Age-related Macular Degeneration (AMD) is the #1 cause of vision impairment and severe vision loss among elderly people in the United States.
✨
Our groundbreaking solution enables disease risk determination years before vision loss.
1
Family Doctor Visit
During routine checkup (age 40+)
2
Blood Analysis
Advanced biomarker detection
3
AI Processing
ML-powered risk assessment
4
Risk Assessment
Early Intervention and Monitoring Opportunity
Unique Value Proposition
✨
The market's first blood test opportunity for AMD risk assessment before vision loss begins
✨
Proprietary AI-powered algorithm
✨
AMD Risk Assessment using blood samples in Primary Care
✨
Medicare reimbursement opportunity under existing preventive care frameworks
Critical Investment Metrics
$42.3 Billion
Total Addressable Market
94-95%
Test Accuracy Rate
169 Million
Target Population (Americans 35+)
Market Opportunity: Inspired by the Exact Sciences model ($9.90 billion market value, $2.76 billion annual revenue), we are positioned to capture significant market share in the high-impact healthcare sector.
💡 Phase 1 Detailed Milestones
Phase 1: Validation and Regulatory Strategy Preparation
Phase 1 Key Milestones
✓C-Corp incorporation in Delaware
✓Stock allocation and vesting plan creation
✓Cap table preparation
✓Banking and accounting systems setup
✓Initial investment secured
✓Provisional patent applications for AMD algorithm
✓Analysis of 240 new blood samples from at least 3 centers (Asymptomatic early AMD, early AMD with vision symptoms, Dry AMD, Wet AMD)
✓Algorithm accuracy improvement using comprehensive training data
✓Laboratory partnership establishment and operationalization (Determination of whether FDA requires CLIA-certified laboratory for our studies and verification of existing laboratory certification status. Investigation of FDA consultation opportunities for regulatory guidance)
Regulatory Strategy Preparation
✓Investigation of FDA consultation opportunities for regulatory guidance
✓FDA pre-submission meeting execution (Q-Sub)
✓Regulatory strategy definition (510(k) vs. PMA pathway)
✓International regulatory requirements mapping (EU CE marking)
Proactive Vision Analysis
See the Future Clearly
Let's Assess AMD Risk Years Before Vision Loss
💡 Critical Problem
Current detection methods identify the disease only after irreversible damage has occurred, when treatment options are limited and costly.
20 Million
Americans with AMD diagnosis
200 Million
People affected globally
Disease Progression Stages
AMD progresses through four distinct stages: Early Stage (mild central vision changes), Intermediate Stage (increasing central vision loss), Advanced Dry AMD (significant central vision loss), and Advanced Wet AMD (severe central vision loss with rapid progression). Current screening methods detect the disease far too late in this progression.
Critical Challenge: Progressive and irreversible vision loss occurs over time. When vision problems become apparent, the damage is permanent and irreversible.
💡 Early Risk Assessment Opportunity
✨
Chronic diseases develop silently over years before symptoms appear. This creates a critical window of opportunity for early intervention.
✨
Navigate through the five interactive visualizations below to explore disease progression and early detection opportunities.
Fasting Blood Glucose Levels
Illustrative Disease Progression Timeline
⚠️
Note: This visualization is an illustrative educational model demonstrating how chronic diseases develop silently over years before symptoms appear. The temporal progression (ages 35-45) represents typical disease development patterns based on established medical science, highlighting the critical early detection window where intervention is most effective.
peptide-28 Expression & Vision Impact
Illustrative Disease Progression Model
Vision Progression: Normal → Dry AMD → Wet AMD
⚠️
Note: This visualization is an illustrative model based on our cross-sectional data (Wet AMD patients vs age-matched healthy subjects) and established scientific understanding of AMD progression. While we measured peptide-28 at 93× elevation in AMD patients compared to healthy subjects, the temporal progression shown (ages 35-45) is hypothetical and represents how the disease typically develops over time. The vision deterioration video illustrates the progression from healthy vision to early dry AMD to wet AMD central vision loss patterns for educational purposes.
Multi-Disease Biomarker Platform
Illustrative Multi-Disease Progression Model
⚠️
Note: This side-by-side comparison demonstrates that the temporal patterns (ages 35-45) are hypothetical illustrative representations over time.
