Confidential — Business Report

HAD Digital

CTCAE-native toxicity monitoring & care coordination for oncology hospitalisation à domicile
Business plan, cost–benefit analysis & investment case — France

€600k

Investment needed (base)

30–36 mo

To cash break-even

€2.1M

Year-5 ARR (base)

2.7–3.4×

Customer ROI (base)

€10–18M

Exit value range (Y6–7)

Prepared for Dr Kais Al Dabbagh (founder & concept owner) · 7 September 2026 · Companion documents: HAD_Digital_Journey_to_Market_France.md (regulatory playbook) · MVP_PLAN.md (product)

1. Executive summary

HAD Digital is a medical-device software platform that lets oncology patients under hospitalisation à domicile (HAD) report treatment toxicity in structured form, auto-grades it to CTCAE v5.0, and fires tiered alerts to the care team — converting today's phone-and-paper monitoring into a real-time shared timeline. The mission: cut avoidable emergency admissions and re-hospitalisations among home-treated cancer patients.

What this report concludes

The asset is real and defensible. A Class IIa CE-marking path is defined (18–30 months), the IP stack (trade secret + e-Soleau + EU trademark + optional patent) protects the owner before any disclosure, and the pricing anchors already exist in French reimbursement law (télésurveillance forfaits €28–70/patient/month).
The investment is modest for medtech: €185k (lean, grant-heavy) to €925k (funded/fast). The recommended base case is €600k over ~30 months, of which a large share is grant-eligible (Bpifrance i-Lab up to €600k ceiling). Cash break-even is reached in Year 4 on base-case volumes.
Customers earn their money back 2–3×. A HAD structure spending ~€22–27k/yr avoids an estimated €74k/yr in re-admissions, ED visits and coordinator time (base case) — the ROI story that closes sales.
Five routes to monetise exist — sell direct, license through an established hospital-software editor, partner with an HAD operator, ride the reimbursement inscription, or build-to-sell to a télésurveillance operator. Each is detailed in §9–10.
Exit potential: with inscription and €2.5–3M ARR, trade-sale value of €10–18M at Year 6–7 (4–6× ARR, consistent with digital-health precedents). The Moovcare delisting (2025) is the standing warning: clinical evidence quality is the whole game.

Owner's decision asked by this report: approve the €600k base-case plan (funding mix in §8), start Stage-0 IP actions this week, and choose a commercialisation route (§10) by Month 6 — Route A/B hybrid recommended.

2. Product & value proposition

Dimension	Description
What it is	Web platform (SaaS) + roles for oncologist, HAD coordinating nurse, community nurse, GP, pharmacist, patient, caregiver. Structured symptom capture → automatic CTCAE v5.0 grading → routine/urgent/emergency alerts → shared care timeline → exportable toxicity summaries.
Status today	Working MVP skeleton (standalone Windows demo with SQLite) built by AI agent under governance framework; specifications (cahier des charges) complete. Production product = SaaS on HDS-certified hosting.
Regulatory identity	Medical device software, EU MDR Rule 11, Class IIa minimum (per MDCG 2019-11 rev.1, 2025). Deterministic rules engine → outside EU AI Act scope. CE mark required before sale.
Core value metric	Target ≥20% reduction of unplanned re-hospitalisations in monitored oncology HAD patients (pilot MOE-4), plus ≥30% clinician documentation-time reduction.
Differentiation	Only offering built around the HAD workflow (multi-professional home-care coordination), by a practising oncologist-founder. Competitors (Cureety, Satelia, Continuum+, Resilience) are hospital/ambulatory-centric.

3. Market & competition

TAM — France oncology e-monitoring

~€30–40M/yr. ~280 authorised HAD structures (>7.6M HAD days in 2024, +5.9% yoy) plus hospital ambulatory oncology (day hospitals, CLCC network, regional oncology networks).

SAM — HAD + partner wards

~€10–15M/yr. 280 HAD structures + ~100 oncology wards/networks reachable with a HAD-centred workflow and existing reimbursement levers.

SOM — 5-year capture (base)

~70 structures/networks ≈ €2.1M ARR at Year 5 (25% of the HAD segment). EU extension is optional upside ×5–8 (not modelled).

