What Photocure does

Photocure ASA is a Norwegian commercial-stage diagnostics company specializing in uro-oncology precision diagnostics for bladder cancer. Founded in 1997 and headquartered in Oslo, Photocure markets Hexvix®/Cysview® (hexaminolevulinate HCl), a proprietary photosensitizing agent used during Blue Light Cystoscopy (BLC®) to make malignant cells fluoresce bright pink under blue light, improving tumor detection and complete resection compared to standard white light cystoscopy. Cysview is the tradename in the U.S. and Canada; Hexvix is the tradename elsewhere. The company also owns the largest bladder cancer patient registry in the world, with 3,100+ patients enrolled and a goal of 4,400+, used for real-world evidence and AI biomarker development.

The business model is primarily product sales of Hexvix/Cysview through two direct field sales forces—in North America (Princeton, NJ) and Europe (Düsseldorf, Germany)—with licensing and distribution partners in non-core markets including Asieris (China/Taiwan), Endotherapeutics (Australia/New Zealand), Genotests (Chile), IGL Medical (Israel), and Equity Pharmaceuticals (South Africa). The Cevira (APL-1702) asset, a photodynamic therapy for cervical precancer licensed globally to Asieris in 2019, generates milestone payments and royalties; Q1 2026 included NOK 125.6 million in Cevira milestone payments following China NMPA approval. In June 2026, Photocure acquired Vesica Health for approximately USD 30.5 million, adding AssureMDx, a urine-based molecular diagnostic test with FDA Breakthrough Device Designation, 96% sensitivity, and 99.7% NPV for early bladder cancer detection in hematuria patients.

Photocure serves urologists, hospitals, and clinics that perform cystoscopy procedures. FY2025 Hexvix/Cysview revenue was NOK 530 million (up 10% YoY in constant currencies), the company has delivered 11 consecutive quarters of positive commercial EBITDA, and the balance sheet held NOK 192.7 million in cash with no term debt at Q1 2026. The 413 active US accounts (+21% YoY) and 75+ Olympus Visera Elite III BLC systems deployed in Europe indicate ongoing commercial expansion, while AI partnerships with Artera, Intelligent Scopes, and Convergent Genomics—anchored on the BLC registry—position the company toward an AI-integrated bladder cancer diagnostics platform.

Name

Photocure

Legal name

Photocure ASA

Website

https://photocure.com

Company type

Public

Founded year

1997

Operating status

Operating

Headcount range

101–250 employees

Short description

Photocure ASA is a Norwegian commercial-stage diagnostics company that markets Hexvix/Cysview blue light cystoscopy products for bladder cancer detection, serving urologists, hospitals, and clinics across North America and Europe via direct sales and global partner distribution.

Ownership category

akta.pro rank

Product category

Bladder Cancer Diagnostics

NAICS

Surgical Appliance and Supplies Manufacturing (339113), In-Vitro Diagnostic Substance Manufacturing (325413), Pharmaceutical Preparation Manufacturing (325412), Medical and Diagnostic Laboratories (62151)

SIC

Surgical & Medical Instruments & Apparatus (3841), In Vitro & In Vivo Diagnostic Substances (2835), Pharmaceutical Preparations (2834)

akta.pro primary industry

Urologic Oncology (HLAKAOAB)

akta.pro secondary industries

Endoscopy Systems & Accessories (Scopes, Cameras, Light Sources, Insufflation) (HLAHADAB), Endoscopic Therapeutic & Access Devices (Trocars, dilators, biopsy/ablation tools) (HLAHADAN)

Keywords

• Bladder cancer diagnostics
• Blue light cystoscopy
• Uro-oncology pharmaceuticals
• Fluorescence cystoscopy imaging
• Urological cancer screening

Headquarters

HQ city

Princeton

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Hexvix/Cysview Product Sales: Direct commercial sales of Hexvix (outside US/Canada) and Cysview (US/Canada) products for blue light cystoscopy procedures through established sales forces in North America and Europe.
2. Milestone Payments: Photocure receives milestone payments from Asieris for regulatory approvals of Cevira in various markets (China NMPA approval, EMA MAA acceptance). Q1 2026 included NOK 125.6 million in milestone payments for Cevira approvals.
3. Cevira Licensing Royalties: Photocure developed Cevira (APL-1702) and licensed global rights to Asieris in 2019. Photocure is eligible for milestone payments plus royalties on global sales of Cevira if commercially successful.
4. Transfer Price and Royalties from Partners: For Hexvix sold to Asieris for Chinese and Taiwanese markets, Photocure receives transfer price on manufactured product plus royalties on Asieris' sales.
5. AssureMDx (post Vesica Health acquisition): Urine-based molecular diagnostic test for early bladder cancer detection. Initial revenues expected in 2027 with positive EBITDA contribution by 2030.

