Inside information: Bioretec Ltd's Board of Directors is assessing a potential rights issue in the near future

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Inside information: Bioretec Ltd's Board of Directors is assessing a potential rights issue in the near future

Bioretec Ltd Inside information 13 February 2026 at 9.31 a.m. EET

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE PEOPLE'S REPUBLIC OF CHINA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

The Board of Directors of Bioretec Ltd ("Bioretec" or the "Company") is assessing a potential rights issue based on the shareholders' pre-emptive subscription right (the "Offering") in the near future. The targeted gross proceeds to be raised through the Offering would preliminarily be approximately EUR 15 million.

Bioretec announced its updated strategy and financial targets in a company release on 16 December 2025. The potential Offering would strengthen the Company's capital base and financing resources supporting the execution of the new strategy.

The execution of the potential Offering would be subject to, among other things, a share issue authorisation granted by a general meeting of shareholders of Bioretec and a resolution by the Board of Directors of Bioretec regarding the Offering. The Board of Directors of Bioretec has not made any final decisions concerning the execution of the Offering and emphasizes that the execution of the potential Offering is not yet certain.

DNB Carnegie Investment Bank AB, Finland Branch has been mandated to investigate the structure and terms for a potential Offering.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Tuukka Paavola, CFO, +358 50 386 0013

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 fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

The company's latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

IMPORTANT INFORMATION

The information contained herein does not constitute an offer of securities for sale in the United States, nor may the securities of Bioretec Ltd (the "Company") be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended, and the rules and regulations thereunder. The Company does not intend to register any portion of the offering in the United States or to offer securities to the public in the United States.

The distribution of this release may be restricted by law and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such restrictions. Neither this release nor the information contained herein is for publication, distribution or release, in whole or in part, directly or indirectly, in or into Australia, Canada, The Hong Kong Special Administrative Region of the People's Republic of China, Japan, New Zealand, Singapore, South Africa or the United States or any other jurisdiction in which publication or distribution would be unlawful. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. This release is not directed to, and is not intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

This release is not a prospectus within the meaning of the Regulation (EU) 2017/1129 of the European Parliament and of the Council (as amended, the "Prospectus Regulation") and as such, does not constitute or form part of and should not be construed as, an offer to sell, or the solicitation or invitation of any offer to buy, acquire or subscribe for, any securities or an inducement to enter into investment activity.

The Company has not authorised any offer to the public of securities in the United Kingdom or in any Member State of the European Economic Area other than Finland. With respect to each Member State of the European Economic Area and which applies the Prospectus Regulation (each, a "Relevant Member State"), no action has been undertaken or will be undertaken to make an offer to the public of securities requiring publication of a prospectus in any Relevant Member State. As a result, the securities may only be offered in the Relevant Member States (a) to any legal entity, which fulfils the requirements of a qualified investor as defined in the Prospectus Regulation; or (b) in any other circumstances falling within Article 1(4) of the Prospectus Regulation. For the purposes of this paragraph, the expression "offer of securities to the public" means a communication to persons in any form and by any means, presenting sufficient information on the terms of the offer and the securities to be offered, so as to enable an investor to decide to purchase or subscribe for those securities.

This communication is directed only at persons who are outside the United Kingdom or persons who are qualified investors within the meaning of the Prospectus Regulation as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 and are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any investment activity to which this communication relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.

No part of this release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The information contained in this release has not been independently verified. No representation, warranty or undertaking, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The Company or any of its respective affiliates, advisors or representatives or any other person, shall have no liability whatsoever (in negligence or otherwise) for any loss however arising from any use of this release or its contents or otherwise arising in connection with this release. Each person must rely on their own examination and analysis of the Company, its subsidiaries, its securities and the offering, including the merits and risks involved.

FORWARD-LOOKING STATEMENTS

Certain statements in this release are "forward-looking statements". Forward-looking statements include statements concerning plans, assumptions, projections, objectives, targets, goals, strategies, future events, future revenues or performance, capital expenditures, financing needs, plans or intentions relating to acquisitions, the Company's competitive strengths and weaknesses, plans or goals relating to financial position, future operations and development, its business strategy and the anticipated trends in the industry and the political and legal environment in which it operates and other information that is not historical information. In some instances, they can be identified by the use of forward-looking terminology, including the terms "believes," "intends," "may," "will" or "should" or, in each case, their negative or variations on comparable terminology.

Forward-looking statements in this release are based on assumptions. Forward-looking statements involve inherent risks, uncertainties and assumptions, both general and specific, and the risk exists that the predictions, forecasts, projections, plans and other forward-looking statements will not be achieved. Given these risks, uncertainties and assumptions, you are cautioned not to place undue reliance on such forward-looking statements. Any forward-looking statements contained herein speak only as at the date of this release. Save as required by law, the Company does not intend to, and does not assume any obligation to, update or correct any forward-looking statement contained in this release.

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A year of rebuilding and renewed focus

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A year of rebuilding and renewed focus

Bioretec Ltd Company announcement 13 February 2025 at 9:30 a.m.

This company announcement is a summary of Bioretec Ltd’s financial statements bulletin for January–December 2025. The complete financial statements bulletin with tables is attached to this release as a pdf file and available at the company’s web pages at https://investors.bioretec.com/en/reports_and_presentations The financial statements bulletin is unaudited.

