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Bioretec Ltd's Business Review: January-September 2025

On November 13, 2025, Bioretec Ltd released its business review covering the first three quarters of 2025. The review highlights the company's efforts to strengthen its commercial foundations and design effective strategies for future growth in the orthopedic sector.

Key Financial Performance

In the third quarter of 2025, Bioretec reported net sales of EUR 715,000, a modest increase from EUR 685,000 in the same period of 2024. Notably, the sales margin decreased to 61.6% from 72.9%, reflecting the challenges faced in maintaining profit levels. The EBITDA for the quarter stood at -EUR 1.768 million, marking a significant rise in losses compared to -EUR 1.353 million from the previous year.

For the total period of January to September 2025, net sales reached EUR 2.789 million, slightly higher than EUR 2.746 million in 2024. The overall financial situation remained challenging with an EBITDA loss of EUR 6.325 million and a net loss of EUR 7.482 million.

Leadership Changes

A major highlight of the review was the change in leadership. On August 27, 2025, Bioretec appointed Sarah van Hellenberg Hubar-Fisher as the new Chief Executive Officer. She has been steering the company towards recognizing the need for strategic adjustments after her initial six months in the role.
Moreover, the company strengthened its management team by appointing René Eve as the Director of Operations and Jordy Winters as Vice President of Sales Outside the U.S. These changes are indicative of Bioretec's commitment to enhance its commercial capabilities and effectively navigate the product's market landscape.

Commercialization Efforts

Bioretec recognizes the need to shift from a stocking distribution model to a direct one, particularly in the U.S. market, to boost performance and improve growth expectations. The appointment of experienced professionals, such as Blake Helm as Vice President of Sales for the Western Area, aims to solidify the company's market presence. Furthermore, during the third quarter, Bioretec added seven new direct distribution partners in the U.S., bringing the total to fifteen.

Jordy Winters will lead the international expansion efforts and help Bioretec identify strategic markets outside the U.S., which are crucial for the company's future success.

Product Innovation and Regulatory Milestones

The review also highlighted significant developments in Bioretec's product pipeline, notably the RemeOs™ product line, which has gained regulatory approval milestones in recent years. The trauma screw from this product line has attracted attention due to its innovative design, with the U.S. Centers for Medicare & Medicaid Services (CMS) granting it Transitional Pass-Through Payment (TPT) status. This designation will facilitate hospital adoption and make the RemeOs™ accessible to a wider range of patients.

The current transition period within Bioretec is not without its challenges. The company acknowledged the need for strategic reassessment and has begun processes to ensure operational efficiency and effective commercialization strategies.

Looking Ahead

As 2025 progresses, Bioretec aims to finalize its new strategy and will communicate revised financial targets by the end of the year. The company remains focused on strengthening its market position while ensuring transparency with shareholders and prospective investors.

The future holds promise for Bioretec, especially with ongoing product development and the commitment to enhance orthopedic surgical solutions that prioritize patient outcomes. By investing in leadership change, honing its distribution strategy, and focusing on innovative products, Bioretec aims to pave the way for a successful trajectory in the years to come.

For further information, the complete business review can be accessed on Bioretec's official website.