1. COMPANY OVERVIEW
Mission Statement
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. We integrate cutting-edge AI agents with real-time medical device monitoring and advanced imaging analysis to deliver comprehensive, personalized cardiac care.
Vision
To become the global standard for AI-driven cardiovascular care, serving 100M+ lives worldwide by 2030. We envision a future 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%+.
Our Approach
We've built the industry's first Unified Master Orchestrator that seamlessly integrates three critical subsystems: CardioAI (7 specialized AI agents), IoMT (real-time device monitoring), and PACS/DICOM (advanced medical imaging). This unified architecture enables complete cardiac workups with cross-subsystem data sharing, ensuring no critical information is missed and every clinical decision is optimally informed.
Core Values
- Innovation Excellence: Pioneering cutting-edge AI solutions for cardiovascular diagnostics
- Patient-Centered Care: Prioritizing patient safety, privacy, and improved health outcomes
- Scientific Rigor: Maintaining the highest standards of accuracy and evidence-based practice
- Collaborative Partnership: Working seamlessly with healthcare professionals to enhance clinical decision-making
- Ethical AI: Ensuring transparency, fairness, and accountability in all AI applications
2. EXECUTIVE LEADERSHIP TEAM
| Position | Leader & Expertise |
|---|---|
| Founder & CEO |
Sampson Kontomah AI Scientist-Engineer specializing in Multi-Agent Systems. 15+ years driving innovation in technology and product development. Expert in transformer models, IoMT integration, and HIPAA-compliant platforms. Track record: $1.5M operational savings, 25% efficiency improvement, 30% revenue growth. |
| Co-Founder & Chief Medical Advisor |
Dr. Tamanna Nahar, MD, MBA, FACC, FASE Board-Certified Nuclear Cardiologist with 25+ years clinical experience. Former Chief Cardiologist at Harlem Hospital, NY. Assistant Professor at Mount Sinai. Cardiology fellowships at Yale and Cornell. Prolific author in cardiology. |
| Chief Financial Officer |
Everlyn Ndirangu Visionary financial strategist expert in accounting, FP&A, and AI-driven forecasting. Architect of financial strategy aligning capital with mission-driven priorities. Expert in financial modeling, fundraising, ERP implementation, and predictive analytics. |
| Chief Technology Officer |
Galax Womack Expert in building secure, scalable systems across healthcare, biotech, and media. Specializes in Python, Flask, Django, AWS. Led backend teams, designed telehealth platforms, integrated EHR systems using FHIR and HL7. Proficient in cloud architecture and real-time data processing. |
Key Scientific Leadership
- Dr. Dibakar Sigdel, PhD - Chief Data Scientist: 8+ years AI/ML and biomedical informatics. Led projects at UCLA and Truveta integrating AI and multi-omics data. Founder of Mindverse Computing.
- Dr. Syed Khairul Bashar, PhD - Senior Research Scientist: Cardiovascular health, signal processing, and machine learning specialist. PhD in Biomedical Engineering from UConn. Postdoctoral work at Johns Hopkins and Georgia Tech.
3. UNIFIED MASTER ORCHESTRATOR & FLAGSHIP PRODUCTS
Master Orchestrator - Central Coordination Engine
The Unified Master Orchestrator is the central nervous system managing task routing, load balancing, and real-time orchestration across all three subsystems. This coordination engine ensures optimal performance, automatic error recovery, and seamless data flow throughout the entire cardiac care workflow.
Core Capabilities
- Task Routing: Intelligent queue management, priority sorting, and optimal subsystem selection
- Load Balancing: Dynamic agent distribution, resource allocation, and throughput optimization
- State Management: Complete task lifecycle tracking, real-time status monitoring, result aggregation
- Event Broadcasting: Instant notifications via WebSocket, real-time alerts, distributed event handling
- Error Recovery: Automatic retry logic, fallback strategies, comprehensive failure handling
- Metrics Collection: Performance monitoring, health checks, real-time analytics tracking
Three Integrated Subsystems
Subsystem 1: CardioAI Platform - 7 Specialized AI Agents
Complete cardiac analysis suite providing comprehensive diagnostic support, risk assessment, and treatment recommendations through seven specialized agents working in concert.
