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