Instructions (CLAUDE.md)
This directory contains documentation for the EPIC-X 2026 grant application, a European acceleration program for women-led deep-tech startups.
The final application must be submitted in English.
Grant Program Overview
| Field | Value |
|---|---|
| Program | EPIC-X European Acceleration for Women-Led Deep-Tech Startups |
| Grant Amount | EUR 60,000 (equity-free lump sum) |
| Coaching Requirement | Minimum EUR 20,000 allocated for business coaching (15-20 days) |
| Official Deadline | January 5, 2026 at 17:00 CET |
| Internal Deadline | December 19, 2025 (recommended by Zabala due to Christmas holidays) |
| Program Duration | 6 months (April 1 - September 31, 2026) |
| Total Budget | EUR 1.2 million across 20 selected startups |
| Official Website | https://ec.europa.eu/eusurvey/runner/ce2aa52e-20db-8c4b-7e39-396bbdcc9e91 |
Eligibility Criteria - How Legit.Health Qualifies
Women Leadership Requirement ✓
Legit.Health meets the women-led requirement through Andy Aguilar:
- Role: CEO (Chief Executive Officer)
- Co-Founder: Equal partnership established 2020 (3 co-founders)
- Ownership: 33.33% equal top shareholder (among 3 equal top shareholders)
- Board Position: Presidenta del Consejo de Administración (Board Chair)
- Decision-Making Authority: Strategic, operational, and financial oversight
Qualification: Women-led company with woman in founder + C-level position + 25%+ ownership equivalent ✓
Geographic Eligibility ✓
- Location: Bilbao, Spain
- Spain: One of 16 eligible moderate/emerging innovator countries ✓
SME Status ✓
- Founded: September 2017 (before January 1, 2024) ✓
- Team Size: 31 FTEs (< 50 employees = Small enterprise) ✓
- Classification: Small SME ✓
Deep-Tech Focus ✓
- Technology Domain: Artificial Intelligence and Machine Learning ✓
- Application Sector: Healthcare and Life Sciences ✓
- Innovation: Computer vision + deep learning for medical diagnosis (239 ICD-11 conditions) and severity assessment (7 validated scales) ✓
Market Validation ✓
- Regulatory Clearances: CE MDR Class IIb, FDA 510(k) ongoing, ANVISA Brazil, MHRA UK ✓
- Clinical Studies: 7 completed studies with 1000+ patients, 6+ peer-reviewed publications ✓
- Hospital Contracts: Active contracts with European hospitals ✓
- Seed Financing: CDTI Sello de Excelencia (EUR 2.5M grant) ✓
- Revenue: Proven market fit with recurring SaaS revenue ✓
Evaluation Criteria (100 Points Total)
Excellence and Innovation (40 points)
| Criterion | Max Points | Weight | Minimum Threshold | Application Section |
|---|---|---|---|---|
| A.1 Relevance to EPIC-X Scope | 15 | 15% | N/A | Section 2 - Excellence |
| A.2 Unbiased Mission | 10 | 10% | N/A | Section 2, Section 6 |
| A.3 Business Coaching Plan | 10 | 10% | N/A | Section 2, Section 5 |
| A.4 European Added Value | 5 | 5% | N/A | Section 2 |
| SUBTOTAL | 40 | 40% | N/A |
Key Elements:
- A.1 Relevance (15pts): Deep-tech innovation, alignment with AI/ML + healthcare, scalability, market potential, S3 priorities
- A.2 Unbiased Mission (10pts): Gender equality focus, inclusive AI design, bias-free models, social impact
- A.3 Coaching Plan (10pts): Clear needs assessment, measurable outcomes, strategic fit, realistic EUR 20k allocation
- A.4 European Value (5pts): EU market focus, cross-border potential, regulatory compliance (GDPR, MDR)
Impact and Market Potential (25 points)
| Criterion | Max Points | Weight | Minimum Threshold | Application Section |
|---|---|---|---|---|
| B.1 Impact on Growth | 15 | 15% | N/A | Section 3 - Impact & Market |
| B.2 Regional Ecosystem Impact | 10 | 10% | N/A | Section 3 |
| SUBTOTAL | 25 | 25% | N/A |
Key Elements:
- B.1 Growth Impact (15pts): Revenue trajectory, market size, expansion plan, short/medium/long-term impacts
- B.2 Ecosystem Impact (10pts): Technological contributions, societal impact, environmental benefits, economic value, role model effect
Implementation and Capacity (35 points)
| Criterion | Max Points | Weight | Minimum Threshold | Application Section |
|---|---|---|---|---|
| C.1 Quality and Feasibility | 20 | 20% | N/A | Section 4 - Implementation |
| C.2 Team and Resources | 10 | 10% | N/A | Section 4, Section 6 |
| C.3 Budget and Cost-Effectiveness | 5 | 5% | N/A | Section 4 |
| SUBTOTAL | 35 | 35% | N/A |
Key Elements:
- C.1 Work Plan (20pts): Clear milestones, realistic timeline, risk management, feasibility, deliverables alignment