ECG Agent
• STEMI/NSTEMI Detection
• Arrhythmia Classification
• Automated ICD-10 Coding
Echo Agent
• HFrEF/HFpEF Assessment
• Valve Function Analysis
• EF Calculation
Lab Agent
• Troponin & BNP Analysis
• Lipid Profile Assessment
• Biomarker Trends
Risk Agent
• TIMI & GRACE Scoring
• Mortality Risk
• 10-Year CVD Prediction
Diagnostic Agent
• Evidence Synthesis
• Differential Diagnosis
• Decision Support
Treatment Agent
• Protocol Generation
• Drug Recommendations
• Dosage Optimization
Prognosis Agent
• Outcome Prediction
• Survival Analysis
• Follow-up Planning
Subsystem 2: IoMT Platform - Real-Time Device Monitoring
Comprehensive device management supporting MQTT, HTTP, CoAP, and WebSocket protocols for continuous patient monitoring and real-time data acquisition from wearable and medical devices.
- Device Registration: Seamless provisioning, credential generation, patient association
- Telemetry Processing: Real-time ingestion, stream processing, time-series storage
- Alert Generation: Anomaly detection, threshold violations, intelligent prioritization
- Device Monitoring: Connectivity tracking, battery status, heartbeat monitoring
- Performance: 24/7 real-time monitoring, <1 second alert latency, 4 supported protocols
Subsystem 3: PACS/DICOM Platform - Medical Imaging Analysis
Advanced medical imaging platform with 6 specialized agents for comprehensive analysis of cardiac CT, MRI, and echocardiography with full DICOM, FHIR, and HL7 compliance.
- DICOM Ingestion: C-STORE reception, C-FIND queries, metadata extraction
- Preprocessing: Image normalization, quality enhancement, artifact removal
- Segmentation: 4 parallel agents for cardiac chambers, vessel detection
- Quantification: Volume calculations, EF measurement, strain analysis
- Specialized Analysis: T1/T2 mapping, calcium scoring, perfusion analysis
- Report Generation: DICOM SR creation, PDF export, HL7 integration
4. FIVE AI-POWERED CVD RISK CALCULATORS
Comprehensive risk stratification framework with five specialized calculators for predicting cardiovascular event risk. Each calculator provides 1-year, 5-year, and 10-year predictions with 95% confidence intervals, aligned with AHA guidelines.
AMI
C-stat ≥0.75
Primary prevention
Secondary prevention
1, 5, 10-year predictions
Stroke
C-stat ≥0.75
Ischemic stroke
Hemorrhagic stroke
TIA assessment
Heart Failure
C-stat ≥0.75
HFrEF model
HFpEF model
Hospitalization risk
SCD
C-stat ≥0.78
ICD placement guidance
Primary prevention
Risk-based recommendations
AFib
C-stat ≥0.80
Targeted screening
Stroke risk stratification
Anticoagulation guidance
Key Risk Calculator Features
- Multi-Timeframe Predictions: 1-year, 5-year, and 10-year risk estimates
- 95% Confidence Intervals: Statistical rigor with validated models
- 4 Risk Categories: Low (<5%), Moderate (5-10%), High (10-20%), Very High (>20%)
- Comprehensive Data Inputs: Demographics, vitals, clinical history, lab values, medications
- Personalized Recommendations: Evidence-based clinical guidance for each risk level
- EHR Integration: Seamless data import/export with automated documentation
- AHA Guidelines Aligned: 100% compliance with American Heart Association standards
5. COMPLETE 6-STEP CARDIAC WORKFLOW
Seamless integration across all subsystems delivering comprehensive patient assessment from real-time monitoring to final treatment recommendations.
