1. Executive Summary

Investment Thesis

Cardio AI represents an extraordinary investment opportunity at the intersection of artificial intelligence and cardiovascular healthcare. The company is developing the first comprehensive, multi-agent AI platform for cardiovascular care while demonstrating world-class operational efficiency with 60% EBITDA margins. With $10.26 billion in projected revenue and $6.16 billion in EBITDA over five years—requiring current seed round of $5M and subsequent Series A & B rounds—Cardio AI offers investors unprecedented returns in the $187 billion AI healthcare market.

Investment Highlights

• Massive Market Opportunity: $187B global AI healthcare market, $52.4B cardiovascular AI segment growing 37-40% annually
• Exceptional Financial Performance: $10.26B revenue, $6.16B EBITDA (60% margins) over 5 years
• Immediate Profitability: $30.6M EBITDA in Year 1 - no burn period, no bridge financing
• Extraordinary Capital Efficiency: 1,231x return on $5M seed round and $25M Series A round
• World-Class Operating Margins: 60% EBITDA margins, 2x better than best-in-class SaaS
• First Comprehensive Platform: Only unified solution combining risk, diagnostics, imaging, and monitoring
• Rapid Market Leadership: 50,000 → 2.5M members (50x growth), 20% market share by Year 5
• Defensible Women's Health Moat: Only comprehensive solution in $500B market
• Proven Regulatory Pathway: Clear FDA 510(k) route with 100+ precedent AI cardiovascular devices
• Multiple High-Value Exits: $10-15B IPO or strategic acquisition by tech/healthcare giants

The Problem

Cardiovascular disease remains the leading cause of death globally, responsible for 17.9 million deaths annually (32% of all deaths) and costing the U.S. healthcare system over $555 billion per year. The healthcare system faces critical challenges:

• Severe Specialist Shortage: 25% of U.S. population in areas with inadequate cardiology coverage; 29-day average wait times
• Fragmented Care Delivery: Disconnected point solutions for ECG, imaging, labs, and risk assessment
• Algorithmic Bias Crisis: Women face 50%+ misdiagnosis rates; CVD is #1 killer of women
• Rising Disease Burden: 121.5M Americans (48% of adults) have cardiovascular disease
• Unsustainable Costs: Global CVD economic burden exceeds $1.1 trillion annually

Our Solution

Cardio AI delivers the industry's first unified Master Orchestrator coordinating three integrated subsystems for comprehensive cardiovascular care. Complete cardiac workup in 2-3 minutes versus hours with traditional approaches.

2. Company Overview

Mission

To save lives and improve patient outcomes by providing healthcare providers with a unified AI-powered platform that predicts, prevents, and manages cardiovascular disease across the entire care continuum.

Vision

To become the global standard for AI-driven cardiovascular care, serving 100M+ lives worldwide by 2030, where every heart patient benefits from proactive, AI-guided interventions that prevent emergencies, optimize treatments, and dramatically improve quality of life while reducing healthcare costs by 40%+.

Company Information

• Founded: 2024
• Headquarters: 6500 Emerald Parkway, Suite 100, Dublin, Ohio
• Additional Office: San Francisco, California
• Website: www.cardioailive.com
• CEO Email: ksampson@cardioailive.com
• Investment Inquiries: invest@cardioailive.com
• General Inquiries: Support@cardioailive.com
• Business Development: tonywell@cadrgioailive.com
• Phone: +1 (614) 967-8728

3. Market Analysis & Opportunity

Market Size & Growth

Total Addressable Market (TAM): $187 Billion

The global artificial intelligence in healthcare market represents a $187 billion opportunity experiencing explosive growth, with a projected CAGR of 37-40% through 2030. Key drivers include increased healthcare data digitization, cloud computing adoption, growing need for cost-effective solutions, and strong regulatory support for AI-powered medical technologies.

Serviceable Available Market (SAM): $52.4 Billion

Within the broader healthcare AI market, cardiovascular applications represent approximately 28% of the total addressable market. This includes AI-powered imaging analysis, risk prediction algorithms, clinical decision support systems, remote patient monitoring platforms, and comprehensive cardiovascular management solutions.

Serviceable Obtainable Market (SOM): $10.3 Billion

Based on Cardio AI's projected revenue of $10.26 billion over five years, the company is targeting approximately 20% of the serviceable available market. This aggressive but achievable target factors in first-mover advantages, superior technology, comprehensive platform capabilities, and strong execution across all customer segments.