Comparison of Expression Levels of Native Peptides
Wet AMD Patients vs Healthy Subjects
🔬
Transthyretin-Derived Peptide
Note: This is a transthyretin-derived peptide (p < 0.03), indicating altered retinal homeostasis associated with AMD pathogenesis. Unlike other peptides showing decreased expression, peptide-269 exhibits significantly elevated levels in AMD patients, suggesting disrupted protein homeostasis and altered retinal metabolism crucial for vision.
🧬
Complement C3-Derived Peptide
Note: This is a Complement C3-derived peptide (p < 0.009), supporting complement pathway dysregulation and indicating altered retinal homeostasis. The significantly elevated expression in AMD patients reflects chronic complement system activation, a key inflammatory mechanism in AMD pathogenesis and retinal tissue damage.
⚡
ATP Synthase F(1) Complex Subunit Beta - Mitochondrial-Derived Peptide
Note: This mitochondrial-derived peptide (p < 0.003) represents the catalytic subunit beta of the ATP synthase complex (F1F0 ATP synthase or Complex V) that produces ATP from ADP. The 93-fold elevation in AMD patients indicates severe mitochondrial dysfunction and impaired cellular energy production in retinal pigment epithelial (RPE) cells. Mitochondrial damage has been strongly implicated in AMD pathogenesis through retrograde signaling that affects epigenetic regulation and leads to oxidative stress, inflammation, and cell death (Nashine et al., Exp Eye Res, 2019).
Statistical Methods: Statistical analyses were performed using Python Version 3.12.4 with libraries (NumPy, SciPy, Pandas, and Matplotlib) and GraphPad Prism Software. The Shapiro-Wilk test was used to determine the distribution of continuous variables in each group. For comparing two groups, Welch's t-test was applied if both groups showed normal distributions, while the Mann-Whitney U test was used if at least one group had a non-normal distribution. To control for multiple comparisons, we applied the Benjamini-Hochberg procedure with a False Discovery Rate (FDR) of 1%.
Proof-of-Concept Success
Breakthrough Results in Native Peptide Biomarker Discovery
Results demonstrate feasibility for larger validation studies
Statistical Analysis & Power Analysis
Statistical Methods: Statistical analyses were performed using Python Version 3.12.4 with libraries (NumPy, SciPy, Pandas, and Matplotlib) and GraphPad Prism Software. The Shapiro-Wilk test was used to determine the distribution of continuous variables in each group. For comparing two groups, Welch's t-test was applied if both groups showed normal distributions, while the Mann-Whitney U test was used if at least one group had a non-normal distribution. To control for multiple comparisons, we applied the Benjamini-Hochberg procedure with a False Discovery Rate (FDR) of 1%.
Power Analysis & Sample Size Calculation: Based on our proof-of-concept study data, power analysis (Cohen's d effect size calculations) was performed. A sample size of 60 subjects per group will be needed to provide >90% power to detect significant differences between groups (alpha = 0.05). Groups are Age-matched Older Healthy Subjects, Early Dry AMD, Late Dry AMD, Wet AMD. For the full validation study, we plan to enroll 240 total samples to ensure robust statistical power across multiple biomarker comparisons.
Data Visualization: Volcano plots were generated using Matplotlib and Seaborn libraries, highlighting significantly regulated peptides (p < 0.05, |log2FoldChange| > 2). These visualizations demonstrate clear separation between biomarker expression levels in AMD patients versus healthy subjects, validating the diagnostic potential of our platform.
Healthy Phase (Ages 35-37)
Early Disease (Ages 38-39)
Intermediate Disease (Ages 40-42)
Late Disease (Ages 43-45)
Early Detection Window: This visualization demonstrates how diseases progress gradually over many years. Our blood-based risk assessment platform can detect biological changes during the early phase—years before traditional diagnostic methods identify symptoms—enabling timely intervention when treatment is most effective.
💡 Our Breakthrough Solution
✨
The current standard of care is symptom-driven—people seek treatment only after vision loss occurs.
✨
Our platform enables early risk assessment through a simple blood test during routine family doctor visits.
1
Family Doctor Visit
During routine checkup (age 40+)
2
Blood Analysis
Advanced biomarker detection
3
AI Processing
ML-powered risk assessment
4
Risk Assessment
Early Intervention and Monitoring Opportunity
Unique Value Proposition
✨
The market's first blood test opportunity for AMD risk assessment before vision loss begins
✨
Proprietary AI-powered algorithm
✨
AMD Risk Assessment using blood samples in Primary Care
✨
Medicare reimbursement opportunity under existing preventive care frameworks
💡 Proof-of-Concept Success
✨
Our proof-of-concept study demonstrates breakthrough results in identifying native peptide biomarkers for wet AMD detection and risk assessment.
