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WHEN YOUR PATH IS UNCLEAR, WE POINT THE WAY . Nasdaq: CLPT November 2025
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DISCLAIMERThis presentation and discussion contain forward-looking statements within the context of the federal securities laws, including the Company’s expectation for revenues, gross margin, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of the Company’s products and services, the Company’s belief about the outcome of regulatory interactions with respect to its biotech partners’ therapies, the timing of commercialization of such therapies, the market potential for such therapies, the anticipated adoption of the Company’s products and services for use in the delivery of gene and cell therapies, and other performance and results. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: macroeconomic and inflationary conditions; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of the Company’s biotech partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s ability to maintain its current relationships with biotech partners or enter into new relationships with such partners; the Company’s biotech partners’ risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech partners’ therapies; the limitation or modification of the FDA’s eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company’s biotech partner’s continued use of the Company’s products and services in their delivery of gene and cell therapies; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products and the new products of its biotech partners. For a detailed description of the Company’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. 2© 2025 CLEARPOINT NEURO
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OUR COMPANYWe Enable Cell, Gene and Device Therapies by Offering Precise Navigation to the Brain and Spine Our Unique Platform Includes Both Proven Clinical Products Used by Neurosurgeons, and Drug Development Services Used by BioPharma Partners 3© 2025 CLEARPOINT NEURO
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CLEARPOINT NEURO EXECUTIVE SUMMARY 15+ years building a complete drug delivery ecosystem including navigation solutions, predictive modeling, delivery devices, infusion monitoring software and clinical case support Combination device success, proprietary technology and deep FDA experience provide our BioPharma partners with a meaningful head start, and our investors with a Portfolio-like biotech strategy An expanding global installed base of regional treatment centers are scaling capacity to be ready for additional cell and gene therapy patients to be treated with a unified platform Evolved beyond the MRI and into operating room CT navigation, laser ablation therapy, surgical access tools and preclinical CRO services which fuel growth via new product launches and provide path to profitability Our dedicated team of engineers, scientists and clinical specialists wake up every morning focused on the future of neurosurgery and drug delivery - This is all that we do… A UNIQUE PLATFORM TECHNOLOGY USED FOR CELL AND GENE THERAPY DELIVERY CURRENT PORTFOLIO PROVIDES ACCESS TO A ≈$500M MARKET OPPORTUNITY TODAY 100+ ACTIVE GLOBAL CENTERS A GROWING & PASSIONATE TEAM 4© 2025 CLEARPOINT NEURO A $10B POTENTIAL MARKET DIVERSIFIED ACROSS 60+ PARTNERS, 20+ INDICATIONS* *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies
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Neurological diseases cost Americans nearly $800 billion annually. The only way to decrease these costs is to improve treatment. Despite some available treatments, very few of these patients undergo a direct surgical intervention to improve their quality of life…© 2025 CLEARPOINT NEURO5 More than 30 million people in the U.S. are estimated to suffer from severe and debilitating neurological disorders:•Parkinson’s Disease (≈1,000,000)•Essential Tremor (≈7,000,000)•Epilepsy (≈2,900,000)•Huntington’s Disease (≈41,000)•Rare Childhood Genetic Disorders (≈25,000) •Dementia and Alzheimer’s Disease (≈6,900,000)•Tumor and Glioblastoma (≈280,000)•Severe OCD (≈1,000,000)•Treatment Resistant Depression (≈2,900,000)•ALS and Spinal Cord Injury (≈300,000)•Stroke Rehabilitation (≈7,000,000)•Neuropathic Pain (≈2,000,000) The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAYOur Company Sources on file at ClearPoint Neuro
