CS Medica is a Danish medico company committed to developing and commercializing evidence-based and innovative medical devices within pain relief and care taking. The company is exploring and harnessing the potential of substances in the Cannabis sativa L. plant and related to its cannabinoid technology. CS medica’s vision is to become a world-leading Manufacturer of medical devices containing cannabinoids from cannabis. The Company will continuously develop effective, and safe products which increase the life quality of patients and people in general.
Deutsch-Pharm visited us at CPHI in October, and we are pleased to have an agreement in place where we can enhance our footprint in the Eastern Europe market and especially demonstrate our commitment to supporting our customer as consumers under challenging conditions. While we have a three-year forecast in place, our immediate focus is on the swift launch of the first 20,000 units, utilizing the strength of our MDR-compliant skincare solution to expedite local registration and product availability.
We are happy for the exclusivity granted, which underscores the support and confidence CANNORDIC has in our operations during these challenging times. With Deutsch-Pharm's robust distribution network and our commitment to delivering MDR-compliant products, we are poised to make an impact on the healthcare market. These unique products will allow us to effectively meet the growing demand for advanced skincare solutions and ensure that these innovative treatments are accessible to all Ukrainians.
CS MEDICA’s focus on regulatory preparedness has generated strong interest from customers and partners, many of whom are awaiting the MDR transition as confirmation of our trusted, safe, and high-quality offerings. Demand for our portfolio remains high; however, some B2B customers are holding final orders pending the completion of MDR classifications prior investing in new products. Achieving this milestone will undoubtedly accelerate ongoing negotiations and support further growth, as it could potentially double our forecast from partners on especially pain products.
With this milestone, CS MEDICA is, with the assistance of BSI, positioned to achieve timely certification of our product range, thanks to the dedication of our teams and partners who have worked to reach this critical compliance milestone.
As a company, we are committed to accelerating access to cannabinoid-based medicines for German patients. In this effort, we constantly look for complementary products to expand our offering to meet patients' needs, especially in pain management. That is why Cannordic's CBD-infused pain patch will be an important product in our portfolio.
This partnership represents a significant advancement in our mission to enhance access to scientifically validated, CBD-infused products. Incorporating our proven formulations under Nimbus's brand will address the growing patient demand for effective and reliable medical cannabinoid therapies.
We began our discussions over a year ago. Our engagement with a partner as Nimbus Health, a Dr. Reddy's Laboratories company, that prioritizes patient safety, compliance, and accessibility has enriched our processes and commercial strategies.
We are excited to partner with Scan MedPartners. Their extensive expertise and strategic connections in the US healthcare market will help us navigate this important market's complexities and drive the adoption of our treatments with bioactive CBD among patients and providers alike.
We see tremendous potential in CS MEDICA A/S's regulated treatments with bioactive CBD across multiple therapeutics fields, highlighting pain management, arthritis, anti-hair loss, wound care and allergies, to the benefit of millions of US patients in need of better, more patient effective products. We are eager to support CS MEDICA A/S on their explosive sales growth journey, helping them accelerate their US market entry via US commercial partners. Our deep market insights and robust relationships with key stakeholders will ensure that CS MEDICA A/S's products gain the traction needed to succeed in this competitive environment.
The approval of the CANNASEN® Pain Patch is another essential step in our Asian expansion strategy. It supports our goal to introduce innovative healthcare solutions across the region, starting with Malaysia.
Our Letter of Intent with Zuventus Healthcare represents an exciting development towards bringing our advanced, scientifically-backed medical devices with CBD to the Indian market. We are eager to see how our joint efforts can improve healthcare outcomes for the market.
Incorporating CANNORDIC's innovative products enhances our top-tier healthcare offerings. This partnership is set to deliver significant benefits to patients across India and advance the market for compliant, evidence-based treatments with CBD.
It's important to note that the launch of these medical devices is contingent upon successful registration with Indian regulatory authorities, setting a precedent as they may be the first of their kind in the Indian market.
Our 'hybrid' approach not only adheres to stringent regulations but also embraces consumer-centric innovations, paving the way for the future of healthcare. These regulatory milestones are not just achievements; they are a testament to our dedication to advancing healthcare globally.
We are on track to meet MDR compliance deadlines, diligently certifying our products under stringent MDR regulations with BSI as our notified body," Lone emphasizes. "Our patient-first approach is deeply committed to transparency, responsiveness to feedback, and educational efforts, all of which strengthen our collaborations with industry partners and stakeholders that want to be first to capture the market potential.
Our portfolio's classification as medical devices with CBD positions us to confidently approach the final stages of product registration in Jordan.
