Visiopharm A/S

Visiopharm is a leading provider of AI-driven precision pathology software for research and diagnostics, founded in 2002 and headquartered in Denmark's Medicon Valley. With over 20 years of experience working alongside pathologists and research scientists, Visiopharm combines deep domain expertise with the power of artificial intelligence to deliver accurate, reproducible, and versatile tissue image analysis solutions. The company serves more than 750 customer accounts across 40+ countries, with legal entities in Sweden, the UK, Germany, the Netherlands, and the United States, and local representation in France and China.

Visiopharm's solutions support scientists developing next-generation therapies as well as clinical laboratories matching those therapies with the right patients. The company is certified according to EN ISO 13485:2016 and holds no fewer than nine diagnostic algorithms cleared under IVDR for EU customers. Its software and applications have been featured in over 3,500 scientific publications, reflecting its strong standing in the global life sciences community.

Core Software Products

• Phenoplex™ – A complete image analysis workflow designed for all multiplexed image analysis needs in spatial biology, enabling deep phenotyping and spatial quantification of tissue samples.
• Discovery (Oncotopix® Discovery) – An intuitive tissue image analysis platform that allows anyone with an understanding of tissue morphology to train AI deep learning APPs, producing accurate and reproducible results without requiring advanced programming skills. Launched in 2022 with easy-to-use deep learning capabilities.
• Qualitopix – A solution for measuring and documenting IHC staining consistency through standardized analysis of next-generation reference materials, ensuring quality control across laboratory workflows.
• Diagnostic Decision Support APPs – IVDR-certified CE-IVD APPs that provide AI-driven diagnostic decision support and integrate seamlessly into existing laboratory workflows, advancing standardization in clinical pathology.

APP Center

• Visiopharm's APP Center contains over 130 modular analysis units, each designed to solve specific tissue analysis problems across all tissue types, stain types, and imaging modalities.
• APPs cover a broad range of research and diagnostic applications, including breast cancer, lung cancer, colorectal cancer, ovarian cancer, melanoma, Hodgkin's lymphoma, hepatocellular carcinoma, pancreatic cancer, liver fibrosis, liver steatosis, kidney disease, skin cancer, and neuroscience.
• Example APPs include CD8 quantification in ovarian cancer tumor microenvironments, HER2-FISH analysis in breast cancer, Ki-67 in pancreatic cancer, PSR liver fibrosis AI analysis, RNAscope for skin and liver cancers, virtual 8-plex multiplexing, and multiplex lung cancer tumor microenvironment analysis.
• The APP Center significantly reduces development time by providing a ready-to-use base for building and refining custom analysis workflows.
• APPs launched in 2013 and have grown to include both ready-to-use AI-based applications and scalable solutions tailored to customer needs.

Key Research and Clinical Applications

• Oral Cancer: Proteocyte developed an APP using the Discovery platform to predict the development of high-risk lesions, validated as a laboratory developed test (LDT) with 96.2% sensitivity and negative predictive value.
• Colorectal Cancer: Deep learning APPs were used to segment colorectal cancer tissue into core and margin regions, enabling automated quantification of invasive lymphocytes and reducing inter-observer variability.
• Bladder Cancer: An algorithm trained on objective nuclear features was developed to reduce inter-observer variability in cancer grading, which can differ among experienced pathologists up to 20% of the time.
• Dermatology: Chanel used the Discovery platform to measure the efficacy of a novel exfoliating skin product by visualizing three proteins associated with exfoliation in an animal-free skin model.
• Nephrology: Novalix uses a PKD1-inducible knockout mouse model with Visiopharm's Discovery to precisely quantify cysts, vessels, and fibrosis over time, enabling robust tracking of disease progression and therapeutic response.
• Hepatology: Researchers at the University of Texas Medical Branch use Phenoplex to quantify immune cells in fibrotic liver diseases, revealing complex macrophage diversity patterns and advancing patient stratification for precision medicine.
• Neuroscience: CND Life Sciences used the Discovery platform to create an APP measuring the highly elusive biomarker P-SYN, enabling Parkinson's disease risk identification up to 15 years in advance, now widely used by the company's pathologists.

Technology, Compliance, and Partnerships

• Visiopharm is certified under EN ISO 13485:2016, covering design, development, manufacture, installation, and service of in vitro diagnostic pathology software.
• The company holds multiple patents, including a granted patent for labelling histopathological images and training deep learning models, and a patent for assessment of staining quality.
• Visiopharm has established partnerships and integrations with leading industry players including Agilent (global reseller and co-development agreement), Proscia, Fluidigm, Philips, Sectra, Akoya Biosciences, and JiNan Danjier for the Chinese market.
• The company operates a growing network of authorized distributors and partners across North America, Europe, and Asia.
• Visiopharm's scientific advisory board (SAB), established in 2020, comprises 11 industry experts in digital pathology, quality assessment, oncology, and immunology.

Awards and Recognition

• Frost & Sullivan Global Company of the Year Award (2019) – Recognized for a high degree of innovation in products and technologies and leadership in customer value and market penetration in digital pathology solutions.
• CIO Applications Top 25 Machine Learning Solution Providers (2019) – Recognized as one of the most prominent machine learning solution providers in the industry.
• Børsen Gazelle Growth Accelerator Award (2017) – Awarded by Denmark's leading business newspaper for continuous revenue growth and doubling of revenue over four consecutive financial years.
• EY Entrepreneur Of The Year™ (2016 & 2017) – Nominated twice and placed among the top three finalists in the Life Science category in 2017.

With over two decades of innovation, a robust and growing APP ecosystem, IVDR-certified diagnostic solutions, and a strong global presence, Visiopharm continues to advance precision medicine by transforming pathology through AI-powered image analysis for both research and clinical diagnostics.