Market Drivers

1. Massive Disease Burden

• Cardiovascular disease is the leading cause of death globally, responsible for 17.9 million deaths annually (32% of all deaths)
• 121.5 million Americans (48% of adults) have some form of cardiovascular disease
• Prevalence expected to increase 18-20% by 2030 due to aging populations and rising obesity rates
• Global economic burden exceeds $1.1 trillion annually, with U.S. cardiovascular costs alone surpassing $400 billion

2. Critical Healthcare System Pressures

• Severe shortage of cardiologists: 25% of U.S. population lives in areas with inadequate cardiology coverage
• Average wait time for cardiology appointments: 29 days (up from 19 days in 2014)
• 50% increase in cardiac imaging studies over past decade straining existing infrastructure
• Physician burnout: 63% of cardiologists report burnout from administrative burden and time constraints

3. Accelerating Technology Advancement

• Rapid improvements in AI/ML algorithms - deep learning accuracy now matches or exceeds human experts for many imaging tasks
• Increasing availability of large, diverse healthcare datasets enabling robust model training
• Cloud infrastructure costs declining 20-30% annually while capabilities expand
• IoMT device market growing at 28% CAGR - providing continuous, high-quality cardiovascular data
• 5G connectivity enabling real-time remote monitoring and AI analysis at scale

4. Value-Based Care Transformation

• Major shift from fee-for-service to value-based payment models incentivizing preventive care and outcomes
• CMS targeting 100% of Traditional Medicare in value-based arrangements by 2030
• AI tools enabling better risk stratification and targeted interventions - proven to reduce hospitalizations by 25-40%
• Demonstrated ROI: $3-5 return for every $1 invested in AI-powered preventive cardiovascular care
• Commercial payers increasing coverage for AI-powered diagnostic and monitoring services

Target Customer Segments

Primary Care Practices (35% of market)

Market Size: $18.3 billion annually

Profile: 200,000+ practices in U.S., 2-10 physicians each, managing cardiovascular risk in general patient populations

Value Proposition: Cardio AI Tier 1 and Tier 2 provide accessible risk calculators and diagnostic support, extending primary care cardiovascular capabilities

Cardiology Groups (30% of market)

Market Size: $15.7 billion annually

Profile: 15,000+ specialized cardiology practices, 5-25 physicians, high patient volumes requiring efficient diagnostic workflows

Value Proposition: Tier 2 and Tier 3 with advanced AI agents enhance diagnostic efficiency by 40-60% and improve accuracy

Hospital Systems & ACOs (30% of market)

Market Size: $15.7 billion annually

Profile: 6,100+ hospitals, 1,000+ ACOs, multi-facility health systems, academic medical centers

Value Proposition: Tier 3 Complete Platform with full integration, unlimited capacity, enterprise analytics, 25-30% reduction in readmissions

Women's Health & Specialty Clinics (5% of market)

Market Size: $2.6 billion annually

Profile: 40,000+ OB/GYN practices, women's health centers, maternal-fetal medicine specialists

Value Proposition: Women's Health module addressing gender-specific cardiovascular risk factors - only comprehensive solution in market

4. Product & Technology Overview

Platform Architecture

Cardio AI is built on a sophisticated Unified Master Orchestrator architecture that coordinates three specialized subsystems to deliver comprehensive cardiovascular care. The platform integrates real-time device monitoring, advanced AI diagnostics, medical imaging analysis, and validated risk prediction into a seamless clinical workflow that processes patient data from initial vital signs through final treatment recommendations.

Master Orchestrator: Central Coordination Engine

The Master Orchestrator serves as the central intelligence hub managing all subsystems with real-time task routing, load balancing, and state management. This sophisticated coordination layer ensures optimal resource utilization, automatic error recovery, and comprehensive performance monitoring across the entire platform.

• Task Routing: Intelligent routing of clinical tasks across all subsystems based on task type, priority, and system capacity
• Load Balancing: Optimal resource distribution ensures maximum efficiency and consistent performance
• State Management: Real-time tracking of all clinical workflows from initiation to completion
• Event Broadcasting: Instant alerts and notifications ensure clinicians receive critical information immediately
• Error Recovery: Automatic failover and retry mechanisms ensure continuous operation
• Metrics Collection: Comprehensive performance monitoring and analytics drive continuous improvement

CardioAI Platform - 7 Specialized AI Agents

The CardioAI Platform features seven specialized AI agents that work collaboratively to provide comprehensive cardiac analysis. Each agent is optimized for specific data types and clinical tasks, working in parallel to deliver rapid, accurate assessments.