Go-to-market motion1 record

Distribution channels7 records

Marketing channels5 records

Core offering

Photocure develops and commercializes Hexvix/Cysview (hexaminolevulinate HCl), a proprietary photosensitizing agent used with Blue Light Cystoscopy (BLC) to make bladder cancer cells glow bright pink, enabling improved tumor detection, more complete resection, and better disease management for urologists, hospitals, and clinics. The company also sells the Saphira BLC tower system in the US, distributes the AssureMDx urine-based molecular diagnostic test (acquired via Vesica Health in June 2026), and licenses Cevira (a photodynamic therapy for cervical precancerous lesions) to Asieris. Direct sales forces operate in North America and Europe; other geographies are served via distribution and licensing partners.

Differentiator

Problem solved

Functional benefit

Brands

• Hexvix: Brand name for hexaminolevulinate HCl in all markets except U.S. and Canada; used during Blue Light Cystoscopy (BLC) to detect bladder cancer by making cancer cells glow bright pink.
• Cysview
• AssureMDx
• BLC (Blue Light Cystoscopy)
• Saphira

Products and services

• Hexvix/Cysview (hexaminolevulinate HCl) Proprietary photosensitizing agent that preferentially accumulates in bladder cancer cells, making them glow bright pink during Blue Light Cystoscopy (BLC). Sold as Cysview in the U.S./Canada and Hexvix in all other markets. Used by urologists, hospitals, and clinics for improved bladder tumor detection and complete resection.
• Blue Light Cystoscopy (BLC) Procedure Enhanced cystoscopy procedure pairing the Hexvix/Cysview agent with specialized blue light equipment to detect bladder cancer tumors that fluoresce bright pink, enabling more complete resection and better management decisions versus standard white light cystoscopy.
• Saphira Tower System Proprietary blue light cystoscopy tower equipment system marketed to U.S. hospitals and urology practices to enable the BLC procedure with Cysview.
• AssureMDx Multi-omic urine-based biomarker test integrating six epigenetic and somatic biomarkers for early bladder cancer detection in hematuria patients. Validated with 96% sensitivity, 99.7% NPV, and 0.96 AUC. Granted FDA Breakthrough Device Designation. To be offered through Vesica Health's CAP-accredited, CLIA-certified laboratory in Irvine, California.
• Cevira (APL-1702) Photodynamic drug-device combination product developed by Photocure for non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL/cervical precancerous lesions). Licensed to Asieris Meditech for global development and commercialization; Photocure receives milestone payments and royalties on global sales.
• ArteraAI Bladder Test AI-powered digital pathology test under co-development that uses multimodal AI (MMAI) histopathology biomarkers combined with BLC registry data to provide prognostic and predictive insights for non-muscle invasive bladder cancer (NMIBC) management.

Quantifiable outcome

• BLC significantly improved CIS detection (8.5% vs 3.4%) and increased BCG therapy use (31.0% vs 15.9%) over 3.5 years of follow-up
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

AI capability6 records

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core, minor and secondary.

• ArteracoreStrategic or Co-development Partner · 8 June 2026Joint research initiative to evaluate and validate Artera's AI-powered ArteraAI Bladder Test using data from Photocure's U.S. BLC registry. The collaboration aims to develop multimodal AI histopathology biomarkers for NMIBC patients to improve disease grading, staging, and treatment decision-making.
• Vesica Health Inc.coreStrategic or Co-development Partner · 4 June 2026Photocure acquired Vesica Health for USD 30.5 million (net ~USD 28.5M after cash). Adds AssureMDx, a urine-based molecular test for early bladder cancer detection with 96% sensitivity and 99.7% NPV. USD 13.75M at close, USD 13.75M tied to Medicare milestones.
• Equity Pharmaceuticals PTY LimitedminorChannel Partner/ Reseller/ Distributor · 1 September 2024Named Patient Program (NPP) agreement enabling bladder cancer patients in South Africa to receive BLC with Hexvix, entered in September 2024.
• IGL MedicalsecondaryChannel Partner/ Reseller/ Distributor · 1 June 2022Exclusive distribution agreement for Hexvix in Israel entered in June 2022.
• Endotherapeutics GroupsecondaryChannel Partner/ Reseller/ Distributor · 1 January 2022Exclusive distribution agreement for commercialization of Hexvix in Australia and New Zealand entered in Q1 2022.
• Genotests SpAsecondaryChannel Partner/ Reseller/ Distributor · 1 August 2020Exclusive distributor for Hexvix in Chile appointed in August 2020.
• Asieris Meditech Co., LtdcoreOEM/ Whitelabel/ Licensing Partner · 1 July 2019Photocure licensed global rights to Cevira (APL-1702) for treatment of HPV-induced cervical precancerous lesions to Asieris in July 2019. Additionally, Asieris obtained exclusive rights to register and commercialize Hexvix in China and Taiwan in January 2021. Photocure receives milestone payments and royalties on global sales of Cevira.
• Richard WolfcoreStrategic or Co-development PartnerPartnership for flexible BLC expansion with co-developed 4K global Flex system targeted for global launch in 2027. Richard Wolf received approval for System blue BLC platform in China in April 2026.
• Intelligent Scopes CorporationcoreStrategic or Co-development PartnerPartnership to develop AI software to support blue light cystoscopy for bladder cancer detection, with initial promising testing results and FDA approval as goal.
• StrykersecondaryStrategic or Co-development PartnerLeading global medtech company with CE mark for blue light-compatible systems in Europe, reinforcing growing recognition of BLC as important standard in bladder cancer management.
• Convergent GenomicsminorStrategic or Co-development PartnerTrial comparing minimal residual disease outcomes between blue light and white light cystoscopy using Convergent Genomics' UroAmp biomarker at EAU 2026.
• Karl StorzminorOthersKarl Storz submitted Citizen Petition for FDA reclassification of OAY equipment (diagnostic endoscopic light source systems) from Class III to Class II. FDA response indicated additional clinical evidence needed but maintained current classification.