Results demonstrate feasibility for larger validation studies
💡 Proven Business Model
Our business model is inspired by the highly successful Exact Sciences model, which achieved a $9.90 billion market value and $2.76 billion annual revenue through blood-based diagnostic tests.
Inspiration for Our Business Strategy
Exact Sciences Analysis - 2025 Growth Strategy
4M+ Tests
Tests Completed in 2024
$2.76B Revenue
2024 Total Revenue
$315M+ EBITDA
2024 Adjusted EBITDA
$9.90B Market Value
Company Market Value
💡
Understanding EBITDA Growth
$315M+ Adjusted EBITDA in 2024 represents earnings before interest, taxes, depreciation and amortization, adjusted for non-recurring items. 44% annual growth demonstrates strong operational performance and improved profitability compared to 2023.
📈
$22 Billion
Total US Healthcare System Savings
2024 Revenue Distribution
Healthcare Pre-Assessment Screening Tests
76%
Targeted Personalized Tests
24%
💡
2025 Product Portfolio: $58B Target Market Volume
Cologuard Plus™
$18B
Launch: Q2 2025 Start
Oncodetect™
$15B
Launch: Q2 2025
Cancerguard™
$25B
Launch: H2 2025
💡 US Insurance Reimbursement Pathway
✨
In US, Medicare covers the cost of tests performed before disease onset. Our AMD risk assessment test can also be covered after necessary procedures.
Medicare Preventive Services Framework
Patient Cost
They pay no fees or minimal amounts - Insurance covers costs
Healthcare Assessment Tests Currently Covered by Medicare
Various blood-based and biomarker tests are covered
🛡️
Preventive Services
Comprehensive coverage for early detection programs
💡 Stakeholder Interest & Path to Market
🏛️
Government Interest
U.S. Department of Health & Human Services
Elijah P. Wood, MPP, PMP
Senior Health Insurance Specialist
Technical Advisor - AI Governance & Strategy Lead, CMS/CCIIO
• Leads AI initiatives for HHS
• Requested detailed presentation and follow-up discussion on our AI Risk Assessment Solution
✓ Regulatory pathway interest
🎓
Academic Interest
ARVO Conference Association for Research in Vision and Ophthalmology
World's largest and most respected eye and vision research organization
NEI Leadership Engagement
In-Person and Zoom meetings with
Dr. Tony Gover, Ph.D.
National Eye Institute Program Director
Annual Presentations Since 2021
✓ Scientific community interest
🚀
Phase 3: Distribution Partnership
MARK CUBAN
Billionaire Entrepreneur Shark Tank
Post-FDA Distribution Interest
"Once you get FDA approval, I'm happy to help you sell it"
— Mark Cuban, Direct Communication
240K+
Physicians
50M+
Reach
$2B+
Market Cap
✓ Commercial distribution interest
👨⚕️
Clinical Partners
Physicians Ready to Collaborate
Retinal Specialists & Family Physicians ready to analyze post-FDA & offering pre-FDA development collaboration
🎓
ACADEMIC & INDUSTRY INTEREST
AI Healthcare Conference at Stanford University
Conference supported by PHILIPS • Presented our results of Early risk identification of AMD using AI at this premier AI healthcare venue
💡 Market Opportunity Analysis
AMD
%1
Target market share within 5 years
%99
Remaining Market Share
Small slice. Big opportunity.
$42.3 Billion
Total Market Opportunity
169.1 Million
Target Population (Americans 35+)
4.5 Million
New Users Turning 35 Each Year
$250
Test Price
Market Calculation: 169.1 million target population × $250 test price = $42.3 billion total addressable market
💡 Financial Projections
Market Share Growth
Achieving approximately 1% market share by Year 5
Growth Projections
Revenue and Annual Test Volume
5-Year Revenue and Test Volume Growth
Conservative projections show steady growth from market launch to 1% market penetration, with revenue scaling to $400M+ by Year 5 after initial clinical launch.
Year
Market Share
Annual Tests
Estimated Revenue
Year 1
%0.02
50,000
$12.5M
Year 2
%0.1
200,000
$50M
Year 3
%0.3
500,000
$125M
Year 4
%0.6
1,000,000
$250M
Year 5
%1.0
1,600,000
$400M
💡 FDA Regulatory Strategy and Timeline
Our comprehensive regulatory roadmap follows established FDA pathways for AI-based diagnostic devices, utilizing proven precedents and expert guidance to ensure efficient approval.