- C.2 Team Capacity (10pts): Expertise, track record, organizational capacity, women in leadership emphasis
- C.3 Budget (5pts): Appropriate allocation, cost-effectiveness, ROI justification, co-financing
Minimum Threshold: 50 points total required to pass
Bonus Points (up to 5):
- Prior recognition as scale-up in Horizon Europe programs (EIC Scaleup 100, EIT)
- Digital Europe Programme participation
- National "Plug-in" certified programme funding
Task Tracking (6 Deliverables)
| Task # | Deliverable | Status | Deadline | Owner | Location |
|---|---|---|---|---|---|
| 1 | Legal Entity Form (Annex 2) | Not Started | Dec 19, 2025 | Finance | Google Docs (external) |
| 2 | Women's Leadership Declaration (Annex 3) | Not Started | Dec 19, 2025 | Andy/HR | Google Docs (external) |
| 3 | Business Coaching Plan (Annex 4) | Not Started | Dec 19, 2025 | Andy/Strategy | Section 5 + Google Docs |
| 4 | Market Fit & Investment Documents | Not Started | Dec 19, 2025 | Commercial | Section 3 + Supporting Docs |
| 5 | Online Application Form | Not Started | Jan 5, 2026 | Andy | Online Portal + Copy from Sections |
| 6 | 2-Minute Pitch Video | Not Started | Jan 5, 2026 | Andy | YouTube/Vimeo/Google Drive |
Google Drive Links (from epic-to-do.pdf):
- Legal Entity Form: https://drive.google.com/drive/folders/1GRd4BZiVs8dS_owUgNCHdtTeqDSRLKiV
- Women's Leadership Declaration: https://docs.google.com/document/d/1mL1Ph9pJxn7i6hQa6okVTqCJYh8nWedG/edit
- Business Coaching Plan: https://docs.google.com/document/d/1mYtlaePhfAX67NXfNqJx0wjRUOmfVkB8/edit
- Market Fit Documents: https://docs.google.com/document/d/1G6V98h0yLkgsSZj16u675t19L0FkLfL2/edit
Content Strategy: Alignment Matrix
This matrix shows how each application section addresses the 100-point evaluation criteria:
| Application Section | Excellence (40pts) | Impact (25pts) | Implementation (35pts) |
|---|---|---|---|
| Section 1: Executive Summary | Overview | Overview | Overview |
| Section 2: Excellence | PRIMARY (40pts) | Supporting | Supporting |
| - Deep-Tech Innovation | A.1 Relevance (15pts) | ||
| - Unbiased AI Mission | A.2 Mission (10pts) | B.2 Ecosystem | |
| - Coaching Plan Alignment | A.3 Coaching (10pts) | Integration | |
| - European Value | A.4 European (5pts) | B.1 Growth (EU market) | |
| Section 3: Impact & Market | Supporting | PRIMARY (25pts) | Supporting |
| - Growth Impact | Innovation evidence | B.1 Growth (15pts) | |
| - Ecosystem Impact | Unbiased AI mission | B.2 Ecosystem (10pts) | |
| Section 4: Implementation | Supporting | Supporting | PRIMARY (35pts) |
| - Work Plan | C.1 Feasibility (20pts) | ||
| - Team Capacity | Innovation capability | C.2 Team (10pts) | |
| - Budget Justification | ROI/value | C.3 Budget (5pts) | |
| Section 5: Coaching Plan | A.3 Coaching (10pts) | Acceleration | Integration |
| Section 6: Women Leadership | A.2 Mission (10pts) | B.2 Ecosystem (role model) | C.2 Team (women evidence) |
Legit.Health Context
Company Overview
| Field | Value |
|---|---|
| Legal Name | Legit.Health |
| Founded | September 2017 (8+ years) |
| Location | Bilbao, Spain |
| Team Size | 31 FTEs (62 total including former employees) |
| Classification | Medical Device (SaMD - Software as a Medical Device) |
| Regulatory Class | CE MDR Class IIb |
| Technology | AI-powered dermatology diagnosis (239 ICD-11) + severity assessment (7 validated scales) |
| Market Focus | Hospitals, clinical trials, teledermatology |
Andy Aguilar - CEO & Co-Founder
Full Name: Sheyla Andina Aguilar (goes by "Andy Aguilar")
Leadership Roles:
- Chief Executive Officer (CEO)
- Co-Founder (September 2017, equal partnership with 2 others)
- Presidenta del Consejo de Administración (Board Chair)
- Equal Top Shareholder (33.33%)
Decision-Making Authority:
- Strategic: Company vision, market positioning, partnership strategy
- Operational: Team management, product roadmap, execution oversight
- Financial: Budget allocation, fundraising, investor relations
Key Achievements:
- Forbes 30 Under 30 - Recognition as one of the 30 most influential young entrepreneurs
- Forbes 100 Most Creative Individuals in Business - Honored for innovative approach to healthcare technology
- Led CE MDR Class IIb certification (2023)
- Secured EUR 2.5M CDTI Sello de Excelencia grant (2024)
- Established 7 clinical validation studies with 1000+ patients