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We will Enable fast, minimally invasive, asleep procedures for a more comfortable and predictable patient experience… © 2025 CLEARPOINT NEURO6 We will partner to Develop Device, Cell and Gene Therapies that may cure the underlying disease and restore function… Our Goal is to Help More Patients by Addressing Two Primary Barriers to Treatment Our Company 1 2 The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAY
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© 2025 CLEARPOINT NEURO7 Partners have programs selected for expedited review - the FDA recognizes the urgency The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAYOur Company 9 Partner has received FDA approval for a neuro gene therapy that is co-labeled with ClearPoint1
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9 Active Clinical-Stage Partners have been selected for expedited review, including: AADC DeficiencyHuntington’s DiseaseParkinson’s DiseaseEpilepsy (MTLE)Parkinson’s Disease Parkinson’s DiseaseFrontotemporal Dementia RMAT- -- Indication Fast Track - --- Clinical StatusApprovedTrials in US, EUTrials in NorthAmTrials in the USTrials in US, EU Trials in the USTrials in US, EU The Future of Cell and Gene Therapy is Not Coming…it is HERE TODAYOur Company © 2025 CLEARPOINT NEURO8 Hunter Syndrome (MPSII) Trials in US, Brazil Friedreich’s Ataxia - Trials in the USUndisclosed
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In 2025 Our Journey Enters the NEXT CHAPTEROur Company © 2025 CLEARPOINT NEURO9 Discovery. Design.•Neurosurgeon-Led Ideation •Unique MRI Navigation•Initial FDA Clearance and Product Revenue•Accumulation of Clinical Trial Experience Using SmartFlow•Maestro A.I. Software Development •Initial IP Generation and Licenses•NASDAQ Listed Funded. Foundation.•100+ Activated Customers•60+ Biopharma Partners•20+ Potential Disease Indications*•Preclinical Team Creation•Operating Room Product Launch•Laser Therapy Product Launch•100+ Owned & Licensed Patents•EU MDR Certification•Expanded, Audit-Ready Manufacturing in California•Leadership Team Complete Fast. Forward. •Grow into an estimated, existing $500M Market Opportunity•150 Activated Customers•First Commercial CGT Launched•GLP Preclinical Capability•Operating Room Nav Growth•Laser Therapy Growth•MR Drill and Access Growth•‘Harmony’ Software Launch •New Routes of Administration•Operational Cash Breakeven Essential. Everywhere.•$10B Potential Revenue Opportunity•‘Combination Product’ Regulatory Designation for multiple cell and gene therapy indications•Meaningful Revenue from Sophisticated BioPharma Deal Structures beyond product sales including royalty and milestone payments, co-development•One Unified Platform with both MR and Operating Room Capability and Workflows•Additional Global Regulatory Approvals Beyond the U.S. and E.U. 2010 - 2020 2021 - 2024 2025 - 2027 2028+ *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies
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Our Start: Unique Neurosurgery Navigation Guided by Live MRIDiscovery. Design. © 2025 CLEARPOINT NEURO10 Neurosurgery has traditionally been done via open craniotomy or by using CT guidance in the operating room The historical limitations of CT accuracy would often require patients to remain awake for hours-long brain surgery to confirm the location and impact of technologies like DBS ClearPoint believed that building a navigation system that could harness the power of live MRI would be accurate enough that the patient could be comfortably asleep for this minimally invasive procedure The ClearPoint SmartFrame family of products uses MR-safe materials and enables surgeons to Decide, Guide & Confirm using live MR Imaging to achieve sub-millimetric accuracy
