Neuraxis, Inc. · AMEX:NRXS
Neuraxis — Q1 2025 Earnings Presentation
30 slides from Neuraxis's earnings presentation, May 12, 2025
Slide 1: NRXS
NRXS May, 2025 NYSEAMERICAN: NRXS | NeurAxis.com
Slide 2: Forward Looking Statements
2 | Forward Looking Statements Information included herein has been prepared by NeurAxis, Inc. (“NeurAxis”) or obtained from These forward-looking statements are subject to a number of risks, uncertainties and sources believed to be reliable, but the accuracy or completeness of such information is n
Slide 3: Who We Are
3 | Who We Are Neuromodulation Therapies for Chronic and Debilitating GI Conditions in Pediatrics and Adults NeurAxis is a growth-stage Medtech company Developing and commercializing neuromodulation therapies utilizing proprietary PENFS to address chronic and debilitating conditions in children and
Slide 4: Corporate Overview
4 | Corporate Overview We have secured a Category I CPT® code for the PENFS technology and obtained expanded commercial payer coverage, reinforcing our technology's clinical and economic value and increasing patient access nationwide. Category I CPT Code – PENFS Policy Coverage Streamlined Billing &
Slide 5: NeurAxis Quarterly Revenue
5 | NeurAxis Quarterly Revenue Strong Data = Strong Policy Coverage & Reimbursement = Strong Revenue Growth Confidential – Do Not Distribute
Slide 6: FDA Pipeline - Indications and Timelines
6 | FDA Pipeline - Indications and Timelines Indication 2023 2024 2025E 2026E 2027E Clinical Study* Functional Abdominal Pain & Irritable Children's Wisconsin RCT** Bowel Syndrome - Pediatric RED – Adult University of Michigan Functional Dyspepsia (Nausea) RCT/Registry - Pediatric Functional Abdomin
Slide 7: NeurAxis PENFS: First FDA Indicated Treatment for Pediatric FAP/IBS
7 | NeurAxis PENFS1: First FDA Indicated Treatment for Pediatric FAP/IBS2 Strong Data = Strong Policy Coverage & Reimbursement = Strong Revenue Growth Large Global Market with Significant Unmet Need Unique, Innovative Product ▪ $ 22B+ SAM3 for target pipeline indications Supported by Clinical Eviden
Slide 8: $22B+ Serviceable Available U.S. Market (SAM) for Pipeline Indications
8 | $22B+ Serviceable Available U.S. Market (SAM) for Pipeline Indications Pediatric Indications Adult Indications $2B $1B CVS $2B Concussion RED $8B $2B $14B Pediatric Functional Pediatric Dyspepsia SAM* SAM* $12B FAP/IBS $3B FAP/IBS Why Pediatrics? Entering Pediatric markets first with: ▪ Signific
Slide 9: Abnormal processing of signals to and from the gut
9 | Abnormal processing of signals to and from the gut Disorders of the Gut-Brain Interaction (DGBIs) Irritable Bowel Cyclic Vomiting Syndrome Functional Recurrent episodes of intense Syndrome (IBS) Dyspepsia nausea and vomiting lasting Characterized by abdominal Pain or discomfort hours to days wit
Slide 10: DGBIs: A Problem with an Unmet Need
10 | DGBIs: A Problem with an Unmet Need ▪ No FDA-approved therapies for children with abdominal pain-related disorders of the gut-brain interactions (DGBIs). ▪ Disorders negatively impact quality of life and ability to function (attend school, sports, and social activities). ▪ Insufficient data to
Slide 11: Established Technology with Demonstrated Safety and Efficacy
11 | Established Technology with Demonstrated Safety and Efficacy What is IB-Stim? ▪ PENFS system intended for patients 8-21 years of age with functional abdominal pain (FAP) associated with IBS FDA De Novo ▪ Aids in pain reduction via neuromodulation to Clearance branches of Cranial Nerves (V,VII,I
Slide 12: IB-Stim Research: By the Numbers
12 | IB-Stim Research: By the Numbers Strong Data = Strong Policy Coverage & Reimbursement = Strong Revenue Growth 16 Current Publications Utilizing NeurAxis' PENFS Technology 13 Children’s Hospital Study Sites 10 Types of Studies ▪ Double Blind Placebo Controlled ▪ Real World Clinical Data ▪ Long-T
Slide 13: Percutaneous Electrical Nerve Field Stimulation (PENFS)
13 | Percutaneous Electrical Nerve Field Stimulation (PENFS) How Does Neuromodulation Work? * Access Stimulate Change 1 Direct access to central nervous system (CNS) through 2 Stimulation reduces firing of amygdala 3 Induces changes in brain pathways/connectivity peripheral cranial nerves * Second G
Slide 14: Data Does Not Support Standard Pharmacotherapy in Children with IBS
14 | Data Does Not Support Standard Pharmacotherapy in Children with IBS No data to support use Significant Risk of TCA Substantial Patient of Antidepressants in Side Effects in Children Need for Safe & Effective, Children with Functional Non-Pharmacological ▪ Increased risk of suicidal Abdominal Pa
Slide 15: Growing Body of Clinical Evidence
15 | Growing Body of Clinical Evidence Improvement of Global Symptoms in Patients with Irritable Bowel Syndrome Global Symptom Improvement *Percent of patients reporting improvement of global symptoms using Symptom Response Scale score ≥2 (*p≤0.001), ≥3 (#p=0.002) and ≥4 (p=0.077) Kovacic K, et al.
