CS MEDICA Group Achieves Complete Registration of CANNASEN® CBD-Infused Medical Devices in Israel

CS MEDICA A/S / Key word(s): Regulatory Approval

CS MEDICA Group Achieves Complete Registration of CANNASEN® CBD-Infused Medical Devices in Israel

17-Jun-2024 / 15:35 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group AG.

The issuer is solely responsible for the content of this announcement.


 

Strategic Milestone Achieved as CANNORDIC, a CS MEDICA Subsidiary, Navigates Regulatory Challenges to Expand Global Footprint

 

CS MEDICA Group, a leader in innovative substance-based medical devices containing bioactive CBD, is proud to announce the successful completion of the product registration process for its entire CANNASEN® portfolio of CBD-infused medical devices in Israel under its subsidiary CANNORDIC. This significant milestone, achieved in partnership with Forbe Healthcare Ltd., sets a new standard for medical device compliance and innovation in the region, as it is the first complete product portfolio of over-the-counter products containing CBD that has been approved for sale by Israel’s Ministry of Health.

 

In August 2022, CANNORDIC, the manufacturing and commercial entity of CS MEDICA Group, initiated a distribution agreement with Forbe Healthcare Ltd., known for its strong distribution network across pharmacies and hospitals. The agreement covers the distribution of CANNASEN® medical device products in Israel and Palestine. It includes the distribution of 852,000 units valued at DKK 37.1 million over the next 3.5 years.

 

The strategic agreement was to launch multiple medical devices, starting with the CANNASEN® Pain Patch. After an 8-9 month product registration process at Israel’s Ministry of Health, it became the first ever over-the-counter (OTC) product with CBD in Israel. Due to the new market conditions, it launched in December 2024 with a 2-month delay and has been well-received.

 

The registration process for the remaining products faced delays due to regulatory changes and regional conflicts. However, the US FDA approval previously obtained significantly facilitated the resumption and successful completion of the product registration process for the entire portfolio.

 

Lone Henriksen, CEO of CS MEDICA Group, comments: “”Despite delays due to the complex regulatory environment and the unfortunate ongoing regional challenges, the complete product registration of our 6 medical devices reflects the resilience and strategic focus of CANNORDIC and Forbe HealthCare. These factors required detailed navigation of regulatory pathways and adaptation to changing market conditions, contributing to the extended approval timeline.”

 

As CANNORDIC and Forbe Healthcare finalize preparations for production and market launch, they are dedicated to adapting their strategy to reflect current market conditions, ensuring the responsible delivery of high-quality healthcare solutions.

 

 

Forbe Healthcare Ltd. is committed to providing high-end healthcare products and services, striving to meet consumers’ daily needs with innovative, high-quality, evidence-based solutions. With an extensive distribution network across all pharmacies and hospitals in Israel and Palestine, Forbe Healthcare Ltd. plays a crucial role in introducing groundbreaking medical devices to the market.

 

CS MEDICA Group, a Danish MedTech pioneer, specializes in developing evidence-based, CBD-integrated treatments for pain management, autoimmune and stress-related disorders. With a focus on patient-centric care, our products range from innovative R&D to registered over-the-counter substance-based medical devices and dermaceuticals. Our flagship CANNASEN® brand, alongside our own-label solutions, exemplifies our dedication to safe, high-quality treatments for both human and veterinary health globally. The company is listed on Spotlight Stock Market in Stockholm (symbol: “CSMED”). For more information, visit cs-medica.com and LinkedIn.

CANNORDIC A/S, a subsidiary of CS MEDICA Group, is a pioneering MedTech company specializing in innovative substance-based medical devices containing bioactive CBD. Our dedication to enhancing lives by integrating innovation, science, technology, and natural cannabis compounds positions it as a pioneer in the medical technology industry. The company ensures robust research, development, manufacturing, compliance, data insights, and commercialization processes with strong partners globally.

 

End of Inside Information


17-Jun-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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