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Our Start: Decide, Guide & ConfirmDiscovery. Design. © 2025 CLEARPOINT NEURO11 Three Primary Use Cases demonstrate the value of the ClearPoint Neuro Navigation System: 1.Functional neurosurgeons could confidently place DBS electrodes with the patient comfortably asleep 2.Neuro-oncologists could perform entire tumor laser ablations in one room instead of having to transport the patient from the OR to the MRI 3.BioPharma researchers could confirm that cell and gene therapies are not only delivered to a precise location, but could also confirm proper coverage of the target structure before closing the patient Pre-Plan Trajectoryand D E C I D EEntry Point Automatically G U I D EPrecision Adjustments Prior to Insertion C O N F I R MQuality of Delivery IntoPermanent Record
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Our Start: Assemble the Building BlocksDiscovery. Design. © 2025 CLEARPOINT NEURO12 Leveraging our unique platform and dedicated team, we developed and acquired essential technologies necessary to complete the entire ecosystem for MR-Guided Navigation with a focus on cell and gene therapy delivery SmartFlow Cannula(FDA and CE Marked, more than 8,000 cannulas sold to date) Radial Branching Cell Therapy Devices and Spinal Infusion Anchors(Investigational Use Only) ClearPoint Maestro Brain Model Segmentation and Image FusionBiophysical Modeling of patient specific drug infusions(Investigational Use Only) SmartFrame XG and Surgical Accessory Kit 3D Peri-procedural Infusion Monitoring Software (Investigational Use Only)
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Building the BusinessFunded. Foundation. © 2025 CLEARPOINT NEURO13 ClearPoint Neuro Navigation Software v.2.2.1 ClearPoint ArraySoftware v.1.2 ClearPoint MaestroBrain Model SmartFrame XGAnd accessories SmartFrame ORwith ClearPointer Inflexion HeadFixation Frame SmartFrame ArrayAnd accessories ClearPoint PrismNeuro Laser Fibers ClearPoint Prism Neuro Laser Therapy System VelocityPower Drill SmartFlow Cannula Radial Branching Cell Therapy Devices& Spinal Infusion Anchors(Investigational Use Only) ClearPoint Neuro built a complete and unique ecosystem of clinical and preclinical products and has achieved regulatory approvals in multiple geographies This proven technology has more than 10 years of experience and been used in more than 7,000 procedures to date Demand for our platform has grown driven by the promise of cell and gene therapies, new DBS indications, and the expansion of laser therapy ClearPoint Neuro activated a record 25 new Global Customers in 2024
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Building the Business: Our Four-Pillar Growth Strategy Remains Our FoundationFunded. Foundation. © 2025 CLEARPOINT NEURO14 BIOLOGICS & DRUG DELIVERY1NEUROSURGERY NAVIGATION2 VISUALASELASER THERAPY & ACCESS3 CLEARPOINT NAVIGATION IS COMPATIBLE WITH MAJOR DIAGNOSTIC AND INTRAOPERATIVE MRI AND CT SCANNERS GLOBAL SCALE4 100+ GLOBAL CENTERS 60+ INDUSTRY & ACADEMIC PARTNERS
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Albany Medical Center HospitalBanner Health TucsonBaptist Hospital of MiamiBaptist Memorial Hospital-MemphisBarnes-Jewish HospitalBarrow Neurological Institute/St. Joseph's HospitalBayCare Health SystemBenioff Children's HospitalBeth Israel DeaconessBoston Children's HospitalBrigham & Women's HospitalBrown University / Rhode Island HospitalCarilion ClinicChildren's Hospital of AlabamaChildren’s Mercy HospitalChildren's National HospitalCHOA Scottish RiteCincinnati Children's HospitalCincinnati Jewish HospitalCleveland Clinic HospitalCook Children's HospitalCooperman Barnabas Medical CenterCorewell HealthDallas Presbyterian HospitalDartmouth-HitchcockDuke UniversityEmory UniversityFroedtert HospitalHackensack University Medical CenterHenry Ford HealthHenry Ford West