Bioretec Ltd’s Financial Statements and Annual Report 2025 published

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Bioretec Ltd’s Financial Statements and Annual Report 2025 published

Bioretec Ltd  | Company announcement | 13 March 2026 at 5:15 p.m.

Bioretec Ltd has today published its 2025 Financial Statements and Annual Report. The publications are attached to this release and also available in Finnish and English on the company’s website at investors.bioretec.com/en/reports_and_presentations

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   



Inside information: Timo Lehtonen takes on a new role at Bioretec as External Executive Advisor and steps down from the management team

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Inside information: Timo Lehtonen takes on a new role at Bioretec as External Executive Advisor and steps down from the management team

Bioretec Ltd  Inside information 12 March 2026 at 4:30 p.m. EET

Timo Lehtonen, the current Chief Technology Officer of Bioretec Ltd ("Bioretec" or the "Company"), will transition to the role of External Executive Advisor (Technology & Strategy) and step down from the Company's management team and Chief Technology Officer role as of 6 July 2026.

In this non-executive role, Lehtonen will support the Company as an external advisor, providing strategic advice on materials science, technology development, the product pipeline, and clinical and regulatory strategy. He will also support the Company in key external interactions with regulators, investors, partners and key opinion leaders, and help ensure continuity of technological expertise during the leadership transition.

Lehtonen has indicated that he intends to participate in Bioretec's planned rights issue announced by the Company on 10 March 2026.

As part of this transition, Bioretec will not be replacing the Chief Technology Officer role on a like-for-like basis. Instead, Bioretec is planning to establish two new dedicated roles to cover the Company's day-to-day operational needs in both product development and clinical affairs.

"Timo has been, and will continue to be, a valuable part of the Bioretec team. His leadership has shepherded Bioretec from early materials science to breakthrough designation leadership, establishing a solid foundation of world-class materials science and technology development. I am thrilled that Timo will be continuing his journey with Bioretec following 6 years of leadership, providing both knowledge continuity and strategic counsel on technology development and materials science, in support of our journey ahead," says Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec.

"This is a natural moment for me to transition to a new advisory role, while continuing to support Bioretec going forward. Together, we have built a strong foundation in absorbable metal implant technology and advanced a promising product pipeline supported by substantial clinical and regulatory progress. I strongly believe in the future of this technology and in the talented team that will continue to develop it. The progress achieved reflects the deep expertise, persistence and hard work of many people across the organisation. I am proud of what we have accomplished together and look forward to continuing to support Bioretec's development and long-term success in my advisory capacity," says Timo Lehtonen.

 

Further enquiries

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

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



Notice of the Extraordinary General Meeting of Bioretec Ltd

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Notice of the Extraordinary General Meeting of Bioretec Ltd

Bioretec Ltd | Company announcement | 10 March 2026 at 21:31 p.m. EET

NOTICE OF THE EXTRAORDINARY GENERAL MEETING OF BIORETEC LTD

 

The shareholders of Bioretec Ltd are hereby invited to the Extraordinary General Meeting of shareholders to be held on 27 March 2026 at 10:00 a.m. (Finnish time) without a meeting venue as a real-time virtual meeting in accordance with Article 10 of the Articles of Association and Chapter 5, Section 16, Subsection 3 of the Finnish Companies Act. Instructions for participation are presented in this notice under section C "Instructions for the participants".

 

A shareholder may participate in the Extraordinary General Meeting and exercise their rights at the meeting by way of proxy representation. A proxy representative shall present a dated power of attorney or in another reliable manner demonstrate their right to represent the shareholder.

 

Shareholders must register for the meeting no later than 19 March 2026 at 4:00 p.m. (Finnish time). Instructions for registration are set out below in section C. "Instructions for the participants".

 

Shareholders can also exercise their voting rights by voting in advance. Instructions for advance voting are also presented in this notice under section C “Instructions for the participants”.

