#Bioretec #Finland #Tampere #RemeOs #CE approval

Bioretec Ltd's Business Review for Q1 2025

Bioretec Ltd, a pioneering Finnish medical device company, released its business review for the first quarter of 2025, revealing a substantial increase in net sales driven by strong market performance and strategic advancements. The key highlights from this report include impressive growth figures, regulatory approvals, and significant steps towards future expansion of the RemeOs product line.

Major Achievements in Q1 2025

In January, Bioretec received comprehensive CE approval for its RemeOs™ trauma screw product family, marking a significant milestone for the company. This approval enables the products' market launch across Europe and in various non-European countries that recognize the CE mark. The RemeOs product line includes both cannulated and non-cannulated screws designed for fracture fixations in adult and pediatric patients, covering a broad range of sizes and indications.

Furthermore, Bioretec's commercialization efforts have been bolstered by signing several new distribution agreements within the U.S., paving the way for a robust entry into key hospitals and surgical centers.

Impressive Sales Growth

The company's net sales reached EUR 1.396 million during the first quarter, which marks a staggering 104.7% increase compared to the EUR 682,000 recorded in the same period of the previous year. This sales surge has been largely attributed to high-volume orders from China, demonstrating a strong demand for their products. The net sales increase allowed Bioretec to allocate more resources to their RemeOs products for the remainder of the year, thus further accelerating their growth strategy.

Despite this positive growth in sales, the company's EBITDA for Q1 showed a deficit of EUR -1.236 million. This was primarily due to elevated personnel costs stemming from staff expansions and the costs associated with commercialization and research projects. Nonetheless, the sales margin, although slightly lower at 58.9%, reflects a solid performance given the increased sales to China and the costs linked to ramping up production capacities.

Expansion Into the U.S. Market

Bioretec's aggressive push into the U.S. market is evident through its recent partnership agreements. By signing eight new distribution contracts in the first quarter alone, the company has expanded its footprint to cover 14 states and over 80 representatives. These strategic partners were selected for their capability to reach major metropolitan areas with high surgical volumes, ensuring the products are available where they are most needed. The expansion strategy coincides with the ongoing successful rollout of the Activa product line in the U.S.

The approval obtained from the CE mark will not only facilitate the European launch of RemeOs products but will also aid in collecting real-world clinical data that supports future market expansions. Bioretec has commenced training for its distributor teams, ensuring that early commercial activities are already in motion across Europe.

Innovations and Future Steps

Looking ahead, Bioretec continues to focus on innovation and improving the RemeOs product line. The company reported advancements in their RemeOs Spinal Interbody Cage program, which has successfully completed proof-of-concept implantations. Moreover, the RemeOs DrillPin study is set to begin patient enrollment soon.

In a significant move, Bioretec is preparing to launch single-use surgical instruments in the latter half of 2025, responding to a growing demand for efficiency and safety in surgical environments. Concurrently, the company plans to scale up its manufacturing capabilities to meet the projected rise in demand for RemeOs products.

The recent CE approval has indeed unlocked a plethora of opportunities for Bioretec, enabling immediate market entry and facilitating access to essential clinical data that will drive future expansions of market indications, particularly in the U.S. Bioretec remains vigilant amidst ongoing global economic uncertainties, emphasizing the unique clinical and economic value of its bioabsorbable implants.

Conclusion

As the first quarter of 2025 draws to a close, Bioretec Ltd stands at a pivotal juncture in its journey towards sustainable growth and market leadership. With strong sales performance, strategic expansions, and a commitment to innovation, the company is poised to capitalize on the opportunities within the expanding global orthopedic market. Kustaa Poutiainen, Chair of the Board, expressed confidence in their strategic focus and execution capabilities, which will guide them through the challenges that lie ahead.