Neuropace, Inc. · NASDAQ:NPCE
Neuropace — Investor Day (January 2025)
126 slides from Neuropace's investor day presentation, Jan 28, 2025
Slide 1: NeuroPace, Inc. Investor Day
NeuroPace, Inc. Investor Day January 28, 2025
Slide 2: 2025 Investor Day Agenda
2025 Investor Day Agenda 9:00 Welcome and Introductions (Rebecca Kuhn) 10:30 RNS System Clinical Trials (Martha Morrell, MD) Platform and Data Applications (Martha Morrell, MD) NeuroPace Overview (Joel Becker) Potential Future Applications (Sameer Sheth, MD, PhD) 9:05 Mission, Unmet clinical need, V
Slide 3: Speakers
Speakers Special Guest Speakers NeuroPace Management Mark Richardson, MD, PhD Vikram Rao, MD, PhD Sameer Sheth, MD, PhD Joel D. Becker Rebecca Kuhn Martha Morrell, MD Associate Professor, Associate Professor, Professor and Vice-Chair of CEO and Board Member Chief Financial Officer, Chief Medical Off
Slide 4: NeuroPace Overview
NeuroPace Overview Joel Becker
Slide 5: Disclaimer
Disclaimer This presentation may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,
Slide 6: Mission: transform the lives of people suffering from epilepsy
Transform the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. 6
Slide 7: NeuroPace: Strong Fundamentals and Positioned for Growth
NeuroPace: Strong Fundamentals and Positioned for Growth >$55B total U.S. addressable market; >$2B annual core market opportunity Large, underpenetrated market within Comprehensive Epilepsy Centers with additional upside from expanding outside Level 4 centers Unique technology Closed loop, brain-res
Slide 8: 2024 in Review
2024 in Review • Revenue grew over 20% • Preannounced $79.4 - $79.9 million in revenue, growth of 21% - 22% • Excluding sales from the NAUTILUS trial in 2023, revenue grew 25%+ NAUTILUS: Idiopathic Generalized Epilepsy • Revenue growth accelerated in 2H vs 1H • Delivered strong gross margins at high
Slide 9: 2024 in Review: We are just getting started
2024 in Review • Revenue grew over 20% • Delivered strong gross margins at high end of guidance range • Maintained operating expenses at low end of guidance range • RNS active prescribers increased to new record highs NAUTILUS: Idiopathic • Project CARE pilot demonstrated increasing momentum in 2H G
Slide 10: Long Range Plan: Vision
NeuroPace Long Range Plan: Vision To become the recognized leader in drug- resistant epilepsy therapy and fully develop the potential of the RNS System 10
Slide 11: Long Range Plan: Key Areas of Focus
Long Range Plan: Key Areas of Focus Market Expansion Financial Discipline Operating Execution and Revenue Growth • Gross Margin Improvements • Expanded Indications Approval and • IGE and Pediatric Indication Launch • Operating Expense Allocation • Project CARE Site of Service • Commercial Execution
Slide 12: Multiple Growth Initiatives Underway
Multiple Growth Initiatives Underway Clinical Product Market Development Development Development • PAS – Adult Focal • Incremental Sales Force Expansion • Annual AI SW Releases • NAUTILUS – IGE • Project CARE • Remote Programming • NEST – Pediatric Focal • Expanded Direct to Patient • Next Generatio
Slide 13: Increasing Catalysts Planned Over 2025 - 2027
Increasing Catalysts Planned Over 2025 - 2027 Long Range Plan CAGR: 20%+ 2027 • Remote Programming Launch • Enhanced PDMS User Interface Launch 2026 • IGE Market Penetration • Pediatric Market Penetration • IGE Launch • Level 4 Adoption & Utilization • Pediatric Launch • Project CARE Execution 2025
Slide 14: NeuroPace Vision and Long Range Plan Objectives
NeuroPace Vision and Long Range Plan Objectives Market Leader with LRP Revenue Growth of 20%+ CAGR Indication expansion to Idiopathic Generalized and Pediatric DRE patients Neuromodulation category leader in efficiency and ease of use with AI Tools and Remote Programming Significantly expanded patie
Slide 15: The NeuroPace RNS System and Effectiveness in Focal Epilepsy
The NeuroPace RNS System and Effectiveness in Focal Epilepsy Martha Morrell, MD
Slide 16: Epilepsy: a brain disorder that causes recurring, unprovoked seizures
Epilepsy: a brain disorder that causes recurring, unprovoked seizures • 4th most common brain disorder; > 3.6 M persons in US1 • Seizures caused by abnormal brain electrical activity • 30-40% of persons with epilepsy are drug resistant Treatment options Focal • More medication Epilepsy • VNS/DBS/RNS