 

A. Agenda of the Extraordinary General Meeting

 

  1. Opening of the meeting
  2. Calling the meeting to order
  3. Election of persons to scrutinize the minutes and to supervise the counting of votes
  4. Recording the legality of the meeting
  5. Recording the attendance at the meeting and adoption of the list of votes
  6. Authorizing the Board of Directors to resolve on a rights offering

The Board of Directors of the company proposes that the Extraordinary General Meeting authorizes the Board of Directors to resolve on a rights offering as follows:

 

Pursuant to the authorization, up to 1,500,000,000 new shares may be issued. The shares to be issued based on the authorization will be offered to the company's shareholders for subscription under pre-emptive subscription rights in the same proportion as they already hold shares in the company. Shares that remain unsubscribed at the end of the subscription period of the rights offering on the basis of shareholders' pre-emptive subscription rights may be offered on a secondary basis for subscription to other shareholders or third parties. The Board of Directors is authorized to decide to whom such shares that remain unsubscribed, if any, are offered to. In the event that shares are to be issued to potential subscription guarantors in a secondary offering, the company would be authorized to issue the shares to itself first without consideration and then further convey such treasury shares to subscription guarantors to enable delivery versus payment in respect of such subscription guarantors without the authorization being exercised twice in respect of such shares. The Board of Directors is authorized to resolve on all other terms and conditions of the rights offering, including the subscription and payment period and the grounds for determining the subscription price.

 

The authorization is valid until 30 June 2026. The authorization does not cancel previous unused authorizations granted to the Board of Directors.

Stephen Industries Inc Oy, which represents approximately 12.00 percent of all the shares and votes in Bioretec on the date of this notice, has given an irrevocable commitment to vote in favor of the above-mentioned authorization proposal of the Board of Directors. In addition, Stephen Industries Inc Oy has, subject to certain conditions, provided an advance commitment to subscribe for new shares in the Offering on the basis of all subscription rights to be recorded to it (the "Subscription Commitment"). Stephen Industries Inc Oy has also, subject to certain conditions, provided an underwriting commitment for the Offering, pursuant to which Stephen Industries Inc Oy will subscribe for any and all new shares not otherwise subscribed and paid for pursuant to the subscription rights or in the secondary subscription for an aggregate amount of up to EUR 5 million, which amount shall include Stephen Industries Inc Oy's aggregate subscriptions under the Subscription Commitment and any and all new shares subscribed by it in the primary and secondary subscription (the "Underwriting Commitment"). Should Stephen Industries Inc Oy's Subscription Commitment and Underwriting Commitment given in respect of the rights offering be exercised, the proportion of voting rights held by Stephen Industries Inc Oy, and thereby indirectly also by Kustaa Poutiainen, in Bioretec may exceed the 30 percent and 50 percent mandatory public takeover bid thresholds referred to in Chapter 11, Section 19 of the Finnish Securities Markets Act (746/2012, as amended, the "SMA"), in the event that the other shareholders of Bioretec do not exercise their subscription rights in full in the rights offering. Stephen Industries Inc Oy and Kustaa Poutiainen intend to apply for a permanent exemption from the Finnish Financial Supervisory Authority pursuant to Chapter 11, Section 26 of the SMA from the obligation to launch a mandatory public takeover bid that may arise as a result of exceeding the mandatory public takeover bid thresholds. The Subscription Commitment and the Underwriting Commitment given by Stephen Industries Inc Oy in respect of the rights offering are conditional upon the Finnish Financial Supervisory Authority granting such an exemption and upon certain customary conditions. In addition, the Underwriting Commitment is conditional upon no change, event, occurrence, circumstance or development having occurred between the date of the Underwriting Commitment and the settlement and delivery date of the Offering that, individually or in the aggregate, has had or would reasonably be expected to have a material adverse effect on the business, financial condition, results of operations, assets, liabilities or prospects of Bioretec and its subsidiaries, taken as a whole. If the exemption is granted, it is expected to be conditional upon at least two-thirds of the votes cast at the company's Extraordinary General Meeting, independent of the arrangement, supporting the above-mentioned authorization. Stephen Industries Inc Oy is a company controlled by the Chair of the Board of Directors of the company, Kustaa Poutiainen.

