CE Marking, supported by an EU Declaration of Conformity and independently assessed by a Notified Body, represents SQ Innovation’s formal declaration that the Company’s Infusor for subcutaneous delivery of furosemide meets the General Safety and Performance Requirements (GSPRs) of EU MDR 2017/745. CE Marking is a prerequisite for marketing medical devices within the EU and is recognized in numerous other countries as a basis for market authorization. Achieving CE Marking for Lasix ONYU is a critical milestone in SQ Innovation’s global regulatory strategy and underscores the Company’s commitment to rigorous quality and safety standards.

In a separate but complementary development, the EMA has confirmed that the Company’s subcutaneous furosemide product, marketed in the United States under the name Lasix ONYU, is eligible for review under its centralized procedure — the regulatory pathway that, upon approval, grants simultaneous market authorization across all EU member states. Notably, the EMA’s acceptance is based on technical innovation, a designation that reflects the EMA’s recognition of the product as a meaningfully novel drug-device combination addressing an unmet medical need. This designation is consistent with the EMA’s mandate to facilitate patient access to innovative medicines across the EU.