Slide 17: Drug-Resistant Epilepsy
Drug-Resistant Epilepsy International League Against Epilepsy1 "failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom" Treatment of drug-resistant epilepsy The expected
Slide 18: Epilepsy Syndromes
Epilepsy Syndromes International League Against Epilepsy Classification of the Epilepsies Localization related epilepsy with focal Generalized epilepsy with generalized (partial) seizures onset seizure 60% 1 40%1 Idiopathic: Symptomatic: 1-2 foci (regions) > 2 foci; large regional presumed genetic w
Slide 19: Responsive Neuromodulation – The RNS System
Responsive Neuromodulation – The RNS® System 19
Slide 20: An Unprecedented Window to the Brain
An Unprecedented Window to the Brain Patient sends RNS data via internet to the secure Patient Data Management System (PDMS) Data includes: • Samples of intracranial EEG iEEG • Numbers and times of detections recording Data used to: • Personalize detection and stimulation • Monitor the stimulation r
Slide 21: Benefits of Choosing RNS System Treatment
Benefits of Choosing RNS System Treatment • Novel, differentiated therapy • Excellent safety and efficacy outcomes • Personalized and modifiable • Non-destructive; does not preclude other options • Delivers therapy and provides data to help inform treatment decisions • Flexible tool that enables man
Slide 22: Rigorous Clinical Trials Provide Rich Data
Rigorous Clinical Trials Provide Rich Data 580 patients followed prospectively in RNS System trials1 Feasibility Trial Pivotal Trial Open Label Safety, 2 year follow-up Double blind RCT, 2 year follow-up (65 patients) (191 patients) Open Label Long-term Treatment Trial1 7 year follow on study (230 p
Slide 23: Impressive Seizure Reductions Improve Over Time
Impressive Seizure Reductions Improve Over Time Median % Reduction in Seizures Original FDA Study Real World & FDA 82% 82% Results:1,2 Post Approval Study 75% 75% 73% 75% Results: 72% • Statistically greater 67% 67% 67% 63% seizure reduction than • 67% median seizure 62% 58% sham therapy at reductio
Slide 24: Cognitive and Quality of Life Improvements Differentiate RNS
Cognitive and Quality of Life Improvements Differentiate RNS from Other Neuromodulation Therapies • Group improvements in overall QOL and in subdomains, including cognitive function and mental health1 • No negative mood or cognitive effects2 • Significant cognitive improvements in: − Naming (p<0.001
Slide 25: Power of the RNS Data
Power of the RNS Data Vikram Rao, MD, PhD
Slide 26: The Clinical Value of the RNS Data
The Clinical Value of the RNS Data Data drives patient improvement • Informs detection and stimulation programming for each patient • Data provides opportunity to improve programming for all patients Diagnostic Capabilities • Long-term ambulatory intracranial EEG monitoring Clinical value today- Imp
Slide 27: RNS System Data Contributes to Better Epilepsy Management Today
RNS System Data Contributes to Better Epilepsy Management Today # of detections Med effective Electrographic seizures Med ineffective Seizure counter Hours of day/ week over week See Titrate seizure Meds cycles iEEG Menstrual cycle trigger Data Right temporal resection Identify Inform seizure future
Slide 28: Diagnostic Value of RNS System
Diagnostic Value of RNS System Enhanced temporal sampling 1-2 weeks in EMU; weeks, months, years with RNS System Benefits: • Track outcomes using electrographic data, as well as patient reported seizures • Monitor response to addition or removal of a medication using electrographic data– before pati
Slide 29: Lateralization of Mesial Temporal Lobe Epilepsy with Chronic Ambulatory ECoG
Lateralization of Mesial Temporal Lobe Epilepsy with Chronic Ambulatory Electrocorticography 1st week: 36.2% (25/69) 82 patients with RNS System bilateral MTL depth leads Time to record 1st contralateral seizure • Average: 41.6 days • Median: 13 days (0-376) 2nd week: 17.4% (12/69) In 64% of patient
Slide 30: RNS System Data Reveals Lateralization in Temporal Lobe Patients