STEP 1
IoMT Vitals
Real-time device monitoring
STEP 2
ECG Analysis
Arrhythmia detection
STEP 3
Risk Calculation
5 CVD calculators
STEP 4
Imaging Analysis
DICOM/PACS
STEP 5
Diagnosis
Evidence synthesis
STEP 6
Treatment Report
Final recommendations
6. MARKET POSITION & INVESTMENT OPPORTUNITY
Massive Market Opportunity - $183 Billion by 2030
$183B
Global CV Care Market
by 2030
by 2030
659M
People with CVD
Worldwide
Worldwide
32%
CAGR for
AI in Healthcare
AI in Healthcare
$500B
Women's Health
Market Opportunity
Market Opportunity
Seed Investment Round - $5 Million
Cardio AI is raising a $5 million seed round to accelerate clinical validation, FDA submission, and market entry. This investment will fund our 18-month pathway to commercialization, with strategic milestones designed to achieve FDA clearance and establish market leadership in AI-powered cardiovascular care.
| Use of Funds | Amount & Allocation |
|---|---|
| Clinical Validation Studies (40%) | $2,000,000 - Multi-center prospective trials, external validation, peer-reviewed publications, clinical events committee, data management |
| FDA Regulatory Submission (30%) | $1,500,000 - 510(k) pathway development, quality management system (QMS), regulatory consulting, compliance documentation |
| Product Development (20%) | $1,000,000 - Platform enhancement, IoMT integration, security infrastructure, EHR interoperability, clinical workflow optimization |
| Market Development (10%) | $500,000 - Partnership development, pilot deployments, team expansion, operational infrastructure |
Addressable Market Segments
- Remote Patient Monitoring: $3.8B (2024) - Real-time IoMT monitoring for cardiac patients
- AI Clinical Decision Support: $1.9B (2024) - AI-powered diagnostic and treatment recommendations
- Cardiovascular Diagnostics: $8.2B (2024) - Advanced imaging analysis and risk prediction
- Population Health Management: $4.5B (2024) - Value-based care and preventive cardiology
Financial Projections - 3-Year Outlook
| Metric | Year 1 | Year 2 | Year 3 |
|---|---|---|---|
| Monitored Patients | 50,000 | 250,000 | 1,000,000 |
| Revenue (PMPM $40) | $24M | $120M | $480M |
| Gross Margin | 75% | 82% | 85% |
| EBITDA | $12M | $24M | $168M |
Why Leading Healthcare Systems Choose Us
- 30% Reduction in Hospitalizations: Predictive risk calculators designed to prevent cardiac events before emergency care
- 5 Validated Risk Calculators: AI-powered CVD event prediction with C-statistics 0.80-0.84
- Complete System Integration: First platform unifying AI analysis, device monitoring, and medical imaging
- Real-Time Processing: Master Orchestrator coordinates tasks with automatic load balancing
- Comprehensive Validation Program: 95,500+ patients enrolled in risk studies, IoMT & PACS validation in progress
- $40 PMPM Pricing: Transparent risk-adjusted pricing aligned with value-based care, projected ROI positive in 6 months
Current Traction & Strategic Partnerships
- Strategic Partnerships: MOU with 3 major health systems (combined 18M lives covered)
- Academic Collaborations: Stanford Medicine, Weill Cornell Medicine, Harvard Medicine
- Technical Milestones: Platform MVP complete, 95,500+ patients enrolled in risk calculator studies, IoMT & PACS validation studies launched
- Advisory Board: 8 prominent cardiologists from leading institutions
- Compliance: HIPAA compliance and SOC 2 Type II certification achieved
7. CLINICAL VALIDATION & FDA REGULATORY STRATEGY
Cardio AI maintains the highest standards of clinical validation with a comprehensive multi-phase validation program across all platform components. Our validation strategy encompasses 95,500+ patients enrolled across risk calculator studies, AI agent validation trials launching in Q1 2026, and ongoing IoMT & PACS/DICOM imaging validation studies.