Competitive set (honest positioning)

Player	Status	Where HAD Digital wins
Cureety	CE-marked, inscribed 03/2025 (opérateur €28 + distributeur €50 /patient/mo)	HAD multi-professional coordination; HAD-specific escalation protocols
Satelia (Nobla)	CE DMN, inscribed 03/2025, onco-haematology focus	True shared timeline for home teams vs hospital portal UX
Continuum+ Connect	First oncology DMN via PECAN (09/2024)	HAD-centric (they target systemic therapy/radio ambulatory)
Resilience (care)	Patient-app positioning, deployed at CLCC Rennes	Clinician-grade CTCAE engine + reimbursement-grade workflow
Moovcare	Delisted 03/2025 after HAS refusal	Lesson adopted: our clinical-evidence plan is designed to HAS standards from day 1

4. Journey timeline — 8 stages to revenue

S0 · IP lockdown (e-Soleau, trademark, NDA)

S1 · SASU incorporation

S2 · Med-device-grade build (62304/14971)

S3 · GDPR / DPIA / HDS hosting

S4 · Notified Body → ISO 13485 → CE mark

S5 · PMCF clinical pilot (2–3 HADs) + publication

S6 · Paying pilots → PECAN / forfait innovation

S7 · Licensing scale-up (70 structures)

S8 · Marketing engine (societies, Santexpo, KOLs)

M0M6M12M18M24M30M36

Key gates: CE mark ≈ M18 · first paid pilots M15–18 · reimbursement dossier M18–24 · break-even volume M40+.

5. Investment needed — full cost model

Three execution scenarios. All figures are total cash to first paying clients (pre-revenue phase). The base case is the recommended plan; the lean case trades speed for minimal burn (grant + founder-funded).

Cost category (pre-revenue)	Lean	Base ★	Funded	Notes
Legal, IP, company creation	3k	5k	8k	e-Soleau €15, EU trademark ~€1.1k, SASU ~€250, contracts lawyer
Regulatory consultants	15k	35k	50k	Classification memo, tech-doc support, NB liaison
Notified Body (initial certification)	25k	45k	60k	QMS + technical documentation audit (IIa)
QMS setup (ISO 13485 tooling, internal audits)	8k	15k	20k	eQMS + training
Clinical evaluation & usability studies	10k	30k	60k	IEC 62366 file, simulated-case validation
PMCF pilot (sites, statistics, publication)	15k	40k	70k	2–3 HAD sites, ~60–120 patients
Data protection (DPIA, DPO, legal)	8k	15k	20k	CNIL-aligned docs, art. 28 contracts
Hosting & infrastructure (HDS provider)	8k	15k	25k	Purchased HDS hosting — no self-certification
Team (net, loaded, pre-revenue period)	60k	250k	450k	Lean: founder + autoclaw + part-time QA. Base: +1 dev (M6), +1 regulatory/quality engineer (M12). Funded: +clinical sales (M12)
Marketing, congresses, travel	5k	15k	30k	SFRO/FNEHAD attendance, materials
Insurance (RC pro → product liability)	3k	8k	12k	Product cover scales up at CE
Contingency (~15%)	25k	71k	120k	—
Total cash to first revenue	€185k	€544k	€925k	Time to CE: 30–36 / 24–30 / 18–24 months

Where the base-case €544k goes

€544k

base case

Team (2 hires + founder) — €250k · 46%

Notified Body + reg. consultants + QMS — €95k · 17.5%

Clinical evidence (eval + usability + PMCF) — €70k · 13%

Contingency — €71k · 13%

Data protection + HDS hosting — €30k · 5.5%

Marketing — €15k · 2.8%

Insurance — €8k · 1.5%

Legal/IP — €5k · 0.9%

Post-CE recurring quality costs (surveillance audit ~€15k/yr, PSUR, DPO, hosting) are included in the operating P&L, §6.

Recurring operating costs after CE (at ~30 clients): team of 5 FTE (2 dev, 1 quality/regulatory, 1 clinical sales, 1 support) ≈ €320k/yr + NB surveillance €15k + hosting €25k + DPO €6k + quality upkeep €10k + marketing €40k + insurance €15k + admin €20k ≈ €450k/yr — driving the Year-4/5 margins below.