Scale indicators21 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Olympus Corporation: Olympus is the dominant global manufacturer of flexible and rigid cystoscopes and the Visera Elite III BLC-compatible imaging system installed across Photocure's European footprint (75+ systems). As a broad medical/endoscopy incumbent, Olympus competes with Photocure-adjacent technologies while also serving as a critical distribution partner for BLC adoption.
• Stryker: Stryker is a large diversified medical device company with CE-marked blue light-compatible endoscopy systems in Europe, reinforcing BLC as standard in bladder cancer management. Comparable as a broad medtech incumbent participating in the BLC equipment ecosystem alongside Photocure's diagnostic drug business.
• Exact Sciences: Exact Sciences commercializes Cologuard, a non-invasive molecular screening test for colorectal cancer, and has expanded into multiple cancer screening/diagnostic indications. Comparable as a larger, established molecular diagnostics incumbent with a similar urine/stool-based biomarker test model targeting mass-market cancer screening markets.

Direct peers

• Karl Storz: Karl Storz is a leading manufacturer of endoscopes and visualization systems used in urology, including cystoscopy equipment that Photocure's BLC technology integrates with. Filed the citizen petition for FDA OAY reclassification relevant to BLC equipment. Directly comparable as the upstream equipment partner for blue light cystoscopy procedures.
• Pacific Edge Diagnostics: Pacific Edge commercializes Cxbladder, a urine-based molecular diagnostic test for bladder cancer detection and recurrence monitoring. Directly comparable to Photocure's recently acquired AssureMDx in the non-invasive bladder cancer diagnostic category, serving the same hematuria evaluation and surveillance use cases.
• Richard Wolf: Richard Wolf is a Germany-based endoscopy equipment manufacturer and a core Photocure partner co-developing a 4K flexible BLC system for 2027 global launch. Their System blue BLC platform received China approval in April 2026. Closely comparable as a specialty endoscopy peer and direct BLC ecosystem participant.

Emerging players

• Veracyte: Veracyte is a molecular diagnostics company with a urologic oncology portfolio (including the Decipher Bladder test for bladder cancer recurrence risk). Comparable business model of proprietary molecular tests serving urology specialists, with a similar specialty oncology diagnostic commercial approach to Photocure's AssureMDx.
• Nonagen Bioscience: Nonagen Bioscience is an emerging cancer diagnostics company developing non-invasive bladder cancer detection technologies. Comparable as a niche emerging player with overlapping bladder cancer diagnostic focus, potentially competing with Photocure's AssureMDx in urine-based molecular testing.

Others

• Ferring Pharmaceuticals: Ferring Pharmaceuticals manufactures BCG (Bacillus Calmette-Guérin) immunotherapy, a primary treatment for non-muscle invasive bladder cancer that Photocure's BLC helps identify candidates for. Adjacent ecosystem participant - not a direct diagnostic competitor but a critical downstream therapy partner in bladder cancer management.
• NeoGenomics: NeoGenomics operates a major cancer-focused diagnostics laboratory with urologic oncology testing capabilities. Comparable as a clinical laboratory services provider in oncology, sharing similar specimen handling and reimbursement dynamics with Photocure's Vesica Health/AssureMDx CLIA-certified lab operations.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/photocure-asa

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments1 record

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

Frequently asked questions about Photocure