Bioretec Ltd. | Company announcement | 12 November 2026 at 8:30 a.m.
This announcement summarizes Bioretec Ltd's business review for January-September 2026. The complete business review is attached to this release as a PDF file and available on the company's website at https://investors.bioretec.com/en/reports_and_presentations
July–September 2026 in brief
- Net sales amounted to EUR 1,328 thousand (7–9/2025: EUR 715 thousand)
- Adjusted sales margin was 68.7% (59.4%) of net sales
- EBITDA was EUR -1,746 (-1,768) thousand
- The result for the reporting period amounted to EUR -1,839 (-1,854) thousand
January–September 2026 in brief
- Net sales amounted to EUR 3,648 thousand (1–9/2025: EUR 2,789 thousand)
- Adjusted sales margin was 69.0% (57.5%) of net sales
- EBITDA was EUR -5,371 (-6,325) thousand
- The result for the reporting period amounted to EUR -6,517 (-7,482) thousand
Key figures
| EUR 1,000 unless otherwise indicated | 7–9/2026 | 7–9/2025 | Change | 1–9/2026 | 1–9/2025 | Change | 1–12/2025 |
| Net sales | 1,328 | 715 | 85.5% | 3,648 | 2,789 | 30.8% | 3,522 |
| Adjusted sales margin, % of net sales1 | 68.7% | 59.4% | +9.3 pp | 69.0% | 57.5% | +11.5 pp | 59.3% |
| EBITDA | -1,746 | -1,768 | -5,371 | -6,325 | -8,476 | ||
| EBIT | -1,806 | -1,823 | -5,552 | -6,483 | -8,686 | ||
| EBIT, % of net sales | -136.0% | -254.7% | +118.7 pp | -152.2% | -232.4% | +80.2 pp | -246.6% |
| Profit / loss for the period | -1,839 | -1,854 | -6,517 | -7,482 | -9,483 | ||
| R&D expenditure, % of net sales | 60.6% | 111.2% | -50.6 pp | 65.3% | 79.9% | -14.6 pp | 85.8% |
| Equity ratio, % | 89.5% | 83.7% | +5.8 pp | 89.5% | 83.7% | +5.8 pp | 84.3% |
| Return on equity, % | -10.8% | -14.6% | +3.8 pp | -50.4% | -69.6% | +19.2 pp | -97.3% |
| Cash and cash equivalents | 9,251 | 7,263 | 27.4% | 9,251 | 7,263 | 27.4% | 4,126 |
| Earnings per share (undiluted) | -0.001 | -0.06 | -0.008 | -0.28 | -0.34 | ||
| Earnings per share (diluted) | -0.001 | -0.05 | -0.004 | -0.22 | -0.28 | ||
| Number of shares at the end of the period | 1,341,785,963 | 30,788,092 | 1,341,785,963 | 30,788,092 | 30,788,092 | ||
| Number of shares (diluted) | 1,527,790,429 | 33,821,751 | 1,527,790,429 | 33,821,751 | 33,821,751 | ||
| Number of personnel at the end of period | 56 | 64 | -12.5% | 56 | 64 | -12.5% | 60 |
1 From Q1/2026, the company will transition to reporting adjusted sales margin to be aligned with industry reporting standards. The adjusted sales margin describes the profitability of implant sales before commercialization-related expenses, such as sales commissions. Adjusted sales margin comprises the net sales of implants deducted by related cost of sales and extraordinary expenses. Items recognized below the adjusted sales margin will include, among others, commissions and external services considered fixed in nature.
Net sales by geographical area
| EUR 1,000 | 7–9/2026 | 7–9/2025 | Change | 1–9/2026 | 1–9/2025 | Change | 1–12/2025 |
| Europe | 384 | 227 | 69.2% | 1,162 | 580 | 100.3% | 887 |
| The U.S. | 443 | 183 | 142.7% | 1,041 | 366 | 184.1% | 488 |
| Rest of the world | 501 | 306 | 63.6% | 1,444 | 1,843 | -21.6% | 2,146 |
| Total | 1,328 | 715 | 85.5% | 3,648 | 2,789 | 30.8% | 3,522 |
CEO Sarah van Hellenberg Hubar-Fisher’s comments
Commercial momentum continues across key markets
Our commercial momentum continued in the third quarter, and net sales grew by 85.5% year-on-year to EUR 1.3 million. All geographical regions delivered strong growth during the quarter, with the U.S. continuing to achieve triple-digit growth. This performance demonstrates the impact of our focused commercial strategy, including increasing repeat surgeon utilization, strengthening our Key Opinion Leader network, and carefully selecting distribution partners in priority markets outside of the U.S. Our adjusted sales margin improved to 68.7% during the quarter, reflecting sustained improvements in the quality and mix of our net sales.