RNS System Data Reveals Lateralization in Temporal Lobe Patients Incorrect lateralization can lead to incorrect surgical decisions RNS System’s long-term data can be more accurate than inpatient EMU monitoring Data from the EMU was misleading in 7 out of 12 patients (58%) who had both intracranial E
Slide 31: Types of Data Collected by RNS System
Types of Data Collected by RNS System Rao VR. Exp Rev Med Dev (2021) 18(11):1093-1105. 31
Slide 32: Challenge: Data Review
Challenge: Data Review == x 69 NELROPACE
Slide 33: Conceptual renderings, not approved for use
Conceptual renderings, not approved for use 33
Slide 34: AI-Powered Seizure Review Reduces Physician Burden
AI-Powered Seizure Review Reduces Physician Burden Goal: help clinicians identify electrographic seizures and important trends efficiently • Validated AI model to sort types of iEEG recordings – Non-Seizure – Electrographic Seizure Lead 1, 2 or both leads • Integrated with PDMS physician platform •
Slide 35: AI-Powered Seizure Detection Improves Accuracy and Reduces Physician Burden
AI-Powered Seizure Detection Improves Accuracy and Reduces Physician Burden Physician selected onset Current practice 1. Physician looks at iEEG and decides when seizure begins 2. Manually selects detection settings AI selected onset AI-proposed detections 1. Vision Transformer model identifies seiz
Slide 36: AI Data Tools: Designed to Improve Outcomes and Ease of Use
AI Data Tools: Designed to Improve Outcomes and Ease of Use Machine and Deep Learning Standard treatment Propose stimulation settings based protocol on response of other similar patients Alternative Bayesian Optimization treatment protocols Use data from every patient to using clinical predict next
Slide 37: RNS System Clinical Applications
RNS System Clinical Applications Mark Richardson, MD, PhD
Slide 38: There is a Substantial Treatment Gap for DRE Patients
There is a Substantial Treatment Gap for DRE Patients 6.5K DRE patients get treatment beyond drugs3 1.2M people living with DRE 50K in the US1 admitted to EMUs at CECs2 1.Chen, Z., et al., JAMA Neurology, 2018. 2.Definitive Health 3.Ostendorf, et al, Neurology, 2022 38
Slide 39: Minimal Growth in Surgical Procedures
Minimal Growth in Surgical Procedures Localization Driven Procedures at CECs* Epilepsy procedures at CECs 4500 2016 – 20191 4000 • EMU admissions +5% per year Therapeutic Procedures 3500 • Intracranial monitoring +8% per year 3000 • Localization related interventions +4% 2500 per year 2000 – Decreas
Slide 40: Why does the surgical Treatment Gap Persist?
Why does the surgical Treatment Gap Persist? Many patients with localized seizures do not get resection/LiTT because their seizure onset is… Many of these patients can benefit from treatment with the RNS System Tomson, et al., Lancet Neurol. 2008 Solli, et al., Epilepsia, 2020 Loring, et al., Epilep
Slide 41: Expanded Thinking: Paradigm Shifts in Epilepsy
Expanded Thinking ”These paradigm shifts may facilitate closure of Paradigm Shifts in Epilepsy the surgical treatment gap in DRE”1 1. Richardson, et al., Neurologic Clinics, 2022 41
Slide 42: Flexible Lead Placement Enables Diverse Stimulation Approaches
Flexible Lead Placement Enables Diverse Stimulation Approaches for a Broad Group of Focal DRE Patients Regional Neocortical Corticothalamic Large or Multifocal* MTL Onsets Discrete Cortical Onsets Stimulation Stimulation** Onsets *The RNS System is indicated to treat up to 2 epileptogenic foci. Expa
Slide 43: Treating the Seizure Network with Corticothalamic Stimulation
Treating the Seizure Network with Corticothalamic Stimulation Pulvinar CM • Treat spatially extensive seizure foci by targeting a deep nucleus that projects diffusely to cortex ANT • Target thalamic nuclei based on networks Kokkinos, et al, Neurosurgery, 2020; Herlopian, et al, Ann Clin Transl Neuro
Slide 44: Responsive v. Open-Loop Stimulation
Responsive v. Open-Loop Stimulation Advantages of the responsive stimulation approach RNS System intracranial EEG (iEEG) data: • Ictal patterns are seen in the cortex, hippocampus and thalamus • iEEG data used to guide stimulation settings and pathways RNS System studies show no acute or chronic sid
Slide 45: The Epilepsy Treatment Gap Persists: ILAE Recommendations
