OSLO – – October 29, 2026 -- Photocure ASA raised its 2026 product revenue growth guidance to 10% to 12% on a constant currency basis, up from 8% to 11%, after Hexvix/Cysview revenues of NOK 134.2 million in the third quarter matched the prior-year level of NOK 134.1 million.
Reported earnings fall despite flat core sales
Adjusted EBITDA came in at NOK 18.5 million, against NOK 18.9 million in Q3 2025. Total revenues rose to NOK 140.9 million from NOK 135.0 million. Reported EBITDA dropped to NOK 4.0 million from NOK 10.2 million, and EBIT swung to NOK -3.4 million from NOK 2.9 million. Cash and cash equivalents stood at NOK 162.4 million at quarter-end.
The company also expects continued expansion of its adjusted EBITDA margin in 2026.
Photocure adds 13 Saphira towers and lifts US active accounts to 454
The 13 new U.S. Saphira tower installations comprised 9 in new accounts and 4 upgrades. Active U.S. accounts reached 454, up 20% on Q3 2025. In Europe, 87 Olympus Visera Elite III systems capable of blue-light cystoscopy (BLC) have been installed since the Q1 2025 launch. Year to date, 29 rigid systems from Karl Storz, Richard Wolf and Stryker have been upgraded.
FDA proposal to downgrade BLC systems to Class II could widen the hardware field
The U.S. Food and Drug Administration published a proposal in August to reclassify applicable BLC systems from Class III to Class II. The change would create special controls and a 510(k) pathway, subject to the agency's final determination. Photocure expects the move to bring in more equipment manufacturers, increase the number of compatible BLC platforms and support wider adoption across U.S. healthcare systems.
Recent studies using U.S. real-world data found cost neutrality between BLC and white light cystoscopy in the studied population. They also pointed to ways of improving the prediction of bladder cancer recurrence and progression in patients treated with BLC.
AssureMDx revenue is due in 2027 after the Vesica Health acquisition
Photocure acquired Vesica Health and now calls its AssureMDx test the company's "second growth engine." The multi-omic, urine-based molecular test supports risk stratification and the evaluation of patients presenting with hematuria. Initial revenue is expected in 2027, with reimbursement secured in the first half of that year.
AI and data partnerships target tumor detection and diagnostic validation
The ENAiBLE trial, co-sponsored with Claritas HealthTech and its subsidiary Intelligent Scopes Corporation, has recruited more than 100 patients. It tests AI-enabled technology intended to improve tumor detection and resection completeness during BLC procedures. Separately, Photocure is working with Artera to evaluate the ArteraAI Bladder Test, which remains under development, using the company's Cysview registry as a validation dataset.
Dennis Camporeale joins as chief financial officer
Camporeale comes from medtech and diagnostics investment banking, with experience in mergers and acquisitions, strategic advisory, business development and corporate finance. CEO Dan Schneider said the company must also navigate an evolving competitive environment while demonstrating the commercial resilience of its established franchise.