Spotlight Medical

What Spotlight Medical does

Spotlight Medical is a Paris-based diagnostics company that develops AI-powered prognostic tests for cancer treatment. Founded in 2024 as a spin-off from Institut Curie, the company's core product is myStage Dx, an in vitro diagnostic medical device that analyzes digitized H&E-stained whole slide images of breast cancer tissue alongside clinicopathological variables to classify ER+/HER2- early breast cancer patients as Low Risk or Not Low Risk for distant recurrence within nine years of diagnosis. The underlying technology combines computer vision analysis of tumor and microenvironment morphology with structured baseline clinical data, using AI to produce actionable relapse risk scores. Clinical validation published in the Journal of Clinical Oncology demonstrated that 95.4% of patients classified as Low Risk remained free of distant recurrence at nine years, and that 19.4% of clinically high-risk patients were reclassified as Low Risk by the assay — identifying a cohort that could potentially forgo treatment intensification.

The company received IVDR CE marking for myStage Dx as a Class C medical device in June 2026, following conformity assessment by BSI Group The Netherlands B.V., and is certified to ISO 13485:2016. Spotlight Medical generates revenue through its myStage Dx test services sold on a recurring, quote-based, multi-year contract basis to healthcare institutions. The go-to-market motion is enterprise B2B field sales targeting oncology centers, pathology laboratories, and digital pathology partners across Europe. The product is ordered by healthcare professionals for patient risk stratification and is not available directly to consumers. Geographic reach is currently limited to Europe, with markets outside Europe restricted pending local regulatory clearances. The company raised €6.2 million in seed funding in July 2024 from Kurma Partners, Heal Capital, and supported by Bpifrance, and operates with a team of approximately 10-15 employees including two PhD co-founders.

Name

Spotlight Medical

Legal name

Spotlight Medical

Website

https://spotlightmedical.com

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

11–50 employees

Short description

Spotlight Medical is a Paris-based AI diagnostics company that has developed myStage Dx, an IVDR CE-marked prognostic test analyzing H&E whole slide images and clinicopathological data to classify ER+/HER2- early breast cancer patients by distant recurrence risk, sold to European oncology centers and pathology laboratories.

Ownership category

akta.pro rank

Product category

Oncology Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (62151)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro industry

PRIMARYHLACANAG

SaMD – Imaging & Signal Analysis (AI/ML)

Healthcare & Life Sciences/Digital Health & Health IT/Digital Therapeutics (DTx) & Software as a Medical Device (SaMD)

SECONDARYHDAAAEAH

Medical Imaging AI

Hardware, Technology & Telecom/Artificial Intelligence & Machine Learning/Computer Vision & Video Analytics

SECONDARYHLAHAAAE

Anatomic Pathology & Histology/Cytology IVD (Tissue Diagnostics)

Healthcare & Life Sciences/Medical Devices & Diagnostics/In Vitro Diagnostics (IVD) & Laboratory Diagnostics

SECONDARYHLAAAMAI

Molecular Pathology & Tissue Biomarkers (IHC/ISH, digital pathology-linked markers)

Healthcare & Life Sciences/Biotechnology & Biologics/Biomarkers and Companion Diagnostics

Keywords

• AI prognostic diagnostics
• Cancer risk stratification
• Digital pathology
• Breast cancer assays
• In vitro diagnostics

Headquarters

HQ city

Paris

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. myStage Dx Test Services: Spotlight Medical generates revenue through its AI-powered prognostic test myStage Dx, a CE-IVDR marked medical device for healthcare professionals. The test is ordered by oncology centers and pathology laboratories for classifying breast cancer patient risk.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Spotlight Medical develops and commercializes myStage Dx, an AI-enabled CE-IVDR marked prognostic in vitro diagnostic medical device (Class C under Regulation 2017/746) that analyzes digitized H&E-stained whole slide images alongside clinicopathological variables to classify ER+/HER2- early breast cancer patients as Low Risk or Not Low Risk for distant recurrence within nine years. The company complements this test with the Spotlight Platform, the operational interface connecting healthcare professionals to its AI diagnostic algorithm, and supports both products under an ISO 13485:2016 quality management system.

Product overview

Spotlight Medical offers a focused product portfolio centered on AI-powered prognostic diagnostics for oncology. The core product is myStage Dx, an AI-enabled IVD medical device that analyzes digitized H&E-stained histopathology slides combined with clinicopathological variables to generate prognostic risk classifications for breast cancer patients. This is complemented by the Spotlight Platform, which provides the operational interface between healthcare professionals and the AI-based diagnostic algorithm. Both products are regulated as Class C medical devices under IVDR and are certified to ISO 13485:2016.