The Epilepsy Treatment Gap Persists: Goal: Identify ways to address DRE patient treatment 2022 ILAE Consensus Recommendations gaps and clarify when to initiate surgical evaluation Key Recommendations 1. Referral for surgical evaluation should be offered to every DRE patient (up to 70 years) a. Regar
Slide 46: The Cost of Doing Nothing or Delaying Treatment
The Cost of Doing Nothing or Delaying Treatment • SUDEP kills 1 in 150 people with uncontrolled seizures each year.1 • 20 years of lost quality of life for DRE patients spent on ineffective anti-seizure medications.2 • Delayed intervention reduces the potential impact of treatment.2,3 • Early treatm
Slide 47: Living with the RNS System
Living with the RNS System Mike McKenna, MSW
Slide 48: Patient Educator Introduction
Patient Educator Introduction Mike McKenna, MSW • Over eight years ago, I joined NeuroPace as a Patient Educator, after volunteering as an RNS Ambassador for about two years. • I've seen the importance of patient education for patients who are considering, or moving forward, with the RNS System. Pat
Slide 49: Oct 26, 2008: First Seizure Recorded
Oct 26, 2008: First Seizure Recorded 49
Slide 50: Oct 26, 2008: First Seizure Recorded Spectrogram
Oct 26, 2008: First Seizure Recorded Spectrogram 50
Slide 51: May 28, 2012: Last Seizure Recorded
May 28, 2012: Last Seizure Recorded 51
Slide 52: 2008 - 2025: All Events Recorded
2008 - 2025: All Events Recorded 52
Slide 53: 2008 - Beyond: Health & Life Transformation Histogram
2008 - Beyond: Health & Life Transformation Histogram 2014 2015 2017 2019 Graduated college Moved to OR Filed Taxes Credit Score: Bought Excellent small home 2012 2016 2017 2019 Last seizure Started work Stopped SSDI Driver’s license at NeuroPace reinstated 2008 2014 My Future Started Pivotal Study
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Slide 55: Questions?
Questions?
Slide 56: Break
63 NELROPACE
Slide 57: RNS System Clinical Trials and Applications for RNS Data
RNS System Clinical Trials and Applications for RNS Data Martha Morrell, MD
Slide 58: RNS System Clinical Discovery: Clinical Trials and AI
RNS System Clinical Discovery: Clinical Trials and AI Clinical Trials to Collect Data and AI to Drive Continued Improvement in Expand Indications Effectiveness • Five-year post-approval study in adults with • Find device-provided objective neural focal epilepsy for additional safety and biomarkers e
Slide 59: Post-Approval Study
Post-Approval Study Largest FDA required prospective post-approval study in neuromodulation for epilepsy • Five-year post-approval multicenter study: 324 patients implanted at 32 centers • Primary effectiveness endpoint at 3 years and primary safety at 5 Complete 5-yr f/u Submission Accepted By 5-yr
Slide 60: Post-Approval Study: Patient Baseline Data
Post-Approval Study: Patient Baseline Data PAS patients One third of patients did not have • 271 completed 3 years intracranial monitoring • Median baseline seizure frequency was 5.7/month • 67% had prior intracranial monitoring • 65% in PIV/LTT trials1 Seizure onsets similar to Piv/LTT trials PAS p
Slide 61: Primary Efficacy Endpoint by Time from Implant
Primary Efficacy Endpoint by Time from Implant Median % Change in Seizure Frequency Compared to Baseline1 Time after Implant N (1st quartile, 3rd quartile) Months 0-6 314 -62.5% (-91.6%, -11.8%) Months 6-12 292 -62.3% (-93.3%, -14.6%) Months 12-18 282 -68.2% (-97.4%, -15.5%) Months 18-24 273 -69.4%
Slide 62: Seizure Reductions Similar for All Seizure Onset Zones
Seizure Reductions Similar for All Seizure Onset Zones Improvement in seizure frequency for patients with mesial temporal, neocortical, and mesial temporal + neocortical onset seizures -95% Median % Reduction by 6-month Periods by Onset Zone -90% All Cohorts (N = 324) -85% -80% MTL -75% (N = 178) -7
Slide 63: Real World DBS Study
Real World DBS Study • Medtronic Registry for Epilepsy (MORE) of long term outcomes of DBS in clinical practice • Prospective and retrospective observational study Link: https://onlinelibrary.wiley.com/doi/10.1111/epi.18003 63 63
Slide 64: Impressive Seizure Reductions with RNS System