De Novo Classification Pathway - Optimal Route for Approval
Our AI-based blood test is suitable for the De Novo pathway as a novel technological approach without existing predicate devices. This moderate-risk innovation will establish new device classification standards under Class II designation with special controls.
Regulatory Precedent: IDx-DR (DEN180001), the first autonomous AI diagnostic system approved via De Novo pathway in 2018, established the regulatory framework for retinal diagnostic software devices under 21 CFR 886.1100 (Class II).
Applicable FDA Classifications and Regulatory Framework
Our device falls under multiple established FDA classifications and provides clear regulatory pathway:
21 CFR 862.1840: Mass spectrometry test systems (Class II with special controls)
21 CFR 886.1100: Retinal diagnostic software device (Class II with special controls)
21 CFR 809: In Vitro Diagnostic (IVD) labeling requirements
Our development follows the latest FDA guidance including "AI-Enabled Device Software Functions: Lifecycle Management" (January 2025) and "Good Machine Learning Practice for Medical Device Development" (October 2021), ensuring comprehensive oversight and future-ready regulatory compliance.
Regulatory Timeline Advantages: FDA De Novo review process provides 150-day timeline with performance goals established under MDUFA V. Small business fee reductions (50% for companies with ≤$100M revenue) and free CDRH statistical consultation minimize regulatory costs while ensuring compliance.
💡 Development Phases and Timeline
✨
Our structured three-phase development approach aims to provide systematic progression from clinical validation to commercial launch.
✨
Each phase will have clear milestones and regulatory checkpoints.
1
Phase 1: Pre-Clinical Validation and FDA Consultation (9 - 24 months)
FDA Q-Submission for De Novo pathway approval and statistical guidance
Sample collection and analysis for algorithm validation (minimum 240 samples)
Quality Management System implementation (ISO 13485:2016 compliance)
Clinical validation study design with CDRH statistical consultation
Analytical validation following FDA mass spectrometry guidance
2
Phase 2: Clinical Validation and Regulatory Submission (6-24 months)
Multi-center clinical studies at minimum 3 sites with 80% statistical power
De Novo classification request submission with special control recommendations
FDA review process (150-day timeline under MDUFA V performance goals)
Predetermined Change Control Plan (PCCP) development for algorithm updates
Post-market surveillance system establishment
3
Phase 3: Commercial Launch and Market Penetration (1 year)
CLIA laboratory certification and commercial partnerships
Medicare coverage determination application and private insurance negotiations
Healthcare provider training and market access programs
Real-world performance monitoring and algorithm optimization
Platform expansion to additional retinal diseases (glaucoma, diabetic retinopathy)
💡 Phase 1 Investment Requirements
AI Healthcare Innovation
Sample Analysis
Mass Spectrometry (n=240)$144,941
AMD Plasma Samples (n=180) IRB Approved, Commercially Available by BioIVT LLC$36,000
Age-matched Control Samples (n=60)$600
Quality Control Fee$50,000
Personnel
Principal Investigator Salary (2 Years)$160,000
Benefits (25%)$40,000
Scientific Consultation Fee$50,000
Equipment & Lab Space
Lab Space (24 months)$120,000
Data Storage System (Lab)$25,000
-80C Freezer$15,000
Lab Consumables$10,000
Regulatory Consultation & AI/ML Infrastructure
AWS Infrastructure & AI/ML Platform$160,302
Cloud Storage$10,000
Regulatory Consulting$125,000
Contingency$52,257
Final Investment Request: $1,000,000
Risk Mitigation: Investment is structured to meet FDA requirements including minimum 240 samples for statistical power, multi-center validation design, and expert regulatory consultation. Small business fee reductions (50%) and free FDA statistical consultation minimize regulatory costs.
💡 Development Pipeline
Our comprehensive development pipeline showcases multiple risk assessment platforms across various medical conditions, with AMD as our flagship product leading the way.