Bloomfield HospitalHospital of University PennsylvaniaHouston Methodist HospitalINOVA FairfaxJFK University Medical CenterJohns Hopkins UniversityKaleida HealthKettering HealthLoma Linda University HealthLucile Packard Children's HospitalMassachusetts General HospitalMayo Clinic in Arizona Mayo Clinic in FloridaMD Anderson Cancer CenterMedStar Georgetown University HospitalMemorial Sloan-Kettering Cancer CenterMethodist Hospital San AntonioMt. Sinai WestNationwide Children'sNorthwestern Central DuPageOchsner Medical CenterOhio State East HospitalOhio State UniversityOregon Health & Science UniversityOrlando Health Arnold Palmer Hospital for ChildrenPrisma HealthRiverside Methodist HospitalRutgers/Robert Wood JohnsonSan Francisco VA Health Care SystemSouthern Arizona VA Health Care SystemStanford UniversitySunnyside Kaiser PermanenteTampa General HospitalTexas Children's HospitalUniversity Hospital San AntonioUniversity of Alabama at BirminghamUniversity of California Los AngelesUniversity of California San DiegoUniversity of California San FranciscoUniversity of ColoradoUniversity of Florida JacksonvilleUniversity of Kansas Medical CenterUniversity of Maryland Medical CenterUniversity of MichiganUniversity of MinnesotaUniversity of North Carolina (UNC) HealthUniversity of Oklahoma Medical CenterUniversity of UtahUniversity of WisconsinUSC Keck HospitalUT Southwestern Medical CenterWolfson Children’s HospitalYale University Charité –Universitätsmedizin Berlin (Berlin, Germany)Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Milan, Italy)Great Ormond Street Hospital (London, UK)Hôpital Fondation Rothschild (Paris, France)Hospital Israelita Albert Einstein (São Paulo, Brazil)Hospital Santa Joana (Recife, Brazil)Mazowiecki Szpital Bródnowski (Warsaw, Poland)Policlinico Umberto I (Rome, Italy)Rigshospitalet (Copenhagen, Denmark)Sahlgrenska Universitetssjukhuset (Gothenburg, Sweden)Skänes Universitetssjukhus Lund (Lund, Sweden)Santobono Children’s Hospital (Naples, Italy)Universitätsklinikum Tübingen (Tübingen, Germany)Universitätsklinikum Düsseldorf (Düsseldorf, Germany)Universitätsklinikum Freiburg (Freiburg, Germany)University Hospital of Wales (Cardiff, UK) Charles River Labs (Laval, Canada)Charles River Labs (Lyon, France)Charles River Labs (Mattawan, Michigan) Children's Hospital of PhiladelphiaLabcorp (Madison, Wisconsin)Prisys Biotechnologies (Shanghai, China)TIDU GENOV - Institut du Cerveau (Paris, France)University of Pennsylvania Gene Therapy United States CentersInternational CentersPreclinical Centers 100+GLOBAL CENTERS NOW ACTIVATED 15© 2025CLEARPOINT NEURO
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Building the BusinessFunded. Foundation. © 2025 CLEARPOINT NEURO16 We have invested in the Development, Quality and Supply infrastructure to build confidence for both hospitals and BioPharma partnersWe are not a start-up company but an experienced and sophisticated medical device extension for any cell and gene therapy company ClearPoint Neuro assets available to our partners:•HQ & Training Facility in Solana Beach, California•Research Laboratory in San Diego, California•Manufacturing Facility in Carlsbad, California•ISO 13485 / MDSAP / EU MDR Certified QMS•Significant and positive experience with BioPharma Audits, FDA and Global Notified Body inspections
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Building the BusinessFunded. Foundation. © 2025 CLEARPOINT NEURO17 Key Products: Marked Platforms EMPLOYEES100+ 2024 REVENUE $31.4M(A) CASH & CASH EQUIVALENTS$38.2M(B) HEADQUARTERSSolana Beach, CA GROSS MARGIN61%(B,D) MANUFACTURINGCarlsbad, CA (A)For the year ended December 31, 2024(B)Unaudited, as of, and for the quarter ended, September 30, 2025(C)Including owned and licensed patents(D)For the Trailing Twelve Months (TTM) PATENTS ISSUED100+(C) 2024 Operational Cash Burn($9.0M) (A) Hostius polibu atus patiaedi, esct lorestimo conduces2018201920202021202220232024 23.8% CAGR $7.4$11.2$12.8$16.3$20.6$24.0 $31.4 27% CAGR 2025 (est.) $36 - $38 (est.)
