Photocure Charts a New Course in Bladder Cancer Diagnostics

OSLO, Norway – July 29, 2026 – At first glance, Photocure's second-quarter results paint a picture of steady, predictable growth. The uro-oncology specialist reported revenues of NOK 140.0 million for its flagship Hexvix/Cysview product, a modest increase from the prior year, and raised its full-year revenue growth forecast. But looking past the headline numbers reveals a company in the midst of a profound strategic transformation, methodically assembling the pieces to become a comprehensive leader in bladder cancer diagnostics, from early detection to precision treatment.

Beneath the surface of a solid financial report, the Norwegian firm detailed a series of moves—a key acquisition, a promising AI collaboration, and an anticipated regulatory tailwind in the U.S.—that signal a clear ambition beyond its established Blue Light Cystoscopy (BLC) technology. Photocure is building a multi-faceted platform that aims to address the entire patient journey, a strategy that could redefine its market position and, more importantly, patient outcomes.

Steady Growth Fuels a Broader Vision

Photocure's core business remains the engine of its expansion. The company reported an adjusted EBITDA of NOK 27.2 million, holding steady from the same quarter last year. While reported EBITDA showed a loss, the adjusted figure, which strips out non-cash and non-operational items, provides a clearer view of the underlying health of the commercial business. This stability is crucial as it provides the financial firepower for the company's strategic investments.

Growth in the core business is being driven by wider adoption of its BLC technology, which makes cancer cells visible during cystoscopy procedures. The company installed six new Saphira BLC towers in the U.S. during the quarter, expanding its active accounts to 436—a 20% increase from the previous year. Similar expansion is underway in Europe with partners like Olympus, Karl Storz, and Stryker. This consistent execution has given management the confidence to raise its 2026 product revenue growth guidance to a range of 8% to 11% on a constant currency basis.

"Photocure continued to execute well during the second quarter of 2026, delivering sustained commercial momentum across our core business while advancing several strategic initiatives that strengthen our long-term growth profile," said Dan Schneider, President & CEO of Photocure, in the company's announcement.

Beyond Imaging: The Leap into Biomarker Testing

The most significant strategic move this quarter was the acquisition of Vesica Health, a company developing a non-invasive test for the early detection of bladder cancer. Photocure had already taken a minority stake in Vesica earlier this year, and this full acquisition signals a decisive pivot. Vesica's lead product, AssureMDx, is a urine-based biomarker test that analyzes multiple biological signals—a "multi-omic" approach—to identify the presence of cancer.

This acquisition strategically repositions Photocure. For years, its value proposition has been enhancing the visualization of cancer during invasive procedures. With AssureMDx, the company enters the crucial, and rapidly growing, field of non-invasive early detection. This not only diversifies its portfolio but also moves it further upstream in the patient care pathway, where it can help identify at-risk individuals sooner. The company expects initial revenue from AssureMDx in 2027, with a clearer reimbursement pathway anticipated by mid-2028.

"The acquisition of Vesica significantly advances our strategy of building a comprehensive precision diagnostics platform by combining non-invasive biomarker testing with our market-leading BLC franchise," Schneider stated, emphasizing the synergy between the technologies. This combination could allow for a more streamlined process, where a non-invasive test could help risk-stratify patients, leading to more targeted and effective use of advanced imaging like BLC.

Unlocking the Market with AI and Regulatory Shifts

Two other developments are poised to accelerate Photocure's growth. The first is a significant regulatory catalyst in the United States. The FDA has confirmed it will initiate a reclassification of BLC equipment in the second half of 2026. This move, which follows a petition from equipment manufacturer Karl Storz, is expected to create a more predictable regulatory framework. For Photocure, this is a major tailwind. A simpler path to market for BLC equipment from various manufacturers would expand the installed base of compatible systems, thereby increasing the addressable market for the company's Cysview drug, which is used in every BLC procedure.

"We believe this represents an important milestone towards establishing a more predictable regulatory framework for BLC equipment and will significantly expand our addressable market by enabling broader participation from equipment manufacturers," Schneider explained.

The second development looks even further into the future of diagnostics. Photocure has entered a research collaboration with Artera to explore the use of artificial intelligence in digital pathology. The partnership will use data from Photocure's extensive BLC registry to help evaluate Artera's AI Bladder Test, which is currently in development. This move positions Photocure at the forefront of integrating AI, advanced imaging, and molecular diagnostics to create a more personalized approach to managing bladder cancer.

These strategic pillars—a strong core business, a new non-invasive test, a favorable regulatory shift, and a forward-looking bet on AI—demonstrate a cohesive vision. Photocure is no longer just a company that helps doctors see cancer better; it is building an integrated platform to detect, diagnose, and manage it with greater precision than ever before. As Schneider concluded, "Our priorities remain clear: execute consistently, expand access to BLC, invest thoughtfully in innovation, and build a broader precision diagnostics platform that improves patient outcomes while creating sustainable long-term shareholder value. We remain confident in our strategy and encouraged about the opportunities that lie ahead for Photocure."