Photocure ASA, based in Oslo, describes itself as “The Bladder Cancer Company”. Its core commercial offering centres around the use of its fluorescent imaging agent – marketed as Hexvix® (outside the U.S.) and Cysview® (U.S.) – which enables improved detection of non-muscle invasive bladder cancer (NMIBC) using blue-light cystoscopy (BLC™). Clinical and real-world data show that BLC with Hexvix/Cysview leads to more complete tumour resection and lower residual disease compared to standard white-light cystoscopy.
In recent years the company has shifted from being primarily a single-product firm to one developing a diagnostics platform and pipeline of complementary assets. Under its “Precision Diagnostics” pillar the company emphasises integration of advanced imaging, biomarkers and artificial intelligence (AI) to strengthen early detection, stratification and therapy-guidance in bladder cancer.
Key innovation announcements:
- In October 2025, Photocure entered a partnership with Intelligent Scopes Corporation (ISC) to develop AI software for use with BLC systems in bladder tumour detection. Initial testing (about 200 procedures and 80 000+ images) showed encouraging results. Regulatory filings (FDA, EU) are planned after beta-version development over the next 12-18 months. Photocure will hold exclusive perennial commercialisation rights.
- In its pre-clinical research, Photocure has published data on an anti-tumour and immune-modulating effect of its imaging agent (HAL = hexaminolevulinate) plus blue light illumination in a rat bladder cancer model. The authors speculate HAL + blue light may not only detect but also impact tumour behaviour, particularly when combined with checkpoint inhibitor therapy.
- Through its development portfolio, Photocure has out-licensed the photodynamic drug-device combination Cevira® (APL-1702) to Asieris Pharmaceuticals for treatment of high-grade squamous intraepithelial lesions (HSIL). The NDA is advancing in China, indicating potential value creation for Photocure via milestones/licensing income.
From a financial and commercial standpoint: In the third quarter of 2025 Photocure reported revenues of NOK 134.1 million for Hexvix/Cysview (Q3 2024: NOK 120.1 million), with positive EBITDA (NOK 10.2 million) and guidance for product revenue growth of 8-10 % constant-currency. Expansion of BLC equipment installation (e.g., 14 new Saphira towers in the U.S., plus mobile tower deployment) highlights active market penetration.
Third-party commentary and market context reinforce the strategic thrust: A 2024 Photocure white paper highlights the significant unmet need in NMIBC (high recurrence rates, costly lifetime management) and positions early diagnostics, AI and precision stratification as “transformative”. Moreover, industry data show the global AI in medical diagnostics market is projected to expand at ~22 % CAGR to 2032—creating a favourable macro tailwind for Photocure’s AI initiatives.
Photocure moves beyond a single-technology diagnostics company to a broader precision diagnostics platform with licensed therapeutic upside, leveraging imaging + AI + biomarker synergies in the bladder-cancer domain and executed commercial roll-out across mature and growth markets.
Key findings:
- Photocure’s core product: Hexvix/Cysview + blue-light cystoscopy (BLC®) for NMIBC tumour detection and resection.
- Strong clinical evidence and guideline support for BLC vs white light.
- Strategic pivot to “Precision Diagnostics” by combining advanced imaging, AI software, biomarkers and data to improve diagnosis, stratification and treatment planning.
- Partnership with Intelligent Scopes Corporation to develop AI for BLC: ~200 procedures, 80 000+ images, next β version in 12-18 months, pursuing FDA/EU clearance.
- Pre-clinical data suggest HAL + blue-light may exert anti-tumour/immune effects, hinting at therapeutic potential beyond detection.
- Development pipeline asset: Cevira (photodynamic therapy) out-licensed to Asieris for HSIL treatment, regulatory review underway in China.
- Commercial traction: Q3 2025 revenues for Hexvix/Cysview rose to NOK 134.1 m; active U.S. accounts increased; product revenue growth guided at 8-10 % cc.
- Market context: AI in medical diagnostics is a high-growth segment (~22 % CAGR) supporting Photocure’s strategic direction.
- Investment-relevance: Dual exposure to diagnostics revenues (commercial sales) and potential milestone/licensing upside from therapy and AI platforms.
- Risk considerations: Execution of AI development & regulatory clearance, competitive imaging/diagnostic technologies, reimbursement/penetration of BLC in under-penetrated markets.
Photocure ASA is evolving from a niche bladder-cancer diagnostics company into a broader precision diagnostics and therapeutic platform, combining its established Hexvix/Cysview imaging franchise with AI, biomarker stratification and an out-licensed photodynamic therapy pipeline to capture growing markets in early detection, treatment guidance and value-based care.
Photo: Photocure ASA