Multi-Platform Risk Assessment Portfolio
Transforming preventive healthcare across multiple therapeutic areas
Risk Assessment Platforms
Planning
Proof-of-Concept
Phase 1 Validation
Phase 2 FDA Approval
Phase 3 Launch
AMD Risk Assessment & Prediction
Blood-based early detection platform
Endometriosis Risk Analysis
Women's health diagnostic platform
Alzheimer's Risk Prediction
Neurological assessment tools
Autism Risk Assessment Tools
Developmental screening platform
Risk Assessment Focus Areas
AMD Risk Assessment
Endometriosis Risk Analysis
Alzheimer's Risk Prediction
Autism Risk Assessment
Platform Strategy & Scalability
🚀
Lead Product: AMD Risk Assessment drives initial market entry and validation
🔬
Technology Foundation: Blood-based biomarker analysis platform expandable across conditions
📈
Sequential Expansion: Systematic rollout to additional therapeutic areas after AMD success
💡
Market Validation: Each platform leverages proven regulatory and reimbursement pathways
Strategic Advantage: Our development pipeline positions A1 Diagnosis as a comprehensive platform company rather than a single-product venture. This multi-platform approach provides significant competitive advantages, diversified revenue streams, and enhanced investor value proposition.
💡 Our Founders and Potential Advisors
✨
Our experienced leadership team combines deep scientific expertise with proven entrepreneurial success in health innovation.
Team and Advisors
Dr. Mustafa Ozgul
Founder & CEO
UC Irvine AMD Researcher
6 years experience
Dr. Murat Baday
Co-Founder
Stanford & Synapses Ventures
$6.1M Series A Success
Daniel Chatelain
Strategic Business Advisor
BayPay Forum Foundersu
20+ years Fintech Experience
Prof. Prashanth Asuri
Health Innovation Advisor
Santa Clara University
Ex-Genentech Coach
Prof. Ramasamy Paulmurugan
Scientific Advisor
Stanford University Professor
$10M+ NIH Funding + 203+ Publications
Danny Seth
Neurology Diagnostics Expert
Redwood Bio CEO (Alzheimer Blood Test)
Harvard MBA + MIT + $5M Funding
Dr. Chirag Patel
Neuro-Oncology Specialist
MD Anderson Cancer Center
MD, PhD
Prof. Emre Araci
Technology Advisor
Santa Clara University
Smartlens Inc. Co-Founder
Team Expertise Areas
🧬
Medical Research: AMD biomarker development, mass spectrometry, proteomics, molecular imaging
🔬
Stanford Research: Early disease detection, ultrasound molecular imaging, clinical translation
🚀
Startup Successes: $6.1M Series A + $84M Series D + $5M Grant funding, technology commercialization
Health Innovation: FDA processes, bioengineering, 3D bioprinting
🤖
AI & ML: 5,000+ molecule analysis, machine learning algorithms
⚡
Technology Innovation: Continuous health monitoring devices, Smartlens technology, bioengineering
📊
Mentor Network: 500 Startups, Plug and Play, 10,000+ professional network
Team Strength Metrics
108+ Years
Combined Experience
$115M+
Proven Funding
250+
Scientific Publications
Competitive Advantage: Our team offers a unique combination in medical research, technology commercialization, fintech experience and health innovation. With proven startup successes and strong industry connections, we have an ideal team structure to bring the AMD risk analysis platform to market.
💡 Competitive Landscape
✨
Comprehensive analysis of the AMD diagnostics market reveals a unique opportunity: while 8 well-funded AI imaging companies are targeting AMD detection, there are zero competitors in blood-based early risk assessment.
0
Blood-Based Competitors
3
Direct AI Imaging Competitors
$177M
Direct Competitor Funding
Complete Competitive Vacuum in Blood-Based Diagnostics
After extensive competitive research, no startups founded after 2015 are developing blood-based AMD risk assessment tests. While academic research has identified promising biomarkers from Mass Eye and Ear, Cleveland Clinic, and multiple institutions, none have been commercialized. This represents a massive white space opportunity.