6. Revenue model & 5-year projection

Pricing architecture (anchored to reimbursement)

Tier	Contents	Annual license	Per active patient / month
HAD Core	Toxicity capture + CTCAE grading + tiered alerts + timeline	€12k	€18
HAD Coordinate ★	+ messaging, summaries/exports, treatment-plan views, GP/pharmacist access	€20k	€22
HAD Réseau	Multi-site networks, analytics, PSUR-ready reporting	€45k	€20
Reimbursed mode (after L.162-52 inscription): Assurance Maladie pays the operator forfait €28–70/patient/month — HAD Digital bills within that envelope		forfait-borne

Average client value builds from ~€22k/yr (Year 3, mostly Core/Coordinate) to ~€30k/yr (Year 5, networks + forfait volumes). Pilot offer: 3-month proof-of-value at €15k, fully credited against the first annual license — stays under the €40k public-procurement threshold, so a hospital can buy without a tender.

Base-case projection (k€)

Revenue Operating costs EBITDA (labels)

Revenue: 20 / 60 / 300 / 900 / 2,100 k€ (Y1–Y5). Costs: 260 / 280 / 420 / 640 / 1,150 k€. Clients: 1 / 3 / 12 / 30 / 70 structures. EBITDA turns positive in Year 4.

k€	Y1	Y2	Y3	Y4	Y5
License revenue	0	45	260	730	1,500
Patient usage & pilot fees	20	15	40	50	120
Reimbursed forfaits (post-inscription)	0	0	0	120	480
Total revenue	20	60	300	900	2,100
Operating costs	260	280	420	640	1,150
EBITDA	-240	-220	-120	+260	+950
Cumulative EBITDA	-240	-460	-580	-320	+630

Sensitivity: if the reimbursement inscription slips one year, Y4–Y5 revenue drops ~€300–400k cumulative and break-even moves ~2 quarters later; the license-only model still breaks even at ~45 structures. If inscription lands with a €56–70 forfait level, Y5 revenue upside ≈ +€0.8M. The Moovcare precedent cuts both ways — the bar is high but the winners are insulated.

7. Cost–benefit analysis

7.1 For the customer — one HAD structure, per year (the number that closes deals)

Assumptions: structure monitors ~120 oncology patients/yr for ~3 months each (≈30 concurrent); license tier Coordinate €20k + usage fees ~€6k + internal effort ~€5k → total cost ≈ €31k/yr. Benefits: unplanned re-admissions (oncology HAD baseline ~15–20% at ~€4,500/stay), avoided ED visits (~€650), coordinator time (≥30% documentation reduction ≈ 0.6 FTE ≈ €24k).

Benefit stream	Conservative	Base	Optimistic
Avoided re-admissions (10% / 20% / 30% reduction)	€19k	€38k	€57k
Avoided ED visits	€6k	€12k	€18k
Coordinator/nurse time released	€15k	€24k	€35k
Total annual benefit	€40k	€74k	€110k
Net vs €31k cost · ROI	+€9k · 1.3×	+€43k · 2.4×	+€79k · 3.5×

Annual cost Annual benefit

Scale: 1.9 px per k€. Unquantified upsides for the hospital: bed-days freed, quality-certification indicators, team satisfaction, recruitment appeal.

7.2 For Assurance Maladie / society (what the HAS dossier will test)

Cost side: operator forfait €28–70/patient/month (≤ €480–840 per patient-year at 12 months; typical oncology monitoring lasts ~3 months → ~€84–210/patient-episode).
Benefit side: one avoided re-admission ≈ €4,500 ≈ the cost of forfaits for 21–160 patient-episodes; one avoided ED visit ≈ €650. Break-even ≈ 1 avoided acute event per 10–30 monitored patient-episodes plus home-visit substitution (each substituted nurse visit ≈ €60). The PMCF pilot is designed to measure exactly these ratios.

7.3 For the investor — project economics

Cumulative EBITDA / cash position

Base-case cumulative cash. The maximum drawdown (~€580k at Month 36) defines the funding ask (§8).