July–December 2025 in brief

• Net sales amounted to EUR 1,448 thousand (6–12/2024: EUR 2,482 thousand)

• Sales margin was EUR 1,006 (1,770) thousand, or 69.5% (71.3%) of net sales

• EBITDA was EUR -3,919 (-2,189) thousand

• The result for the reporting period amounted to EUR -3,855 (-2,730) thousand

• On December 16, Bioretec updated its strategy for 2026–2028 and provided new financial targets for the strategy period

January–December 2025 in brief

• Net sales amounted to EUR 3,522 thousand (1–12/2024: EUR 4,544 thousand)

• Sales margin was EUR 2,314 (3,221) thousand, or 65.7% (70.9%) of net sales

• EBITDA was EUR -8,476 (-4,053) thousand

• The result for the reporting period amounted to EUR -9,483 (-4,614) thousand

• The Board of Directors proposes that no dividend be distributed for the financial period January 1 – December 31, 2025

Key figures

EUR 1,000 unless otherwise indicated	7–12/2025	7–12/2024	Change, %	1–12/2025	1–12/2024	Change, %
Net sales	1,448	2,482	-41.7%	3,522	4,544	-22.5%
Sales margin	1,006	1,770	-43.1%	2,314	3,221	-28.1%
Sales margin, %	69.5%	71.3%		65.7%	70.9%
EBITDA	-3,919	-2,189		-8,476	-4,053
EBIT	-4,026	-2,281		-8,686	-4,202
Profit / loss for the period	-3,855	-2,730		-9,483	-4,614
R&D expenditure, % of net sales	109.8%	53.5%		85.8%	48.0%
Equity ratio, %	84.3%	84.9%		84.3%	84.9%
Cash and cash equivalents	4,126	6,289	-34.4%	4,126	6,289	-34.4%
Earnings per share (undiluted)	-0.13	-0.12		-0.31	-0.20
Earnings per share (diluted)	-0.11	-0.10		-0.28	-0.17
Number of shares at the end of the period (undiluted)	30,788,092	23,336,858		30,788,092	23,336,858
Number of shares (diluted)	33,821,751	27,515,133		33,821,751	27,515,133
Number of personnel at the end of the period	60	47	27.7%	60	47	27.7%

Significant events in 2025

• On January 31, Bioretec announced that it has received CE mark approval of its RemeOsTM Trauma Screw portfolio, allowing for market launch in Europe.

• On March 7, Bioretec announced the appointment of Mirva Ekman as Quality Director and member of the Management Team as of April 22, 2025. As part of the transition, Mari Ruotsalainen, previously RA/QA Director, will continue as a member of the Management Team as Regulatory Affairs Director.

• On March 21, Bioretec announced that its Board of Directors has decided on a new option program for the CEO.

• On May 8, Bioretec announced that CEO Alan Donze will resign from his position and will remain available for the company until July 7, 2025.

• On May 15, Bioretec announced that it has appointed Sarah van Hellenberg Hubar-Fisher as the company’s interim CEO.

• On May 28, Bioretec’s Board of Directors resolved on a rights issue of approximately EUR 9.2 million.

• On June 24, Bioretec announced the final results of the successful rights issue. Bioretec received gross proceeds of approximately EUR 9.2 million from the offering.

• On July 11, Bioretec announced the appointment of René Eve as Director of Operations and member of the Management Team as of August 18, 2025. Esa Hallinen, former Director of Operations, will pursue a career outside Bioretec.

• On August 27, Bioretec announced that it has appointed Sarah van Hellenberg Hubar-Fisher as CEO.

• On September 2, Bioretec announced the appointment of Jordy Winters as Vice President of OUS Sales and member of the Management Team. In parallel, Rami Ojala, previously Vice President of OUS Sales, will transition into the newly created role of Head of Global Medical Education.

• On September 4, Bioretec announced the appointment of Dr. Christopher W. DiGiovanni to the Scientific Advisory Board.

• On September 12, Bioretec updated the commercialization status of RemeOsTM DrillPin. The planned commercialization of the DrillPin in the U.S. will progress on a revised timeline to reflect recent FDA guidance on data requirements specific to novel materials.

• On September 15, Bioretec announced the appointment of Anne-Mari Matikainen as interim CFO. Former CFO Johanna Salko will support the company during the transition phase until November 30, 2025.

• On September 16, Bioretec announced the composition of the Shareholders’ Nomination Board, consisting of Tor-Oskar Karlberg from Stephen Industries Inc Oy, Rami Vehmas from Keskinäinen Eläkevakuutusyhtiö Ilmarinen, and Heinz Moitzi from W&M GmbH.

• On October 1, Bioretec announced on that the RemeOsTM Trauma Screw has been granted Transitional Pass-Through Payment (TPT) status by the U.S. Centers for Medicare & Medicaid Services (CMS).

• On October 27, Bioretec announced that the company is in the process of assessing and updating its overall commercialization strategy and pipeline and will be providing an update by the end of 2025. In the course of its assessment, the Board of Directors of Bioretec concluded that the financial targets published on October 4, 2024 were unattainable and will likely not be met. Accordingly, Bioretec withdrew its previously disclosed financial targets.

• On October 27, Bioretec announced that it adjusts and restates previously reported H1/2025 figures and does not expect accelerated sales in 2025. Bioretec published the corrected H1/2025 half year report on October 31, 2025.

• On November 12, Bioretec announced that it initiates change negotiations to enhance operational efficiency and competitiveness. The negotiations will focus on Bioretec's production and marketing functions in Finland. The change negotiations were completed on December 4.

• On December 14, Bioretec announced that it has been granted FDA Breakthrough Device Designation status for its RemeOsTM DrillPin, becoming the third Breakthrough Device Designation granted to Bioretec by the FDA (Trauma Screw 2021, Spinal Cage 2024).

• On December 16, Bioretec updated its strategy for 2026–2028 and provided new financial targets for the strategy period. The new financial targets are to reach net sales exceeding EUR 10 million by the end of the year 2028 and to maintain an average sales margin exceeding 70% during the strategy period.

CEO Sarah van Hellenberg Hubar-Fisher’s comments

A year of rebuilding and renewed focus

2025 was a year of transition and rebuilding. After stepping into the CEO role in May, it quickly became clear to me and the leadership team that to unlock Bioretec’s full potential, we first needed to strengthen the foundation. We therefore spent the year reviewing every aspect of our operations, commercial structure, and performance to ensure a stable base, capable of supporting Bioretec’s future growth. As a result of these necessary adjustments, we exit the year with a more agile commercial organization, a strengthened strategic focus, and greater readiness to execute our next phase.