Impressive Seizure Reductions with RNS System RNS System PAS1 DBS MORE Registry2 Median Seizure Reduction at Year 1 62.3% 25.3% (N=292) (N=163) Median Seizure Reduction at Year 2 69.4% 33.1% (N=273) (N=155) Median Seizure Reduction at Year 3 82.0% 39.6% (N=255) (N=101) 1RNS System Post-Approval Stud
Slide 65: RNS Post-Approval Study: Effectiveness Conclusions Based on 3-Year Results
RNS Post-Approval Study: Effectiveness Conclusions Based on 3-Year Results RNS System therapy is observed to be effective for all types of focal epilepsy • Efficacy improves over time • Seizure reduction in upper quartile • Exceeds 90% within 6 months of implant • 100% at 3 years Results better than
Slide 66: RNS System Treatment of Drug-Resistant Focal Epilepsy in Children
RNS System Treatment of Drug-Resistant Focal Epilepsy in Children 66
Slide 67: Response Study: Prospective Open-Label Study in Pediatric Patients
Response Study: Prospective Open-Label Study in Pediatric Patients with Focal Epilepsy • NeuroPace is committed to expanding use of the RNS System to pediatric patients with drug- resistant focal epilepsy • Response Study: FDA required prospective open label trial • NeuroPace faced typical challenge
Slide 68: A New Approach: Use Real World Data to Expand RNS to Pediatrics
A New Approach: Use Real World Data to Expand RNS System Treatment to Pediatrics Consortia: > 25 peer reviewed Advocacy Group Support RNS System data from 27 publications about RNS • AES Pediatric Special Pediatric Epilepsy Centers System use in pediatrics Interest Group • Lennox-Gastaut Foundation
Slide 69: Pursuing a Pediatric Indication: Collaboration with NEST and FDA
Pursuing a Pediatric Indication Using Real World Data: Collaboration with NEST and FDA Submission planned 2H 2025 We are here: 69
Slide 70: Idiopathic Generalized Epilepsy
Idiopathic Generalized Epilepsy • Majority of patients are cognitively and neurologically normal • Generalized tonic-clonic, absence, and/or myoclonic seizures • Confident diagnosis by clinical history and outpatient EEG • Intracranial EEG is not necessary • Serious life consequences: • Challenges t
Slide 71: NAUTILUS Study
RNS® System Responsive Thalamic Stimulation for Primary Generalized Seizures (NAUTILUS) Study Bilateral centromedian nucleus of Adjunctive therapy for the treatment of thalamus (CM) responsive stimulation generalized seizures in individuals 12 years of age or older who have drug- resistant idiopathi
Slide 72: NAUTILUS Study Timeline
NAUTILUS Study Timeline 2021: FDA Grants Breakthrough Designation • Data monitoring and lock • Submission planning with regulatory and Primary endpoint safety statisticians and effectiveness • Dry and final run analyses on mock data evaluations to be • Data inspections, modification with sites as Fi
Slide 73: Thalamocortical Responsive Neurostimulation for LGS
Thalamocortical Responsive Neurostimulation for the Treatment of Lennox Gastaut Syndrome (LGS) • Devastating generalized epilepsy with frequent seizures and progressive cognitive decline • Medically intractable, surgery not effective • NIH Brain Initiative Grant1 Clinical Goal: provide preliminary e
Slide 74: Treatment of Generalized Seizures in LGS
Treatment of Generalized Seizures in LGS: Responsive stimulation of bilateral thalamocortical networks • Prospective two-stage single-blind feasibility cross-over IDE study • All 20 patients implanted • Acceptable safety profile to date • Grant funds • AI biomarker discovery • Computational methods
Slide 75: An Unprecedented Dataset of Chronic Ambulatory iEEG
An Unprecedented Dataset of Chronic Ambulatory iEEG • Chronic ambulatory iEEG data in > 6500 patients • > 19M stored intracranial EEG samples • Baseline, interictal and ictal samples Baseline Abnormal discharges Electrographic seizure NeuroPace-developed AI algorithms identify activity that is corre
Slide 76: AI-Fueled Discovery: Guide RNS System Treatment Using Biomarkers
AI-Fueled Discovery: Guide RNS System Treatment Using Biomarkers Machine learning shows biomarker trends in in the best Deep Learning finds features that responders distinguish the best responders Epileptiform spikes go down in MTLE best responders Spectral frequency Epileptiform spikes Desai et al.
