Occlutech Q1 2022 – Strong revenue growth and major milestones in strategic U.S. markets

Schaffhausen, Switzerland / ACCESSWIRE / 31 May 2022 / Occlutech Holdings

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 addressable market for congenital and structural heart devices presents significant growth opportunities. To address the heightened focus on Occlutech and its development, the company will issue a quarterly press release starting in the first quarter of 2022, which will include revenue developments and comments from the CEO.

Comments from CEO Sabine Bois on Q1 2022:

Strong revenue growth and positive sales trends
Occlutech showed strong revenue growth in the first quarter of 2022, approaching an all-time high in March. All markets performed well, with the best direct market sales in the company’s history. The strong performance underscores the rebound in the global healthcare market and confirms the quality and competitiveness of our products. Compared to the same period in 2021, our revenue in the first quarter of 2022 increased by 14.2% to EUR 8.114 million (EUR 7,106), with a gross margin in line with the company’s financial targets. We have a profitable underlying business in the structural heart market and are now investing in geographically expanding growth areas as well as the heart failure market, and we aim to be profitable within 3 to 5 years.

Significant milestones achieved in strategic U.S. markets
Capturing the important US market is an important part of Occlutech’s growth strategy. A milestone was reached this quarter when Occlutech met all FDA criteria in the AFR study FROST and can continue the pivotal human clinical study of Occlutech’s atrial flow regulator (AFR) in heart failure. Patient enrollment is expected to begin in 2022, and Occlutech expects to receive FDA marketing approval in the United States in 2027.

During the quarter, our U.S. PFO study, OCCLUFLEX, launched its first hospital site in Canada, ready to enroll patients, with the first patient enrolling in May 2022. The study was designed to investigate the safety and efficacy of Occlutech’s patented foramen ovale (PFO) occluder and allow Occlutech to collect data upon completion to support submission of a premarket approval application to the FDA, which we expect by 2026 Approved PFO occluder in the United States.

In May 2022, Occlutech signed an exclusive distribution agreement with B. Braun Interventional Systems Inc. (BIS), providing an important foundation for Occlutech’s commercial development in the United States. Under the agreement, which is effective immediately, BIS will initiate U.S. commercialization of Occlutech’s FLEX II ASD occluder, with FDA approval expected in 2022. Through the partnership, Occlutech is positioning itself to succeed in the largest congenital and structural heart medical device market worldwide, characterized by a premier and commercially attractive healthcare system. I believe this partnership will successfully propel us into the market.

Create value for people, society and shareholders
We are seeing the positive effects of a gradual recovery in the market, with stronger demand and easier access to customers. With the equity capital we raised at the end of 2021, I believe that with our proven expertise in innovation and commercialization and our experienced organization, we can improve the quality of people’s lives, improve the health economics of society, and at the same time Our shareholders create long-term value.

For more information, please contact:

Lars Waddle
Email: lars.wadell@occlutech.com
Tel: +46 763 20 04 34

Sabine Bois
Email: sabine.bois@occlutech.com

About Occlutech

Occlutech is a leading specialist provider of minimally invasive structural heart implants with a mission to improve the quality of life of cardiac patients. The vision is to become the world’s leading specialist in cardiac implants, addressing congenital heart defects, stroke prevention and heart failure. Since 2003, the company has developed, manufactured and commercialized occluder and atrial shunt products. Occlutech has an extensive and proven product portfolio based on proprietary technology with over 200 patents and more than 146,000 products sold. The company markets and sells its products in approximately 85 countries. The company has approximately 290 employees and is a public limited liability company registered in Switzerland. to know more information: www.occlutech.com.

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Lars Waddell Chief Financial Officer
Sabine Bois Chief Executive Officer


Occlutech Q1 2022 – Strong Revenue Growth and Key Milestones in Strategic U.S. Markets

resource: Occlutech Holdings

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