Our financial results reflect a year of taking one step back to reposition for lasting progress. Absorbing significant changes in leadership roles, commercial capabilities, distribution models, and ordering cycles were investments in resilience and scalability. The deliberate transition from stocking distributors to a direct distribution model in the United States in 2025, marks a strategic move that provides stronger transparency, predictability and long-term quality of net sales. While the financial results reflected the impact of strategic resets, they also reinforced the value of decisive action. At the same time, continued R&D momentum advanced our world class portfolio, further paving the way for sustainable topline growth.

Looking ahead, our commitment is to clarity of execution, anchored by measurable goals, data-driven accountability, and clear communication around our strategy and its developments. Despite ongoing macroeconomic headwinds, the healthcare sector remains strongly receptive to Bioretec’s leading absorbable technologies focused on healing. With disciplined execution and clear objectives, Bioretec enters 2026 better aligned, more resilient, and ready to capture market opportunity.

Commercial momentum

Commercial momentum is accelerating as we actively expand awareness of Bioretec’s technology across key markets. In H2 2025, we re-established our commercial presence in high impact geographic regions where Bioretec’s technology had been underrepresented. Demand for next-generation biomaterial solutions is clear—and our sharpened “where to play” strategy ensures we are targeting the right markets with precision. We now have greater insight into adoption timelines, regulatory pathways, and procurement dynamics within both the U.S. and international markets and are prepared to execute with clear intent.

Across all key geographies, we’ve deepened our understanding of key drivers of adoption—from pricing strategies and clinical advocacy to surgeon education and partnership engagement- and converted those insights into actions. These foundations are already showing results: direct sales revenue in the U.S. grew for three consecutive quarters in 2025, representing commercial growth in both our Activa and RemeOsTM product families, a strong signal that our rebuilt commercial strategy and structure is poised to deliver. Outside of the U.S., the activation of key markets with new distribution partners, contractual improvements, and a full review of margin improvement opportunities, strengthens our market position and aligns with more profitable performance in the year ahead.

In addition to our world class Scientific Advisory Board, 2025 marked the establishment of our Key Opinion Leader (KOL) network in the United States, bringing fresh guidance and support for Bioretec’s commercial strategy from respected thought leaders in their field. With an energized pipeline, new product launches ahead, and a renewed go-to-market strategy in place, Bioretec enters 2026 positioned to accelerate.

Milestones for the RemeOsTM product family

Our RemeOs™ product family achieved important milestones in 2025. The CE mark approval for the Trauma Screw in January marked a major step into commercialization for countries that recognize the CE mark. Since then, the RemeOs™ line has advanced from development to early commercial uptake, bolstered by new surgeon experiences and country-level approvals.

Regulatory and reimbursement progress in the U.S. further strengthened our position with key milestones in the fourth quarter. In October, the RemeOs™ Trauma Screw received Transitional Pass-Through Payment status from CMS, underscoring the economic potential of absorbable metal technology. Shortly after, the FDA granted Breakthrough Device Designation for the DrillPin—our third such designation, and a first for any absorbable implant company worldwide. These achievements affirm the clinical and economic relevance and differentiation of Bioretec’s portfolio and highlight our capacity to lead this emerging segment.

Focus on performance and growth

December marked the announcement of our updated near-term strategy for the period 2026–2028. The strategy prioritizes disciplined execution, capital efficiency, and continued innovation through the expansion of the RemeOs™ platform. Our financial trajectory balances our ambition with the recognition of the resources needed to advance in our key markets and the opportunity for acceleration through key partnerships. The strategy is designed to translate opportunity into results, concentrated resources where we see the strongest clinical demand and commercial return.

Our financial trajectory is both deliberate and balanced. We are advancing priority markets while preserving the flexibility to accelerate through select partnerships that enhance scale, access, or capability. This approach aligns ambition with operating discipline and reflects our commitment to sustainable value creation.

Throughout 2025, Bioretec strengthened its operating foundation. We sharpened accountability, reinforced the organization, and demonstrated the resilience required to execute through change. The team, fully aligned with the Board and shareholders, has demonstrated the resilience needed to navigate change and has emerged stronger and in position to deliver.

We now enter 2026 with renewed confidence, clear priorities, and a unified organization ready to execute on our priorities. The rebuilding phase was essential; the momentum now begins.

Board of Director’s dividend proposal

On December 31, 2025, the parent company’s distributable funds totaled EUR 8,031,881.58. The Board of Directors proposes that the parent company loss of EUR 7,848,906.59 for the financial period from January 1 to December 31, 2025 be credited in the equity as Profit (loss) for previous accounting periods and that no dividend be distributed.

Financial reporting and Annual General Meeting in 2026

In 2026, Bioretec will publish the following financial reports:

• Annual report, Board of Directors’ report and financial statements for 2025 on Friday, March 13, 2026

• Business review for January–March 2026 on Thursday, May 14, 2026

• Half-year report for January–June 2026 on Thursday, August 13, 2026

• Business review for January–September 2026 on Thursday, November 12, 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

Bioretec Ltd’s Annual General Meeting is planned to be held on Friday, May 8, 2026. The company's Board of Directors will convene the Annual General Meeting separately later.

Webcast

A webcast for investors and media will be arranged on February 13, 2026 at 1:00 p.m. EET.

The webcast can be streamed live at https://events.inderes.com/bioretec/2025-results A recording of the webcast can be viewed at the same address later the same day.

During the event, Bioretec’s CEO Sarah van Hellenberg Hubar-Fisher and CFO Tuukka Paavola will review the 2025 results and the main events of the review period. The event is held in English.

Tampere, 13 February 2026

Board of Directors

Bioretec Ltd.

