#Bioretec #Trauma Screw #Finland #Tampere #RemeOs

Bioretec Ltd's Financial Bulletin for 2024: Key Insights and Future Growth

On February 14, 2025, Bioretec Ltd released its financial statements for the year ending in December 2024, showcasing notable achievements and strategic advancements poised to benefit the company significantly. Here’s what you need to know about their performance and what lies ahead.

Overview of Financial Performance

During the second half of 2024, Bioretec accomplished several vital milestones in preparation for market launch and product development. The company's net sales demonstrated robust growth, increasing by 23.2% to €2,482,000 compared to €2,016,000 in the previous year. This positive trend reflects the heightened investor confidence as Bioretec successfully concluded an oversubscribed share issue, raising €6.0 million in November to bolster its growth trajectory.

Furthermore, Bioretec also managed to record total annual net sales of €4,544,000, showing a significant 16.3% increase from €3,906,000 in 2023. Notably, the sales margin, excluding other income, saw improvement, rising to 70.9%, compared to 69.8% in 2023. Despite these gains, the company faced challenges with a net loss of €4,614,000, up from €3,789,000 in the previous year, primarily attributed to costs related to financing arrangements.

Significant Events of 2024

Throughout 2024, Bioretec advanced on multiple fronts:

• - In June, the company resubmitted its application for market authorization of the RemeOs™ trauma screw after feedback from an expert panel indicated a delay.
• - The FDA granted Breakthrough Device Designation to the RemeOs™ Spinal Interbody Cage in March, marking a crucial endorsement of Bioretec's innovative approach.
• - The patent for Bioretec's RemeOs™ biodegradable magnesium alloy was approved by the U.S. Patent Office, safeguarding its proprietary technology.
• - A strategic update in October saw the company accelerate product development for the RemeOs™ Spinal Interbody Cage.
• - With the completion of a private placement in November, the raised funds were earmarked for the commercialization of the RemeOs™ Trauma Screw across the U.S. and Europe, directly following the achievement of CE mark status.

CE Mark Achievement and Its Implications

The CE mark, received in January 2025, is a pivotal milestone for Bioretec. It confirms that the RemeOs™ product portfolio complies with EU safety and health regulations, allowing for immediate market launch across Europe. This certification also opens doors for commercialization in non-European markets recognizing the CE mark. Following this approval, Bioretec is now set to expand its RemeOs™ offerings to a broader range of EU distributors and customers.

Bioretec CEO, Alan Donze, expressed pride in the company’s resilience to navigate challenges from delayed market approvals while simultaneously building U.S. infrastructure. The projected agility in their U.S. operations will support the upcoming second phase of the trauma screw launch. Positive results from initial controlled launches indicate a strong foundation for widespread distribution across hospitals.

Future Outlook

The prospects for Bioretec in 2025 and beyond appear promising. With the expected roll-out of RemeOs™ products to enhance the efficiency of surgical procedures, the company aims to strengthen its footprint in the global orthopedic trauma marketplace, currently valued at over $9 billion. Factors contributing to this ambition include robust sales strategies and partnerships established with prominent logistics and distribution firms in the U.S.

The strategic focus will involve expanding RemeOs™ distribution networks, enhancing clinical evidence collection, and addressing domestic demand as regulatory approvals are pursued. Continued capital raises are anticipated to support these developments and target the achievement of positive cash flows by year-end 2027.

In conclusion, Bioretec's financial bulletin illustrates a clear commitment to innovation, as it navigates the complexities of regulatory processes and infrastructure challenges while keeping sight of its vision for growth within the orthopedic sector. The company is well-positioned for significant advancements following the CE mark approval, and stakeholders can look forward to an exciting 2025 as Bioretec strives to shape the future of orthopedic solutions.