  1. Authorization of the Board of Directors to resolve on the issuance of shares and special rights entitling to shares

The Board of Directors proposes that the Extraordinary General Meeting authorizes the Board of Directors to resolve on the issuance of shares as well as the issuance of stock options and other special rights entitling to shares as referred to in Chapter 10, Section 1 of the Finnish Companies Act as follows:

The total number of shares to be issued under the authorization may not exceed 250,000,000 shares in aggregate, including shares to be issued on the basis of special rights. Shares or special rights entitling to shares may be issued in one or more tranches, either against payment or without payment.

The shares to be issued under the authorization may be new shares or shares held by the Company. The authorization may be used for implementing the Company’s share-based incentive schemes as well as for financing or carrying out acquisitions or other arrangements (including for the payment of any share-based fees in consideration for subscription or underwriting commitments relating to the rights offering referred to in item 6 above), for strengthening the Company’s balance sheet and financial position, or for other purposes determined by the Board of Directors.

Under the authorization, the Board of Directors may resolve to issue new shares to the Company itself without consideration. The Board of Directors shall be authorized to resolve on all terms and conditions of the share issuances and the issuance of special rights entitling to shares in the Company.

Shares and special rights entitling to shares may be issued in deviation from the shareholders’ pre-emptive rights within the limits set by law.

The authorization shall remain effective until the close of the Annual General Meeting of the Company held in 2027, however no longer than until 30 June 2027. The authorization revokes all previous unused authorizations regarding the issuance of shares and the issuance of special rights entitling to shares. The authorization does not, however, revoke the authorization issued under item 6 above.

The Board of Directors intends to use the authorization to issue shares on the basis of special rights in an amount corresponding to a dilution effect of no more than 12.00 percent after the potential completion of the rights issue referred to in item 6 above.

  1. Closing of the meeting

B. Documents of the General Meeting

 

Documents referred to in Chapter 5, Section 21 of the Finnish Companies Act are available and printable on the company's website at https://investors.bioretec.com/en/corporate_governance/egm_2026 as of 20 March 2026, at the latest.

The meeting minutes of the Extraordinary General Meeting will be available on the company's website no later than 10 April 2026.

 

C. Instructions for the participants

 

Eligibility to attend and registration for the Extraordinary General Meeting

 

  1. Shareholder registered in the shareholders’ register

Each shareholder who is registered on 17 March 2026 in the shareholders’ register of the company held by Euroclear Finland Oy has the right to participate in the General Meeting. A shareholder whose shares are registered on his/her/its personal Finnish book-entry account is registered in the shareholders’ register of the company.

Registration period for the General Meeting begins on 11 March at 10:00 a.m. (Finnish time). A shareholder, who wants to participate in the General Meeting, shall register for the meeting no later than on 19 March 2026 at 4:00 p.m. (Finnish time), by which time the registration must be received.

The registration may take place by:

a) via the Company’s website at https://investors.bioretec.com/en/corporate_governance/egm_2026 (electronic registration requires strong identification of the shareholder or their legal representative or proxy with a Finnish, Swedish, or Danish bank ID, or a mobile certificate);

b) e-mail. Shareholders registering by e-mail shall submit the registration form and advance voting form available on the company's website at https://investors.bioretec.com/en/corporate_governance/egm_2026 or equivalent information to egm@innovatics.fi; or;

c) mail. Shareholders registering by mail shall submit the registration form and advance voting form available on the company's website at https://investors.bioretec.com/en/corporate_governance/egm_2026 or equivalent information to Innovatics Ltd by mail to Innovatics Ltd, General Meeting / Bioretec Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland.

