Occlutech Holding AG continued its progress in the US market. The first patient has now been enrolled in the global US study OCCLUFLEX in Europe. The OCCLUFLEX study aims to investigate the safety and efficacy of Occlutech's PFO Occluder compared with the standard of care PFO Occluders approved by the Food and Drug Administration ("FDA") in patients who have suffered a cryptogenic stroke.

In 2021, FDA granted Occlutech IDE approval for a prospective, randomized, multi-center, controlled, clinical study. The study allows Occlutech to collect safety and effectiveness data to support a Premarket Approval (PMA) application to the FDA upon completion. The OCCLUFLEX study aims to enroll 450 patients in the US, Canada, and Europe.