- Built multidisciplinary team from 3 founders to 31 FTEs (8+ years growth)
- Drove European market expansion (Spain, UK, Brazil)
- EUR 192K+ in won contracts with hospitals and pharmaceutical companies
Vision: Democratizing dermatology expertise through inclusive, bias-free AI technology
Technology & Innovation
AI/ML Technology:
- Computer vision architectures: Convolutional Neural Networks (CNNs), Vision Transformers
- Deep learning models for multi-class classification (239 ICD-11 dermatology conditions)
- Severity assessment algorithms (7 validated scales: PASI, SCORAD, ASCORAD, EASI, IGA, APASI, ALADIN, AUAS, ASCORAD, GAGS, DLQI)
- Training dataset: Diverse representation across Fitzpatrick skin types I-VI, gender-balanced
Clinical Validation:
- 7 completed clinical studies with 1000+ patients
- Hospitals: Vall d'Hebron, Virgen de las Nieves, Gregorio Marañón, others
- 6+ peer-reviewed publications in dermatology and AI journals
Regulatory Achievements:
- CE MDR Class IIb (European Union)
- FDA 510(k) ongoing (United States)
- ANVISA registered (Brazil)
- MHRA registered (United Kingdom)
- ISO 13485:2016 certified by BSI
Market Fit Evidence
Hospital Contracts: Active partnerships with European hospitals for clinical decision support, teledermatology, clinical trials
Clinical Trial Partnerships: Collaborations with pharmaceutical companies (Boehringer Ingelheim, Janssen, SUN Pharma, others) and CROs
Revenue: Proven market fit with recurring SaaS revenue from hospital subscriptions and clinical trial licensing
Funding: CDTI Sello de Excelencia grant (EUR 2.5M) for AI development and clinical validation
Acceleration Needs (Aligned with EPIC-X)
- US Market Entry & FDA 510(k): Regulatory strategy, pre-submission meetings, clinical data package
- Series A Fundraising: EUR 5-10M target for European expansion, US market entry, team scaling
- European Hospital Partnerships: C-suite engagement strategies, partnership development in Germany, France, Italy
- Women Leadership Visibility: Conference speaking, media presence, thought leadership platform for Andy Aguilar
Resources
Primary Reference Documents
| File | Location | Description |
|---|---|---|
| EPIC-X Open Call Guidelines | resources/guidelines/ | Official program requirements |
| epic-to-do.pdf | resources/reference/ | Task breakdown and deadlines |
| Annex 2: Legal Entity Form | resources/templates/ | Template for corporate documentation |
| Annex 3: Application Form | resources/templates/ | Main application template |
| Annex 4: Coaching Plan | resources/templates/ | Business coaching plan template |
Company Evidence (Supporting Data)
These files contain comprehensive evidence for use throughout the application:
| File | Location | Contents |
|---|---|---|
| andy-aguilar-bio.md | resources/company-evidence/ | CEO biography, leadership, achievements |
| women-leadership-evidence.md | resources/company-evidence/ | Ownership, board, team diversity |
| market-fit-evidence.md | resources/company-evidence/ | Contracts, revenue, clinical studies |
| seed-financing-evidence.md | resources/company-evidence/ | CDTI grant, investment rounds |
Clinical Evidence Resources
Performance claims and clinical benefits data for demonstrating impact:
| Resource | Location | Description |
|---|---|---|
| Performance Claims (148) | /packages/ui/src/components/PerformanceClaimsAndClinicalBenefits/performanceClaims.ts | Validated clinical metrics with SOTA comparisons |
| Clinical Benefits (7) | /packages/ui/src/components/PerformanceClaimsAndClinicalBenefits/clinicalBenefits.ts | Intended clinical benefits from device |
| PC-042 (Skin Tone Equity) | Performance Claims file | Critical for unbiased AI mission (Section 2, 6) |
Clinical Studies (7 Studies, 1000+ Patients)
Implementation plans and study details:
| Study Code | Hospital/Partner | Location |
|---|---|---|
| BI_2024 | Boehringer Ingelheim (Psoriasis) | /apps/qms/docs/records/GP-009/r-009-001/ |
| AIHS4_2025 | Vall d'Hebron (Hidradenitis Suppurativa) | Implementation plans folder |
| SAN_2024 | Various hospitals | Implementation plans folder |
| DAO_2022 | Time savings study | Referenced in clinical benefits |
| IDEI_2023 | Eczema study | Implementation plans folder |
| MC_EVCDAO_2019 | Early validation | Historical reference |
Key Content Themes (Throughout All Sections)
Consistently emphasize these 6 themes across all application sections:
