CEO Letter: Updates on BSI and Last Months' Activities

I am happy to share our four key CS MEDICA updates, demonstrating our commitment to resilience and market expansion.
 

ISO 13485 Certification Progress

Last week, we completed the second audit stage for the ISO 13485 certification with the notified body, BSI. This critical milestone underscores our dedication to the highest quality, safety, and compliance standards—vital for European medical device companies. The thorough audit reassured us that we are aligned with the path to the new, stricter medical device regulations. We are actively working on the audit's actions and developing a plan to stay on track for our certification evaluation in November. While we currently operate under an MDR transition period in Europe, most customers eagerly anticipate the MDR transition's completion, impacting market speed. Hence, achieving this certification will significantly strengthen our position in compliance with the MDR framework, marking a key milestone in our global best practices journey.

Advancements in India

Our efforts in the Indian market are quickly progressing. We are finalizing pricing agreements with Contract Manufacturing Organizations (CMOs) and are poised to sign contracts once we finalize all details for us to be optimally represented in the APAC markets. We've recently signed a Letter of Intent with the pharmaceutical company Zuventus Healthcare for four medical devce products, a pivotal step in introducing our CANNASEN® medical devices with CBD to the Indian market, pending regulatory approvals.

Commitment to Transparency and Ethical Partnerships

As a publicly listed company, we prioritize transparency. Some may think it is too much, while others want complete insight due to our financial struggles as a scaleup MedTech. Our commitment extends to communicating openly about potential partnerships and the associated risks. This approach, however, also means we have to communicate changes or cancel certain LOIs when new information arises or market conditions change, affecting our compatibility with potential partners. Recently, we terminated contracts with IPO Invest Sweden and Novtec due to misalignments and ethical issues, highlighting our dedication to enhancing our vetting processes.

Progress on EGM Resolutions: Dual Listing and CANNORDIC IPO

Following our Extraordinary General Meeting on June 28, 2024, we are advancing towards a dual listing of CS MEDICA on German stock exchanges. We expect an independent analysis of our shares and company valuation to be shared with all stakeholders to support a successful listing. This dual listing will allow CS MEDICA shares to be traded on both the German stock exchange and the Spotlight Stock Market in Sweden, increasing our market presence and investor engagement.

Simultaneously, we are preparing for the IPO of our subsidiary, CANNORDIC A/S, beginning with pre-selling shares and distributing them to our CS MEDICA shareholders, as resolved in the EGM. This move is strategic in fostering our growth and enhancing shareholder value.

Looking Ahead

The coming months are critical as we continue to manage costs and refine our operational procedures to scale and meet market demands. We are committed to sustainable growth and introducing innovative solutions globally.

Thank you for your ongoing support. We eagerly anticipate sharing further achievements with you soon.

Warm regards,

Lone Henriksen

CEO & Founder, CS MEDICA