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.
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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