StratifAI
StratifAI is a Berlin-based precision oncology company developing the Polaris™ multimodal AI platform, which derives prognostic and predictive biomarkers from routine histopathology to support cancer diagnostics for oncology providers and pharmaceutical partners.
- Company typePrivate
- Founded2023
- HeadquartersBerlin, Germany
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What StratifAI does
StratifAI is a Berlin-based precision oncology company founded in 2023 that develops the Polaris™ multimodal AI biomarker discovery platform for cancer diagnostics. The platform applies weakly supervised deep learning to digitized H&E-stained histopathology slides and integrates them with RNASeq gene expression data and patient outcomes to derive prognostic and predictive biomarkers at scale. Its flagship commercial product, Polaris™ Breast, assesses metastatic risk in early breast cancer directly from routine histology slides and has been retrospectively validated on more than 6,000 patients; Polaris™ TME, an AI biomarker for tumor-infiltrating lymphocyte quantification, has been validated across four Phase III trials with 1,214 patients and will be presented at ASCO 2026. Both products are currently available for research use only while StratifAI pursues CE-IVDR certification in the EU and FDA approval in the US.
The company operates a direct enterprise field-sales motion targeting oncology healthcare providers, academic medical centers, and pharmaceutical companies, and has built an extensive clinical evidence network through flagship partnerships with Memorial Sloan Kettering Cancer Center (MSK iHub Challenge 2025), the Hellenic Cooperative Oncology Group (HeCOG), Prof. Dr. Ion Chiricuță Oncology Institute (IOCN) in Romania, and German Medical Institute Cyprus (GMI). Revenue mechanics are anchored on future clinical diagnostic sales post-regulatory approval, complemented by pharmaceutical partnerships for companion diagnostics and biomarker validation. StratifAI has raised €14M total to date (€1.5M pre-seed in September 2024, €12.5M seed in September 2025 led by Picus Capital and Alven), holds ISO 27001, ISO 27701, SOC 2 Type II, GDPR, and HIPAA certifications, and is led by CEO and co-founder Omar El Nahhas alongside co-founder/CSO Firas Khader and managing directors Daniel Truhn and Jakob Nikolas Kather.
StratifAI firmographics
Firmographics- Name
- StratifAI
- Legal name
- StratifAI GmbH
- Website
- https://stratifai.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- StratifAI is a Berlin-based precision oncology company developing the Polaris™ multimodal AI platform, which derives prognostic and predictive biomarkers from routine histopathology to support cancer diagnostics for oncology providers and pharmaceutical partners.
- Ownership category
- akta.pro rank
StratifAI industry classification
Industry- Product category
- Precision Oncology Diagnostics Software
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk) (HLAAAMAF)
- akta.pro secondary industries
- Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Translational Medicine & Biomarkers (HLAIALAF)
Keywords
Where StratifAI is headquartered
LocationHeadquarters
- HQ city
- Berlin
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
StratifAI business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- AI Biomarker Diagnostics (Research Use): Products are currently available for research use only while undergoing regulatory approval in EU and US. Revenue will be generated from clinical diagnostic tests once regulatory approval is obtained.
- Pharmaceutical Partnerships: Collaborations with pharmaceutical companies to generate clinical evidence for biomarker validation and potential companion diagnostics development.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels5 records
StratifAI product offering
Product offeringCore offering
StratifAI develops Polaris™, a multimodal AI biomarker discovery platform that integrates digitized H&E histopathology slides with RNASeq gene expression data and patient outcomes to identify prognostic and predictive cancer biomarkers. Its lead products are Polaris™ Breast, which assesses metastatic risk in early breast cancer directly from histology slides, and Polaris™ TME, an AI biomarker that quantifies tumor-infiltrating lymphocytes from whole-slide images. Products are currently available for research use only while the company pursues CE-IVDR and FDA regulatory approval.
