RetinAI

RetinAI, operating under its parent company Ikerian AG, develops a data management and AI analysis platform called RetinAI Discovery, designed for use in ophthalmology and broader healthcare settings. The platform serves pharmaceutical and life sciences companies, clinics and hospitals, clinical and academic researchers, and academic AI researchers, enabling them to manage medical imaging data, run AI-based analyses, and support clinical and research workflows.

Founded in 2017 by Carlos Ciller, Stefanos Apostolopoulos, and Sandro De Zanet, RetinAI has grown to serve 15 pharma and research customers, support 20 clinical studies, and process over one million patient images. The platform holds CE marking as a Class IIa Medical Device under EU MDR (2017/745) and has received FDA clearance. RetinAI has published 40 or more peer-reviewed research papers and maintains partnerships with organisations including Novartis, Boehringer Ingelheim, Retina Consultants of America, the Stephen J. Ryan Initiative for Macular Research (RIMR) AMD Consortium, and MAXO.

RetinAI Discovery — Core Platform

• A modular, certified software platform that ingests multiple data formats including DICOM-compliant files, proprietary formats, EHR data, demographics, genetics, and imaging data (OCT volumes, fundus images, PDFs, JPEG, PNG, TIFF).
• Provides data harmonisation, organisation, aggregation, and AI-based analysis at scale to extract insights about disease progression, treatment outcomes, and progression prediction.
• Operates as a vendor-neutral platform, accepting data from multiple imaging devices and data types.
• Offers secure, cloud-based access to support collaboration across organisations, with configurable permission levels for different collaborators.
• Includes annotation tools that allow users to extract annotations from datasets to train or improve their own AI models.

Discovery Modules and Use Cases

• Discovery Unity: Developed in collaboration with Novartis; supports data management and clinical trial workflows.
• Discovery for Clinical Studies: Centralises data collection and analysis for clinical trials, provides real-time evaluation of enrollment criteria and endpoints, and enables stakeholders to monitor study progress, enrollment quality, and data collection from anywhere.
• Discovery for Clinics: Functions as a tele-ophthalmology platform, consolidating OCT volumes, fundus images, and other imaging data in a single viewer, and providing immediate evaluation and centralised insights for clinical workflows.
• Real World Evidence: Supports the construction of real-world evidence databases, including a collaboration with Retina Consultants of America to build a U.S.-based real-world evidence database in ophthalmology.
• Precision Medicine: Listed as a dedicated solution area within the platform offering.

AI Models and Biomarker Library

• Provides a library of more than 30 CE-marked and Research Use Only (RUO) biomarkers covering ophthalmology, neurodegenerative conditions, vascular diseases, and rare diseases and omics.
• CE-marked models include RetinAI OCT Atlas®, Macula Biomarkers, Layer Segmentation, Fluid Segmentation, and a Diabetic Retinopathy Screening algorithm (LuxIA®, co-developed with FVS and CE-MDR certified as of April 2025).
• Research Use Only (RUO) models include Geographic Atrophy Segmentation and Progression analysis.
• AI models support assessment of AMD (age-related macular degeneration), diabetic retinopathy (DR), diabetic macular edema (DME), cystoid macular edema (CME), geographic atrophy (GA), and glaucoma.
• AI-based measurements include retinal thickness and fluid volume for use in real-time data analysis during clinical studies.

Capabilities and Workflow Support

• Supports AI analysis, clinical trials management, multicenter collaborations, real-world data collection, data management, and AI automation.
• Enables participative research across organisations through secured cloud-based data access.
• Allows users to access and create their own AI models using annotated datasets.
• Provides real-time collaboration features, allowing instant invitation of collaborators with different permission levels.

Regulatory Status and Certifications

• RetinAI Discovery received initial CE marking in 2020 and was certified as a Class IIa Medical Device under EU MDR (2017/745) in 2023.
• In 2024, four devices received EU-MDR certification: the RetinAI Discovery platform and three AI models (Macula Biomarkers, Layer Segmentation, and Fluid Segmentation).
• FDA clearance was obtained for RetinAI Discovery, covering disease areas including diabetic retinopathy, diabetic macular edema, glaucoma, and geographic atrophy.
• In April 2025, the LuxIA® diabetic retinopathy screening algorithm received CE-MDR certification.

Company and Commercial Details

• Headquartered in Bern, Switzerland (Ikerian AG), with a U.S. office in Boston, Massachusetts (RetinAI US Inc.).
• Completed a Series A Extension financing of USD 6.18M (CHF 5.65M) in May 2024.
• Completed a first close of a Series B round of USD 8M in October 2024, led by Sanoptis, which also includes a commercial agreement to expand RetinAI Discovery across Europe.
• Serves life sciences and pharma companies, clinics and hospitals, and device manufacturers.

RetinAI's platform is designed to support the full data lifecycle from collection and harmonisation through AI-based analysis and collaborative research, with a focus on ophthalmic imaging and expanding coverage across related disease areas.