Occlutech Q1 2022 – Strong revenue growth and milestones achieved in US strategic market

SCHAFFHAUSEN, SWITZERLAND / ACCESSWIRE / May 31, 2022 / Occlutech Holding SA

Occlutech Holding AG (Occlutech) is a leading specialist supplier of minimally invasive structural heart implants. The company sells and markets its products in approximately 85 countries and the global potential market for congenital and structural heart devices offers significant growth opportunity. To respond to the strong interest in Occlutech and its development, the company will publish a quarterly statement starting in the first quarter of 2022, which will include the evolution of revenues and comments from the CEO.

Sabine Bois, CEO, comments on Q1 2022:

Strong revenue growth and positive sales trends
Occlutech reported a strong increase in revenue in the first quarter of 2022, with March approaching an all-time high. All markets performed well with the best result in the company’s history coming from direct market sales. The good performance highlights the rebound of the global healthcare market and confirms the quality and competitiveness of our products. Our turnover increased by 14.2% in the first quarter of 2022 compared to the corresponding quarter of 2021 and amounted to EUR 8,114,000 (7,106) and the gross margin was well in line with the financial objective of the company. We have a profitable core business with our structural heart market and are now investing in the growth areas of geographic expansion as well as the heart failure market, and aim to be profitable within 3-5 years.

Important milestones achieved in the US strategic market
The conquest of the important American market is an important element of Occlutech’s growth strategy. An important milestone was reached during the quarter when Occlutech met all FDA conditions in the AFR FROST study and can proceed with a pivotal human clinical study of Atrial Flow Regulator (AFR) from Occlutech for heart failure. Patient enrollment is expected to begin in 2022 and Occlutech expects to receive US FDA marketing clearance in 2027.

During the quarter, the first hospital site in Canada was activated in our US OCCLUFLEX PFO study, ready to enroll patients, and in May 2022, the first patient was enrolled. The study aims to investigate the safety and efficacy of Occlutech’s patented Oval Foramen Occlusion (PFO) and allows Occlutech to collect data to support an application for premarketing approval with the FDA once completed and we expect FDA approval of PFO occlusion in the United States by 2026.

A major milestone in the commercial development of Occlutech in the United States was reached in May 2022, when Occlutech signed an exclusive distribution agreement with B. Braun Interventional Systems Inc. (BIS). The agreement is, indeed, immediate and under this agreement, BIS will begin commercialization activities in the United States of Occlutech’s FLEX II ASD Occluder, where FDA approval is expected in 2022. collaboration, Occlutech is positioning itself for success in the largest congenital and structural heart devices market in the world, characterized as a leading and commercially attractive healthcare system. I am confident that this collaboration will successfully lead to our market entry.

Create value for people, society and shareholders
We are seeing a positive impact from the gradual market recovery, with stronger demand and better access to customers. With the social capital we raised at the end of 2021, I am convinced that with our proven expertise in innovation and commercialization coupled with our experienced organization, we can improve the quality of life of people, improve the health economy in society and at the same time create long-term value for our shareholders.

For more information please contact:

Lars Wadell
Email: [email protected]
Telephone: +46 763 20 04 34

Sabine Wood
Email: [email protected]

About Oclutech

Occlutech is a leading specialty provider of minimally invasive structural heart implants, dedicated to improving the quality of life for people with heart disease. The vision is to become a leading global specialist in heart implants, treating congenital heart defects, stroke prevention and heart failure. Since 2003, the company has been developing, manufacturing and marketing obturators and interatrial shunt products. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with over 146,000 products sold. The company markets and sells its products in approximately 85 countries. The company has approximately 290 employees and is a limited company registered in Switzerland. For more information: www.occlutech.com.

Image attachments

Lars WadellChief Financial Officer
Sabine Bois CEO


Occlutech Q1 2022 – Strong revenue growth and milestones achieved in US strategic market

THE SOURCE: Occlutech Holding SA

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