Investor briefing
Europe's regulatory-protected reasoning layer for oncology.
POLI8 is the only tumor board-native Clinical AI built from day one for MDR Class IIa and EU AI Act compliance.
The thesis
Three structural levers.
Regulatory moat.
From August 2, 2026, high-risk medical AI requires a conformity assessment under the EU AI Act. POLI8 is built for this from day one.
Anonymised reasoning traces as an asset.
Every board decision generates an anonymized trace: which options were checked, which sources were used, why deviations occurred.
Reproducible reasoning beats generalist chat.
A study published in Nature Medicine (Ramaswamy et al., 2026) showed: ChatGPT achieves only 34% sensitivity in health triage. Specialized reasoning systems are superior.
Market frame
Oncology AI EU: €338 to 563M ARR potential by 2034.
TAM EU Onkologie: 3.000 bis 5.000 Institutionen mit Top-Tumorboards × 45k € pro Boar
USA question
Europe first. USA from Series B, indication-led.
Wir starten bewusst in Europa: dort wirkt der regulatorische Vorsprung am stärksten,
Competitive matrix
Specialised. Transparent. Locally compliant.
| Dimension | POLI8 | ConcertAI | Roche NAVIFY | OpenEvidence | Tempus AI |
|---|---|---|---|---|---|
| Geographic focus | EU / DACH first | USA | USA | Global | USA |
| Product approach | Tumor board verification, audit-trailed. | Clinician Q&A, ad-supported. | Diagnostics plus RWD platform. | MTB workflow container. | RWD analytics for pharma. |
| EU MDR / AI Act | MDR IIa plus AI Act, day one. | Not the focus. | Beginning EU strategy. | CE-marked (large vendor). | EU entry unclear. |
| S3 oncology native | Yes, primary. | No. | No. | Partial. | No. |
| Valuation (latest) | Pre-seed-seed. | ≈ $12B (Series D, 2026). | Public, mkt cap variable. | Roche group asset. | Private, sponsor-backed. |
Why now
Three drivers, time-aligned.
KHVVG Transformationsfonds
Bis zu 50 Mrd. Euro für die strukturelle Transformation deutscher Kliniken, 2026 bis
EU AI Act phase-in
Pflichten für Hochrisiko-Medizin-KI sind ab dem 2. August 2026 durchsetzbar (Verordn
Generalists collapse in specialty
Die Februar-2026-Auswertung in Nature Medicine zur ChatGPT-Health-Triage hat den Mar
Scientific anchoring
ESMO-compliant · shared-responsibility model.
POLI8 folgt dem von ESMO 2025 publizierten ELCAP-Framework zur Nutzung großer Sprach
The ask
€0.8M pre-seed.
We are raising EUR 0.8m to bring POLI8 through CE certification (MDR IIa) and into the first 10 paying clinics.
40% · Tech & product
Multimodale Erweiterung (Text plus Bildgebung), UI-Härtung, FHIR-Integration tiefer
30% · Regulatory & CE
MDR-Klasse-IIa-Dossier, Notified-Body-Verfahren, ISO 13485, klinische Evidenzsammlun
30% · Sales & pilot
Skalierung von Pilot zu zahlenden Boards, KHZG-Beratungs-Vertriebsweg, KIS-Integrati
Business model
Three revenue streams. Scaled to board volume.
Die Standard-SaaS-Lizenz inkludiert ein Fallvolumen von bis zu 1.000 Fällen pro Jahr
pro Tumorboard pro Jahr, inkl. bis zu 1.000 Fälle. Standard-Audit-Trail, Leitlinien-
per case, above the license envelope. Small practices can run fully on per-case.
ARR pro Modul pro Standort. Audit-Reporting, Leitlinien-Diff-Dashboard, RWE-Connecto
Three-stage roadmap
From MVP to multimodal, CE-certified platform.
UI finalisation & integration
Eigenfinanzierung über Caps & Collars. Gründung in Zug (CH). Erste zahlende Pilot-Bo
Technical file for MDR Class IIa
Software as a medical device. KHZG-consultancy sales active. 10 paying boards.
CE mark, multimodal, 2nd indication
CE-Mark erteilt. Indikationsausweitung Brust, Lunge, Kolon. Top-4 Tumorboards 2027,
Financial forecast 2026–2028
Three years. Break-even in 2028.
Annahmen: Personal 80k € pro FTE plus 1,3-Faktor (Sozialabgaben). Hohe Regulatorik-I
Regulatory moat
Compliance is not a tax. It is part of the product.
The EU AI Act classifies medical AI systems as high-risk. Full compliance requires technical documentation, human oversight, and transparency obligations. POLI8 is built for this from day one.
„The EU AI Act classifies medical AI as high-risk. Compliance is not optional. It is the entry ticket to a EUR 3.6bn market."
Ab dem 2. August 2026 sind Hochrisiko-KI-Systeme im medizinischen Bereich verpflichtend:
- Technische Dokumentation gemäß Anhang IV
- Konformitätsbewertungsverfahren (Benannte Stelle)
- Menschliche Aufsicht und Eingriffsmöglichkeit
- Transparenz- und Aufzeichnungspflichten
- Post-Market Surveillance System
Status
Pre-founding. Ready to incorporate immediately.
POLI8 wird aktuell als Marke und Venture innerhalb der Caps & Collars GmbH (Hamburg)
Pre-Seed
Open for strategic and financial investors.
3 LOIs
DACH clinics, formally declared.
Zug, CH Q1 2026
Entity formation upon funding close.
Founding team
Medical excellence and specialised execution.
Onkologen, KI-Forscher, Regulierer. Keine Career-Pivoter.
Tech & operations
Medical & strategy
PD Dr Christian von Bodman
Med-Expert · CMO & Urologist
Medical Executive mit Erfahrung in der Leitung großer Klinik-Netzwerke (Uroviva) und