This milestone potentially indicates the upcoming launch of CANNASEN®, backed by a preliminary distribution agreement for 100,000 units through Nabih Nabulsi Drugstores, but may also accelerate the registration processes across other countries in the MENA region. We believe that establishing this precedent in Jordan could streamline our efforts with several strategic partners throughout MENA, potentially leading to fulfilling a large part of our order pipeline.
This milestone is part of our ongoing efforts to enhance healthcare with innovative treatments that meet stringent safety standards. As we move forward, our focus remains on providing products that adhere to local regulatory requirements and offer new therapeutic options for patients seeking effective alternatives to conventional treatments.
In a complex global market, we've experienced substantial interest from sectors including pharmaceuticals, retailers, and cosmetic firms. Our unique blend of CBD and pharmaceutical regulatory compliance distinguishes us globally. With a robust pipeline valued at mDKK 49.3 and increasing product registrations, we aim to convert significant orders into revenue over the next 12-18 months.
Over the past year, we have engaged in negotiations with several potential partners poised to elevate our business to new heights. These partnerships still need to be reflected in our pipeline as we diligently prepare for the next growth phase, ensuring we have the capacity and infrastructure to support these advancements.
Partnering with CANNORDIC represents a step forward in meeting the health needs of Brazilians with high-quality, innovative, and compliant cannabinoid solutions. CANNORDIC's product range perfectly matches the dynamics of our market, and we are excited about its potential.
Pharma Avanti is a leading force in Brazil's pharmaceutical sector. With its robust network and deep regulatory expertise, it is positioning itself as an ideal partner for CANNORDIC's market penetration efforts, as we can't enter this complex, rapid-growing territory ourselves.
At Pharmalink, and through our MEDICINA and Al Manara chain of pharmacies, we strive to pioneer and integrate innovative health solutions that meet the high standards of care we uphold. Choosing CANNORDIC's CANNASEN® brand was a strategic decision driven by our commitment to offer only the best-in-class treatment options. We believe CANNASEN's unique approach to healthcare will benefit our customers, helping them live healthier and happier lives.
The partnership with PHARMALINK represents a significant milestone for CANNORDIC. Collaborating with a well-established partner like PHARMALINK, who has a profound understanding of the regional healthcare landscape and consumer needs, will enhance our market presence and consumer access to our innovative products.
Our exploration of pre-IPO share distribution is not just about protecting our share and value our shareholders. We see this as an opportunity to lay a stronger foundation for CANNORDIC with a shareholder base before the public listing this year's fall, ensuring continuity and stability in our growth track.
Recognizing we haven't fully decoded market dynamics in these regions, our targeted strategies, including our partnership with IBG Best Life AB, are essential for adapting our offerings and penetrating the Asian markets more effectively.
We are delighted by the 'Intention To Grant' status for our European patent application. This validation underscores our commitment to pioneering innovations that meet stringent regulatory standards, including MDR, MHRA, FDA, and TGA, ensuring our product's compliance and efficacy
We believe that securing patent protection not only validates our novel approach but also sets a precedent for CBD-infused therapies in dermatology,
These recurring orders reflect our partners' trust in our products and underscore their success in local markets, supporting our continued growth in the healthcare sector.
By including our shares on the XETRA trading platform, we offer both existing and future shareholders an additional trading opportunity
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.
"We chose CS MEDICA as our partner because they have successfully positioned themselves as leaders in compliant medical devices with CBD, which perfectly matches current market trends and regulations. Their proactive transition to MDR with a Notified Body sets them ahead of the competition, aligning perfectly with our mission to support superior health outcomes."
"This partnership with OneMed represents a pivotal development in our strategy to expand access and deliver innovative solutions to the healthcare market while being able to focus on our core DNA as a MedTech. We are confident that OneMed's expertise and network will help us reach more patients than we can."
Our heavy investments and commitment to R&D, compliance, and patent protection positions us strongly in the evolving market, particularly with the consumer shift towards Evidence-Based Complementary and Alternative Medicine (CAM). This partnership with GP Holding represents a strategic alignment to enhance our supply chain and financial robustness, essential for scaling our operations and boosting our market lead.
Today, we navigate our challenges by partnering with exceptional CMOs who meet the stringent quality and regulatory demands of our products and provide the flexibility needed as a smaller player in the market. In aligning with GP Holding, we foresee an opportunity to create a seamless value chain from seed to shelf, significantly impacting our cost structures and lead times, enhancing our financial robustness and market agility.
We see significant potential in the pharmaceutical sector, particularly with CS MEDICA's innovative approach in the CBD space. Our collaboration is poised to extend our product lines and presence in global markets and leverage economies of scale to optimize our production capabilities.