Metric (base case)	Value	Comment
Total investment to self-funding	€600k	€544k program + working-capital buffer
Time to positive EBITDA	Year 4	~42–46 months from start
Cumulative EBITDA by Y5	+€630k	Before any exit value
Project IRR (to Y7, with exit)	~35–45%	Exit at 4–6× ARR on €2.5–3M
Payback on invested capital	~Year 6	Cumulative cash covers investment
Exit value range (Y6–7)	€10–18M	Trade sale to DMN operator / DPI editor / pharma-services group
Investor multiple (seed at €2–3M post-money)	4–6×	Assumes 15–20% dilution across rounds

8. The investment ask — how much, for how long, on what milestones

Ask: €600k over 30–36 months

Target mix (maximise non-dilutive first — the French way):

Bpifrance i-Lab grant: €300–325k (60% of €544k eligible costs; ceiling €600k) — apply Month 2–4
Founder & family: €50–100k (Stages 0–1 + first consultants)
Business angels / seed: €200–250k for 10–15% — raise at Month 6–9, after classification memo + NB contract (derisked story)
Optional: France 2030 / ARS demonstrator co-funding of the pilot (€50–100k, non-dilutive)

Lean fallback (if grants+BA underdeliver): €185k scenario — autoclaw-heavy build, CE at M30–36, founder keeps ~100%.

Milestone tranches

Tranche	Amount	Unlocks / gate
T1 (M0–6)	€150k	IP locked, SASU live, QMS skeleton, NB contract signed
T2 (M6–18)	€250k	Technical file complete → CE mark (value inflection #1)
T3 (M15–30)	€200k	PMCF pilot read-out, ≥12 paying clients, PECAN/FI dossier filed

Each tranche is independently justifiable: CE mark alone typically re-rates a SaMD company to €3–6M+.

9. How to sell it — the commercial machine

9.1 Sales motion (consultative, clinical-first)

Design partners (M12–15): 2 HAD structures co-design protocols; letter of intent + NDA; they get founding-customer pricing locked for 3 years.
Proof-of-value pilot (M15–18): standardised 3-month pilot, €15k, credited to annual license; success criteria = alert-response times, structured-capture %, ≥1 avoided-escalation case documented.
Lighthouse references (M20–24): convert pilots; co-publish results; 1-page case study per site ("before/after" workflow).
Scale (M24+): clinical-sales hire (ex-HAD coordinating-nurse profile — the most credible voice in the room), 10-structure pipeline, UGAP/RESAH catalogue listing for procurement-fast purchases.

9.2 Who signs, and what they each need to hear

Buyer	What convinces them
Direction médicale HAD + coordinating nurses	Clinical evidence, CTCAE rigour, workload relief (≥30% documentation time), founder-oncologist credibility
DSI (hospital IT)	CE mark, HDS hosting, ISO 27001-aligned security, Ségur roadmap, cybersecurity documentation
DG (finance)	€31k cost vs €74k benefit (§7.1), under-€40k entry (no tender), ARS co-funding angles
ARS / network	Regional demonstrator narrative, re-admission KPIs, oncology télésurveillance référentiel (2025) alignment

9.3 Pricing & contracting essentials

Year-1 offers sized under €40k HT (simplified procurement); licences on CCAG-TIC 2021-based contract with SLA (≥99.5% care-hours availability), réversibilité/data export, art. 28 GDPR annex, materiovigilance contact.
Reimbursed mode post-inscription: forfait-aligned pricing with volume tiers (€28 entry / €56–70 full-coordination service levels).
Multi-year discounts capped at 15% — protect the ARR ladder.

10. Partners & investors — who can carry it and profit from it

Route A — Solo + grants max ownershiprecommended start

Bpifrance · France 2030 · ARS · incubators (Agoranov, Wilco, Medicen, Eurasanté)

Founder retains ~100% (post-BA ~85%). Slower but cleanest. Grants (i-Lab up to €600k ceiling) + incubator credibility + Bpifrance HealthTech acceleration. Exit optionality fully preserved.

Route B — Clinical-industrial partner (design partner HAD operator) fastest evidence

Santé Service · Santélys · Groupe Adène · HaD France · LNA Santé (HAD operators) · Unicancer / CLCC network

Structure: partner co-funds the PMCF pilot (€50–150k), supplies patients + clinical governance; in exchange gets founding pricing + 2–3 years' regional preference (not exclusivity — never give exclusive IP rights). They benefit from avoided re-admission costs (§7.1 is literally their P&L), ARS visibility, and differentiation vs other operators. I keep IP, CE certificate, and the right to sell to their competitors. Guardrails: NDA + secret-des-affaires regime + explicit IP acknowledgment in the research agreement.