Validation Program Overview - 95,500+ Total Patients
| Study Component | Total Patients | Status | Key Findings |
|---|---|---|---|
| Risk Calculators | 95,500 | Phase 1 & 2 Active | Avg C-stat: 0.821 |
| AI Agents (Phase 2) | 5,000 | Enrollment Starting | 12 sites, 5 cohorts |
| IoMT Platform | 2,000 | ⟳ In Progress | Target: 85% sensitivity |
| PACS/DICOM | 1,950 Studies | ⟳ In Progress | 16 agents, 3 modalities |
CVD Risk Calculators Validation - 95,500 Patients
Overall Performance: Average C-statistic 0.821
64% enrollment complete • 24 active studies • All calculators exceed target thresholds
64% enrollment complete • 24 active studies • All calculators exceed target thresholds
Current Enrollment Status by Calculator
AMI
12,000 / 35,000
C-stat: 0.804
NRI: 0.124
NRI: 0.124
Stroke
18,500 / 38,000
C-stat: 0.819
NRI: 0.147
NRI: 0.147
Heart Failure
25,000 / 53,000
C-stat: 0.798
NRI: 0.108
NRI: 0.108
SCD
8,000 / 31,000
C-stat: 0.812
NRI: 0.186
NRI: 0.186
AFib
32,000 / 60,000
C-stat: 0.843
NRI: 0.132
NRI: 0.132
Performance Highlights
- All Calculators Meet Target C-statistics: Every calculator exceeds minimum threshold (AMI/Stroke/HF ≥0.75, SCD ≥0.78, AFib ≥0.80)
- Superior to Standard Models: Net Reclassification Improvement (NRI) ranges from 0.108 to 0.186, all statistically significant (p < 0.001)
- Excellent Calibration: Hosmer-Lemeshow p-values all >0.05, indicating well-calibrated models
- High Sensitivity: Sensitivity at 10% threshold ranges from 0.831 to 0.889 across all calculators
AI Agents Phase 2 External Validation - 5,000 Patients
Study CA-AGENTS-VAL-PHASE2: Retrospective multi-center validation study across 12 US sites to validate Phase 1 findings across diverse patient populations and healthcare settings. Timeline: Q1 2026 - Q4 2026 enrollment, Q3-Q4 2027 FDA submission.
Five Validation Cohorts
| Cohort | Target N | Data Elements | Endpoints | Primary Focus |
|---|---|---|---|---|
| Echocardiography | 1,500 | 27 | 7 | EF correlation (r≥0.90), MAE≤5% |
| ECG Analysis | 2,000 | 30 | 8 | Overall accuracy ≥95%, STEMI sens ≥92% |
| CAD Detection | 600 | 41 | 8 | Accuracy ≥92%, AUC ≥0.93 |
| Risk Stratification | 1,000 | 41 | 8 | 12-month MACE prediction AUC ≥0.85 |
| Longitudinal Monitoring | 1,000 | 40 | 10 | HF exacerbation 7-day sens ≥84% |
IoMT Platform Validation - 2,000 Patients IN PROGRESS ⟳
STATUS: VALIDATION IN PROGRESS
Target enrollment: 2,000 patients • 15 academic medical centers • Q4 2026 completion
Target enrollment: 2,000 patients • 15 academic medical centers • Q4 2026 completion
Target Performance Metrics
≥80%
PRIMARY ENDPOINT
Overall Sensitivity
Target Threshold
Overall Sensitivity
Target Threshold
≥90%
Critical Events
STEMI/VT/VF Detection
Target Sensitivity
STEMI/VT/VF Detection
Target Sensitivity
≥80%
Patient Adherence
Device wear ≥20 hrs/day
Target Compliance
Device wear ≥20 hrs/day
Target Compliance
<15s
Alert Latency
Critical Event Detection
Target Response Time
Critical Event Detection
Target Response Time
Planned Patient Cohorts (Target: 2,000 patients across 15 sites)
- Post-MI Monitoring (Target: 600 patients): Remote monitoring after myocardial infarction
- Heart Failure Management (Target: 800 patients): Chronic HF monitoring with exacerbation prediction
- High-Risk Pregnancy (Target: 200 patients): Maternal cardiac monitoring with preeclampsia detection
- Post-Cardiac Procedure (Target: 300 patients): Monitoring after cardiac interventions
- Arrhythmia Management (Target: 100 patients): Continuous arrhythmia detection
Study Endpoints & Timeline
- Primary Endpoint: Overall sensitivity ≥80% for critical cardiac event detection
- Secondary Endpoints: Alert latency <15s, patient adherence ≥80%, false alert rate ≤20%
