdominal pain-related functional gastrointestinal

disorders in adolescents.

NNT means the number of patients that need to be treated for one patient to get the targeted improvement (≥30%

improvement).

Reimbursement

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.

to extensively ramp-up our marketing efforts to patients and physicians as we gain additional indications.

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.

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, 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.

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.

finalized CPT code (1/1/2026) will strengthen PENFS access as Fee Schedules and claim payments become more transparent, allowing

both commercial and Medicaid payer entities to more-effectively process covered claims.

markets its products through a direct sales team, online channels, and to clinicians via affiliated academic societies.

Our main goal

is to raise educational awareness among clinicians and hospitals about the unmet needs of patients with functional abdominal pain and

NeurAxis’ FDA-cleared, drug-free product solutions.

Our primary focus is with the 260 children’s hospitals within the United

As our FDA-indications expand, so will our outreach and education to adult gastroenterology providers.

Direct-to-patient marketing

efforts will be considered in the future.

Patients/Customers

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.

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 indicated for patients 8 years and older suffering from functional abdominal pain, functional dyspepsia (FD),and associated FD nausea

Customers are currently primarily children’s hospitals who serve these patients, but is currently expanding to adult

gastroenterologists and adult pain physicians.

(Rectal Expulsion Device)

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.

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.

is one of the most encountered gastrointestinal complaints in clinical practice.

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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

When it is opened to atmospheric pressure, RED safely self inflates and contains a proprietary foam technology that

mimics the “feel” of stool.

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

clinical workflow.

Sensation Testing

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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.

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.

integrates with clinical workflow

is an urgent need to better identify patients with pelvic floor abnormalities and/or rectal hypersensitivity.

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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.

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.

Shah et.al., An Office-Based, Point-of-Care Test Predicts Treatment Outcomes

With Community-Based Pelvic Floor Physical Therapy in Patients With Chronic Constipation.

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.

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

The pressure is therefore

never greater than room air.

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.

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.

RED is therefore safer with regard to patients with decreased compliance.

have been no safety events reported 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.

● 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

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

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executive officers and directors.

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

Company has nine (9) registered trademarks, and three (3) pending applications for registration:

nerve stimulator apparatus

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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

EXPULSION DEVICE

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

– RECTAL EXPULSION DEVICE (word)

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

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

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.

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.

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NERVE FIELD STIMULATION DEVICE

27-March-2023

25-April-2039

NERVE FIELD STIMULATION DEVICE

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AUDITORY CANAL PHOTOBIOMODULATION DEVICE

14-April-2037

OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION

14-April-2037

OF TREATING DISEASE USING AURICULAR PERIPHERAL NERVE FIELD STIMULATION

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AND METHODS FOR AURICULAR PERIPHERAL NERVE FIELD STIMULATION

14-April-2037

NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME

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NERVE FIELD STIMULATION DEVICE AND METHODS FOR USING THE SAME

Exclusive License Agreement

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and additional associated/continuation patent filings for the TKBMN Patents.

License and Collaboration Agreement

License and Collaboration Agreemen t

April 9, 2020, the Company entered into a license and collaboration agreement with Masimo.

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is material breach by the Company that remain uncured for thirty (30) days or without cause by providing thirty (30) days prior written

July 1, 2025, The Company terminated the NSS-2 Bridge license with Masimo in exchange for $200,000 of consideration payable in equal

installments on December 31, 2025 and June 30, 2026.

The termination agreement allowed the Company to recapture the rights to the trademark

Registration No.

7,394,465) and two patent applications (Application No.

18/821/255 and Application No.

29/960.608) that

were originally licensed to Masimo on April 9, 2020.

See ”—Our Corporate History ” for more information.

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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.

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 .

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

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have not yet been finalized or adopted, although the FDA may work with Congress to implement such proposals through legislation.

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.

The FDA has developed and maintains a list device types appropriate for the “safety and performance based”

pathway and continues to develop product-specific guidance documents that identify the performance criteria for each such device type,

as well as recommended testing methods, where feasible.

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

The FDA has developed and maintains a list device types appropriate for the “safety and performance based” pathway

and continues to develop product-specific guidance documents that identify the performance criteria for each such device type, as well

as recommended testing methods, where feasible.

Approval Process

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or suppliers’ manufacturing facility or facilities to, among other things, ensure compliance with the QSR.

PMA applications are

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

NeurAxis, Inc.

is a designated small business with the FDA and enjoys

discounted fees.

NeurAxis, Inc.

PENFS technology is a Class II medical device and typically pursues De Novo or 510K clearances.

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

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Manufacturing

Services Agreement

August 21, 2020, the Company entered into a Manufacturing Services Agreement with GMI Corporation (“GMI”), dated as of August

21, 2020 (“MSA”), for the manufacture and supply of the Company’s IB-STIM device based upon the Company’s product

specifications as set forth in the MSA.

Company provides the necessary equipment to GMI and retains ownership.

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.

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.

was established in 1990 and manufactures our IB-Stim device in its 69,000 square foot facility that including offices, factory, environmentally

controlled room, warehouse, parts processing, assembly, quality control, of which approximately 1,000 square feet is dedicated to producing

our product, located in Indiana.

controlled, repeatable, monitored production process, GMI has kit production capacity that is sufficient for all our projected needs.

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

All of our materials

are now maintained in this room.

has a quality management system that is ISO 13485:2016 certified, FDA registered, and ITAR registered.

connection with the MSA, the Company entered into a quality agreement with GMI, dated as of August 24, 2020, for GMI to test product

provided by the Company and perform quality assurance services.

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 Company’s IB-Stim and RED devices are manufactured in Indiana and Michigan, respectively.

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.

The Company also entered into quality agreements with the manufacturers to perform quality assurance services on product

provided by the Company.

of December 31, 2025, we had 24 full-time employees.

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