Product overview
StratifAI offers Polaris™, a multimodal AI biomarker discovery platform for precision oncology. The platform comprises Polaris™ Breast for metastatic risk assessment in early breast cancer and Polaris™ TME for tumor-infiltrating lymphocyte quantification. Polaris™ integrates H&E histology with RNASeq gene expression and patient outcomes to generate spatial biology insights and novel cancer biomarkers. Both products analyze digitized histology slides and are available for research use only while undergoing regulatory approval in the EU and US.
Differentiator
Problem solved
Functional benefit
Brands
- Polaris™: Multimodal AI biomarker discovery platform for precision oncology that links histology, RNASeq, and patient outcomes at scale.
- Polaris™ Breast
- Polaris™ TME
Products and services
- Polaris™ Multimodal AI biomarker discovery platform for precision oncology that applies deep learning to digitized H&E histopathology slides and integrates RNASeq gene expression with patient outcomes to identify prognostic and predictive biomarkers across solid-tumor cancers. Targeted at oncology healthcare providers, academic medical centers, and pharmaceutical companies for biomarker research and clinical validation.
- Polaris™ Breast Diagnostic AI biomarker that assesses metastatic/recurrence risk in early breast cancer directly from digitized histology slides, providing 10-year invasive disease-free survival prognostic data to refine adjuvant treatment decisions. Validated on more than 6,000 patients and available for research use only pending CE-IVDR and FDA approval. Targeted at oncology healthcare providers and pharmaceutical companies.
- Polaris™ TME AI biomarker for quantification of tumor-infiltrating lymphocytes (TILs) from H&E-stained whole-slide images, providing standardized and reproducible AI-derived TIL scoring that reduces interobserver variability inherent in manual pathologist scoring. Validated on more than 1,200 patients across four Phase III trials in high-risk early breast cancer. Targeted at oncology healthcare providers and academic research centers.
Quantifiable outcome
- Validated on more than 6,000 patients for Polaris™ Breast
- +2 more outcomes
Companies that use StratifAI
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
StratifAI technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature5 records
StratifAI partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and flagship.
- German Medical Institute Cyprus (GMI)coreAnalytical validation study assessing precision and reproducibility of Polaris™ Breast across histology slide preparation and digitization variables. Includes both core needle biopsy specimens and surgical resection specimens. Led by Prof. Dr. Constantinos Zamboglou, Medical Director & Director Research and Innovation Department.
- Hellenic Cooperative Oncology Group (HeCOG)flagshipIntegrates computational pathology with clinical data from large-scale Phase III Randomized Controlled Trials to validate Polaris™ for cancer prognosis and treatment decision support. Collaboration spans breast and ovarian cancer indications. Dr. Elena Fountzila represents HeCOG in the partnership.
- Memorial Sloan Kettering Cancer Center (MSK)flagshipSelected for MSK iHub Challenge 2025 Cohort, gaining access to MSK's extensive clinical datasets and oncology expertise to accelerate validation of Polaris™ for breast cancer recurrence risk. Collaboration aims to advance toward regulatory approval and guideline inclusion in EU and US.
- Prof. Dr. Ion Chiricuță Oncology Institute (IOCN)flagshipExclusive clinical data access partnership to validate Polaris™ using IOCN's extensive clinical data. Validation includes retrospective analysis of previously treated breast cancer patients and prospective evaluation in newly diagnosed patients within an observational study. Partnership also expanding to ovarian cancer analysis.
Scale indicators7 records
Recent moves6 records
Expansion highlights8 records
StratifAI competitors and assessment
Company assessmentDirect peers
- Paige.AI: Paige builds AI-based clinical-grade diagnostic applications in pathology, with FDA-authorized products for prostate cancer detection. Closest direct peer in regulated AI pathology diagnostics and computational biomarker discovery.
- PathAI: PathAI develops AI-powered computational pathology platforms for cancer diagnosis and biomarker discovery, partnering with pharma and diagnostic labs. Direct competitor in AI-driven histopathology biomarker development with comparable technology and customer base.
