Occlutech Q4 2024 Performance Update: Continued Progress in Clinical Development and Steady Sales Growth

Occlutech Holding AG (Occlutech) is a leading specialist provider of minimally invasive structural heart implants. The company sells and markets its products in around 80 countries and the global addressable market for congenital and structural heart devices provides a significant growth opportunity. 

In the fourth quarter we saw continued progress in clinical development and solid financial performance. Sales growth aligned with our 2024 annual target of 20 percent, reflecting the strength of our product portfolio and market positioning. Significant operational efficiencies were achieved in 2024; this topic will remain a focus as we move into 2025. 

Clinical Development Progress
During the quarter, patient enrolment in the OccluFlex U.S. trial was successfully completed. This represents a critical step in the Pre-Market Approval (PMA) process for the PFO Occluder as part of our FDA submission strategy. 

Global Patient Impact
In November, we reached our target of treating over 20,000 patients ahead of schedule, driven by strong operational execution and support from our team and distribution partners. 

Customer Engagement
Occlutech maintained a strong presence at key industry events, including CSI APAC and CSI-DHF in Frankfurt, reinforcing engagement with healthcare professionals and industry stakeholders. 

Regulatory Progress
The MDR process proceeds as planned. The AFR was finalized in November, and we expect all products to be approved before the deadline. We remain on track for PFO approval in the U.S. by the end of 2026. 

LAA Distribution Update
The planned distribution of the Eclipse Medical LAA Omega device in Germany has been postponed until further notice due to identified non-critical performance issues. 

Brand Identity
At the end of Q4, we introduced a refreshed brand identity to reflect our ongoing growth and commitment to innovation. The phased rollout will continue in 2025. 

Outlook for 2025
Occlutech is well-positioned to drive growth and enhance operational efficiency in 2025. I would like to extend my gratitude to our shareholders, employees, partners, physicians, and all stakeholders for their continued dedication and contribution to our success. 

To receive a PDF copy of our quarterly reports, please submit your details via the form on the Occlutech website. 


Tor Peters CEO
tor.peters@occlutech.com 


Johan Sundell CFO
johan.sundell@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 for people with heart conditions. The vision is to become a leading global specialist in cardiac implants, addressing congenital heart defects, stroke prevention and heart failure. Since 2003, the company has developed, manufactured, and commercialized occluders and interatrial shunt products. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with approximately 200,000 products sold. The company markets and sells its products in around 80 countries. The company has approximately 330 employees and is a public limited liability company registered in Switzerland. For more information: www.occlutech. com. 


Attachments
Occlutech Q4 2024 Performance Update: Continued Progress in Clinical Development and Steady Sales Growth 

Disclaimer

The information contained in this section of Occlutech Holding AG’s (the “Company”) website contains information relating to an offering to the general public in Sweden and institutional investors in Sweden and abroad to subscribe for Swedish Depository Receipts (“SDR’s”) in the Company in connection with the admission to trading of the SDR’s on Nasdaq First North Premier Growth Market. This information may not be accessed by residents of certain countries based on applicable securities law regulations.

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, WHOLLY OR PARTLY, IN THE UNITED STATES OF AMERICA (INCLUDING ITS TERRITORIES AND POSSESSIONS), ANY STATE OF THE UNITED STATES INCLUDING THE DISTRICT OF COLUMBIA, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SWITZERLAND, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW.

This website and the information contained herein is not intended for, and may not be accessed by, or distributed or disseminated to, persons resident or physically present in the United States of America (including its territories and possessions), any state of the United States including the District of Columbia (the “United States”), Australia, Canada, Hong Kong, Japan, New Zealand, Singapore, Switzerland, South Africa, South Korea and do not constitute an offer to sell or the solicitation of an offer to purchase or acquire, any SDR’s in the Company in any of the above mentioned jurisdictions or in any other jurisdiction in which such offer or solicitation would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The SDR’s in the Company referred to on this website have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act.

All persons residing outside of the above mentioned jurisdictions who wish to access the documents contained on this website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this website, or require registration or approval for any acquisition of securities by them. The Company assumes no responsibility if there is a violation of applicable law and regulations by any person.If you are not permitted to view materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this website.

Access to electronic versions of these materials is being made available on this website by the Company in good faith and for information purposes only.

By clicking “Confirm” you confirm and certify that:

  • You are not a resident of or physically present in any of the above jurisdictions or any other restricted jurisdiction and are not a U.S. person (as defined in Regulation S under the Securities Act); and
  • you are either:
    1. a resident of, or physically present in Sweden;
    2. if resident or physically present in a Member State of the European Economic Area other than Sweden, a qualified investor as defined in Regulation (EU) 2017/1129 of the European parliament and of the council; or
    3. otherwise authorized to access this information pursuant to applicable laws or regulations.