Differentiator

Problem solved

Functional benefit

Brands

• myStage Dx: AI-enabled prognostic test for ER+/HER2- early breast cancer that analyzes digitized H&E-stained whole slide images and clinicopathological variables to classify patients as Low Risk or Not Low Risk.

Products and services

• myStage Dx AI-enabled prognostic in vitro diagnostic (IVD) medical device that analyzes digitized H&E-stained whole slide images combined with clinicopathological variables to classify ER+/HER2- early breast cancer patients as Low Risk or Not Low Risk for distant recurrence within nine years from diagnosis. CE-IVDR marked as a Class C medical device under Regulation 2017/746 and intended for use by healthcare professionals in oncology centers and pathology laboratories.
• Spotlight Platform Operational interface that connects healthcare professionals with Spotlight Medical's AI-based diagnostic algorithm for breast cancer risk assessment, supporting ordering, processing, and delivery of myStage Dx prognostic results within regulated clinical workflows.

Quantifiable outcome

• 95.4% of Low Risk patients remained free of distant recurrence at nine years
• +2 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature2 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Institut CuriecoreStrategic or Co-development PartnerSpotlight Medical is a spin-off from Institut Curie, leveraging technology developed at the institution. Institut Curie is a leading French cancer research center that provided the foundational research and patient data for developing the AI pathology assay.
• Gustave RoussyminorStrategic or Co-development PartnerListed as a partner on the About page. Gustave Roussy is a leading French cancer center, one of Europe's largest cancer research institutes, potentially involved in clinical validation or research collaboration.
• BSI Group The Netherlands B.V.coreOthersNotified body that conducted conformity assessment for IVDR CE marking of myStage Dx. BSI Group is a leading certification organization that assessed Spotlight Medical's medical device against Regulation 2017/746 requirements.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• PathAI: AI pathology platform serving both clinical diagnostics and biopharma R&D. Comparable technology foundation (deep learning on whole slide images) and pathology customer base, though more oriented toward pharma services and assay development partnerships.
• Paige AI: AI pathology company with FDA-authorized prostate cancer detection product and oncology-focused deep learning models. Comparable in using AI on H&E whole slide images for clinical decision support, though Paige focuses more on detection/diagnosis than prognosis.
• Ibex Medical Analytics: AI-powered digital pathology platform for cancer diagnosis across multiple tissue types. Comparable technology stack (AI on H&E images for clinical pathology workflows) and target customer (pathology laboratories) though focused on detection/grading rather than prognosis.
• StratifAI: Berlin-based AI pathology company developing prognostic and predictive biomarkers from H&E slides for solid tumors. Closely comparable in applying deep learning to routine pathology for prognostic use cases, with overlapping European clinical footprint.

Regional players

• Owkin: France-based AI biotech applying machine learning to oncology and pathology. Comparable as a French AI health company leveraging hospital-academic data partnerships, though Owkin operates as a broader AI platform rather than a single-product IVD.

Broad incumbents

• Veracyte: Genomic diagnostics leader with multiple oncology products including the Prosigna acquisition. Broader portfolio across thyroid, urologic, and breast cancer diagnostics; overlaps with Spotlight in breast cancer prognosis and in IVD commercialization.
• Tempus Labs: AI-enabled precision medicine company offering multimodal oncology diagnostics (molecular, imaging, clinical data). Comparable at a category level in AI-driven oncology decision support, though much broader in scope than Spotlight's breast-only focus.

Direct peers

• Agendia: Markets MammaPrint, a 70-gene signature prognostic assay for early breast cancer recurrence risk. Directly comparable in clinical use case (deciding whether to escalate treatment) and target customer (oncology centers and pathology labs).
• Exact Sciences: Owns Oncotype DX, the dominant gene-expression-based prognostic test for early breast cancer. Direct competitor to myStage Dx in guiding treatment intensification decisions for ER+/HER2- early breast cancer patients, with established reimbursement and guideline inclusion.
• NanoString Technologies (now part of Veracyte): Developed Prosigna, an FDA-cleared, IVDR-marked gene-expression-based prognostic test for early breast cancer. Closely comparable regulatory pathway (IVDR Class C) and clinical positioning to myStage Dx in the same patient population.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/spotlight-medical

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds1 record

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Spotlight Medical