In connection with the registration, a shareholder shall notify his/her/its name, date of birth / business ID, address, phone number and email address, and the name, date of birth, email and phone number of a possible assistant, proxy representative and legal person's representative. A shareholder and his/her/its representative or proxy representative shall, when necessary, be able to prove his/her/its identity and/or right of representation.

Further information on registration and advance voting is available by telephone during the registration period of the General Meeting by calling Innovatics Ltd at +358 10 2818 909 on weekdays from 9.00 a.m. to 12.00 p.m. and from 1.00 p.m. to 4.00 p.m. 

  1. Holders of nominee-registered shares

 

A holder of nominee-registered shares has the right to participate in the General Meeting by virtue of such shares, based on which the shareholder on the record date of the General Meeting, i.e. on 17 March 2026 would be entitled to be registered in the shareholders’ register of the company maintained by Euroclear Finland Oy. The right to participate in the General Meeting requires, in addition, that the shareholder has on the basis of such shares been registered into the temporary shareholders’ register of the company held by Euroclear Finland Oy at the latest on 24 March 2026 by 10:00 a.m. (Finnish time). As regards nominee-registered shares this constitutes due registration for the General Meeting.

A holder of nominee-registered shares is advised to request without delay necessary instructions regarding the registration in the temporary shareholder register of the company, the issuance of proxy documents and voting instructions, and registration for the General Meeting from his/her/its custodian bank as well as participating in the virtual meeting and voting in advance. The account management organization of the custodian bank shall register a holder of nominee-registered shares, who wants to participate in the General Meeting and who is entitled to be registered in the shareholder register based on the shares as mentioned above, into the temporary shareholders’ register of the company at the latest by the date and time mentioned above.

A holder of nominee-registered shares who has registered for the General Meeting may also participate in the meeting in real time using telecommunication connection and technical means. In addition to the temporary registration in the company’s shareholders’ register, the real-time participation in the meeting requires the submission of the shareholder’s e-mail address and telephone number and, if necessary, a proxy document and other documents necessary to prove the right of representation by regular mail to Innovatics Ltd, General Meeting/Bioretec Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland or by email to egm@innovatics.fi before the end of the registration period for the holders of nominee registered shares, so that the shareholders can be sent a participation link and password to participate in the meeting. If a holder of nominee-registered shares has authorized their custodian to cast advance votes on their behalf, such advance votes will be taken into account as advance votes of the nominee-registered shareholder at the General Meeting, unless the holder of nominee-registered shares votes otherwise during the General Meeting.

  1. Proxy representative and powers of attorney

A shareholder may participate in the General Meeting and exercise his/her/its rights at the meeting by way of proxy representation. A proxy representative shall produce a dated proxy document or otherwise provide reliable evidence of the right to represent the shareholder. The authorization applies to one meeting only unless otherwise stated. If a shareholder participates in the General Meeting by means of several proxy representatives representing the shareholder with shares at different securities accounts, the shares by which each proxy representative represents the shareholder shall be identified in connection with the registration for the General Meeting. A sample power of attorney is available at the company’s website: https://investors.bioretec.com/en/corporate_governance/egm_2026.

The proxy representative must authenticate to the electronic registration service and advance voting personally with strong authentication, after which they will be able to register and vote in advance on behalf of the shareholder who they represent. Proving the right to represent can be done by using the suomi.fi e-Authorizations service available in the electronic registration service.

Any proxy documents are requested to be submitted preferably as an attachment with the electronic registration or alternatively by mail to Innovatics Ltd, General Meeting / Bioretec Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland or by e-mail to egm@innovatics.fi before the end of the registration period. In addition to submitting the proxy documents, the shareholder or their proxy shall register for the General Meeting in the manner described above in this notice.  

  1. Participation instructions

A shareholder who has the right to participate in the Extraordinary General Meeting can participate in the meeting and use their rights in full and in real-time during the meeting via remote connection.