Competitive Comparison Table
Blood-Based vs AI Imaging Approaches
Key Factor
Digital Diagnostics
Eyenuk
AEYE Health
Our Blood-Based Platform
Sample Type
Retinal Image
Retinal Image
Retinal Image
Blood
Equipment Required in Doctor Office
✗ YES - Special Camera
✗ YES - Special Camera
✗ YES - Portable Special Camera
✓ NO - Simple Blood Draw (Existing Infrastructure)
Self-Directed Patient Access
✗ NO - Requires doctor visit
✗ NO - Requires doctor visit
✗ NO - Requires doctor visit
✓ YES - Direct online ordering via Quest/LabCorp
Detection Window
After structural damage
After structural damage
After structural damage
Before structural damage
Platform Expandability
Eye diseases only
Eye diseases only
Eye diseases only
Potential to expand to multiple diseases
Primary Care Deployment
Complex (equipment barrier)
Complex (equipment barrier)
Moderate (portable device)
Simple (existing infrastructure)
FDA Status
✓ Cleared (DR, 2018)
✓ Cleared (DR)
✓ Cleared (DR, 2024)
🔄 Development stage
Commercial Status
Operational
Operational
Operational
Pre-commercial
Total Funding
$130M+
$43M+
$4.3M
$1M (Pre-Seed)
Note on Self-Directed Patient Access: Future capability enabling direct-to-consumer blood testing workflow: (1) Patient orders AMD risk assessment test online through our platform, (2) Patient visits any Quest Diagnostics or LabCorp location nationwide to provide blood sample using provided lab requisition, (3) Our laboratory partner analyzes blood biomarkers using our proprietary AI algorithm, (4) Patient receives comprehensive AMD Risk Assessment Report directly (typically within 7-10 business days). This model eliminates the need for doctor visits or specialized equipment, enabling convenient access to early AMD risk screening.
DR = Diabetic Retinopathy. These companies have FDA clearance for diabetic retinopathy screening; AMD capabilities are in development or available in specific markets.
Primary Care AMD Screening Landscape
5 companies targeting AMD detection outside of specialist clinics
3
📷 EQUIPMENT DEPENDENT
AI Imaging Competitors (Require Cameras)
$177.3M Funding
2
🟢 ALTERNATIVE MODELS
Home Monitoring & Telehealth Infrastructure
Non-AI Approaches
💡
Why OCT-Based Companies Are NOT Our Competitors
Specialist clinic OCT tools (Altris AI, RetinAI, OphtAI) operate in a different market: They require expensive equipment ($50K-150K+), operate only in retina specialist clinics, and detect existing structural damage. Our blood-based platform targets primary care for early risk assessment before structural damage occurs - a completely different market segment and use case.
⚠️
AI Imaging Competitors Targeting Primary Care
Key Barrier: All 3 require special imaging devices/cameras to be installed in family doctor offices. Our blood-based approach requires no equipment - just a simple blood draw.
📷 IMAGING DEVICE REQUIRED
Digital Diagnostics
Founded 2010 • Funding: $130M+ • Status: Commercial
First-ever FDA De Novo clearance for autonomous AI in healthcare (2018). Explicitly announced AMD development as part of multi-disease expansion. $75M Series B led by KKR in 2022. Medicare reimbursement already established at $40-127 per test. Requires retinal camera installation in doctor offices.
📷 IMAGING DEVICE REQUIRED
Eyenuk
Founded 2010 • Funding: $43M+ • Commercial in 18 countries
Most broadly adopted autonomous AI ophthalmology platform globally. Already CE-marked for AMD detection in Europe. Deployed in 200+ locations, 230,000+ patients screened. Requires fundus camera equipment at each screening location.
📷 PORTABLE DEVICE REQUIRED
AEYE Health
Founded 2018 • Funding: $4.3M • FDA Cleared
First-ever FDA clearance for portable/handheld autonomous AI screening (May 2024). Explicit AMD roadmap in company materials. Requires portable/handheld camera device for each screening. Reduces burden vs. desktop devices but still equipment-dependent.
🟢
Alternative Delivery Models (Not Direct AI Competitors)
These companies use different approaches (home monitoring, telehealth infrastructure) but don't compete directly with blood-based early risk assessment
🏠 Home MonitoringMedicare Covered
Notal Vision
ForeseeHome & SCANLY
FDA Cleared
2009
Patients
44,000+
Sensitivity
88.4%
Home-based monitoring for existing intermediate AMD patients. Patient self-operated retinal imaging between clinic visits to detect conversion to wet AMD. Medicare & private insurance covered. Different market: monitors existing patients, not early risk screening.
Mobile telemedicine platform for retinal imaging. Important: Camera does not make medical recommendations by itself - images are graded by licensed ophthalmologist or optometrist. Non-AI platform for image transfer/storage/display only.
Academic Biomarker Research: Ready for Commercial Translation
Promising biomarkers identified but none commercialized—the perfect gap for a startup
Cleveland Clinic
Dr. John W. Crabb
Pioneering work on carboxyethylpyrrole (CEP) protein modifications. Combined CEP + genomic markers achieved 80% discrimination accuracy. ELISA-based detection methods published 2009-2010 are ready for commercialization.