For additional information:

Sarah van Hellenberg Hubar-Fisher, CEO

+31 6 1544 8736

sarah.hubar-fisher@bioretec.com

Tuukka Paavola, CFO

+358 50 386 0013

tuukka.paavola@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 fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec’s Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

Appendix

Bioretec Ltd’s financial statements bulletin January–December 2025 (pdf)

Bioretec ENG Financial statements bulletin 2025.pdf

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Bioretec Ltd’s financial statements bulletin for January–December 2025 will be published on February 13, 2026

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Bioretec Ltd’s financial statements bulletin for January–December 2025 will be published on February 13, 2026

Bioretec Ltd Press release February 9, 2026 at 4:30 p.m. EET

Bioretec Ltd will publish its financial statements bulletin for the financial year 1 January–31 December 2025 on Friday, 13 February 2026 at approximately 9:30 a.m. EET.

The company will arrange a webcast for investors and media on the same day starting at 1:00 p.m. EET. The webcast can be streamed live at https://events.inderes.com/bioretec/2025-results. A recording of the webcast will be available at the same address later the same day.

During the event, Bioretec's CEO Sarah van Hellenberg Hubar-Fisher and CFO Tuukka Paavola will review the results of the financial year 2025 and the main events of the year. The event will be held in English.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by native bone, eliminating the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com.

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Proposals of the Shareholders' Nomination Board of Bioretec Ltd to the Annual General Meeting 2026

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Proposals of the Shareholders' Nomination Board of Bioretec Ltd to the Annual General Meeting 2026

Bioretec Ltd Company announcement 30 January 2026 at 1.45 p.m EET

The Shareholders' Nomination Board of Bioretec Ltd (“Bioretec”) has resolved to make the following proposals to the Annual General Meeting. The Annual General Meeting of Bioretec is scheduled to be held on 8 May, 2026, and the company will publish the notice of the meeting separately.

The Shareholders' Nomination Board proposes to the Annual General Meeting that the following remuneration be paid to the Board members for the term starting at the end of the Annual General Meeting and ending at the end of the Annual General Meeting in 2027:

Chairperson of the Board: EUR 3,750 per month (2025: EUR 3,750);
Deputy Chairperson of the Board: EUR 2,500 per month (2025: EUR 2,500) if the Board of Directors elects a Deputy Chairperson e.g. to support successor planning; and
Board members: EUR 2,000 per month (2025: EUR 2,000)

In addition, the Nomination Board proposes that the reasonable travel expenses of the members of the Board of Directors be reimbursed in accordance with the maximum amount of the respective travel allowance based approved by the Tax Administration.

Number of Members of the Board of Directors

The Shareholders' Nomination Board proposes to the Annual General Meeting that six (6) members be elected to the Board of Directors (During 2025, the Board of Directors consisted of six (6) members until 27 August, when Sarah van Hellenberg Hubar-Fisher stepped down from her position as a member of the Board of Directors, in connection with her appointment as the Chief Executive Officer of Bioretec. On 31 December 2025, the Board of Directors consisted of five (5) members)

Election of Members of the Board of Directors

The Shareholders' Nomination Board proposes to the Annual General Meeting that

B.Sc. Microbiology, BBA Michael Piccirillo,
LL.M Päivi Malinen,

M.Sc. (Econ) Kustaa Poutiainen,
Doctor of Science (Technology) Antti Vasara, and

MD Justin Barad be re-elected as members of the Board of Directors.

Furthermore, the Nomination Board proposes that

MBA, BS David Gill be elected as new member of the Board of Directors.

The Shareholders' Nomination Board has assessed that the proposed members of the Board of Directors are independent of Bioretec and its significant shareholders, except for Kustaa Poutiainen, who is assessed to be independent of Bioretec but not of its significant shareholder, Stephen Industries Inc Oy, due to his role as chairperson of the board of Stephen Industries Inc Oy.

The term of the Board members will end at the conclusion of the Annual General Meeting in 2027.

Presentations of the current members of the Board of Directors are available at https://investors.bioretec.com/en/corporate_governance/board_of_directors

A brief presentation of the new candidate is attached to this notice.

When preparing the proposal, the Nomination Board has taken into account the policy concerning the diversity of the Board of Directors.

Regarding the election procedure of the members of the Board of Directors, the Shareholders' Nomination Board recommends that the shareholders take a position on the proposal regarding election of members of the Board of Directors as a whole at the Annual General Meeting. This recommendation is based on that Bioretec has a Shareholders' Nomination Board that is separate from the Board of Directors. The Shareholders’ Nomination Board, in addition to ensuring that individual nominees for membership of the Board of Directors possess the required competences, is also responsible for making sure that the proposed Board of Directors as a whole has the best possible expertise and experience for the Company.

Composition of the Shareholders' Nomination Board

The composition of the Nomination Board is as follows:

Tor-Oskar Karlberg, from Stephen Industries Inc Oy (Chair)
Rami Vehmas, from Ilmarinen Mutual Pension Insurance Company
Heinz Moitzi, from W&M GmbH

Kustaa Poutiainen, Chairperson of the Board, acts as an expert to the Nomination Board.

For further information:

Tor-Oskar Karlberg, Chairperson of the Nomination Board, +358 50 910 6416

Attachment: Presentation of new candidate

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

wkr0006.pdf

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CMS Transitional Pass-Through Payment (TPT) description for HCPCS code C1741 has been revised

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CMS Transitional Pass-Through Payment (TPT) description for HCPCS code C1741 has been revised

Bioretec Ltd Press Release 16 January 2026 at 5:45 p.m. EET

Bioretec Ltd, a pioneer in absorbable orthopedic implants, was granted Transitional Pass-Through Payment (TPT) status by the U.S. Centers for Medicare & Medicaid Services (CMS) for its RemeOs™ Trauma Screw, effective October 1, 2025.

CMS subsequently released an update to the HCPCS Level II codes, effective January 1, 2026. Among the revised codes was C1741, the code associated with Bioretec’s TPT status.

