PR87673

SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire=KYODO JBN/ --

Occlutech, a privately-held company, announced today that the U.S Food and Drug

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

for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF)

patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction.

Heart failure (HF) is a serious condition characterized by the heart's

inability to pump an adequate blood supply to the body. Worldwide, HF affects

over 30 million people, and the lifetime risk of HF increases with age, with

over 50% of hospitalizations of persons aged 65 or older attributable to HF.

Heart Failure Symptoms include fatigue, palpitations, and exertional dyspnea.

HF may result from disorders of the pericardium, myocardium, endocardium, heart

valves, great vessels, or specific metabolic abnormalities. These disorders

affect the heart's structure or function, which results in reduced cardiac

output and/or elevated intracardiac pressures at rest or during exercise. When

HF is left untreated, symptoms gradually worsen, resulting in increased

morbidity, clinically driven hospitalizations, and higher mortality.

The AFR is for use in patients with Heart Failure with Preserved Ejection

Fraction (HFpEF) or Reduced Ejection Fraction (HFrEF) and who, despite optimal

medical therapy, experience worsening symptoms. The AFR maintains an

interatrial shunt with a predetermined diameter allowing for controlled blood

flow from the left to the right atrium enabling the left atrium to decompress

and lower left atrial pressure. Reduced left atrial pressure has been shown to

reduce heart failure symptoms and improve exercise tolerance.

Breakthrough Device Designations aim 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 second breakthrough

designation for our AFR device." says Sabine Bois, CEO Occlutech Group. "After

receiving the first Breakthrough Device designation for pulmonary arterial

hypertension (PAH) in December 2020, the heart failure (HF) indication

addresses a substantial market with rapid growth and only limited options for

the treatment for critically ill patients. We are looking forward to developing

an important new therapy and working closely with the FDA on both indications."

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                        

CEO Occlutech Group                            

Mobile: +49 160 90792130                          

Email: sabine.bois@occlutech.com                    

Source: Occlutech International