 

Remote access to the General Meeting will be provided through Inderes Plc general meeting service on the Videosync platform, which includes video and audio access to the General Meeting. Remote access does not require any paid software or downloads. In addition to an internet connection, participation requires a computer, smartphone or tablet with speakers or headphones for sound and a microphone if you wish to speak. One of the following browsers is recommended for participation: Chrome, Firefox, Edge, Safari, or Opera. It is advisable to log in to the meeting system well in advance of the meeting.

 

The participation link and password for remote participation will be sent by e-mail and/or SMS to the e-mail address and/or mobile phone number provided at the time of registration to all those who have registered for the General Meeting no later than the day before the meeting. It is advisable to log in to the meeting system well in advance of the meeting.

 

For more information on the general meeting service, additional instructions for proxies representing more than one shareholder, contact details of the service provider and instructions in case of possible disruptions can be found here: https://vagm.fi/support. A link to test the compatibility of your computer, smartphone or tablet with the network connection can be found here: https://b2b.inderes.com/knowledge-base/compatibility-testing. It is recommended that you read the detailed participation instructions before the meeting.

  1. Advance voting

Shareholders with a Finnish book-entry account can register and vote in advance on certain matters on the agenda during the time period from 11 March 2026 at 10:00 a.m. (Finnish time) to 19 March 2026 at 4:00 p.m. (Finnish time) in the following ways:

(a) via the company's website at https://investors.bioretec.com/en/corporate_governance/egm_2026. Login to the service is done in the same way as for registration in section C.1 of this notice;

(b) by email, by sending the registration and advance voting form available on the Company’s website at https://investors.bioretec.com/en/corporate_governance/egm_2026 no later than on 11 March 2026 at 10:00 a.m. (Finnish time) or corresponding information to egm@innovatics.fi; or

(c) by mail, by sending the registration and advance voting form available on the Company’s website at https://investors.bioretec.com/en/corporate_governance/egm_2026 no later than on 11 March 2026 at 10:00 a.m. (Finnish time) or corresponding information to the address Innovatics Ltd, General Meeting / Bioretec Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland.

A shareholder’s advance votes must be received by Innovatics by the time advance voting ends. Sending in a duly populated advance voting form as set out above will be deemed to constitute both registration for the General Meeting and voting in advance, provided that the abovementioned information required for registration is provided.

It is not possible for a shareholder who has voted in advance to use the right to ask questions or the right to demand a vote in accordance with the Finnish Companies Act, unless the shareholder itself, or the shareholder's proxy representative, participates in the General Meeting.

The account management organization of the custodian bank shall see to advance voting on behalf of nominee registered shareholders. The account management organization may vote in advance on behalf of the nominee registered shareholders it represents in accordance with these voting instructions during the registration period for nominee registered shareholders.

An agenda item subject to advance voting is considered to have been presented at the General Meeting unchanged. The advance voting form will be available on the Company’s website at https://investors.bioretec.com/en/corporate_governance/egm_2026 as of the beginning of the advance voting period at the latest. 

Other instructions / information

 

The General Meeting will be held in Finnish language.

 

A shareholder present at the General Meeting has the right ask questions pursuant to Chapter 5, Section 25 of the Finnish Companies Act with respect to the matters to be considered at the General Meeting.

 

Personal information collected by Bioretec Ltd shall be used only in connection with the General Meeting and the processing of related necessary registrations and for shareholder communication. The privacy statement in respect of the General Meeting is available at the company’s website: https://investors.bioretec.com/en/corporate_governance/egm_2026.

 

Bioretec Ltd has a total of 30,788,092 shares on the date of publication of the notice of the meeting 10 March 2026. The company does not have any Bioretec shares in its possession. Possible changes in shareholding occurring after the record date of the General Meeting shall not affect the shareholder’s right to participate in the meeting nor the voting rights of a shareholder.

