Occlutech Advances Toward NMPA Approval for ASD Occluder in China with Completion of Patient Enrollment

SCHAFFHAUSEN, Switzerland, June 2, 2021 /PRNewswire/ -- Occlutech AG ("Occlutech" or the "Company") announced that its clinical trial in China for the Atrial Septal Defect (ASD) Occluder has enrolled 180 patients. The Occlutech ASD Occluder is a device designed to treat atrial septal defects (ASD), a congenital heart disease. Completing patient enrollment represents a significant milestone in Occlutech's regulatory approval process for the ASD Occluder in China. This multicenter, randomized, prospective trial is now underway and will support Occlutech's application for market approval of the device in China. Upon completion of the 12-month follow-up for all enrolled patients, the Company expects to submit its regulatory approval application to China's National Medical Products Administration (NMPA).

Market approval in China would represent a significant addition to Occlutech’s global expansion. This atrial septal defect (ASD) occluder has already been approved in over 60 countries worldwide, including Canada, Japan, South Korea, and CE-marked countries such as Germany, France, and Sweden. Additionally, the ASD occluder is currently undergoing the final review for its FDA Pre-Market Approval (PMA) application in the United States.

Sabine Bois, Chief Executive Officer of Occlutech Group, stated:
“Achieving the targeted enrollment despite the severe impact of the COVID-19 pandemic marks a significant milestone for Occlutech. Expansion in China is a key component of our strategy to drive sales growth over the coming years, and this trial represents another crucial step. Upon completion of the 12-month follow-up for all patients, it will bring us closer to our goal of obtaining marketing approval from China’s National Medical Products Administration (NMPA).”