#Bioretec #Finland #Tampere #RemeOs #CE approval

Bioretec Ltd's Q1 2025 Business Review

In a remarkable start to 2025, Bioretec Ltd has reported impressive figures for the first quarter, showcasing a significant increase in net sales and the recent acquisition of CE approval for its RemeOs™ product line. This CE mark opens doors for commercialization in Europe and other countries recognizing the CE labeling, setting the stage for expanded market presence.

Overview of Q1 2025 Results

During the first quarter, Bioretec's net sales skyrocketed to EUR 1.4 million, marking a staggering 104.7% increase compared to EUR 682,000 in the same period last year. This growth can largely be attributed to heightened sales activity in China, demonstrating the growing demand for Bioretec’s innovative products. The company successfully leveraged its Activa product line and concentrated its resources to ensure the RemeOs portfolio remains a priority for the rest of the year.

The sales margin, excluding other income, saw an increase from EUR 418,000 to EUR 822,000, although the margin percentage slightly declined to 58.9% due to increased sales to China, which were impacted by price adjustments required by volume-based procurement policies.

Bioretec's EBITDA for the period was recorded at EUR -1.236 million, reflecting the rising personnel costs associated with expanding their workforce and investment in marketing for product commercialization. The overall profit or loss for the reporting period amounted to EUR -1.298 million, compared to EUR -1.097 million a year earlier.

CE Approval and Expansion Plans

One of the major highlights for Bioretec during Q1 was the comprehensive CE approval granted to its RemeOs™ trauma screw product family in January. This approval encompasses a wide range of screw designs, allowing for applications in both adult and pediatric patients for various fracture fixations.

As a result of this approval, Bioretec has ramped up efforts to commence production of the newly CE-marked products and has entered into various distribution agreements in the United States. By early 2025, Bioretec had signed eight new distribution agreements covering 14 states and more than 80 representatives, further bolstering their commercial reach.

The approval allows for immediate launch across Europe and other territories, promoting stronger operational activities and setting the foundation for the collection of clinical data to enhance market positioning. The Chair of the Board, Kustaa Poutiainen, emphasized that these developments mark a pivotal moment in Bioretec's journey towards sustainable growth.

Forward-Looking Statements

Despite the ongoing external challenges, including macroeconomic impacts, Bioretec has expressed confidence in its growth strategy. With manufacturing capabilities set to expand, the company remains focused on enhancing RemeOs' development and commercialization efforts, aiming to effectively capture the high-demand markets presented by the ongoing recovery in global healthcare.

In addition to its current offerings, Bioretec is innovating by developing additional single-use instruments tailored for higher efficiency and safety in surgical settings, with plans to introduce this new line in the second half of 2025.

Conclusion

The first quarter of 2025 underscores Bioretec Ltd's commitment to innovation and market leadership in orthopedic solutions. With the CE approval, impressive sales figures, and a robust operational strategy, the future looks promising as Bioretec continues to meet the needs of healthcare providers and patients alike. The company is set to reveal more detailed financial updates about its performance in the upcoming months, including the half-year report due in August 2025.

Bioretec's ambitious goals and initiatives position it as a key player in the global orthopedic trauma market, paving the way for better healing outcomes and overall patient care.