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Regulatory press release

CS MEDICA A/S: CS MEDICA Group Completes Product Registration of CANNASEN® CBD-Infused Medical Devices in Israel

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Strategic Milestone Achieved as CANNORDIC, a CS MEDICA Subsidiary, Navigates Regulatory Challenges

CS MEDICA Group, a forerunner in innovative substance-based medical devices containing bioactive CBD, announces the successful completion of the product registration process for the entire CANNASEN® portfolio of CBD-infused medical devices in Israel. This achievement marks a regulatory milestone for our subsidiary, CANNORDIC, and sets a new standard for over-the-counter CBD products in the region.

The first product, the CANNASEN® Pain Patch, received approval from Israel's Ministry of Health in May 2023, becoming the first over-the-counter (OTC) product with CBD in Israel. Despite initial delays due to regulatory complexities and regional conflicts, this launch in December 2023 has been well-received.

"The US FDA's prior approval played a crucial role in expediting the registration process for the remaining products. This strategic advantage allowed us to overcome subsequent regulatory challenges efficiently," says Lone Henriksen, CEO of CS MEDICA. She continues: "The complete registration of our CANNASEN® medical device portfolio in Israel, despite the delays caused by the complex regulatory environment and unfortunate regional conflicts, showcases the resilience and adaptability of our team and the importance of the right partnership."

CANNORDIC and Forbe Healthcare are now focusing on scaling production and preparing for a comprehensive market launch, committed to delivering high-quality healthcare solutions under challenging market conditions to minimize the risk of the distribution agreement volumes and secure the accessibility of the treatments for consumers.

For further details, please visit our website or contact our investor relations team.

This disclosure contains information that CS MEDICA A/S is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-06-2024 15:35 CET.

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