• ECG Agent: Real-time electrocardiogram analysis with STEMI/NSTEMI detection <10 seconds, 20+ arrhythmia types, automated ICD-10 coding
• Echo Agent: Comprehensive echocardiography analysis with HFrEF/HFpEF assessment, valve function analysis, ejection fraction calculation (9.7% median deviation)
• Lab Agent: Biomarker analysis and trend detection including troponin/BNP, lipid profiles, temporal analysis
• Risk Agent: Predictive risk assessment using TIMI & GRACE scoring, mortality risk prediction, 10-year CVD prediction
• Diagnostic Agent: Evidence-based diagnostic synthesis integrating ECG, echo, lab, and risk data into unified clinical picture
• Treatment Agent: Personalized treatment recommendations with protocol generation, drug selection, dosage optimization
• Prognosis Agent: Outcome prediction and care planning with readmission risk, survival analysis, follow-up scheduling

5 CVD Risk Calculators (AI-Powered)

Cardio AI incorporates five validated cardiovascular disease risk calculators, each powered by AI to provide superior predictive accuracy. All calculators deliver predictions with 95% confidence intervals across 1-year, 5-year, and 10-year time frames.

• AMI (Acute MI): ≥0.80 C-statistic, 500K+ patient cohort, primary/secondary prevention screening, 1/5/10-year predictions
• Stroke Calculator: ≥0.78 C-statistic, 350K+ cohort, separate models for ischemic/hemorrhagic/TIA
• Heart Failure: ≥0.79 C-statistic, 400K+ cohort, separate HFrEF/HFpEF models, hospitalization prediction
• SCD (Sudden Cardiac Death): ≥0.78 C-statistic, 200K+ cohort, ICD placement guidance, risk-based recommendations
• AFib (Atrial Fibrillation): ≥0.80 C-statistic (highest accuracy), 450K+ cohort, stroke risk stratification, anticoagulation guidance

IoMT Platform - Remote Patient Monitoring

The Internet of Medical Things (IoMT) Platform enables continuous patient monitoring through integration with wearable devices and remote monitoring equipment. The platform supports four communication protocols and provides sub-second alert latency for critical events.

• Multi-Protocol Support: MQTT, HTTP/HTTPS, CoAP, WebSocket for diverse device ecosystems
• Device Registration: Seamless device onboarding with automated setup and patient association
• Telemetry Processing: Real-time data ingestion with Apache Kafka-based event streaming
• Alert Generation: ML-based anomaly detection with 15-day advance cardiac event warning
• Supported Devices: Apple Watch, Fitbit, Garmin, Omron BP monitors, Withings, KardiaMobile, AliveCor

PACS/DICOM Platform - Medical Imaging Analysis

The Picture Archiving and Communication System (PACS) integrates seamlessly with existing radiology infrastructure, providing AI-powered analysis of cardiac imaging studies. The platform features six specialized agents working in parallel to process DICOM images.

• DICOM Ingestion: C-STORE reception, C-FIND queries, automated metadata extraction
• Preprocessing: Image normalization, quality enhancement, artifact removal
• Segmentation: 4 parallel agents for cardiac chambers, vessels, myocardial boundaries (Dice 0.894)
• Quantification: Automated volume calculations, EF measurement (ICC 0.951), strain analysis
• Specialized Analysis: T1/T2 mapping, calcium scoring, perfusion analysis
• Disease Detection: HCM (AUC 0.93), cardiac amyloidosis (0.87), pulmonary arterial hypertension (0.85)

Women's Health - Obstetrics Cardiology Module

Specialized module addressing critical $500B maternal healthcare market with gender-specific algorithms for pregnancy-related cardiovascular risk assessment.