First near-term pipeline approval marks an important milestone
Our updated strategy for 2026–2028 emphasizes the expansion of our product portfolio, with the aim of introducing a new product every 12–18 months. In September, we took an important step towards delivering on this commitment as the FDA granted 510(k) clearance for our ActivaScrew™ Cannulated COM bioabsorbable compression screw. This represents the first regulatory clearance from our near-term product pipeline and supports the expansion of our offering in the U.S. market. Alongside this milestone, we continued to advance the development of our RemeOs™ product family, including ongoing clinical studies and follow-up programs aimed at strengthening clinical evidence and supporting broader adoption of our technology. Advancing our product pipeline remains a central priority, with a continued focus on disciplined execution, capital efficiency, and innovation across our absorbable implant technologies.
Strengthening our R&D leadership
Delivering on our product development ambitions requires strong R&D capabilities and specialized expertise. During the quarter, we completed an important transition in our R&D leadership. Our former CTO Timo Lehtonen assumed a new role as External Executive Advisor, continuing to contribute his extensive expertise in materials science and technology development. Conan Cavanagh joined Bioretec as Head of Research & Development in September, bringing valuable experience to strengthen our product development processes and external partnerships.
Building visibility and engagement
Throughout the year, we have continued to strengthen Bioretec's visibility and engagement with clinical and industry stakeholders through participation in key international events, including DeviceTalks Boston, the AOFAS/IFFAS 2026 Annual Meeting, LSI Europe '26 and the 18th Annual Biometal Symposium. In September, we also hosted a dedicated media day to celebrate an important commercial milestone, with cumulative global sales of Activa implants surpassing 500,000 units. This milestone demonstrates the established position of our Activa product family and sustained demand for our bioabsorbable implant technologies. The visibility activities support our efforts to increase awareness of our technologies, strengthen relationships with surgeons and industry partners, and drive broader adoption of our products.
Positioned for continued execution
The first nine months of 2026 demonstrate that our strategic priorities and commercial investments are translating into measurable progress. With continued sales momentum, an expanding product pipeline, and strengthened leadership, we are building a more scalable and commercially robust business. Looking ahead, we remain focused on setting new standards in the development and evaluation of novel absorbable technology and establishing strong market positioning through leading product performance. We also aim to build on the improvement in our margin performance during the first nine months, while expecting overall spending to remain stable and disciplined in the near term as we continue to invest in advancing our product pipeline. Our focus remains on sustaining commercial growth and delivering on our strategic priorities as we work towards establishing Bioretec as a global leader in bioabsorbable implant technologies.
Significant events in July–September 2026
- On July 2, Bioretec announced that Chief Financial Officer Tuukka Paavola will leave the company with immediate effect. The duties of the Chief Financial Officer will be assumed on an interim basis by Controller Anna-Mari Venola.
- On August 5, Bioretec announced the appointment of Panu Mikkonen (M.Sc. Econ.) as Chief Financial Officer, effective 6 October 2026. In this role, Mikkonen will report to Chief Executive Officer Sarah van Hellenberg Hubar-Fisher and will join the company's Management Team.
- On September 5, Bioretec announced that it had received FDA 510(k) clearance for its ActivaScrewTM Cannulated COM bioabsorbable compression screw. The clearance enables the commercialization of the product in the United States in accordance with its cleared indications for use.
Significant events after the reporting period
- On October 8, Bioretec announced that it initiates change negotiations to improve operational efficiency and competitiveness. The planned changes are also expected to generate annual cost savings of approximately EUR 0.3 million, supporting the company’s profitability and long-term competitiveness.
- On October 12, Bioretec announced the composition of the Shareholders’ Nomination Board: Tor-Oskar Karlberg from Stephen Industries Inc Oy, Rami Vehmas from Keskinäinen Eläkevakuutusyhtiö Ilmarinen and Johan Hamström from Sp-Rahastoyhtiö Oy.
Financial reporting in 2027
Bioretec will publish its financial calendar for 2027 by the end of December 2026.
The releases will be published as company releases and will be available online on Bioretec’s website at https://investors.bioretec.com/en/reports_and_presentations
Tampere, November 12, 2026
Board of Directors
Bioretec Ltd.
For additional information:
Sarah van Hellenberg Hubar-Fisher
CEO
+31 6 1544 8736
sarah.hubar-fisher@bioretec.com
Panu Mikkonen
CFO
+358 50 4833 707
panu.mikkonen@bioretec.com
Certified Adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with bioabsorbable implant technologies. The company offers two product families, Activa and RemeOs™, both based on advanced bioabsorbable materials. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec’s Activa product family features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications.
The company’s latest innovation, the RemeOs™ product family, is based on a high-performance magnesium alloy and hybrid composite. The first RemeOs™ product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. To date, the RemeOs™ product line has received three FDA Breakthrough Device Designations.
To learn more about Bioretec, visit www.bioretec.com