Bioretec Oy | Company Release | November 12, 2026 at 8:30 AM
This release is a summary of Bioretec Oy’s Business Review for January–September 2026. The full business review is attached to this company release as a PDF file and is also available on the company’s website at https://investors.bioretec.com/fi/raportit_ja_esitykset.
July–September 2026 in Brief
Net sales were EUR 1,328 thousand (7–9/2025: EUR 715 thousand)
Adjusted gross margin was 68.7% (59.4%) of net sales
EBITDA was EUR -1,746 (-1,768) thousand
Net result for the period was EUR -1,839 (-1,854) thousand
January–September 2026 in Brief
Net sales were EUR 3,648 thousand (1–9/2025: EUR 2,789 thousand)
Adjusted gross margin was 69.0% (57.5%) of net sales
EBITDA was EUR -5,371 (-6,325) thousand
Net result for the period was EUR -6,517 (-7,482) thousand
"CEO Sarah van Hellenberg Hubar-Fisher’s Review
Commercial Progress Continues in Key Markets
Our commercial progress continued in the third quarter, with net sales increasing by 85.5% year-on-year to EUR 1.3 million. All geographic regions delivered strong growth, with growth in the United States remaining in triple digits. This performance demonstrates the effectiveness of our targeted commercial strategy. At the core of our strategy is increasing the repeat use of our products by surgeons, strengthening our Key Opinion Leader (KOL) network, and carefully selecting distribution partners in key non-US markets. Our adjusted gross margin improved to 68.7% in the quarter, reflecting the continued improvement in the quality and structure of net sales.
First Near-Term Pipeline Approval Marks a Significant Milestone
Our updated strategy for 2026–2028 emphasizes expanding our product portfolio, with the target of launching a new product onto the market every 12–18 months. In September, we took an important step toward achieving this goal when the US Food and Drug Administration (FDA) granted 510(k) clearance for the ActivaScrew™ Cannulated COM bioabsorbable compression screw. This represents the first regulatory approval from our near-term product pipeline and supports the expansion of our offering in the US market. Alongside this milestone, we continued developing the RemeOs™ product family. We aim to strengthen clinical evidence and support the broader adoption of our technology through ongoing clinical studies and registry programs. Advancing our pipeline remains a priority, as do disciplined execution, capital efficiency, and innovation in our bioabsorbable implant technologies."