 

 

In Tampere, 10 March 2026

 

BIORETEC LTD

 

BOARD OF DIRECTORS

 

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



Inside information: Bioretec Ltd is planning a rights issue of at least EUR 5 million and up to EUR 15 million with a maximum of 1,500,000,000 new shares

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Inside information: Bioretec Ltd is planning a rights issue of at least EUR 5 million and up to EUR 15 million with a maximum of 1,500,000,000 new shares

Bioretec Ltd  Inside information 10 March 2026 at 21:30 p.m. EET

Inside information: Bioretec Ltd is planning a rights issue of at least EUR 5 million and up to EUR 15 million with a maximum of 1,500,000,000 new shares

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.

Transaction highlights

  • The Offering (as defined below) of at least EUR 5 million and up to EUR 15 million, on the basis of which a maximum of 1,500,000,000 new shares may be issued.
  • Support from Stephen Industries Inc Oy, the largest shareholder of Bioretec Ltd ("Bioretec" or the "Company"), representing approximately 12.00 per cent of all shares and votes in Bioretec. Stephen Industries Inc Oy has undertaken to vote in favour of the proposal by the Board of Directors regarding the Offering at a general meeting. Stephen Industries Inc Oy has given a Subscription Commitment (as defined below) to subscribe for new shares in the Offering on the basis of all subscription rights to be recorded to it and to provide an Underwriting Commitment (as defined below), with the the aggregate amount of the shares subscribed for under the Subscription Commitment and the Underwriting Commitment together being up to EUR 5 million, subject to the Finnish Financial Supervisory Authority granting an exemption from the obligation to launch a mandatory public takeover bid and certain other conditions.
  • The Offering is subject to an authorisation to be sought from the extraordinary general meeting of shareholders to be held on 27 March 2026 (the "EGM") and the resolution by Bioretec's Board of Directors.
  • The Company aims to strengthen its balance sheet, ensure sufficient working capital and finance the working capital needs of its targeted business growth with the proceeds from the Offering aligning with the updated strategy announced on 16 December 2025.

Bioretec announced on 13 February 2026 that the Company's Board of Directors is assessing a potential rights issue based on the shareholders' pre-emptive subscription right in the near future (the "Offering"). Bioretec will today publish a notice to convene the EGM for the purpose of authorising the Board of Directors to resolve on the Offering, on the basis of which a maximum of 1,500,000,000 new shares may be issued. The Offering is expected to be completed in the beginning of the second quarter of 2026, subject to market conditions.

Background for the Offering

The purpose of the Offering is to strengthen the Company's capital base and financing resources supporting the Company in the execution of its strategy announced by a company release on 16 December 2025. The Company aims to strengthen its balance sheet, ensure sufficient working capital and finance the working capital needs of its targeted business growth with the proceeds from the Offering.

EGM

Bioretec will seek authorisation for the Offering from the EGM.

Furthermore, Bioretec is currently assessing its incentive schemes and the possibility to establish a new incentive scheme. In addition to the authorisation sought for the Offering, the Company's Board of Directors will also propose to the EGM to resolve on the authorisation of the Board of Directors to resolve on the issuance of shares and other special rights entitling to shares, on the basis of which a maximum of 250,000,000 shares, including shares to be issued on the basis of special rights, may be issued. The authorisation may be used for implementing the Company's share-based incentive schemes as well as for financing or carrying out acquisitions or other arrangements (including for the payment of any share-based fees in consideration for subscription or underwriting commitments relating to the Offering), for strengthening the Company's balance sheet and financial position, or for other purposes determined by the Board of Directors. The Board of Directors intends to use the authorisation to issue shares on the basis of special rights in an amount corresponding to a dilution effect of no more than 12.00 per cent after the potential completion of the Offering.