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Building the BusinessFunded. Foundation. © 2025 CLEARPOINT NEURO18 Joe BurnettPresident & Chief Executive OfficerDanilo D’ AlessandroChief FinancialOfficerJeremy StigallChief Business OfficerMazin SabraChief OperatingOfficerEllisa CholapraneeGeneralCounsel Megan FaulkenberryVice President of Quality Mary McNamara-CullinaneVice President of Regulatory AffairsRob KornVice President U.S. Commercial SalesLyubomir Zagorchev, PhDVice President of Clinical Science & ApplicationsErnesto Salegio, PhDVice President of Translational & Preclinical Research EXECUTIVE LEADERSHIP TEAMExperienced leadership team with decades of leadership in medical devices, pharmaceuticals, and clinical research.
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In 2025 Our Journey Enters the NEXT CHAPTEROur Company © 2025 CLEARPOINT NEURO19 Discovery. Design.•Neurosurgeon-Led Ideation •Unique MRI Navigation•Initial FDA Clearance and Product Revenue•Accumulation of Clinical Trial Experience Using SmartFlow•Maestro A.I. Software Development •Initial IP Generation and Licenses•NASDAQ Listed Funded. Foundation.•100+ Activated Customers•60+ Biopharma Partners•20+ Potential Disease Indications*•Preclinical Team Creation•Operating Room Product Launch•Laser Therapy Product Launch•100+ Owned & Licensed Patents•EU MDR Certification•Expanded, Audit-Ready Manufacturing in California•Leadership Team Complete Fast. Forward. •Grow into an estimated, existing $500M Market Opportunity•150 Activated Customers•First Commercial CGT Launched•GLP Preclinical Capability•Operating Room Nav Growth•Laser Therapy Growth•MR Drill and Access Growth•‘Harmony’ Software Launch •New Routes of Administration•Operational Cash Breakeven Essential. Everywhere.•$10B Potential Revenue Opportunity•‘Combination Product’ Regulatory Designation for multiple cell and gene therapy indications•Meaningful Revenue from Sophisticated BioPharma Deal Structures beyond product sales including royalty and milestone payments, co-development•One Unified Platform with both MR and Operating Room Capability and Workflows•Additional Global Regulatory Approvals Beyond the U.S. and E.U. 2010 - 2020 2021 - 2024 2025 - 2027 2028+ *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies
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We are Pointing the Way for a Cell and Gene Therapy Future: Fast. Forward. Fast. Forward. Our commitment to hospitals & BioPharma partners is to help prepare for tens-of-thousands of anticipated new patients who will be seeking these restorative therapies1.Extend Our Lead in Neuro Drug Delivery by leveraging our complete and unique ecosystem of both products and drug development services 2.Evolve our Portfolio to focus on fast, simple, predictable procedures in both the MRI and Operating Room to increase hospital throughput 3.Expand our Base of global activated centers to increase capacity and ensure access of these novel cell and gene therapies © 2025 CLEARPOINT NEURO20
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3LASER THERAPY & ACCESS 2NEUROSURGERY NAVIGATION BIOLOGICS & DRUG DELIVERY 20272025 COMPLETE PRISM LASER & VELOCITY DRILL LAUNCHES 4GLOBAL SCALEACTIVATE 150 CENTERS & GROW REVENUE FASTER THAN OPEX © 2025 CLEARPOINT NEURO21 1ADD PRECLINICAL GLP SERVICES & NEW ROUTES OF ADMINISTRATION EXPAND INTO THE OPERATING ROOM & CREATE A UNIFIED SOFTWARE PLATFORM Fast. Forward.OUR FOUR PILLAR GROWTH STRATEGYCONTINUES 2025-2027
