PR87342

SCHAFFHAUSEN, Switzerland, Dec 18, 2020 /PRNewswire=KYODO JBN/ --

Occlutech, a privately-held company, announced today that the US Food and Drug

Administration (FDA) has granted the company a Breakthrough Device designation

for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary

Arterial Hypertension (PAH).

PAH affects hundreds of thousands in the U.S. and globally and is resulting

from changes in cells that causes damages of the lung arteries.

Consequentially, the heart is forced to work harder to supply enough oxygen.

The patient experiences symptoms such as shortness of breath, dizziness and

fatigue. The severity of these symptoms usually correlates with progression of

the disease and significantly reduced quality of life. Over time, the right

ventricle enlarges to hold more blood and the additional strain gradually

causes the heart to fail. By placing the Occlutech AFR device into the septum

and creating a restrictive atrial septal opening by maintaining the correct

sizing of a created shunt, the intra cardiac pressure is substantially reduced,

thereby improving the heart's function.

Breakthrough Device Designations are aimed to accelerate the development,

assessment, and approval of new treatments in severe diseases, including a

prioritized review all the way through market approval.

“It is an important milestone for us to have received this breakthrough

designation,” says Sabine Bois, Co-CEO Occlutech Group. “We are very proud and

excited to work closely with the FDA in this opportunity to develop an important

new therapy that positively impacts the lives’ of critically ill patients.”

Occlutech is one of the leading companies in its field, with several major

products including state-of-the-art PFO occluders, ASD occluders among others.

Occlutech has sales of congenital and structural heart products in over 80

countries and maintains manufacturing and R&D facilities in Jena, Germany and

Istanbul, Turkey. Occlutech has developed many novel products and technologies

to improve treatment of patients in these and related areas.

For additional information about the Company’s products, the Occlutech AFR, or

to inquire about participation in our patient registries, please visit

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

AFR@occlutech.com.

The AFR is not approved in the United States.  Product availability is subject

to local regulatory clearance. The AFR is under clinical investigation for use

in patients with pulmonary arterial hypertension and use in these patients is

limited by applicable national laws.

Contact:

Sabine Bois

Co-CEO Occlutech Group

Mobile: +49 160 90792130

Email: sabine.bois@occlutech.com

Source: Occlutech International