Route C — Commercial licensing partner (hospital-software editor) instant salesforce

Established DPI/hospital editors (Maincare, Dedalus, InterSystems profile) · HAD-suite editors

They white-label or co-sell "HAD Digital oncology module" through their catalogue and hospital relationships; I receive a 20–30% royalty on net licence revenue and keep the CE certificate, regulatory files and clinical engine. Fits best after CE + pilot (they buy traction, not promises). Trade-off: channel dependency and brand dilution — best used as a parallel channel, not the only one.

Route D — Build-to-sell / exclusive licence to a digital-health operator monetise early

Télésurveillance operators (Cureety, Satelia/Nobla, Continuum+, Resilience profile) · pharma home-care services groups

Post-CE with pilot data, sell the asset or grant an exclusive field-of-use licence: indicative value €3–8M pre-inscription, €10–18M post-inscription (4–6× ARR at €2.5–3M). They gain the HAD segment + an inscribed indication; I monetise 3–5 years early without commercial scale-up costs.

10.1 Investor map (French digital-health seed)

Type	Names to approach	What they fund / want
Public (non-dilutive)	Bpifrance (i-Lab, Accélérateur HealthTech, Bourse French Tech Émergence), regional ARS demonstrators, EIC later	Innovation depth, IP, feasibility — no equity
Business angels	France Angels networks (health chapters), physician-angel clubs, incubator angel pools	€25–100k tickets; founder-clinician stories travel well
Seed health VCs	Kurma Partners · Seventure (Health for Life) · Omnes Capital · regional seeds (IRDI/Soridec, Aquiti)	€250k–1M; expect CE milestone plan + reimbursement route (this report)
Corporate / strategic	Unicancer & CLCCs (clinical partnership), insurers' corporate funds, home-care groups (BDI/home-infusion players)	Distribution or ecosystem fit; often follow rather than lead

10.2 What investors will ask — be ready with

Written MDR classification memo + NB engagement letter (proves the 18–30-month clock is real and started)
IP position: e-Soleau, trademark, patent filing or reasoned trade-secret strategy, NDA discipline
Reimbursement thesis: PECAN/forfait-innovation route with Cureety/Continuum+ precedents (§3, §6)
Clinical evidence plan to HAS standards (the Moovcare counter-example, addressed)
This report's unit economics: €31k CAC-cycle customer worth €74k/yr benefit and ~€22–30k/yr revenue, 2.4× ROI

11. Key risks & mitigations

Risk	Impact	Mitigation built into the plan
Notified-Body queue delays CE	High	Two NB applications in parallel from Month 3–4; documentation built during the queue; lean fallback extends runway
HAS refuses / delays inscription (Moovcare scenario)	High	PMCF designed to HAS standards; license-only model still breaks even at ~45 structures; FI/PECAN intermediate coverage
IP leakage via partner/pilot	High	Stage-0 stack before any disclosure; no exclusivity clauses; IP acknowledgment in every research agreement
Founder bandwidth (practising clinician)	Medium	Autoclaw build leverage; regulatory hire at M12; clinical-sales hire at M24; Route B/C partners absorb commercial load
NB upclassifies to IIb	Medium	Classification memo pre-argues IIa; budget contingency covers stricter assessment + annual PSUR
Competitor pre-empts HAD niche	Medium	18-month head start on HAD workflow; design-partner lock-ins; founder clinical authority as moat

12. Decision & next 30 days

Approve the base-case plan (€600k / 30–36 months) and the funding sequence: i-Lab + founder now, BA/seed at M6–9 post-NB-contract.
This week: confidential marking + NDA discipline · e-Soleau deposit (€15) · EU trademark filing (€1,050) · employment-invention dossier · INPI prédiagnostic booked.
Week 2–4: SASU incorporation (~€250) · regulatory consultant selected (3 quotes) · NB quote requests drafted · incubator applications (Agoranov/Wilco/Eurasanté).
Month 2–4: i-Lab dossier (uses this report as base) · pilot-HAD soundings (2 design-partner LOIs target) · SaaS-on-HDS architecture build starts with autoclaw.
Month 6 gate: NB contract signed → trigger the €250k tranche and the BA round; choose Route A/B/C/D posture (A+B hybrid recommended).

Why now: EUDAMED-era regulatory clarity, fresh reimbursement precedents (2024–2025 oncology inscriptions), HAD volume growth (+10% patients in 2024), and an unoccupied HAD-workflow position — the window is open; the NB queue makes every month of delay a month of shifted revenue.