• The Crisis: CVD is #1 killer of women, 50% misdiagnosis rate, leading cause of maternal death
• Clinical Impact: 40-60% reduction in pregnancy CV emergencies, 70% reduction in postpartum readmissions
• Market Opportunity: $180B Obstetrics Cardiology, $150B Preventive, $100B Gender-Specific Diagnostics
• Economics: $500-1,500 cost per pregnancy → $30K-100K savings per high-risk case

Platform Performance Characteristics

• ECG Analysis Time: <10 seconds
• IoMT Alert Latency: <1 second
• DICOM Image Processing: <2 minutes per study
• Complete Cardiac Workflow: <5 minutes end-to-end
• System Uptime: 99.9% availability SLA
• Concurrent Capacity: 10,000+ simultaneous patients

5. Business Model & Pricing Strategy

Four-Tier PMPM Pricing Model

Cardio AI operates on a four-tier PMPM (per member per month) subscription model enabling scalability across all customer segments:

• Tier 1 ($30 PMPM): 7 Specialized AI Agents - Complete diagnostic support for primary care and cardiology practices
• Tier 2 ($50 PMPM): 5 CVD Risk Calculators - Multi-timeframe predictions with superior accuracy for preventive care
• Tier 3 ($100 PMPM): PACS/DICOM Platform - 16 AI agents for advanced cardiac imaging analysis
• Tier 4 ($40 PMPM): IoMT-RPM Platform - 24/7 remote monitoring with 15-day advance warning

Revenue Streams

• SaaS Subscription: Four-tier PMPM model with blended pricing growing from $85 to $190 over 5 years
• Per-Study Fees: ECG $25-50, Echo $75-150, MRI/CT $150-300, Multi-agent comprehensive $200-400
• Remote Patient Monitoring: $150-250/patient/month with device leasing, CPT code reimbursement (99453/99454/99457/99458)
• Clinical Trial Services: $500K-$5M per trial for pharmaceutical companies and research organizations

Unit Economics

Exceptional unit economics drive world-class profitability:

• Zero Marginal Cost: AI platform serves 2.5M members at same infrastructure cost as 50K
• Automated Acquisition: Product-led growth drives 40-50% of new customers through word-of-mouth
• Self-Service Platform: Automated onboarding, AI support handles 70% of tickets
• Revenue per Employee: Grows from $680K (Year 1) to $9.14M (Year 5)
• Gross Margins: 75% (Year 1) → 85% (Years 3-5)
• EBITDA Margins: Sustained 60% across all five years

6. Financial Projections

5-Year Revenue & EBITDA Projections

Key Financial Metrics

• Break-Even: Month 12 with 22,500 blended members
• Customer Acquisition Cost (CAC): $120K per customer
• Customer Lifetime Value (LTV): $5.6M (5-year, 10K members, complete platform)
• LTV/CAC Ratio: 47:1 (best-in-class)
• Retention Rate: 95%+ annually
• Payback Period: 2.2 months for IoMT-RPM alone

7. Go-to-Market Strategy

Phase 1: Foundation - Years 1-2 (2027-2028)

Target: 50,000 → 250,000 members

• Focus on progressive primary care practices and cardiology groups in value-based care arrangements
• Leverage pilot programs with 10-15 health systems to generate case studies and clinical validation data
• Demonstrate 25-40% reduction in adverse events through real-world evidence
• Establish reference customers in each major geographic market
• Build foundation for rapid scaling in subsequent years

Phase 2: Acceleration - Years 3-4 (2029-2030)

Target: 1M → 1.75M members

• Scale to mainstream primary care and cardiology markets using proof points from early adopters
• Aggressive enterprise sales to hospital systems and ACOs
• Launch Women's Health module with targeted marketing to 40,000+ OB/GYN practices
• Establish EHR vendor partnerships (Epic, Cerner, Oracle) for native integration and co-marketing
• Expand sales team from 25 to 100+ representatives

Phase 3: Dominance - Year 5+ (2031+)

Target: 2.5M+ members, market leadership

• Establish Cardio AI as category-defining comprehensive cardiovascular AI platform with 15-20% market share
• Begin international expansion: Canada (Year 5), UK/Western Europe (Year 6), Asia-Pacific (Year 7)
• Strategic M&A to acquire complementary technologies and eliminate competition
• Prepare for $10-15B IPO or strategic acquisition by major tech/healthcare company

Sales Channels

• Direct Sales: Enterprise team targeting health systems and large medical groups
• Channel Partners: Healthcare IT companies, EHR vendors for broader market reach
• GPO Contracts: Group Purchasing Organization agreements for hospital systems
• Professional Societies: Partnerships with ACC, AHA for credibility and access

8. Competitive Analysis

Direct Competitors

Aidoc - $250M valuation

Focused primarily on radiology AI with limited cardiovascular-specific features. Strong in acute stroke detection but lacks comprehensive risk assessment. Single-modality solution.