Mass Eye & Ear / Harvard
Dr. Joan Miller, Dr. Deeba Husain, Dr. Ines Lains
Published 2017 study identifying 87 metabolites significantly different in AMD patients. Six of top seven biomarkers were lipid pathway metabolites. Strong foundation for metabolomics-based diagnostic.
Decode Genetics / Amgen
Iceland
Large-scale serum proteomics study (4,782 human serum proteins) published in Nature Communications 2022. Mendelian randomization identified causal proteins predicting AMD progression.
French Research Consortium
INRAE / INSERM
Patent filed for predictive algorithm using 7-cholesterol ester blood biomarker panel. Clinical studies demonstrated high biomarker levels associated with lower advanced AMD risk.
Strategic Implications
Our Advantages
✓
Zero competition in blood-based AMD risk assessment
✓
Can be deployed in primary care, not specialist-dependent
✓
Dual revenue model: B2B (doctor-ordered) and B2C (direct-to-consumer)
✓
Proof-of-concept study completed
✓
Risk Assessment Analysis enabling Early Detection Opportunity
Critical Challenges
!
3 companies already operational in AMD imaging
!
$180M+ already invested in imaging competitors
!
Imaging competitors have FDA clearances & reimbursement
!
Long timeline to profitability (7-10 years, $150-250M capital)
💡 Investment Rationale
Investment Opportunity: This investment opportunity represents the convergence of significant unmet medical need, proven technology platform, experienced leadership, and clear regulatory and reimbursement pathways.
Why Now?
🚀
Market First: First mover advantage for blood-based AMD test
📊
Proven Model: Validated by Exact Sciences success
💡
Clear Regulatory Pathway: Established FDA approval process with Medicare reimbursement precedent
👥
Experienced Leadership: Team with proven success track record in diagnostics and health entrepreneurship
🔬
Scalable Technology: Expandable platform to glaucoma, diabetic retinopathy and other retinal diseases
💎
Large Market: $42.3 billion opportunity
Critical Investment Metrics
$42.3 Billion
Total Addressable Market
94-95%
Test Accuracy Rate
169 Million
Target Population
Investment Advantages
🏆
Market First
First mover advantage for blood-based AMD test
💰
Proven Model
Validated by Exact Sciences success
📋
Clear Regulatory
FDA approval pathway and Medicare reimbursement
📈
Large Market
$42.3 billion opportunity
💡 Sample AMD Risk Assessment Report
✨
Below you can see an example of blood analysis results related to eye disease.
Proactive Vision Analysis
Early Risk Analysis Platform with Next-Generation Algorithms
Demo Explanation: This demo screen shows the user interface of our AMD risk assessment platform that will be applied to real patients. After blood analysis results are processed by the AI algorithm, patients and doctors will receive this type of clear risk assessment.
📋 Appendix - Exact Sciences Analysis
Comprehensive analysis of Exact Sciences Corporation, a proven diagnostic company following the business model we aim to emulate for AMD risk assessment.
📋 Appendix - CLIA Related Info
Major Regulatory Clarity for Laboratory Developed Tests - A1 Diagnosis Investor Update (October 2025)
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LDT Regulatory Update
Major Regulatory Clarity for Laboratory Developed Tests
A1 Diagnosis Investor Update
October 2025
What Are Laboratory Developed Tests (LDTs)?
Laboratory Developed Tests are diagnostic tests that are:
Designed, manufactured, and performed within a single laboratory
Not sold commercially as test kits
Used to analyze patient specimens (blood, tissue, etc.)
Examples of LDTs:
COVID-19 diagnostic tests
Cancer genomic testing
Newborn screening tests
A1 Diagnosis blood test for AMD risk detection
Timeline of Events
May 6, 2024
FDA issued final rule attempting to regulate LDTs as medical devices
March 31, 2025
Federal District Court (Eastern District of Texas) vacated the FDA rule, ruling that FDA lacks statutory authority to regulate LDTs
September 19, 2025
FDA issued final rule reverting back to pre-May 2024 regulations—no FDA appeal filed
Bottom Line: The FDA has formally accepted the court's decision. LDTs are regulated by CMS/CLIA, not FDA.
