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Photocure ASA's Update on Regulatory Changes

On April 13, 2026, Photocure ASA, the Oslo-listed company known for its pioneering solutions in bladder cancer treatment, made a significant announcement concerning regulatory changes from the U.S. Food and Drug Administration (FDA). The FDA has indicated its plans to propose a reclassification of diagnostic endoscopic light source systems, designated by the product code OAY. This reclassification is expected to unfold through a process initiated by the FDA under Section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.

The context of this announcement stems from ongoing discussions between Photocure and the FDA, particularly following a Reclassification Petition submitted earlier by Karl Storz SE & Co. KG. This petition, acknowledged by the FDA, aimed to reassess the regulatory landscape for the endoscopic light source systems that are integral to Photocure’s operations. Although the results of this petition have not excluded the FDA from acting independently, the agency's decision to pursue reclassification underscores the dynamic regulatory environment that Medical Device manufacturers must navigate.

In line with the FDA's planned timeline, the agency aims to issue the proposed order for this reclassification in the second half of 2026. The implementation of this potential reclassification will adhere to the FDA's established protocols, which include comprehensive evaluations and opportunities for public comments. Ultimately, the final decision will be made by the agency after thoroughly assessing the implications of the new classification.

Importance of the Reclassification

For Photocure, this move could significantly impact how its technologies are assessed in the marketplace. The company is recognized for its innovative approach, particularly its unique technology that causes cancer cells to emit a bright pink fluorescence, aiding in more effective diagnosis and treatment of bladder cancer. Should the FDA proceed with this reclassification, it may streamline or complicate the process for future product innovations and adjustments in the regulatory framework for similar devices.

As Photocure ASA continues to liaise with the FDA, stakeholders and investors remain keenly interested in how this regulatory change will unfold and its implications for the company's strategic direction. The developments will also be critical for healthcare professionals who depend on reliable diagnostic tools for bladder cancer treatment.

Contact Information for Further Clarification

For any inquiries regarding this regulatory update or its implications, key contacts at Photocure ASA include:

• - Dan Schneider, President and CEO: Email
• - Erik Dahl, CFO: +47 45055000
• - Priyam Shah, Vice President, Investor Relations: +17176815072
• - Media and IR Inquiries: Geir Bjørlo, Corporate Communications (Norway): +47 91540000

About Photocure ASA

Operating from Oslo, Norway, Photocure ASA is dedicated to enhancing the quality of life for bladder cancer patients through its cutting-edge technologies. As a leading figure in bladder cancer care, the company strives to deliver transformative health solutions, ensuring better outcomes for patients globally. As it continues its innovative journey, maintaining transparency with stakeholders remains a priority, fostering informed decisions and trust in its operations.

For more details, visit Photocure’s official website.

This announcement is deemed inside information in accordance with EU Market Abuse Regulation guidelines, and compliance with section 5-12 of the Norwegian Securities Trading Act is being adhered to.