Effective January 1, 2026, the descriptor for HCPCS code C1741 reads: “Anchor/screw bone fixation, absorbable, metallic (implantable).”

This revised descriptor explicitly narrows the scope of the code to absorbable metallic bone fixation implants. The updated language aligns directly with the FDA regulatory classification for absorbable metallic bone fixation fasteners (21 CFR 888.3041) and with the regulatory pathway under which the RemeOs™ Trauma Screwreceived Breakthrough Device Designation and De Novo market authorization.

The RemeOs™ Trauma Screw received TPT status under the CMS alternative pathway for devices that have both Breakthrough Device Designation and FDA market authorization. The TPT payment (HCPCS billing code C1741) provides hospitals and ambulatory surgical centers with additional reimbursement for new and innovative technologies, helping to offset the incremental cost of adopting novel devices compared with existing treatments. This reimbursement mechanism is intended to lower barriers to adoption and supports patient access to the RemeOs™ Trauma Screw.

RemeOs™ is currently the first and only osteopromotive absorbable metal implant approved and commercially available for orthopedic use in the United States. The implant is designed to support bone healing and gradually degrade as it is replaced by native bone, thereby reducing the long-term risks and costs associated with permanent metallic implants.

This revision to the HCPCS code descriptor associated with the TPT status follows the FDA De Novo authorization granted in March 2023 and underscores Bioretec’s position as one of the few companies to achieve recognition from both regulators and payors for the clinical and economic value of a breakthrough absorbable metal technology.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

by Admin

Tuukka Paavola appointed as Chief Financial Officer of Bioretec

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Tuukka Paavola appointed as Chief Financial Officer of Bioretec

Bioretec Ltd Company announcement 15 January 2026 at 5:30 p.m. EET

Bioretec Ltd., a pioneer in absorbable orthopedic implants appoints Tuukka Paavola (M.Sc. Industrial Engineering, CFA) as Chief Financial Officer, effective 20 January 2025. In this role, Paavola will report to Chief Executive Officer Sarah van Hellenberg Hubar-Fisher and will join the company's management team.

Tuukka Paavola brings over 20 years of experience in finance, capital markets, and strategic planning. Previously, he has served as the CFO of Nightingale Health Plc, and in multiple leadership positions at Nordea Bank Plc. Paavola holds a master's degree in industrial engineering and is a Chartered Financial Analyst (CFA). In his new role, he will oversee all financial operations, including planning, reporting, and compliance, and will play a key role in shaping the company’s long-term financial strategy.

“I am delighted for the opportunity to join Bioretec at this very exciting moment and help the company in continuing its global growth journey”, says Paavola.

“We are excited to welcome Tuukka to Bioretec, and we look forward to his leadership and contributions as we continue to advance our mission to become a global leader in absorbable implants focused on healing. Tuukka join us at a pivotal and exciting time in our journey as a company and we look forward to his contributions in realizing our goals”, says CEO Sarah van Hellenberg Hubar-Fisher. “We also want to express our gratitude to Anne-Mari Matikainen, who has served as Interim CFO during the past months and supported us during a critical transition period for the company. Anne-Mari will continue to support the transition process until the February 13, ensuring a smooth handover and continuity in our financial operations.”

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

by Admin

Bioretec Ltd’s schedule for financial reporting and Annual General Meeting in 2026

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Bioretec Ltd’s schedule for financial reporting and Annual General Meeting in 2026

Bioretec Ltd Company announcement 22 December 2025 at 5:30 p.m. EET

In 2025, Bioretec will publish the following financial reports:

financial statements bulletin for January–December 2025 on Friday 13 February 2025
annual report, Board of Directors’ report and financial statements for 2025 on Friday 13 March 2026
business review for January–March 2026 on Thursday 14 May 2026
half-year report for January–June 2026 on Thursday 13 August 2026
business review for January–September 2026 on Thursday 12 November 2026

Financial reports will be published as company releases and will be available online on Bioretec Ltd’s website at https://bioretec.com/investors/investors-in-english/reports-and-presentations

Bioretec Ltd’s Annual General Meeting is planned to be held on Friday, 8 May 2026. The company's Board of Directors will convene the Annual General Meeting separately later.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

by Admin

Inside information: Bioretec updates its strategy for 2026-2028 and provides new financial targets

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Inside information: Bioretec updates its strategy for 2026-2028 and provides new financial targets

Bioretec Ltd Inside information 16 December 2025 at 8:45 a.m. EET

As announced in September, Bioretec Ltd (“Bioretec” or the “Company”) has assessed its overall commercialization strategy, pipeline, and options to accelerate growth. Bioretec’s Board of Directors has today approved the Company’s updated strategy for 2026–2028 and new financial targets for the strategy period.

To support the execution of the new strategy, Bioretec is also currently assessing financing options.

Bioretec’s strategy for the period 2026–2028:

Bioretec’s strategy and value creation for the next three years focuses on commercial performance and sales acceleration in both the United States and markets outside of the United States (OUS), enabled by continued R&D and expansion of the RemeOsTM product family.

The strategy is based on three pillars:

Industry leading innovation: pioneering world class materials science by demonstrating patient outcomes that validate healing through the absorption of our materials.

World-class clinical and economic evidence generation: expanding the patent portfolio for new and existing materials and research methods to build a sustained competitive market advantage.

Global excellence in commercialization: accelerate our focus on high value repeatable business and collaboration with best-in-class partners globally to achieve market success.