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3LASER THERAPY & ACCESS 2NEUROSURGERY NAVIGATION BIOLOGICS & DRUG DELIVERY 20272025 Add 1.5 Tesla PRISM for full market accessAdd Ablation Coverage & Predictive Thermal ModelingLaunch MRI Conditional Power Drill to reduce procedure time 4GLOBAL SCALEExpand Global Footprint to 150+ CentersPerform Procedures w/ Remote Clinical SupportShow path to 70%+ Margins & Cashflow Breakeven © 2025 CLEARPOINT NEURO22 1Expand Neuro Preclinical CRO Services and Capacity to include larger GLP Study CapabilityExpand Partnerships to Include Co-Development, Commercial Pricing, Drug Clinical Milestones & Royalty Based AgreementsExecute on Development Pipeline for Drug Infusion Monitoring/Modelling, Intracranial Cell Therapy and Spinal Routes of Administration Show Compatibility with Existing Third-Party Navigation w/ SmartFrame ORExpand into the Operating Room w/ ClearPoint Duet and 3.0 SoftwareLaunch Maestro CT, Non-Rigid Fusion, Area-of-Activation and DTI Harmony Software Fast. Forward.OUR FOUR PILLAR GROWTH STRATEGYCONTINUES 2025-2027
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GLP Services & New Routes of AdministrationFast. Forward. Market Growth Drivers:•Improved BioPharma funding environment•Additional cell and gene therapies entering the ‘funnel’•Partner progression into larger spend GLP studies and clinical trials•Successful implementation of FDA ‘Expedited Review’ pathways including RMAT offering faster clinical trials and less capital requiredMarket Share Drivers:•Addition of GLP capability and increased study capacity •Expansion to ClearPoint Advanced Laboratories (‘CAL’)•Product portfolio expansion including new routes of administration•More custom-development and strategic partnerships w/ BioPharma 23© 2025 CLEARPOINT NEURO GLP Preclinical Services and Image Analysis Lab(Expected 2H 2025) New Routes of Administration(Investigational Use Only)Coverage Estimation and Biophysical modeling(Investigational Use Only) 2025 Estimated Preclinical & Clinical Trial Market (≈$300M) Consulting, Bench Testing and Co-Development ServicesPilot Pre-Clinical Testing (non-GLP)FDA Submission Preclinical Testing (GLP)Clinical Trial Products & Support ServicesCurrent CLPT Share Assumptions:150 active cell and gene therapy programs globally7.5 years average program duration200 patients studied clinically on average as part of trials Estimated Market Size, Growth Drivers, and Share Drivers are based on internal estimates and assumptions, market trends, and customer insights. Assumptions may not reflect actual future performance.
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Market Growth Drivers:•Asleep DBS FDA Clearance and Patient Awareness•New DBS Indications including Epilepsy, OCD, Depression, BCI•Increased hospital throughput of laser therapy compared to open surgery•Improved laser insurance decisions and awareness•Additional global approvalsMarket Share Drivers:•3.0 Software for proficient, mirrored CLPT workflow in the MRI and OR•Asleep, simultaneous workflows for fast procedures, low radiation•1.5 Tesla PRISM Laser approval for full market access•Velocity Alpha MR Drill for faster cranial access times Neuro Navigation, Therapy and Access Product GrowthFast. Forward. 2025 Estimated Neuro Navigation, Laser Therapy & Cranial Access Market (≈$200M) Neuro NavigationLiTT DevicesCranial Acc ess DevicesCLPT Share 24© 2025 CLEARPOINT NEURO SmartFrame OR and ClearPointer™ClearPoint 3.0 Software w/ CT Functionality(FDA Cleared January 2025) SmartFrame DUET w/ flexible MRI & CT workflows(Expected 2026) 1.5 Tesla PRISM(FDA Cleared September 2025) Adeor Velocity MRI Conditional Power Drill(Pending FDA Clearance) Estimated Market Size, Growth Drivers, and Share Drivers are based on internal estimates and assumptions, market trends, and customer insights. Assumptions may not reflect actual future performance.
