PR89849

SCHAFFHAUSEN, Switzerland, June 1, 2021 /PRNewswire=KYODO JBN/ --

Occlutech AG ("Occlutech" or the "Company") today announces that the planned

recruitment of 180 patients has been reached in the Company's trial in China

for its ASD Occluder. The Occlutech ASD Occluder is used in the treatment of

Atrial Septal Defects (ASD), which is a congenital heart condition. The

completion of the patient recruitment represents a significant milestone in the

process towards approval of Occlutech's ASD Occluder in China. The trial is

conducted as a multicenter, randomized, prospective trial. It is commencing now

and is supporting Occlutech's application for market approval of the ASD

Occluder in China. Once the 12 months follow-up for all patients is completed

the Company expects to file for regulatory approval by the Chinese National

Medical Products Administration (NMPA).

An approval in China will be an important addition to Occlutech's global

expansion. The ASD Occluder is today approved in more than 60 countries

worldwide, among others Canada, Japan, South Korea and CE marked countries like

Germany, France and Sweden. Furthermore, the ASD Occluder is in its final

review with the FDA in the premarket approval (PMA) application in the United

States.

Sabine Bois, CEO Occlutech Group, comments:

"To reach the intended recruitment goal despite the challenging impact of the

Corona pandemic is an important milestone for Occlutech. The expansion towards

China is a key part of our strategic ambition to drive sales growth over the

coming years and the trial is another important step to bring us closer to file

for market approval by the Chinese National Medical Products Administration

(NMPA), once the 12 months follow up for all patients is completed."

About Atrial Septal Defect (ASD) Occluders

Atrial septal occluders are minimally invasive cardiac devices, addressing

congenital heart defects. Atrial Septal Defect (ASD) is one of the most common

types of congenital heart diseases and formed due to an unclosed connection

between the upper chambers of the heart appearing during fetal development.

For additional information about the Company's products, the Occlutech ASD, or

to inquire about participation in our patient registries, please visit

Occlutech's website at www.occlutech.com, or contact us directly at

info@occlutech.com.

About Occlutech

Occlutech is a leading specialist in minimally invasive cardiac devices,

addressing congenital heart defects, stroke prevention and heart failure. Since

2003, we have been developing, manufacturing, and commercializing structural

heart and interatrial shunt products. We have a track record of over 15 years

of gaining market share, developing and launching innovative products and

building solid market positions. Occlutech has a broad and proven portfolio

with 10 CE marked products covered by over 200 patents. We market and sell our

products to hospitals and clinics in over 85 countries.

Occlutech maintains manufacturing and R&D facilities in Germany and Turkey,

with a global supply, customer support hub located in Sweden.

Contact

Claudia Scalia

Marketing Communications Manager Occlutech Group

Tel: +46 735 199782

Email: claudia.scalia@occlutech.com

Stefan Kleidon

Vice President Sales & Marketing Occlutech Group

Tel: +49 176 31514136

Email: stefan.kleidon@occlutech.com

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SOURCE: Occlutech International