Slide 77: Using RNS System Data to Assess Effects of Anti-Seizure Medications
Using RNS System Data to Assess Effects of Anti- Seizure Medications
Slide 78: Gold Standard for Seizure Counts Are Patient Reports
Gold Standard for Seizure Counts Are Patient Reports One patient knows she has seizures (M= magnet swipe)… And one patient does not. 78
Slide 79: Moving Beyond the Seizure Diary
Moving Beyond the Seizure Diary: Patient reported seizures correlate with RNS System detected events LE= Prolonged epileptiform activity Electrographic seizure not identified by patient as seizure Electrographic seizure identified by patient as seizure LEs are more frequent, but are strongly correla
Slide 80: RNS System Data May Provide Biomarker for Early Effects of ASMs
RNS System Data May Provide Biomarker for Early Effects of Antiseizure Medications (ASMs) within 1-2 Weeks p =0.00043 N=14 8 N=8 Skarpaas et al., Epilepsy & Behavior, 2018 Quraishi IH, et al., Epilepsia, 2020 80
Slide 81: Rapport and NeuroPace Collaboration
Rapport and NeuroPace Collaboration: Demonstrating Meaningful Target Engagement Rapport is conducting a first in epilepsy trial of a novel, neuroanatomically specific, negative allosteric modulator of AMPA receptors for focal epilepsy Long episodes, an objective, electrophysiological biomarker in pa
Slide 82: Potential Future Applications
Potential Future Applications Martha Morrell, MD Sameer Sheth, MD, PhD
Slide 83: RNS Platform Technology Provides Opportunities Beyond Epilepsy
RNS Platform Technology Provides Opportunities Beyond Epilepsy • FDA approved treatment with extensive clinical efficacy and safety data set for focal onset seizures • Long-term monitoring of brain electrical activity in persons with any brain disorder • Targeted and personalized therapy • Biomarker
Slide 84: Investigator-Initiated Studies Outside of Epilepsy: Neuropsychiatric Disorders
Investigator-Initiated Externally Funded Studies Outside of Epilepsy: Neuropsychiatric Disorders RNS for Depression: Mt. Sinai NY RNS for Depression: UCSF Medical Center RNS for Loss of Control Eating: Hospital of the University of Pennsylvania RNS for PTSD: UCLA Medical Center RNS for PTSD: Stanfor
Slide 85: Investigator-Initiated Studies Outside of Epilepsy: Memory and Cognition
Investigator-Initiated Externally Funded Studies Outside of Epilepsy: Memory and Cognition RNS for Spatial Navigation: UCLA Medical Center RNS for Navigation & Free Recall : Dartmouth RNS for Navigation and Memory Boston Medical Center RNS for Cognitive Assessment : UC Berkeley RNS and Brain Plastic
Slide 86: Opportunities for Responsive Neurostimulation
Opportunities for Responsive Neurostimulation Disorders with slowly evolving pathophysiology • Derisking has begun • Philosophy: stimulation adjusts to (slowly evolving) neural biomarkers • Individualization of neural biomarkers (as in epilepsy) may be critical • Examples: • Depression • Memory diso
Slide 87: Depression
Depression Neural biomarkers of mood state • NIH BRAIN Initiative grant (UH3 NS103549) Xiao et al. Biol Psych 2023 Xiao et al. Nat Comm 2024 • Necessary information is at the macro (clinical) electrode scale • Neural biomarkers have some general features (feasibility) and some specific features (ind
Slide 88: Summary Thoughts
Summary Thoughts Opportunities for Responsive Neurostimulation beyond epilepsy • Continuous monitoring of neural biomarkers of target state • Mood, memory, etc. • Adjustment of stimulation output in response to evolving neural biomarkers • Paroxysmal or slowly evolving • Remote monitoring by clinica
Slide 89: Product Development
Product Development Dylan St. John Brett Wingeier, PhD
Slide 90: Key Opportunities
Key Opportunities Therapy Effectiveness Clinic Efficiency Patient & Clinician Ease of Use 90
Slide 91: Product Development Focus Areas: Leverage Our Data
Product Development Focus Areas Leverage Our Data 6,500+ Patients 26k+ Patient 19M+ Patient Implant Years iEEGs 91
Slide 92: Product Development Focus Areas: Next Generation Platforms
Product Development Focus Areas Next Generation Platforms Patient Data Neurostimulator Management & Accessories System (PDMS) Next generation platforms and features are anticipated and not yet approved. 92
Slide 93: Data Enable Continuously Improving Results
Data Enable Continuously Improving Results ASSETS NPCE SKILL SETS PRODUCT FLOW ENHANCED RESULTS Neuroscience Therapy Effectiveness RNS System Deep learning Clinic Efficiency AI and Data x Algorithm Products FCE Efficiency / World- development Scalability leading dataset Modeling Ease of Use Renderin
Slide 94: NeuroPace Patient Data Management System (PDMS)
NeuroPace Patient Data Management System (PDMS) Supports review of data and settings 19M+ iEEG recordings, 19B+ event records Foundation of NeuroPace research programs 94
Slide 95: Next-generation PDMS Architecture