- Ibex Medical Analytics: Ibex develops AI-powered cancer diagnostics in pathology with multiple CE-IVD-marked and FDA-cleared products deployed in clinical workflows. Direct peer in clinically deployed AI oncology diagnostics.
- Owkin: Owkin applies AI to patient data (including histopathology and omics) for oncology drug discovery and diagnostics, with a strong pharma partnership model. Directly comparable multimodal AI/biomarker platform targeting pharma and hospitals in oncology.
- Lunit: Lunit develops AI-powered biomarkers from medical imaging, including a FDA-cleared pathology product (Lunit SCOPE) for TILs analysis. Direct competitor in AI-based TILs and pathology biomarker scoring.
- Artera (formerly ArteraAI): Artera develops multimodal AI biomarkers for prostate cancer prognosis and treatment personalization, with FDA-authorized products. Closely comparable AI biomarker company targeting oncology treatment decision support.
Emerging players
- Mindpeak: Mindpeak develops AI-based image analysis software for pathology, including biomarker quantification tools for clinical and research use. Comparable European-based AI pathology player with overlapping product focus.
Broad incumbents
- Tempus Labs: Tempus is a large precision medicine company combining genomic sequencing, AI, and clinical data for oncology. Broad incumbent in precision oncology with overlapping biomarker and AI capabilities, though with a sequencing-led business model.
- Oncotype DX (Exact Sciences): Oncotype DX is the established genomic breast cancer recurrence risk test embedded in NCCN guidelines. Competes for the same clinical decision (adjuvant chemotherapy in early breast cancer) but via a gene-expression assay rather than AI on H&E.
Others
- MultiplexDX: MultiplexDX is a precision oncology diagnostics company co-leading StratifAI's pre-seed round. Not a direct competitor but a strategic investor and partner in the same oncology diagnostics ecosystem with related biomarker technologies.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
StratifAI social profiles
Digital presenceStratifAI compliance and trust
Trust signalCompliance4 records
StratifAI financial estimates
Financial estimateRevenue estimate
Valuation estimate
StratifAI leadership team
Management profileNumber of profiles
Profiles4 records
StratifAI funding detail
Funding detailFunding overview
Funding rounds3 records
Investors9 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
StratifAI M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about StratifAI
What does StratifAI do?
StratifAI develops Polaris™, a multimodal AI biomarker discovery platform that integrates digitized H&E histopathology slides with RNASeq gene expression data and patient outcomes to identify prognostic and predictive cancer biomarkers. Its lead products are Polaris™ Breast, which assesses metastatic risk in early breast cancer directly from histology slides, and Polaris™ TME, an AI biomarker that quantifies tumor-infiltrating lymphocytes from whole-slide images. Products are currently available for research use only while the company pursues CE-IVDR and FDA regulatory approval.
Is StratifAI a public or private company?
StratifAI is a private company. It is classified as venture growth investor backed and is currently operating.
When was StratifAI founded?
StratifAI was founded in 2023. It employs 11 to 50 people.
Where is StratifAI based?
StratifAI is headquartered in Berlin, Germany, in the Europe region.
How does StratifAI make money?
Two revenue lines are on record. AI Biomarker Diagnostics (Research Use) is the primary driver. The others are pharmaceutical Partnerships.
Who are StratifAI's main competitors?
Direct peers on record are Paige.AI, PathAI, Ibex Medical Analytics, Owkin, Lunit and Artera (formerly ArteraAI). Mindpeak is listed as an emerging player. Broad incumbents are Tempus Labs and Oncotype DX (Exact Sciences). MultiplexDX is listed as an others.
Does StratifAI have an API?
No public API is recorded for StratifAI.
What industry is StratifAI in?
StratifAI's product category is Precision Oncology Diagnostics Software. Its primary akta.pro industry code is HLAAAMAF, Prognostic & Risk Stratification Biomarkers (disease progression, recurrence risk), with a secondary code of HLAAAMAA, Biomarker Discovery & Validation (omics, assay feasibility, clinical validation). Its NAICS code is 541714 and its SIC code is 2835.