Strategic priorities for the period 2026–2028:

Demonstrate industry leading innovation, clinical evidence generation, and commercial scale by progressing a strong R&D pipeline and introducing at least one new product or indication every 12–18 months, reflected by sustained R&D investments
Build strong market presence and solidify our commercial position in the U.S. through direct distribution channels, targeted Key Opinion Leader engagement strategies, and high-impact training and education
Upgrade our OUS commercial strategy through updated distribution partner selections with rigorous and clear commercial targets and a focused effort on RemeOsTM launches in high value markets.
Establish RemeOsTM as the leading metal alloy absorbable solution in the implant market globally

By the end of the strategy period, Bioretec aims to have established itself as a recognized player in the global orthopedic market and a market leader in innovative metal absorbable implants with the RemeOsTM product family. Bioretec is of the strong view that reaching this position will enable the next strategic steps in order to maximize shareholder value.

Financial targets:

In line with its strategy and priorities for 2026–2028, Bioretec’s new financial targets are:

Reach net sales exceeding EUR 10 million by the end of the year 2028
Maintain an average sales margin exceeding 70% during the strategy period

While maintaining a healthy sales margin enables efficient scaling, Bioretec does not expect to reach cash flow positivity or profitability during the strategy period due to the planned strategic investments in R&D and commercialization. The financial targets do not include assumptions of revenue or funding from potential partnership or licensing opportunities within the strategy period.

Bioretec does not consider these financial targets as market guidance for any given year.

Pipeline update:

Bioretec offers two product families, Activa and RemeOsTM. The Activa product family is based on self-reinforced PLGA and facilitate healing in orthopedic indications where carrying capacity is not required. The RemeOsTM product family utilizes state-of-the-art absorbable metal alloy technology. RemeOsTM implants can carry more load and are well suited for treating larger bone fractures.

Bioretec has a strong pipeline for launching additional products. The Company is especially committed to expanding the RemeOsTM family with several synergistic products in the coming years, with new types of absorbables already in advanced development and clinical trials.

As highlighted in the strategic priorities for 2026–2028, Bioretec plans to introduce one new product every 12–18 months and establish RemeOsTM as the leading product family and metal alloys as the preferred solution in the absorbable implant market globally.

Bioretec has divided the introduction and commercialization of new products in the pipeline into three different timeframes:

Short term (<18 months):

RemeOsTM Trauma Screws (US portfolio expansion)
RemeOsTM DrillPins (“Nail”)
Activa Headless Cannulated Screw

Medium term (18–36 months):

A new, differentiated RemeOsTM absorbable trauma product (e.g. elastic stable intramedullary nails (ESINs), specialty screws, staples, anchors)

Long term (36+ months):

RemeOsTM Spine portfolio
RemeOsTM IM Nails
RemeOsTM Plates

Since commercialization progress is dependent on customary regulatory approval timelines and subsequent prioritization of R&D resources, the Company is not in a position to give a specific order or estimated years for the commercialization of individual products.

Further enquiries

Sarah van Hellenberg Hubar-Fisher
CEO
+31 6 1544 8736

Certified Adviser

Nordic Certified Adviser AB
+46 70 551 67 29

Distribution

Nasdaq Helsinki
Key media
www.bioretec.com

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit www.bioretec.com

by Admin

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin

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Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin

Bioretec Ltd Inside information 14 December 2025 at 5:45 p.m. EET

Bioretec Oy (“Bioretec” or the “Company”), a pioneer in biodegradable orthopedic implants, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology‑based, biodegradable RemeOs™ DrillPin.

The designation covers the RemeOs™ DrillPin for fixation of bone fragments in pediatric and adult patients and for the treatment of epi-metaphyseal fractures in pediatric patients ≥2 years of age with an open growth plate, including transphyseal indications where fixation across the growth plate is clinically required.

Breakthrough Device Designation is granted to medical devices that may provide more effective treatment for life threatening or irreversibly debilitating conditions and that represent a breakthrough technology or offer significant advantages over existing approved or cleared alternatives. The designation gives Bioretec prioritized and more interactive communication with the FDA during the remaining development and review process, which is expected to support an efficient clinical and regulatory pathway for the DrillPin.

The RemeOs™ DrillPin is the third Breakthrough Device Designation granted to Bioretec by the FDA for its RemeOs™ product portfolio (Trauma Screw, 2021; Spinal Cage, 2024).

“Securing Breakthrough Device Designation for the RemeOs™ DrillPin is a major milestone for Bioretec and for patients. It confirms that there are no equivalent solutions addressing this unmet clinical need and recognizes the potential of our osteopromotive, magnesium based platform to change the way fractures are treated. Together with the CMS pass through status already granted for our RemeOs™ Trauma Screw, this designation strengthens our ability to build a commercially attractive and patient centric portfolio in the U.S. orthopedic market”, states Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec.

As previously announced, the Company will publish an updated commercialization strategy and product development pipeline, along with revised financial targets by the end of 2025.

Bioretec reminds investors that Breakthrough Device Designation does not change the evidentiary requirements for clinical data, FDA marketing authorization, or other regulatory approvals, nor does it guarantee that such approvals will ultimately be obtained.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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.

Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit https://bioretec.com.

by Admin

Bioretec Ltd’s business review January–September 2025: Strengthening commercial foundations and strategy design

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Bioretec Ltd’s business review January–September 2025: Strengthening commercial foundations and strategy design

Bioretec Ltd Company release 13 November 2025 at 8.30 a.m. EET

T his announcement summarizes Bioretec Ltd’s business review for January–September 2025. 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 2025 in brief

Net sales amounted to EUR 715 thousand (7–9/2024: EUR 685 thousand).
The sales margin (excl. other income) was EUR 441 (499) thousand, or 61.6% (72.9%) of net sales.
EBITDA was EUR -1,768 (-1,353) thousand.
The result for the reporting period amounted to EUR -1,854 (-1,367) thousand.

January–September 2025 in brief

Net sales amounted to EUR 2,789 thousand (1–9/2024: EUR 2,746 thousand).
The sales margin (excl. other income) was EUR 1,749 (1,951) thousand, or 62.7% (71.0%) of net sales.
EBITDA was EUR -6,325 (-3,217) thousand.
The result for the reporting period amounted to EUR -7,482 (-3,251) thousand.

