Photocure ASA: Results for the third quarter of 2026

Dan Schneider, President and Chief Executive Officer of Photocure ASA

“Photocure is progressing toward an important evolution in its development: building on an established commercial franchise while expanding our capabilities across the bladder cancer diagnostic pathway. Our ambition is to combine the reach of Hexvix / Cysview with non-invasive molecular diagnostics, advanced imaging, artificial intelligence and real-world clinical evidence. We believe these complementary capabilities can create new opportunities to improve patient care, expand our addressable market and deliver sustainable long-term growth.”

Dan Schneider, President and Chief Executive Officer of Photocure ASA

“We have also strengthened Photocure’s leadership team with the appointment of Dennis Camporeale as our new Chief Financial Officer. Dennis has a strong background in medtech and diagnostics investment banking, spanning mergers and acquisitions, strategic advisory, business development and corporate finance. This appointment supports our focus on disciplined financial management and execution while we advance our commercial franchise and invest in growth opportunities across the bladder cancer diagnostic pathway.”

Dan Schneider, President and Chief Executive Officer of Photocure ASA

“An important catalyst for our core business is the U.S. Food and Drug Administration’s proposal to reclassify applicable BLC systems from Class III to Class II. Published in August, the proposal will establish a new regulatory framework with special controls and a 510(k) pathway, subject to the FDA’s final determination. We believe this evolution will facilitate broader participation by equipment manufacturers, expand the availability of compatible BLC platforms and support wider adoption of BLC across U.S. healthcare systems. Combined with our commercial infrastructure and mobile access model, the reclassification will create a meaningful opportunity to accelerate market development and strengthen our position in bladder cancer diagnostics.”

Dan Schneider, President and Chief Executive Officer of Photocure ASA

“Following the acquisition of Vesica Health, AssureMDx is our second growth engine and serves as a significant step in extending our reach earlier in the patient pathway through a multi-omic, urine-based molecular test designed to support risk stratification and the evaluation of patients presenting with hematuria. By combining non-invasive molecular testing via AssureMDx with our established BLC franchise, we can connect earlier risk assessment with procedural diagnosis and subsequent patient management. We expect initial AssureMDx revenue in 2027, with reimbursement secured during the first half of 2027.”

Dan Schneider, President and Chief Executive Officer of Photocure ASA

“Artificial intelligence provides another opportunity to extend our capabilities and differentiate our offering. Through our work with Claritas HealthTech and its subsidiary Intelligent Scopes Corporation, we are advancing AI-enabled technology designed to support physicians during BLC procedures, with the potential to enhance tumor detection and resection completeness. The Photocure and Claritas co-sponsored ENAiBLE trial has now recruited over 100 patients into the study. Our collaboration with Artera to evaluate the ArteraAI Bladder Test, which remains under development, illustrates the value of Photocure’s Cysview registry as a rich dataset to support the validation of emerging diagnostic tools. These initiatives enhance complementary aspects of care, from visualization during cystoscopy to pathology-based insights that may inform patient assessment and management.”

Dan Schneider, President and Chief Executive Officer of Photocure ASA

“We believe Photocure’s opportunity extends beyond any single product or technology. By combining an established commercial franchise with capabilities spanning early risk assessment, procedural detection and data-enabled patient management, we are building a broader precision diagnostics platform in bladder cancer. At the same time, we recognize the need to navigate an evolving competitive environment while continuing to demonstrate the clinical value and commercial resilience of our established franchise. Our commitment remains to be disciplined, generate evidence that matters to clinicians and patients, and convert our growing capabilities into sustainable commercial growth and long-term shareholder value.”