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Photocure ASA Updates on AssureMDx and Medicare Coverage Timeline

Oslo, Norway - In a significant announcement on November 9, 2026, Photocure ASA, a dedicated player in bladder cancer diagnostics, provided crucial updates regarding their product AssureMDx™ and the anticipated timeline for Medicare coverage following their acquisition of Vesica Health in June 2026.

The acquisition has propelled Photocure's efforts in refining their commercial and reimbursement strategies for AssureMDx. Early discussions with relevant pricing authorities have been optimistic, suggesting that the potential reimbursement level could significantly surpass initial estimates made during the acquisition underwriting process.

In February 2026, AssureMDx received FDA Breakthrough Device Designation, further solidifying its clinical and regulatory positioning. However, it is important to note that Medicare pricing and coverage processes operate on separate timelines. The Centers for Medicare & Medicaid Services (CMS) is expected to finalize pricing determinations by the end of 2026, with implementation taking place on January 1, 2027.

At the time of the acquisition, Photocure anticipated that Medicare coverage for AssureMDx would materialize around 2028, post-submission of additional clinical evidence. An earlier opportunity for coverage was presented by a proposed Local Coverage Determination (LCD) from Novitas in May 2026. However, the newly published LCD on November 6, 2026, which encompasses urine-based biomarkers for patients with microhematuria, did not include AssureMDx, instead highlighting the need for additional clinical evidence for future coverage considerations. As a result, the projected timeline for Medicare coverage aligns with the company's initial assumptions.

Currently, AssureMDx boasts substantial clinical validation evidence from several published studies. Notably, a significant prospective study demonstrated that AssureMDx can spare approximately 89% of patients with microhematuria from invasive cystoscopy while effectively identifying all upper-tract urothelial cancers within the study group. This impressive diagnostic performance has also led to AssureMDx's inclusion in the 2025 microhematuria guidelines issued by the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, highlighting its clinical relevance.

To bolster their evidence base, Photocure is actively engaged in generating further clinical data. The SeARCH study, an investigator-initiated randomized controlled trial at Erasmus University Medical Center in the Netherlands, is currently in progress. Supported by a grant from the Dutch Cancer Society and involving around 1,100 patients with microhematuria, this study aims to evaluate the clinical utility of AssureMDx in guiding diagnostic decisions while reducing unnecessary cystoscopies.

Concurrently, Photocure is finalizing the trial protocol for PATHWAY, a randomized controlled study in the U.S., aimed at generating more evidence for the microhematuria population. The company plans to reconnect with the Novitas medical review team to discuss expectations related to the published LCD, share their clinical development approach, and garner feedback ahead of initiating the study. Together, the SeARCH and PATHWAY studies are intended to provide robust randomized clinical evidence to facilitate future Medicare coverage reconsideration and potential updates to clinical guidelines.

Dan Schneider, President and CEO of Photocure, expressed optimism regarding the positive acknowledgment of AssureMDx's diagnostic performance found in published clinical literature and guidelines from respected urological organizations. He noted the encouraging progress in pricing and commercial reimbursement strategies and reaffirmed their commitment to generating additional evidence for Medicare coverage and advancing AssureMDx within their uro-oncology precision diagnostics portfolio.

Despite the LCD's publication not precluding the commercialization of AssureMDx via other reimbursement channels, Photocure intends to continue pursuing these avenues. In line with their original acquisition expectations, the company still anticipates generating initial AssureMDx revenue in 2027.

About Bladder Cancer

Bladder cancer is a significant health concern, ranking as the sixth most prevalent cancer globally. It particularly affects men, with a reported incidence of 1,978,000 prevalent cases and about 635,000 new cases in 2024, leading to over 227,000 deaths. The disease is characterized by a high recurrence rate, with approximately 61% in the first year and up to 78% over five years.

For further information, inquiries can be directed to Dan Schneider, President and CEO, or Priyam Shah, Vice President of Investor Relations at Photocure ASA.

To learn more about Photocure's innovative solutions and ongoing research efforts, visit www.photocure.com.