Key figures

EUR 1,000	7–9/2025	7–9/2024	Change, %	1–9/2025	1–9/2024	Change, %	1–12/2024
Net sales	715	685	4.5%	2,789	2,746	1.6%	4,544
Sales margin	533	562	-5.0%	2,043	2,084	-2.0%	3,391
Sales margin (excl. other income)	441	499	-11.7%	1,749	1,951	-10.3%	3,221
Sales, margin, % of net sales	74.5%	82.0%		73.3%	75.9%		74.6%
Sales margin, % (excl. other income)	61.6%	72.9%		62.7%	71.0%		70.9%
EBITDA	-1,768	-1,353		-6,325	-3,217		-4,053
EBIT	-1,823	-1,395		-6,483	-3,316		-4,202
Profit / loss for the period	-1,854	-1,367		-7,482	-3,251		-4,614
R&D expenditure, % of net sales	111.2%	66.1%		79.9%	47.6%		48.0%
Equity ratio, %	83.7%	73.1%		83.7%	73.1%		84.9%
Cash and cash equivalents (end of period)	7,263	2,377	205.5%	7,263	2,377	205.5%	6,289
Number of personnel (end of period)	64	44	45.5%	64	44	45.5%	47

Key events during July–September 2025

Bioretec appointed Sarah van Hellenberg Hubar-Fisher as Chief Executive Officer on 27 August 2025. Van Hellenberg Hubar-Fisher served previously as Bioretec’s interim CEO since May 2025 and as a member of the company’s Board of Directors since 2021.
Bioretec appointed René Eve as Director of Operations and as a member of the Management Team on 11 July 2025.
Bioretec appointed Jordy Winters as Vice President of Sales Outside U.S. and as a member of the Management Team on 2 September 2025. In parallel, Rami Ojala, previously Vice President of OUS Sales, transitioned into the newly created role of Head of Global Medical Education.
Bioretec updated the commercialization status of RemeOs™ DrillPin on 12 September 2025. Bioretec is assessing its overall commercialization strategy and pipeline, including the commercialization of the DrillPin in the U.S., and will provide an update by the end of 2025.
Bioretec appointed Anne-Mari Matikainen as Interim Chief Financial Officer and as a member of the Management Team on 15 September 2025. The recruitment process for a new permanent CFO has been initiated.

CEO Sarah van Hellenberg Hubar-Fisher’s comments: Strengthening commercial foundations and strategy design

Almost six months have passed since I assumed my position as Bioretec’s CEO. While I remain very enthusiastic about Bioretec’s next phase of growth and the opportunity to lead us there, it has become increasingly evident that corrective actions and strategy adjustment are required to set us up for a clear path to success. As announced in late October, we concluded that our previous financial targets are unattainable given lengthened FDA approval timelines, our financing needs, and the planned strategic readjustment initiatives. In addition, we restated our previously reported H1/2025 figures due to incorrect accounting treatment related to past stocking distributor agreements. While these announcements were certainly unpleasant, they were necessary to clean the slate and ensure that the focus of our business is on the strength of our breakthrough technology.

The year 2025 has been, and will continue to be, a period of transition for Bioretec. With a change of both CEO and CFO, as well as the strengthening of our commercial leadership, we will continue to build market presence and to prepare for future acceleration of sales that can be only driven by clear investment in people and strategy today.

Strengthening our commercialization expertise

The biggest lesson we have learned is that our U.S. model and related growth expectations rely on the move from a stocking distribution model to direct distribution, excluding our partnership in pediatrics. It also requires an investment in local presence driven by experienced talent to ensure commercial competitiveness and success. Outside of the U.S., knowing where to focus our time and resources for optimal value is key to our performance. A full review of 'where to play' and how to execute geography is essential for our commercial success. These adjustments in our commercialization strategy have already been initiated.

In the third quarter, we strengthened our commercialization expertise in the U.S. with the appointment of Blake Helm as VP of Sales, Area West. Blake brings more than twenty years of sales and distribution management expertise in orthopedics to Bioretec’s growing U.S. presence. In addition, we increased the number of direct distribution partners in the U.S. by 7 to a total of 15 partners during the third quarter.

Outside the U.S. (OUS), we appointed Jordy Winters as Vice President of Sales (OUS). He will spearhead Bioretec’s commercialization strategy outside the U.S. and advance our expansion into new markets. With nearly two decades of experience in global orthopedic commercial leadership, Jordy’s expertise and international perspective will be instrumental to defining where and how we play in international markets as we continue to expand Bioretec’s impact outside of the United States. Rami Ojala, previously VP of Sales (OUS), has transitioned into the newly created role, Head of Global Medical Education, developing surgeon training programs and educational initiatives to support clinical adoption of Bioretec’s technologies worldwide.

Determined progress in the third quarter

While we are finalizing our new strategy, we have continued to focus on our ongoing operations. Our net sales in the third quarter prove that our Activa products are continuing to perform, whereas the breakthrough commercial impact of RemeOs™ is still underway. Our growth model for RemeOs™ is dependent on a broader portfolio of the product family (especially in the U.S.), and reliant on clear investment in training and education as well as brand and product awareness.

The third quarter represents our largest direct sales revenue in the U.S. to date. This is already an important signal of growth in the right places. Progress was further demonstrated by our October 1 announcement after the reporting period, acknowledging that the U.S. Centers for Medicare & Medicaid Services (CMS) granted our RemeOs™ Trauma Screw Transitional Pass-Through Payment (TPT) status. In addition, we closed a 3-year commercial distribution deal with OrthoPediatrics, specifically for the U.S. pediatric market in the last month of the quarter, further enhancing our distribution presence.

New strategy published by the end of the year

The end of the year marks an important stage in shaping Bioretec’s future. Together with our strengthened international leadership, we will carefully consider the needed strategic readjustments in order to best position Bioretec for the journey ahead and to ensure the successful commercialization of our groundbreaking products. We will provide an update regarding our commercialization strategy and pipeline, along with revised financial targets, by the end of 2025.