Next-generation PDMS Architecture Scalable for growth Platform enables cadence of data products and usability improvements Renderings; features not available in the approved RNS System. Next generation platforms and features are anticipated and not yet approved. 95
Slide 96: AI-Powered Seizure Classifier
AI-Powered Seizure Classifier Present Future Validated AI model identifies electrographic seizures Simplifies review of iEEG by presenting relevant data for streamlined patient care Renderings; features not available in the approved RNS System. Renderings; features not available in the approved RNS
Slide 97: AI Seizure Classifier Creates Insights for Patient Care
AI seizure Classifier Creates Insights for Patient Care AI-powered Electrographic Seizure Trends Renderings; features not available in the approved RNS System. Next generation platforms and features are anticipated and not yet approved. 97
Slide 98: NeuroPace Dataset Enables Cadence of Tools
NeuroPace Dataset Enables Cadence of Tools for Therapy Effectiveness, Efficiency, and Ease of Use Optimal, automated Convenient, clear Precise seizure start settings to detect seizure identification time and location and treat Next generation platforms and features are anticipated and not yet approv
Slide 99: AI Seizure Onset Detection Brings Precision, Insight, and Efficiency
AI Seizure Onset Detection Brings Convenient, clear seizure identification Precise seizure start time and location Optimal, automated settings to detect and Precision, Insight, and Efficiency treat AI-Determined Onset NeuroPace model identifies Epileptologist-Scored Onset seizure onset time, locatio
Slide 100: Automated Proposal of Detection and Treatment Settings
Automated Proposal of Detection Convenient, clear seizure identification Precise seizure start time and location Optimal, automated settings to detect and and Treatment Settings treat Physician setup ✓ Effectiveness ✓ Efficiency AI-proposed setup ✓ Ease of Use Renderings; features not available in t
Slide 101: Automated Proposal of Detection and Treatment Settings
Automated Proposal of Detection Convenient, clear seizure identification Precise seizure start time and location Optimal, automated settings to detect and and Treatment Settings treat Future Present AI tools improve clinic efficiency Past and ease of use System proposes personalized Propose Review S
Slide 102: Remote Programming Solves for Patient Travel, Inconvenience
Remote Programming Solves for Patient Travel, Inconvenience For many patients, the nearest clinic is Problem hours away Remote monitor can receive and update treatment settings Solution Expands use of existing programming functionality More efficient patient care and greater Benefits adoption with t
Slide 103: Next-generation Neurostimulator Enables Automatic Data Transfer
Next-generation Neurostimulator Enables Automatic Data Transfer Renderings; features not available in the approved RNS System. Next generation platforms and features are anticipated and not yet approved. 103
Slide 104: Next-generation Platform for Effectiveness, Efficiency, and Innovation
Next-generation Platform for Effectiveness, Efficiency, and Innovation Automated, overnight data transfer improves patient experience and expands adoption Next-gen hardware supports future innovation in detection and therapy Adds BLE; modernizes microprocessor, ASIC Maintains MRI conditional labelin
Slide 105: Data and Platform Roadmap
Data and Platform Roadmap 2025 LRP Next-Generation Platform Platforms Fully updated RNS System Tablet Remote Monitor Remote neurostimulator with BLE 2.0 (TRM) Programming Ongoing Firmware Updates Capability for enhancement, new modalities Scalable PDMS with AI ECoG Seizure Classifier PDMS & AI Updat
Slide 106: Market Development
Market Development Katie Keller
Slide 107: Current Patient Population Focus
Current Patient Population Focus 6.5K DRE patients get treatment beyond drugs annually3 1.2M 50K DRE people living with patients admitted to Comprehensive Epilepsy Centers annually2 DRE in the US1 Significant Opportunity Exists to Close the Treatment Gap! 1Chen, Z., et al., JAMA Neurology, 2017. 2De
Slide 108: RNS Addressable Market Segments: Current and Untapped
RNS Addressable Market Segments: Current and Untapped RNS Addressable Markets (Patients, $ market size) Adult Focal Epilepsy Generalized Epilepsy Pediatric Focal Epilepsy Total • NAUTILUS • NEST/PERC • LGS • DTC • DTC • CARE ~1.2MM, $55Bn+ • CARE ~145K, $7Bn • PAS Pediatric Focal ~480K, $23Bn • Netw
Slide 109: Closing the Treatment Gap: Enhanced RNS Therapy Access
Closing the Treatment Gap: Enhanced RNS Therapy Access Patient Indication • 40% of DRE Patients Expansion: RNS • Completed implants in ongoing NAUTILUS and LGS trials System Access for • IGE submission after 1-year post-implant follow up Generalized Epilepsy • Potential to be first device in U.S. wi
Slide 110: Fewer Seizures. More Living.
