Oslo, Norway, April 13, 2026 - Photocure ASA (OSE: PHO) today announced that the
U.S. Food and Drug Administration (FDA) has communicated to Photocure that it
plans to issue a proposed order to reclassify diagnostic endoscopic light source
systems (FDA Product Code OAY) under its own initiative per Section 513(f)(3) of
the Federal Food, Drug, and Cosmetic Act.
This information was shared with Photocure as part of its ongoing dialogue with
the FDA, following the Reclassification Petition submitted by Karl Storz SE &
Co. KG and addressed in Photocure's press release of 28 March 2026. Consistent
with FDA's response to the Reclassification Petition, which did not preclude the
agency from reclassifying on its own initiative, and subject to internal
processes, FDA intends on issuing a proposed order to reclassify FDA Product
Code OAY in the second half of 2026. Any potential reclassification will proceed
through the FDA's established processes, with final determinations made by the
agency.
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email:ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email:ed@photocure.com
Priyam Shah
Vice President Investor Relations
Tel: +17176815072
Email:priyam.shah@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email:geir.bjorlo@corpcom.no
About Photocure
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com/news.
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Tolv Hillestad, Photocure ASA, on 13 April 2026 at
08:30 CEST.