- Women Leadership - Andy Aguilar: CEO, co-founder, 33.33% shareholder, Presidenta del Consejo de Administración
- Deep-Tech AI/ML Innovation - Computer vision, clinical validation (7 studies, 1000+ patients), regulatory clearances (CE, FDA)
- Market Fit & Traction - Hospital contracts, revenue growth, clinical trial partnerships
- Unbiased AI & Gender Equality Mission - Skin tone equity (PC-042), women's health focus, team diversity
- European Value Proposition - GDPR compliance, FHIR interoperability, European hospital partnerships, market expansion
- Acceleration Needs - US FDA 510(k), Series A fundraising (EUR 5-10M), partnerships, visibility
Writing Guidelines
Language & Tone
- Language: English (EU program requirement)
- Tone: Professional, evidence-based, technical but accessible
- Approach: Clear assertions backed by quantified data and citations
- Style: Academic/regulatory tone suitable for European Commission evaluators
Evidence-Based Content
- All performance claims must reference Performance Claims (PC-XXX) or clinical studies
- Quantify improvements with specific percentages and confidence intervals where available
- Cite regulatory clearances with certificate numbers and dates
- Include participant counts (n=XXX) for clinical studies
Tables & Data Visualization
- Use tables extensively for structured data (following proyecto-red-ia-salud pattern)
- Clinical metrics: Performance vs. SOTA comparisons
- Timelines: Quarterly milestones (Q1-Q4 2026)
- Budget: Line item breakdowns with rationale
Cross-References
- Link between sections when referencing same content (e.g., "See Section 5 for detailed coaching plan breakdown")
- Reference company evidence files for detailed supporting data
- Point to Performance Claims for specific clinical metrics
Next Steps
- ✅ Phase 1: Directory structure and configuration files created
- Phase 2: CLAUDE.md completed (this file)
- Phase 3: Copy supporting documents (guidelines, templates, task list)
- Phase 4: Create company evidence files (4 markdown files with comprehensive data)
- Phase 5-10: Create 6 application sections aligned with 100-point criteria
- Phase 11: Quality review and stakeholder validation
- Phase 12: Complete external administrative forms (Annexes 2-4, pitch deck)
- Phase 13: Final submission to EPIC-X portal by January 5, 2026
Data Collection Needed
To complete the application sections, gather data from Legit.Health teams:
Andy Aguilar (CEO):
- Full biography with healthcare background
- Leadership timeline (pre-Legit.Health career → founding → current)
- Vision statement on inclusive AI and women in deep-tech
- Conference speaking log (2023-2024)
- Media features and LinkedIn metrics
- Strategic priorities for coaching plan
Finance Team:
- Revenue data: 2022, 2023, 2024 actual
- Revenue projections: 2025, 2026 with growth assumptions
- Hospital contracts: Names, locations, ARR, start dates
- CDTI grant details: Award date, disbursement schedule, scope
- Cap table snapshot (ownership percentages)
Commercial Team:
- Hospital contract details (beyond finance data): Use cases, decision-makers contacted, sales cycle length
- Customer testimonials (1-2 quotes from dermatologists or clinical trial managers)
- Target market expansion: Germany, France, Italy partnerships in pipeline
Clinical Team:
- 7 clinical studies details: Study names, hospital names, n patients, start/end dates, publication references
- Participant demographics for diversity metrics (gender, age, skin tone distribution)
- Publications list: Authors, titles, journals, years, DOIs, citation counts
Regulatory Team:
- Certificate scans: ISO 13485, CE MDR, ANVISA, MHRA (numbers, dates, issuing bodies)
- FDA 510(k) status: Timeline, predicate devices, pre-submission meetings planned
- Regulatory roadmap: 12-month milestones for US market entry
HR Team:
- Team size total: 20+ FTEs (current exact count)
- Diversity metrics: % women overall, % women in leadership, % women in technical roles
- Board composition: Names, roles, gender (for women leadership evidence)
Strategic Planning:
- 12-month milestones for work plan (Q1-Q4 2026): Specific dates for FDA meetings, fundraising close, contract signatures
- Risk assessment: Top 5 risks with mitigation strategies
- Budget allocation justification: How EUR 60k will be spent (4 categories: US market, FDA, EU partnerships, women leadership)