Fewer Seizures. More Living. 82% seizure reduction Significant quality of at 3 years1 life improvements after just 1 year3 Improvements in cognitive function2 1. Razavi, et al., Epilepsia, 2020 2. Loring DW et al., Epilepsia, 2015. No group decline on any of 14 objective neuropsychological measures
Slide 111: Direct to Consumer Strategy
Direct to Consumer Strategy Own patient engagement from diagnosis to implant, providing education and access to care for the RNS System • Expanding digital advertising targeting both patients in CEC & the community • Adding Nurse Navigators & focusing on patients considering surgery • Maximizing con
Slide 112: Patient Education
Patient Education Extensive focus on patient education Nurse Navigators +1600 educations last year Patient Educator +500 educations +90% move to RNS implant Community Chats Patient Ambassadors Michael McKenna, MSW NeuroPace Patient Educator Field rep education for patients & families 112
Slide 113: Market Expansion: Project CARE
Market Expansion: Project CARE Bringing the RNS System into the Community Community Expansion - Making the RNS System Accessible outside of Level 4 CECs • Expanding to additional 1,800 epileptologists and all functional Expanding RNS Facilitating neurosurgeons practicing outside of System Access Ref
Slide 114: Professional Education and Podium Presence
Professional Education and Podium Presence 2024 Highlights • 572 Physicians educated • 78 Courses and Events • American Epilepsy Society (AES) • + 553 physician engagements • +70 publications and podium sessions on RNS • RNS reaching a tipping point 2025 Focus • Network Stimulation • Differentiated
Slide 115: Indication Expansion: Generalized Epilepsy
Indication Expansion: Generalized Epilepsy Patient Eligibility Indication Generalized Epilepsy Clinical Trials Expansion – RNS System NAUTILUS indication for Generalized • Breakthrough Device Designation status Epilepsy • Enrollment and implants complete • 40% of DRE market • One-year follow-up to b
Slide 116: Preparing for Generalized Epilepsy Launch
Preparing for Generalized Epilepsy Launch Prepare the Market Now • CARE program builds centers ready for implanting IGE patients Education • Educate HCPs on generalized epilepsy, NAUTILUS clinical trial design and RNS mechanism of action KOL & Patient Materials Podium Strategy Launch Strong • Peer-t
Slide 117: Scaling for Growth
Scaling for Growth Developing Sales & Marketing to drive and sustain growth • Ongoing incremental increases in sales & marketing teams • Developing teams with launch excellence • Drive adoption & differentiation • Capitalize on CARE community expansion • Launch data and new products • Prepare for po
Slide 118: Vision, Plans and Expectations
Vision, Plans and Expectations Joel Becker Rebecca Kuhn
Slide 119: NeuroPace Long Range Plan: Vision
NeuroPace Long Range Plan: Vision To become the recognized leader in drug- resistant epilepsy therapy and fully develop the potential of the RNS System 119
Slide 120: Increasing Catalysts Planned Over 2025 - 2027
Increasing Catalysts Planned Over 2025 - 2027 Long Range Plan CAGR: 20%+ 2027 • Remote Programming Launch • Enhanced PDMS User Interface Launch 2026 • IGE Market Penetration • Pediatric Market Penetration • IGE Launch • Level 4 Adoption & Utilization • Pediatric Launch • Project CARE Execution 2025
Slide 121: NeuroPace Vision and Long Range Plan Objectives
NeuroPace Vision and Long Range Plan Objectives Market Leader with LRP Revenue Growth of 20%+ CAGR Indication expansion to Idiopathic Generalized and Pediatric DRE patients Neuromodulation category leader in efficiency and ease of use with AI Tools and Remote Programming Significantly expanded patie
Slide 122: Financial Performance
Financial Performance Total Cash Balance of approximately $52.8M (as of 12/31/2024) provides sufficient capital to support key operating priorities Preliminary Preliminary $21.1 $21.0 - $21.5 4Q24 FY2024 (unaudited) (unaudited) $19.3 Revenue $21.0M - $21.5M $79.4M - $79.9M* Revenue growth (y/y) 17%
Slide 123: 2025 Guidance
2025 Guidance Revenue $92 million - $96 million Gross Margin 73% - 75% $92 million - $95 million including approximately Operating Expenses $11 million in stock-based compensation Key Revenue Assumptions • Growth primarily driven by sales of RNS System • No contribution from approved new indications
Slide 124: The Brain is the Next Frontier
The Brain is the Next Frontier • I feel about the Brain today the way I felt about the left atrium and the left ventricle in 1995 – I believe that the Brain is the next frontier in Med Tech • RNS System is only closed loop neuromodulation system • Multiple clinical, product and market development in
Slide 125: Questions?
Questions?
Slide 126: Thank you!
Thankyou! 63 NELROPACE