- Enrollment Period: Q1 2026 - Q3 2026
- Data Analysis: Q4 2026
- FDA Submission: Q1 2027 (510(k) pathway)
- Expected Clearance: Q3 2027
PACS/DICOM Platform Validation - 1,950 Studies IN PROGRESS ⟳
Ongoing Medical Imaging Validation
16 specialized AI agents • 3 modalities (Echo, MRI, CT) • Target completion Q4 2026
16 specialized AI agents • 3 modalities (Echo, MRI, CT) • Target completion Q4 2026
Target Segmentation Performance - Dice Coefficient ≥0.80
| Modality | Target Dice Coefficient | Target Volume Error | Target Studies |
|---|---|---|---|
| Echocardiography | ≥0.80 | <5% | 100 |
| Cardiac MRI | ≥0.80 | <5% | 100 |
| Cardiac CT | ≥0.80 | <5% | 100 |
Target Quantification Metrics - ICC ≥0.75
- Ejection Fraction (Echo): Target ICC ≥0.75, bias within ±2%
- Ejection Fraction (MRI): Target ICC ≥0.75, excellent agreement with expert measurements
- Stroke Volume (MRI): Target ICC ≥0.75 for all quantification metrics
Target Diagnostic Performance - AUC-ROC ≥0.90
- Reduced EF (Echo): Target sensitivity ≥90%, specificity ≥90%, AUC ≥0.90
- Myocardial Infarction (MRI): Target sensitivity ≥90%, specificity ≥90%, AUC ≥0.90
- Coronary Stenosis (CT): Target sensitivity ≥90%, specificity ≥90%, AUC ≥0.90
- System Performance: Target processing time <120 seconds, throughput ≥30 studies/hour
FDA Regulatory Strategy & Pathway
Multi-Component 510(k) Submission Strategy
Cardio AI is pursuing FDA clearance through the 510(k) pathway for multiple platform components. Our comprehensive regulatory strategy leverages extensive clinical validation data across all subsystems, with a phased submission approach designed to achieve clearance within 18-24 months.
IoMT Platform - Class II Medical Device
- Regulatory Pathway: FDA 510(k) clearance as Class II medical device software
- Clinical Evidence: Ongoing 2,000-patient multi-center validation study (CA-IoMT-VAL-001)
- Current Status: Active enrollment across 15 academic medical centers
- Quality Management: QMS development in progress - 21 CFR Part 820, risk analysis per ISO 14971
- Safety Monitoring: Continuous safety surveillance throughout study period
- Submission Timeline: Q4 2026 pre-submission, Q1 2027 formal 510(k) submission, Q3 2027 expected clearance
PACS/DICOM Platform - CADe Software
- Regulatory Classification: Computer-Aided Detection (CADe) software under FDA AI/ML-based medical devices guidance
- Validation Progress: Ongoing validation across 1,950 imaging studies, 16 agents, three modalities (Echo, MRI, CT)
- Target Performance: Dice coefficient ≥0.80, ICC ≥0.75, AUC-ROC ≥0.90 across all diagnostic tasks
- Standards Compliance: Full DICOM compliance development, FHIR integration, HL7 messaging
- Submission Timeline: Q4 2026 validation completion, Q2 2027 pre-submission, Q3 2027 formal 510(k) submission
AI Agents - Clinical Decision Support
- Regulatory Approach: Clinical Decision Support Software (CDS) under 21st Century Cures Act
- Phase 2 Validation: 5,000-patient multi-center study across 12 sites, 5 cohorts (Q1 2026 - Q4 2026)
- External Validation: Diverse patient populations, multiple healthcare settings ensuring generalizability
- Publication Strategy: Peer-reviewed manuscripts in high-impact cardiology journals (Q2 2027)
Risk Calculators - Software as Medical Device (SaMD)
- Classification: Software as Medical Device (SaMD) for cardiovascular risk prediction
- Clinical Validation: 95,500 patients enrolled across all five calculators with 64% overall completion
- Performance Excellence: All calculators exceed target C-statistics (0.798-0.843), superior NRI to standard models