At the same time, we are committed to ensuring the confidence of our shareholders and potential investors. Our reputation and reliability begin with transparent and consistent communication, an updated strategy and demonstrating our ability to execute it. I am more confident than ever that we are now on the path to do just that.

Key events after the reporting period

Bioretec announced on 1 October 2025 that the RemeOsTM Trauma Screw has been granted Transitional Pass-Through Payment (TPT) status by the U.S. Centers for Medicare & Medicaid Services (CMS). The TPT payment provides hospitals and ambulatory surgical centers with additional reimbursement for new and innovative technologies. Its purpose is to cover the additional cost of new and innovative devices compared to existing treatments, thereby lowering the barrier for hospitals to adopt the RemeOsTM Trauma Screw and making it accessible to a broader patient population.
Bioretec announced on 27 October 2025 that the company is in the process of assessing and updating its overall commercialization strategy pipeline and will be providing an update by the end of 2025. In the course of its assessment, the Board of Directors of Bioretec concluded that the financial targets published on 4 October 2024 are unattainable and will likely not be met. Accordingly, Bioretec withdrew its previously disclosed financial targets, which were to:
- Reach net sales of EUR 65 million by the end of year 2028 and to reach net sales in excess of EUR 100 million by the end of year 2030
- Reach positive cash flow from operating activities by the end of the year 2027.
Bioretec announced on 27 October 2025 that it adjusts and restates previously reported H1/2025 figures and does not expect accelerated sales in 2025.
Bioretec published the corrected H1/2025 half year report on 31 October 2025.
Bioretec announced on 12 November 2025 that it initiates change negotiations to enhance operational efficiency and competitiveness. The negotiations will focus on Bioretec’s production and marketing functions in Finland.

RemeOs™ development and commercialization status

Regulatory milestones achieved:

April 2021: The U.S. Food and Drug Administration (FDA) grants Breakthrough Device Designation for Bioretec’s RemeOsTM Screw products, confirming that the product represents a breakthrough technology in traumatology and orthopedic surgery.
December 2021: Bioretec files for CE mark for its RemeOsTM Trauma Screw. The CE mark is a legal prerequisite in order to commercialize a medical device in the European Union.
May 2022: Bioretec submits a De Novo request for market authorization in the U.S. for its RemeOsTM Trauma Screw. The De Novo request provides a registration pathway for novel medical devices for which there is no predicate device available in the U.S. market.
March 2023: FDA approves Bioretec’s RemeOsTM Trauma Screw as the first bioresorbable metal implant in the U.S. market.
March 2024: The FDA grants Breakthrough Device Designation for Bioretec’s RemeOsTM Spinal Interbody Cage, confirming that the product represents a breakthrough technology in spinal surgery.
January 2025: Bioretec receives CE mark approval for its RemeOsTM Trauma Screw product portfolio, allowing market launch in Europe.

Clinical highlights:

Scientific Advisory Board (SAB) Meeting: In July, Bioretec held the annual meeting of its Scientific Advisory Board (SAB) in Stockholm. The SAB, together with members of the Board of Directors, Michael Piccirillo and Justin Barad, reviewed ongoing and forthcoming clinical trials, product pipeline progress, and technology development. The Board members were also invited to follow the SAB’s progress and support its work in advancing Bioretec’s scientific and clinical objectives.

New SAB Appointment: In September, Bioretec appointed Dr. Christopher W. DiGiovanni, Professor and Chief of Foot and Ankle Surgery at Massachusetts General Hospital and Harvard Medical School, to its Scientific Advisory Board. Dr. DiGiovanni’s appointment reinforces Bioretec’s strategy to collaborate with globally recognized clinical leaders to guide product innovation and ensure the company’s solutions meet the highest standards of safety, efficacy, and clinical relevance.
RemeOs™ DrillPin – Hammertoe Clinical Trial: The clinical trial evaluating the RemeOs™ DrillPin in hammertoe correction is ongoing. The first patients have been enrolled and are under follow-up, with additional enrollment continuing as planned.
RemeOs™ DrillPin – Pediatric Wrist Fracture Clinical Trial: The pediatric distal radius fracture clinical trial evaluating the RemeOs™ DrillPin has received all required authority approvals, including those from the ethics committee and national competent authority. Site initiation activities have been completed, and patient enrollment is commencing.
RemeOs™ Trauma Screw – Post-Market Clinical Follow-Up (PMCF): The post-market clinical follow-up for the RemeOs™ Trauma Screw is ongoing, collecting cases and follow-up data of fractures and fusions from both upper and lower extremities of adult and pediatric patients. A wide range of clinical indications are already covered since the launch.
Training and Education initiatives: Bioretec has initiated the development of training and education (T&E) platforms for both U.S. and international (OUS) markets. These programs aim to raise awareness of the clinical benefits and material characteristics of absorbable implant technologies and to support the broader adoption of Bioretec’s RemeOs™ product family.

Next steps:

As announced on 12 September 2025 and on 27 October 2025, Bioretec is assessing its overall commercialization strategy and pipeline, and will provide an update by the end of 2025.

Financial calendar in 2026

Bioretec will publish its financial calendar for 2026 in December 2025.

The financial reports will be available online at Bioretec Ltd’s website at

https://investors.bioretec.com/en/reports_and_presentations.

Tampere, 13 November 2025

Board of Directors

Bioretec Ltd

For additional information about the report:

Sarah van Hellenberg Hubar-Fisher   Anne-Mari Matikainen
CEO        Interim CFO
+31 6 1544 8736      +358 50 322 1069

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

Bioretec’s Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA polymer. These implants deliver secure fixation through patented innovations and naturally degrade in approximately two years, eliminating the need for costly and invasive removal surgeries while supporting optimal bone regeneration. Activa products are both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. 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. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit https://bioretec.com.

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by Admin