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In 2025 Our Journey Enters the NEXT CHAPTEROur Company © 2025 CLEARPOINT NEURO25 Discovery. Design.•Neurosurgeon-Led Ideation •Unique MRI Navigation•Initial FDA Clearance and Product Revenue•Accumulation of Clinical Trial Experience Using SmartFlow•Maestro A.I. Software Development •Initial IP Generation and Licenses•NASDAQ Listed Funded. Foundation.•100+ Activated Customers•60+ Biopharma Partners•20+ Potential Disease Indications*•Preclinical Team Creation•Operating Room Product Launch•Laser Therapy Product Launch•100+ Owned & Licensed Patents•EU MDR Certification•Expanded, Audit-Ready Manufacturing in California•Leadership Team Complete Fast. Forward. •Grow into an estimated, existing $500M Market Opportunity•150 Activated Customers•First Commercial CGT Launched•GLP Preclinical Capability•Operating Room Nav Growth•Laser Therapy Growth•MR Drill and Access Growth•‘Harmony’ Software Launch •New Routes of Administration•Operational Cash Breakeven Essential. Everywhere.•$10B Potential Revenue Opportunity•‘Combination Product’ Regulatory Designation for multiple cell and gene therapy indications•Meaningful Revenue from Sophisticated BioPharma Deal Structures beyond product sales including royalty and milestone payments, co-development•One Unified Platform with both MR and Operating Room Capability and Workflows•Additional Global Regulatory Approvals Beyond the U.S. and E.U. 2010 - 2020 2021 - 2024 2025 - 2027 2028+ *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies
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© 2025 CLEARPOINT NEURO26 Partners have programs selected for expediated review - the FDA recognizes the urgency The FDA & Global Notified Bodies Recognize the UrgencyEssential. Everywhere. 9 Partner has received FDA approval for a neuro gene therapy that is co-labeled with ClearPoint1
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ClearPoint has 60+ Active BioPharma Programs across 20+ indications including DBS, LiTTEssential. Everywhere. © 2025 CLEARPOINT NEURO27 BENCHTOP TESTING PRECLINICAL STUDIES •Device Compatibility Testing•Infusion Pump Testing •Custom Device Development•Performance Assessment•Device Comparisons / Bridging •Running Preclinical Studies•Surgical Planning & Guidance•Writing IACUC / Study Protocols•Dosing and Surgical Support•Post-Infusion Reporting •Surgical Guidance•Procedure Pre-Planning•On-Site Clinical Support•Inventory Management•Data / Infusion Reporting CLINICAL TRIALS
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Sophisticated Partnerships are Enabled by the ClearPoint Ecosystem of Products & Services Essential. Everywhere. © 2025 CLEARPOINT NEURO28 ClearPoint May Provide to BioPharma:•Assurance of Supply•Access to FDA Device Dossier•Redundant Global Manufacturing•Contracted Commercial Pricing•Licenses to Key Intellectual Property•Custom Device Development•Clinical Specialist Procedural Support•Dedicated Inventory Locations•Extensive Audit Access & Experience•Supply Continuity and Reliability We provide the creative flexibility to structure agreements as an essential and long-term supplierClearPoint May Secure from BioPharma:•Demand Planning•Purchasing Commitments•Minimum Device Purchases•Co-Development Design Fees•Strategic Retainer Agreements•Clinical Milestone Payments•Premium Commercial Pricing•Royalties on Drug Revenue•Preclinical Service Purchases•Multiple Program Collaborations