HeartFlow - $2.4B valuation, public (HRTX)

Specialized in coronary artery analysis from CT scans. Point solution, expensive ($1,500/study), requires specific imaging protocols. Limited to anatomical assessment.

Tempus - $8.1B valuation

Broad healthcare AI platform with some cardiovascular applications. Less specialized, primarily focused on oncology and precision medicine. Minimal cardiovascular market penetration.

Cardiologs - $150M valuation

AI-powered ECG interpretation specialist. Point solution, does not integrate broader risk assessment or multi-modal analysis. Limited to rhythm analysis.

Cardio AI Competitive Advantages

• Only Comprehensive Platform: First and only solution combining multiple risk calculators, multi-modal diagnostic AI, imaging analysis, and clinical decision support in one unified platform
• Women's Health Leadership: Specialized module addressing critical $2.6B market gap with zero direct competition
• Superior Economics: PMPM pricing ($30-$190) versus per-study ($500-1,500) - 70% lower cost with infinite scalability
• Complete Workflow Integration: Seamless EHR, IoMT, and PACS connectivity versus standalone point solutions requiring workflow disruption
• Four-Tier Scalability: Modular pricing serves all customer segments from small practices ($30/month) to health systems ($100-190/month)
• Clinical Validation: Evidence-based approach using five validated risk calculators meeting established ACC/AHA guidelines
• Exceptional Profitability: 60% EBITDA margins (2x industry leaders) enable aggressive pricing while maintaining superior returns
• 27 Total AI Agents: 7 diagnostic + 5 risk + 16 imaging + IoMT monitoring (industry-leading)

9. Leadership Team

Sampson Kontomah - Founder, CEO & Chief Product Architect

• 15+ years AI/ML product development and healthcare technology innovation
• Proven ability to scale revenue by 30%+ through strategic product development
• Deep expertise in AI algorithm development and deployment at scale
• Experience building and leading high-performing technical teams
• Responsible for overall company strategy, product vision, and execution

Dr. Tamanna Nahar, MD, MBA - Co-Founder, Executive President & Chief Medical Officer

• 25+ years clinical cardiology experience
• Board-certified nuclear cardiologist with extensive subspecialty training
• Former Chief of Cardiology, Harlem Hospital Center
• MBA focusing on healthcare innovation and operations management
• Expert in translating clinical needs into technology solutions
• Leads clinical strategy, regulatory affairs, and medical advisory board

Dr. Syed Khairul Bashar, PhD - Chief Research Scientist

• PhD Biomedical Engineering, University of Connecticut
• Postdoctoral research: Johns Hopkins University, Georgia Tech
• Published researcher in cardiovascular AI and machine learning
• Expertise in signal processing, deep learning, and medical device algorithms
• Leads AI research, algorithm development, and clinical validation studies

Andrew Young - Director of Investment & Government Relations

• 20+ years of experience leading high-impact fundraising strategies and strategic partnerships, having raised over $400 million across nonprofit, corporate, and government sectors
• Senior Partner at Positive Impact (2015-2025), expanded client base by 225% and led six to eight-figure fundraising campaigns for mission-driven organizations and elected officials
• Former Special Assistant in the U.S. Senate (1999-2004), co-drafted over 200 legislative initiatives and coordinated 1,000+ public events for Banking, Intelligence, and Veterans Affairs committees
• Juris Doctor from Wake Forest University School of Law and B.A. from University of North Carolina at Chapel Hill
• Strategic advisor to elected officials, academic leaders, and business executives; skilled in major donor cultivation, UHNW engagement, and business development for complex technology launches

Todd Wiltshire - Director of Finance & Investment

• Co-founded Pneumeric, Inc. as Chief Financial & Investment Officer, successfully structured and executed Seed and Series A funding rounds (46% over-subscribed), achieving FDA clearance with superiority claim in 18 months
• 14+ years at Fidelity Investments as Vice President - Capital Markets, grew Prime Services business unit from 10 FTE and $10M revenue to 45+ FTE and $300M+ revenue, making it the most profitable unit in Capital Markets
• MBA in Finance from Fordham University and B.A. in Government & Law from Lafayette College; extensive experience in financial strategy, capital raising, investor relations, and business development
• Raised $14M for Phase 2 clinical trials and negotiated $60M At-the-Market facility; increased Q1 2025 sales by 300%+ year-over-year and reduced manufacturing costs by 50%
• Led strategic growth initiatives including international market expansion generating $20M first-year incremental revenue and new product development achieving $27.5M-$36M in first-year revenues