Support for the Offering from the Company's largest shareholder and the Company's management

Bioretec has received an irrevocable advance commitment from Stephen Industries Inc Oy to vote in favour of the proposal by the Board of Directors regarding the Offering at a general meeting. In addition, Bioretec has, subject to certain conditions, received advance commitment from Stephen Industries Inc Oy to subscribe for new shares in the Offering on the basis of all subscription rights to be recorded to it (the "Subscription Commitment"). Stephen Industries Inc Oy has also, subject to certain conditions, provided an underwriting commitment for the Offering, pursuant to which Stephen Industries Inc Oy will subscribe for any and all new shares not otherwise subscribed and paid for pursuant to the subscription rights or in the secondary subscription for an aggregate amount of up to EUR 5 million, which amount shall include Stephen Industries Inc Oy's aggregate subscriptions under the Subscription Commitment and any and all new shares subscribed by it in the primary and secondary subscription (the "Underwriting Commitment"). Stephen Industries Inc Oy is a company controlled by the Chair of the Board of Directors of the Company, Kustaa Poutiainen. No fee will be paid to Stephen Industries Inc Oy for the Subscription Commitment. The Company will pay Stephen Industries Inc Oy a fee of approximately 7.5 per cent for the Underwriting Commitment. The fee will be based on the full aggregated amount of the Underwriting Commitment and it will be due and payable in the form of the Company's shares in connection with the completion of the Offering, provided that the Offering will be completed.

Should Stephen Industries Inc Oy's Subscription Commitment and Underwriting Commitment given in respect of the Offering be exercised, the proportion of voting rights in the Company held by Stephen Industries Inc Oy, and thereby indirectly also by Kustaa Poutiainen, in the Company may exceed the 30 per cent and 50 per cent mandatory public takeover bid thresholds referred to in Chapter 11, Section 19 of the Finnish Securities Markets Act (746/2012, as amended, the "SMA"), in the event that the other shareholders of the Company do not exercise their subscription rights in full in the Offering. Stephen Industries Inc Oy and Kustaa Poutiainen intend to apply for a permanent exemption from the Finnish Financial Supervisory Authority pursuant to Chapter 11, Section 26 of the SMA from the obligation to launch a mandatory public takeover bid that may arise as a result of exceeding the mandatory public takeover bid thresholds.

The Subscription Commitment and the Underwriting Commitment given by Stephen Industries Inc Oy in respect of the Offering are conditional upon the Finnish Financial Supervisory Authority granting such an exemption and certain customary conditions. In addition, the Underwriting Commitment is conditional upon no change, event, occurrence, circumstance or development having occurred between the date of the Underwriting Commitment and the settlement and delivery date of the Offering that, individually or in the aggregate, has had or would reasonably be expected to have a material adverse effect on the business, financial condition, results of operations, assets, liabilities or prospects of the Company and its subsidiaries, taken as a whole.

Furthermore, certain members of the Company's management have indicated that they intend to participate in the Offering as well.

Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec, comments:

"I am very excited by the momentum we are building at Bioretec and the opportunities that lie ahead. With three breakthrough device designations and CMS pass-through payment status for our absorbable metal in hand, now is the moment to accelerate our advantageous position in the market and capitalise on our opportunities. Our US direct sales model has been delivering consistent quarterly growth since Q2 of 2025. There is a clear need to invest in expanding our commercial offering for RemeOs™ and building a US-based commercial organisation that can drive topline growth. Built on a foundation of globally recognised scientific capabilities, Bioretec has a strong platform from which to pursue commercial and operational excellence as well. To capture these opportunities, we will arrange this rights issue with a firm focus on capital-efficient execution of our strategy and disciplined scrutiny across our business, with the aim of generating value for our shareholders."

Lead manager

Bioretec has appointed DNB Carnegie Investment Bank AB, Finland Branch as the lead manager for the 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.

 

 



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.



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 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

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 thebiological interfaceof active implantsto 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 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’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.

 



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

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 thebiological interfaceof active implantsto 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



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

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



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

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