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ClearPoint Neuro is Diversified Across:•60+ BioPharma Partners•20+ Indications including device, cell and gene therapies•Redundant Partners for multiple indications•Many Partners with multiple programs •Additional device treatments including DBS, Laser, BCIMany shots on goal with a path to operational cash breakeven: If just 1% of patients with diseases under expedited review are treated each year, at current ASPs that would yield more than $250M in additional CLPT revenue© 2025 CLEARPOINT NEURO29 CLPT is like a Portfolio of BioPharma without drug development costs or binary outcomesEssential. Everywhere. More than 30 million people in the U.S. are estimated to suffer from severe and debilitating neurological disorders:•Parkinson’s Disease (≈1,000,000)•Essential Tremor (≈7,000,000)•Epilepsy (≈2,900,000)•Huntington’s Disease (≈41,000)•Rare Childhood Genetic Disorders (≈25,000) •Dementia and Alzheimer’s Disease (≈6,900,000)•Tumor and Glioblastoma (≈280,000)•Severe OCD (≈1,000,000)•Treatment Resistant Depression (≈2,900,000)•ALS and Spinal Cord Injury (≈300,000)•Stroke Rehabilitation (≈7,000,000)•Neuropathic Pain (≈2,000,000)
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CLEARPOINT NEURO EXECUTIVE SUMMARY 15+ years building a complete drug delivery ecosystem including navigation solutions, predictive modeling, delivery devices, infusion monitoring software and clinical case support Combination device success, proprietary technology and deep FDA experience provide our BioPharma partners with a meaningful head start, and our investors with a Portfolio-like biotech strategy An expanding global installed base of regional treatment centers are scaling capacity to be ready for additional cell and gene therapy patients to be treated with a unified platform Evolved beyond the MRI and into operating room CT navigation, laser ablation therapy, surgical access tools and preclinical CRO services which fuel growth via new product launches and provide path to profitability Our dedicated team of engineers, scientists and clinical specialists wake up every morning focused on the future of neurosurgery and drug delivery - This is all that we do… A UNIQUE PLATFORM TECHNOLOGY USED FOR CELL AND GENE THERAPY DELIVERY CURRENT PORTFOLIO PROVIDES ACCESS TO A ≈$500M MARKET OPPORTUNITY TODAY 100+ ACTIVE GLOBAL CENTERS A GROWING & PASSIONATE TEAM 30© 2025 CLEARPOINT NEURO A $10B POTENTIAL MARKET DIVERSIFIED ACROSS 60+ PARTNERS, 20+ INDICATIONS* *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies
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Sources © 2025 CLEARPOINT NEURO31 SourcesAlzheimer's Association 2024 Alzheimer's Disease Facts and FiguresHow Many People in the USA Have Essential Tremor? Deriving a Population Estimate Based on Epidemiological Data - PMCParkinson's Disease: Challenges, Progress, and Promise | National Institute of Neurological Disorders and StrokeEpilepsy Facts and Stats | Epilepsy | CDCPrevalence of Huntington’s Disease in the US (954) | NeurologyWhat is Friedreich's ataxia? - Friedreich's Ataxia Research AllianceAngelman syndrome | About the Disease | GARDBrain Tumor Factshttps://pmc.ncbi.nlm.nih.gov/articles/PMC3250269/#Abs1Amyotrophic lateral sclerosis estimated prevalence cases from 2022 to 2030, data from the National ALS Registry | National ALS Registry | CDCSpinal Cord Injury Prevalence In The U.S. | Reeve FoundationAbbott Initiates Clinical Study to Evaluate the Use of Its Deep Brain Stimulation System to Manage Severe Depression - Sep 4, 2024The prevalence of neuropathic pain: Clinical evaluation compared with screening tools in a community population - PMCDeep brain stimulation for obsessive-compulsive disorder: A systematic review of worldwide experience after 20 years - PMCHow common is OCD?Burden of Neurological Disorders Across the US From 1990-2017: A Global Burden of Disease Study | Dementia and Cognitive Impairment | JAMA Neurology | JAMA Network