A1 Diagnosis Position: We committed to FDA validation for maximum credibility. The regulatory clarity gives us strategic flexibility to evaluate CLIA as a potential complementary or alternative route, but doesn't change our commitment to rigorous validation.
What the Court Decided
Key Ruling:
LDTs are professional laboratory services, not tangible medical devices subject to FDA regulation.
Court's Reasoning:
The FDA's device definition requires tangible, physical objects
LDTs are intangible services performed by laboratories
Congress created CLIA specifically to regulate clinical laboratories and their tests
FDA historically chose not to enforce device rules on LDTs (enforcement discretion)
Result: FDA removed the phrase "including when the manufacturer of these products is a laboratory" from its regulations
Current Regulatory Pathway for LDTs
✓ Required: CLIA
Clinical Laboratory Improvement Amendments
Laboratory certification
Quality control standards
Proficiency testing
Personnel requirements
✗ NOT Required: FDA
No FDA Device Regulation
No premarket review
No De Novo pathway
No 510(k) clearance
No PMA approval
Administered by: Centers for Medicare & Medicaid Services (CMS)—the same agency that handles Medicare reimbursement
A1 Diagnosis Approach: We are committed to FDA validation for maximum credibility. The regulatory clarity now allows us to evaluate CLIA as a potential complementary or alternative route, giving us strategic flexibility while maintaining our commitment to rigorous validation.
A1 Diagnosis Regulatory Strategy
Our Commitment: FDA Validation for Maximum Credibility
Primary Path: We are committed to pursuing rigorous FDA validation with 240 samples across multiple centers
✓ FDA Validation Path (Active)
Current Phase 1 Budget: $1M
240 sample clinical validation
Multi-center study design
Rigorous FDA-quality evidence generation
Publication in peer-reviewed journals
De Novo pathway or equivalent
CLIA Pathway (Under Evaluation)
Status: Evaluating as complementary or alternative route
Laboratory quality standards
Proficiency testing programs
Personnel credentialing
Potential faster market entry option
Cost-benefit analysis in progress
Strategic Flexibility:
Maximum Credibility: FDA validation provides gold-standard evidence for clinical adoption and reimbursement
New Options: Regulatory clarity allows us to evaluate CLIA as potential complementary or alternative pathway
Unchanged Commitment: Our focus remains on building the most rigorously validated AMD early detection test
Competitive Positioning
Why FDA Validation Creates Competitive Advantage
Gold Standard
FDA validation (240 samples, multi-center) provides highest level of clinical credibility
Reimbursement
Rigorous FDA-quality data strongly supports Medicare and private payer coverage decisions
Physician Trust
FDA pathway builds confidence with ophthalmologists and retinal specialists
Strategic Flexibility from Regulatory Clarity
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Evaluating CLIA
Potential complementary or alternative route
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Timeline Benefits
Assessing CLIA for potential faster market entry
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Cost Analysis
Dual-pathway vs. FDA-only approach implications
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Commitment
Rigorous validation regardless of pathway chosen
Key Message for Investors: We're building the most rigorously validated AMD early detection test on the market. The regulatory clarity gives us strategic options, but doesn't change our commitment to FDA-quality evidence.
Phase 1 Funding & Strategic Options
Committed: FDA Validation Path ($1,000,000)
Current Phase 1 Investment: FDA-Quality Validation Studies
240-sample clinical validation across multiple centers
Proteomic analysis and machine learning model refinement (94-95% accuracy target)
Statistical validation and clinical utility analysis
Study coordination, data management, and regulatory documentation
Manuscript preparation and peer-reviewed publication
De Novo pathway submission or equivalent FDA engagement
Under Evaluation: CLIA Pathway Option
Analyzing CLIA as potential complementary or alternative route:
Cost assessment: CLIA laboratory certification and accreditation fees
Timeline analysis: Potential faster market entry vs. FDA pathway
Quality standards: Requirements for proficiency testing and personnel credentialing
Strategic value: Reimbursement and competitive positioning implications
Decision timeline: CLIA pathway cost-benefit analysis to be completed very soon.
Regulatory Clarity Impact: The court decision gives us strategic flexibility to evaluate CLIA, but our commitment to rigorous FDA validation remains unchanged. We're assessing whether adding CLIA provides additional strategic value.
References & Additional Information
Official Documents:
1. Congressional Research Service Legal Sidebar (LSB11312): Laboratory Developed Tests - District Court Vacates FDA Rule (March 31, 2025)