Slide 16: FDA Benchmark for Clinically Meaningful Endpoint
16 | FDA Benchmark for Clinically Meaningful Endpoint Treatment for abdominal pain-related functional ≥30% Improvement in Pain gastrointestinal disorders in adolescents: ▪ Number Needed to Treat (NNT): The number of patients that need to be treated for one patient to get the targeted improvement (≥3
Slide 17: Functional Disability Scores at Long-Term Follow-Up
17 | Functional Disability Scores at Long-Term Follow-Up Improvement in Functional Disability in Patients with Irritable Bowel Syndrome Improving functional disability (attending school and activities) is a marker of overall health and clinically meaningful beyond subjective pain measures. Kovacic K
Slide 18: Largest Pediatric Registry in Children with DGBI
18 | Largest Pediatric Registry in Children with DGBI ▪ Pediatric registry with “real world” clinical data ▪ 61% had failed ≥ 4 medications prior to treatment ▪ Sustained efficacy in abdominal pain up to 6-12 months after 4 weeks if IB-Stim treatment A multicenter registry study on percutaneous elec
Slide 19: IB-Stim was equivalent or better than standard medications used for FAPDs
19 | IB-Stim was equivalent or better than standard medications used for FAPDs Confidential – Do Not Distribute
Slide 20: IB-Stim Go-to-Market Strategy
20 | IB-Stim Go-to-Market Strategy Strong Data = Strong Policy Coverage & Reimbursement = Strong Revenue Growth NRXS Quarterly Revenue 2024 Policy Coverage Reimbursement Strategy Total Total # Lives Technology Specific CPT Coding Plans Covered CPT CAT I code* Effective 1/1/26 17 plans ~51M List Pric
Slide 21: NeurAxis IP Portfolio
21 | NeurAxis IP Portfolio ▪ 13 issued and 9 pending patents ▪ Device ▪ Method ▪ U.S. IP runs through 2039 as of now ▪ International IP in process ▪ Freedom to operate completed Confidential – Do Not Distribute
Slide 22: Collaborative Contract Manufacturing Partner
22 | Collaborative Contract Manufacturing Partner In-House Capabilities Manufacturing Capacity Quality Management System ▪ Office and factory in Indiana ▪ Controlled, repeatable, monitored ▪ ISO 13485:2016 Certified ▪ 69,000 square foot facility production process ▪ FDA registered ▪ Offices, factory
Slide 23: Medical Advisory Board
23 | Medical Advisory Board Dr. Samuel Nurko Dr. Carlo Di Lorenzo Dr. Rachel Rosen Dr. Kahlil El-Chammas Dr. Miranda van Tilburg Dr. Leonel Rodriguez Confidential – Do Not Distribute
Slide 24: Management Team
24 | Management Team Brian Carrico Dr. Adrian Miranda Timothy Henrichs Dr. Tom Carrico Dr. Chris Brown Chief Executive Officer, Chief Medical Officer Chief Financial Officer Chief Regulatory Officer Director Of Innovation, Board Member Founder, Board Member Confidential – Do Not Distribute
Slide 25: Board of Directors
25 | Board of Directors Beth Keyser Mitch Watkins Kirstin Ferge Brian Carrico Dr. Chris Brown Dr. Gil Aharon Board Member Board Member Board Member Chief Executive Officer, Director Of Innovation, Board Member Board Member Founder, Board Member Collective Experience: Confidential – Do Not Distribute
Slide 26: Key Investment Highlights
26 | Key Investment Highlights Strong Data = Strong Policy Coverage & Reimbursement = Strong Revenue Growth Large Global Market with Significant Unmet Need Unique, Innovative Product ▪ $22B+ SAM1 for target pipeline indications Supported by Clinical Evidence ▪ $8B+ SAM1 for target pediatric indicati
Slide 27: Expanding Portfolio of Next Generation Devices for Disorders of Gut-Brain Interaction
27 | Expanding Portfolio of Next Generation Devices for Disorders of Gut-Brain Interaction RED – Rectal Expulsion Device ▪ Developed at the University of Michigan Compressed enabling comprehensive constipation care for every adult gastroenterology practice Red Device ▪ RED is a self-inflating balloo
Slide 28: Capital Structure
28 | Capital Structure Stock Information Listing NYSE Symbol NRXS Share Price (May 22, 2025) $3.03 Share Structure (May 22, 2025) Shares Outstanding 9.5 M Warrants 1.7 M Options/RSUs 2.2 M Series B Preferred 3.9 M Shares fully diluted 17.3 M Financial Position (May 22, 2025) Cash Position $6.8 M Lon
Slide 29: Contact Information
29 | Contact Information Investor Relations Ben Shamsian Lytham Partners 646-829-9701 shamsian@lythampartners.com Confidential – Do Not Distribute
Slide 30: Thank you
Thank you NYSEAMERICAN: NRXS | NeurAxis.com