- Regulatory Pathway: 510(k) submission leveraging demonstrated clinical utility and validation data
8. STRATEGIC PRIORITIES & 18-MONTH ROADMAP
18-Month Commercialization Roadmap
Q1 2026 (Months 1-3)
- Complete seed funding close ($5M): Finalize investor commitments and close funding round
- Launch IoMT & PACS validation studies: Begin multi-center validation across 15 sites
- Initiate AI Agents Phase 2 study: Start external validation with 5,000 patient target across 12 sites
- Submit FDA pre-submission meeting request: Engage FDA early for regulatory pathway clarification
- Expand engineering team to 12 FTEs: Add specialized talent in AI/ML, IoMT, medical imaging
Q2-Q3 2026 (Months 4-9)
- Clinical validation interim analysis: Review Phase 2 data at 50% enrollment milestone
- FDA pre-submission meeting: Incorporate FDA feedback into submission strategy
- Complete ISO 13485 QMS implementation: Full quality management system for medical device manufacturing
- Launch pilot with 2 partner health systems: Real-world deployment and workflow integration testing
Q4 2026 (Months 10-12)
- Complete IoMT & PACS validation studies: Finish enrollment, database lock, primary endpoint analysis
- Complete AI Agents Phase 2 validation: Achieve 5,000-patient enrollment across 12 sites
- Submit FDA 510(k) application: IoMT platform submission with complete validation data
- Publish validation results: Peer-reviewed publications in leading cardiology journals
- Scale pilots to 10 sites: Expand to 50,000 monitored patients across partner organizations
Q1-Q2 2027 (Months 13-18)
- FDA clearance obtained: 510(k) clearance for IoMT platform, PACS/DICOM submission
- Commercial launch with 5 anchor customers: Full platform deployment at major health systems
- Series A fundraising ($20M target): Raise growth capital for market expansion
- Achieve 100,000 monitored patients milestone: Demonstrate platform scalability and clinical impact
Medium-Term Goals (1-3 Years)
- Market Penetration: Deploy across 50+ healthcare organizations serving 250,000+ patients
- Complete FDA Clearance: Obtain regulatory clearances for all platform components (IoMT, PACS, AI Agents)
- Women's Health Expansion: Launch obstetrics cardiology platform capturing $500B market opportunity
- International Expansion: Enter European and Asian markets with localized platforms and regulatory approvals
- Revenue Target: $120M annual revenue with 82% gross margins
Long-Term Vision (3-5 Years)
- Industry Standard: Become global standard for AI-powered cardiovascular diagnostics and care management
- 100M+ Lives by 2030: Serve 1,000,000+ patients directly, impact 100M+ lives through platform adoption
- Preventive Care Platform: Expand beyond diagnostics to comprehensive preventive cardiology ecosystem
- 40% Cost Reduction: Achieve documented 40% reduction in cardiovascular healthcare costs through predictive care
- Revenue Target: $480M annual revenue with 85% gross margins, $168M EBITDA
9. CONTACT INFORMATION & NEXT STEPS
Get Connected
- Website: cardioailive.com
- Phone: +1 614-967-8728
- Email: [email protected]
- Locations: Dublin, Ohio | San Francisco, California
- Demo Scheduling: product-demo-request-form.vercel.app
Engagement Opportunities
- Investors ($5M Seed Round): Explore investment opportunities in the $183B cardiovascular AI market (investor-form-cardioai.vercel.app)
- Healthcare Organizations: Become an early adopter partner with pilot implementation, join 18M lives under strategic partnerships
- Career Seekers: Join our growing team at cardioia-all-careers.vercel.app - we're expanding to 50+ team members
- Research Collaborators: Partner on clinical validation and research studies with Stanford, Cornell, Harvard