"The decision to list CANNORDIC A/S on the German stock market is a strategic milestone for us. This spin-off underscores the commitment to leveraging market opportunities and aligning operations with the stringent requirements of the new EU MDR (Medical Device Regulation), ensuring sustained growth and market leadership. Additionally, it highlights the value of CS MEDICA's stock and will enhance our market presence, providing the necessary funding to accelerate our growth and innovation objectives".
"By listing CANNORDIC on the German Stock Exchange, we aim to advance its profile and reach its right potential in market valuation, attracting investors and partners on the most mature, well-fitted market in Europe for the Company's portfolio. This strategic initiative is expected to unlock the potential market value, increasing shareholder value for both the CS MEDICA Group and CANNORDIC. By raising up to MDKK 45 (EUR 6 million), we will also secure growth capital to accelerate and strengthen our market position."
Postponing our fiscal year conversion reinforces our financial priorities, allowing us to strengthen processes and enhance operational efficiency. As a scaleup MedTech company, we've made substantial investments in R&D, clinical evidence, patents, and regulatory compliance. While optimizing operations and wishing to convert to a calendar year, our immediate focus is ensuring financial stability and growing sales in key markets, notably Germany, the largest EU market for our CBD-infused treatments for pain management, autoimmune and stress-related disorders. In addition, we prioritize awareness by activating our share on the German stock markets to strengthen our local presence. This commitment amplifies value delivery to our stakeholders.
Our focus has been on growing the European market, and a pull strategy for emerging markets has been pivotal to our success, reflected in our rapid market gains, now strengthening our access to the German market and extending to the GCC through our partnership with 180˚ Drug Store.
The CEO of 180˚ Drug Store, Reem Mohammed Salim Ashour, comments, “With our strong background in navigating stringent pharmaceutical regulations, we have been on the lookout for a partner like CS MEDICA. Their ability to merge pharma-grade standards with fewer side effects and innovative formulas is precisely what the market we operate in needs. The proactive demand we're witnessing for CS MEDICA's products not only assures us of their strong market potential but also firmly validates our decision to join forces for our strategic expansion in the GCC."
"This approval is a monumental achievement for CS MEDICA. Our journey to this point has been marked by a commitment to our goals and a persistent determination to navigate and comply with diverse regulatory environments. Securing approval in Malaysia signifies our successful compliance and paves the way for future opportunities in Asia."
"The successful registration of CANNASEN® Protective Nasal Gel in Malaysia is a breakthrough moment, signaling CS MEDICA's capability to penetrate the Asian market, previously a formidable challenge due to stringent regulatory standards. Our new compliance and market strategy sets a strong foundation for introducing additional regional products with the potential to revolutionize the medical device industry by providing innovative solutions for autoimmune diseases."
"We're pleased to see our initial talks at CPHI have progressed to a new partnership. Nabih Nabulsi Drugstores possesses the right local expertise to launch our products into pharmacies and drugstores effectively. Their market dominance and well-established relationships in Jordan make them the ideal partner for our global expansion efforts."
"The reason for choosing CANNSEN® as a new treatment option in our market is due to its innovation and uniqueness. Being one of the first in the market to combine the proven track records and legislation of medical devices with the therapeutic benefits of CBD makes it a groundbreaking addition to our portfolio. As a market leader, we must continually seek out innovative products to expand and grow the market. CANNASEN® represents a significant step in this direction, offering a unique value proposition that we believe will resonate with our customers."
"The approval of this patent, our third within a year, is a commitment to our focused approach towards healthcare innovation. Importantly, we are progressing with several more treatments pending patent approval, validating our purpose to deliver innovative healthcare solutions to 2- and 4-legged patients globally."
"Being a first-mover combining science with the therapeutical benefits of cannabinoids, under strict compliance and regulatory rules holds challenges, but this is a recognition for us to continue focusing on providing efficient, over-the-counter alternative treatments to the market."
We are proud that we have managed to adapt and remain compliant and relevant for the market. It's a testament to our team's resilience and commitment. The registration of the CANNASEN Pain Patch, the first substance-based medical device with Cannabis Sativa L in Australia, marks a significant milestone for us. It demonstrates our ability to navigate complex regulatory landscapes.
"We are excited to have partnered with CANNORDIC, their understanding of not only adapting to the registration process but also adjusting the brand to meet our local market requirements while staying brand consistent is commendable. Their products are effective, safe and of high quality, manufactured in Europe."
"Receiving FDA notification approval for these eight products is not just a triumph for us, but a testament to the research and dedication behind our products. The U.S. market is pivotal in the cannabis sector, but yet a grey market for safety and proof of concept, especially for different functions of the cannabis than traditional ones. Hence, our entry through this approval marks a significant milestone in our global expansion strategy. We are eager to bring our innovative treatments to American consumers and are confident that our presence on the market will be a game-changer in how people experience our products and company.".