Everlyn Ndirangu - Co-Founder & Chief Financial Officer

• Visionary financial strategist with a strong background in accounting, FP&A, and AI-driven forecasting
• Architected the financial strategy that fuels Cardio AI's growth—aligning capital decisions with mission-driven priorities and sustainable scaling
• Expert in financial modeling, fundraising, and systems integration; implemented ERP and predictive analytics solutions that optimize cash flow, accelerate reporting, and enhance investor confidence
• Leads capital-raising and investor relations efforts, forging partnerships that support Cardio AI's expansion in the healthcare and AI sectors
• Ensures operational precision, fiscal discipline, and long-term value creation as Cardio AI pioneers AI-powered cardiovascular diagnostics

Galax Womack - Chief Technology Officer (CTO)

• Experienced in building secure, scalable systems in healthcare, biotech, media, and communications
• Specializes in Python, Flask, Django, and AWS for robust backend development
• Led backend teams, designed telehealth platforms, and integrated complex EHR systems using FHIR and HL7
• Proficient in performance optimization, cloud architecture, and real-time data processing
• Expert in wearable device data integration and medical diagnostics system architecture

Kavya Bojja - Senior Backend Developer

• Experienced in backend development and training machine learning models
• Builds scalable APIs, deploys models using Vertex AI, and manages data preprocessing pipelines
• Proficient in Python, TensorFlow, FastAPI, Docker, Google Cloud Platform, and Git
• Expertise in developing production-ready ML systems and cloud-based infrastructure
• Contributes to Cardio AI's platform scalability and model deployment efficiency

Harshal Chalke - Chief AI Officer

• Leads AI innovation and research at Cardio AI, architecting the foundational models and intelligent systems that power the company's cardiac diagnostic platform
• Built state-of-the-art model for apical-4-chamber echocardiogram analysis achieving 89% diagnostic confidence and successfully deployed it on GCP Vertex AI for production use
• Developed EchoFrame—a lightweight 3D MobileNetV3-UNet that achieved 91.37% Dice score for left ventricle segmentation with exceptional computational efficiency
• Master's degree in Artificial Intelligence from Rochester Institute of Technology, specializing in medical imaging applications and advanced AI systems including agentic RAG chatbots using LangChain and LLaMA models
• Oversees AI strategy, research direction, and model development pipeline across multiple diagnostic modalities including ECG signal interpretation and parasternal long axis echocardiogram analysis

Sai Swetha Bodlapati - Senior Data Scientist

• Experienced in designing and deploying advanced machine learning solutions
• Proficient in Python, data structures, and cloud computing platforms
• Expertise in statistical modeling, predictive analytics, and algorithm optimization
• Contributes to development of Cardio AI's risk prediction models and clinical validation
• Specializes in healthcare data analysis and model performance optimization

Avi Patel - Vice President of Engineering

• Leads engineering at Cardio AI, combining technical expertise with strategic vision to build the infrastructure powering next-generation cardiac care solutions
• Instrumental in architecting and scaling the company's technology platform from formative stages; led design and prototyping of initial user interface with clinical workflows optimized for accessibility and real-world healthcare environments
• Oversees full engineering organization, driving technical strategy, architecture decisions, and team development while maintaining highest standards for security, scalability, and reliability
• Embedded HIPAA-compliant practices throughout development lifecycle and established robust cloud infrastructure on GCP supporting company's growth trajectory
• Strong foundation in React, Next.js, and modern web technologies combined with experience in Agile methodologies; excels at aligning engineering execution with clinical requirements and business objectives

Mahitha Vudutha - Vice President of Product

• Leads product strategy and innovation at Cardio AI, bringing unique blend of deep technical expertise and product vision to advance AI-powered cardiac care
• Strong foundation in mobile application engineering and digital health platforms; hands-on experience developing secure, scalable mobile applications for iOS and Android
• Drives strategic roadmap for Cardio AI's platform, translating complex cardiac data and AI capabilities into intuitive, accessible solutions that empower patients and healthcare providers
• Champions product development prioritizing early detection, continuous monitoring, and personalized care experiences designed to improve patient outcomes and engagement
• Combines technical rigor with deep understanding of user needs, ensuring products deliver real-time monitoring capabilities and actionable insights while maintaining highest standards for security, scalability, and clinical utility

10. Clinical Validation & Regulatory Strategy

Clinical Validation Program

• Phase 1 (Internal): COMPLETED - Algorithm development and initial validation on 500K+ patient cohorts
• Phase 2 (External multi-site): IN PROGRESS - Real-world validation across diverse patient populations
• IoMT Integration: Clinical trials IN PROGRESS for remote monitoring platform
• PACS/DICOM: Imaging validation IN PROGRESS on 200K+ studies
• 5 Risk Calculators: Real-world validation IN PROGRESS demonstrating C-statistics ≥0.75-0.80

Academic Partnerships

• Stanford Medicine: Algorithm development and validation for AI diagnostic agents
• Cornell Medical Center: Women's health cardiology research and clinical trials
• Harvard Medical School: Clinical outcomes research and real-world evidence generation

FDA Regulatory Strategy

Classification: Class II Medical Device Software

Pathway: 510(k) clearance for diagnostic agents

• Q1 2026: FDA 510(k) submission for ECG and imaging agents
• Q3 2026: Multi-center clinical study (n=5,000 patients) across 15-20 sites
• Q4 2026: Peer-reviewed publications in major cardiology journals (JACC, Circulation)
• 2027: FDA clearance anticipated - 100+ precedent AI cardiovascular devices already cleared
• Quality Management System: 21 CFR Part 820 compliant, ISO 14971 risk analysis, ISO 12052 DICOM standards

Recent Milestones

• AHA Scientific Sessions 2025 presentation (November 8, New Orleans) - Platform validation results
• Master Orchestrator completion with all subsystems integrated
• Specialized transformer models developed for each AI agent
• Women's Health module clinical validation initiated

Compliance & Security

• HIPAA: Full compliance with AES-256 encryption, comprehensive access controls, detailed audit logging
• SOC 2 Type II: In progress, expected completion Q2 2026
• ISO 27001: Information security management system certification planned
• GDPR & CCPA: Full compliance for patient data privacy and protection

11. Use of Funds

Seeking $5M seed round to fund Year 1 operations. Company becomes self-funded thereafter through operating cash flow generating $30.6M EBITDA in Year 1.

Fund Allocation

Detailed Use of Funds

Product Development (25% - $1.25M)

• FDA 510(k) submission preparation and regulatory documentation
• AI model enhancement and optimization for each specialized agent
• PACS/DICOM platform expansion to additional imaging modalities
• Women's Health module refinement based on clinical feedback
• UI/UX improvements for provider and patient-facing applications

Clinical Validation & Regulatory (35% - $1.75M)

• Multi-center clinical trials across 15-20 academic medical centers
• Peer-reviewed publication development and submission
• Real-world evidence generation and outcomes research
• Clinical advisory board compensation and engagement
• Regulatory consulting and FDA submission fees

Sales & Marketing (20% - $1.0M)

• Sales team expansion (3-5 enterprise representatives)
• Conference presence at ACC, AHA, HIMSS, and other major events
• Marketing materials, website, and thought leadership content
• Customer acquisition and pilot program support
• Industry analyst relations and media outreach

Operations & Infrastructure (10% - $500K)

• Cloud infrastructure scaling (AWS/Azure/GCP)
• SOC 2 Type II certification and security audits
• Customer support team expansion
• IT systems and internal tooling
• Legal and compliance infrastructure

Talent Acquisition (10% - $500K)

• Senior AI/ML engineers (3-4 hires)
• Clinical data scientists (2-3 hires)
• Business development representatives (2 hires)
• Clinical cardiologist medical advisor (part-time)
• Recruiting fees and relocation assistance

12. Risk Factors & Mitigation

Technology Risk

Risk: AI model performance may vary across diverse patient populations

Mitigation: Continuous model improvement with diverse training data, human oversight protocols, regular algorithm updates based on real-world performance

Regulatory Risk

Risk: FDA clearance timeline uncertain, potential for additional requirements

Mitigation: Experienced regulatory advisors, 100+ AI cardiovascular devices already cleared providing precedent, robust clinical validation program, early FDA engagement

Market Adoption Risk

Risk: Healthcare provider AI adoption may be slower than projected

Mitigation: Focus on early adopters and progressive organizations, proven ROI (25-40% reduction in events), value-based care alignment, comprehensive training and support

Competition Risk

Risk: Larger players may enter market or acquire competitors

Mitigation: First-mover advantage with comprehensive platform, 60% margins enable aggressive defense, strong IP position, rapid execution to establish market leadership

Execution Risk

Risk: Achieving 50x member growth requires excellent execution across all functions

Mitigation: Experienced leadership team, proven technology platform, capital efficient model, immediate profitability reduces execution pressure, clear roadmap

Reimbursement Risk

Risk: Changes in healthcare payment models could impact economics

Mitigation: PMPM model aligns with value-based care trends, multiple revenue streams reduce dependence on any single model, demonstrated cost savings support reimbursement

Data Privacy & Security Risk

Risk: Breach or compliance failure could damage reputation and operations

Mitigation: SOC 2 Type II certification, comprehensive security infrastructure, regular third-party audits, HIPAA compliance, insurance coverage

13. Exit Strategy & Returns

Multiple High-Value Exit Paths

IPO (Most Likely Path)

• Timeline: 2031-2032 (Years 5-6)
• Target Valuation: $10-15 billion based on $4.75B Year 5 revenue, $2.85B EBITDA, 60% margins
• Comparables: HeartFlow ($2.4B at $200M revenue), Tempus ($8.1B with lower margins)
• Market Conditions: Strong public market appetite for profitable AI healthcare companies
• Revenue Multiple: 2-3x on $4.75B revenue = $9.5-14.25B valuation range

Strategic Acquisition

Potential Acquirers:

• EHR Vendors: Epic, Oracle (Cerner), Meditech - native integration with cardiovascular AI
• Tech Giants: Google Health, Microsoft Healthcare, Amazon Care - AI capabilities and healthcare push
• Medical Device: Philips, GE Healthcare, Siemens Healthineers - expand diagnostic portfolio
• Healthcare Services: UnitedHealth (Optum), CVS Health - population health management capabilities
• Estimated Valuation: $8-12 billion based on strategic value and competitive bidding

Remain Private with Distributions

$5.5+ billion cumulative cash generation enables return of capital to investors while maintaining independence. Potential for dividend distributions starting Year 3 while continuing growth.

Investor Returns

Seed Round Returns

Based on $5M seed investment at $20M pre-money valuation:

• Ownership: 20% pre-dilution (assumes 10% final ownership post-dilution)
• Conservative Exit ($10B): $1.0B return = 200x on $5M investment
• Base Case Exit ($12.5B): $1.25B return = 250x on $5M investment
• Optimistic Exit ($15B): $1.5B return = 300x on $5M investment
• Even with significant dilution to 5%, seed investors realize 100-150x returns

Return Drivers

• Immediate Profitability: $30.6M EBITDA Year 1 reduces risk and dilution
• Self-Funded Growth: No Series A required, optional Series B only
• Exceptional Margins: 60% EBITDA sustained across all years
• Market Leadership: 20% share of $52.4B market creates acquisition premium
• Multiple Exit Paths: Strategic and financial buyers create competitive tension
• Proven Model: Real revenue and EBITDA de-risk investment

14. Appendices

A. Four-Tier Pricing Model Summary

B. Contact Information

• Sampson Kontomah, CEO: ksampson@cardioailive.com, +1 (614) 967-8728
• Dr. Tamanna Nahar, Executive President: tnahar@cardioailive.com, +1 (201) 314-7922
• Investment Inquiries: invest@cardioailive.com
• General Inquiries: Support@cardioailive.com
• Business Development: tonywell@cadrgioailive.com
• Website: www.cardioailive.com
• Data Room: www.cardioailive.com → Investor Relations → Resources → Data Room

C. Key Assumptions

• Member growth follows proven SaaS adoption curves with 40-50% coming from product-led growth
• Blended PMPM increases from $85 to $190 as customers adopt higher-value tiers
• 60% EBITDA margins maintained through zero marginal cost structure
• FDA clearance achieved Q3 2027 based on 100+ precedent approvals
• No additional funding required beyond $5M seed due to immediate profitability
• Customer retention rate of 95%+ based on demonstrated clinical value