Inside information: Bioretec Ltd's Board of Directors resolved on a rights issue of approximately EUR 9.2 million and publishes the terms and conditions of the fully guaranteed rights issue

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Inside information: Bioretec Ltd's Board of Directors resolved on a rights issue of approximately EUR 9.2 million and publishes the terms and conditions of the fully guaranteed rights issue

Bioretec Ltd Inside information 28 May 2025 at 2.00 p.m. EEST

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SOUTH AFRICA OR SINGAPORE, OR ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

The Board of Directors of Bioretec Ltd ("Bioretec" or the "Company") has today 28 May 2025, based on the authorisation of the Annual General Meeting of the Company held on 21 March 2025, resolved to offer Bioretec's shareholders up to 6,156,618 new shares (the "New Shares") for subscription primarily on the basis of shareholders' pre-emptive subscription right in the same proportion as they already hold shares in the Company (the "Existing Shares") and secondarily by other shareholders or by other persons in a rights issue of approximately EUR 9.2 million (the "Offering"). The subscription price for each New Share is EUR 1.50 (the "Subscription Price"). The objective of the Offering is to strengthen Bioretec's capital structure and to ensure its ability to implement its RemeOs™ commercialisation strategy. The proceeds from the Offering are intended to be used to strengthen the commercialization of the RemeOs™ pipeline by expanding sales and marketing activities and the enhancement of distribution networks in key markets, support the Company’s product development within the RemeOs™ portfolio, and fund operational scaling, covering working capital requirements and investments in machinery and facility expansion.

The Offering in brief

In the Offering, Bioretec is seeking gross proceeds amounting to approximately EUR 9.2 million by offering up to 6,156,618 New Shares for subscription. The Offering is fully guaranteed by the Company's largest shareholder, Stephen Industries Inc Oy by way of underwriting commitment.
As announced by Bioretec in November 2024, the Company estimates that it will require approximately EUR 18 million in total external funding in order to reach positive cash flow from operating activities by the end of the year 2027. Following the announcement, the Company raised approximately EUR 6 million in gross proceeds (net proceeds of approximately EUR 5.5 million) through a directed share issue. Bioretec estimates that the proceeds raised from the Offering would extend the Company's funding into the third quarter of 2026, in accordance with the Company's current operational plans.
Existing shareholders of Bioretec have a primary right to subscribe for New Shares with pre-emptive subscription rights, which will be offered to them in the same proportion as they hold shares in Bioretec on 2 June 2025, being the record date of the Offering (the "Record Date").
Shareholders who are registered on the shareholders register maintained by Euroclear Finland Ltd ("Euroclear Finland") on the Record Date shall receive one (1) subscription right (the "Subscription Right") per each (1) Existing Share held by the shareholder in the form of a book-entry. The Subscription Rights will be recorded on shareholders' book-entry accounts in the book-entry system maintained by Euroclear Finland on 3 June 2025. The first trading day of Bioretec’s Existing Shares without Subscription Rights is 30 May 2025.
Four (4) Subscription Rights entitle the holder to subscribe for one (1) New Share at the Subscription Price of EUR 1.50 (the "Primary Subscription"). No fractional New Shares will be issued, and no Subscription Right may be used only in part.
The subscription period of the New Shares will commence on 5 June 2025 at 9:30 a.m. Finnish time and will end on 19 June 2025 at 4:00 p.m. Finnish time (the "Subscription Period"), unless the Subscription Period is extended. Unused Subscription Rights will become void upon the end of the Subscription Period.
The Subscription Rights are freely transferable and subject to trading on Nasdaq First North Growth Market Finland marketplace ("First North") under the trading code "BRETECU0125" and ISIN code FI4000590948 between 5 June 2025 and 12 June 2025.
Where not all New Shares are subscribed for in the Primary Subscription, both the Company's shareholders and other investors have a right to subscribe for the unsubscribed New Shares without Subscription Rights (the "Secondary Subscription") at the Subscription Price. The Company's Board of Directors will resolve on the allocation of New Shares subscribed for without Subscription Rights in the Secondary Subscription in accordance with the allocation preference described below.
In connection with the Offering, Bioretec will prepare an exemption document (the "Exemption Document") in accordance with Article 1.4 db) of Regulation (EU) 2017/1129 of the European Parliament and of the Council ("Prospectus Regulation"). The Exemption Document will be prepared in the Finnish language and in accordance with the requirements of Annex IX of the Prospectus Regulation. Bioretec will publish the Exemption Document on or about 4 June 2025. An unofficial English-language translation of the Exemption Document will be published on or about 4 June 2025.
Bioretec has received an irrevocable commitment, subject to certain customary conditions, from Stephen Industries Inc Oy to subscribe for New Shares in the Offering on the basis of all Subscription Rights to be recorded to them (the "Subscription Commitment"). The Subscription Commitment represents approximately EUR 1.0 million and approximately 10.4 per cent of the New Shares provided that the Offering will be fully subscribed. In addition, Bioretec has received an underwriting commitment from Stephen Industries Inc Oy to subscribe for any and all New Shares remaining after allocation pursuant to Secondary Subscriptions (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 on the Subscription Commitment or the Underwriting Commitment.
In addition to the Subscription and Underwriting Commitment, the Company's shareholders, including but not limited to Ilmarinen Mutual Pension Insurance Company, Handelsbanken Fonder AB, Sijoitusrahasto Säästöpankki Pienyhtiöt, Varma Mutual Pension Insurance Company, Danske Invest, VR Pension Fund, eQ Finland and Aktia Fund Management Company Ltd for and on behalf of mutual funds managed by it who together hold approximately 38.1 per cent of the Existing Shares in the Company (including the Subscription Commitment by Stephen Industries Inc Oy), have indicated that they intend to subscribe for New Shares in the Offering on the basis of all Subscription Rights to be recorded to them.
DNB Carnegie Investment Bank AB, Finland Branch and Danske Bank A/S, Finland Branch are acting as the joint global coordinators and joint bookrunners of the Offering (the "Joint Global Coordinators").
The terms and conditions of the Offering are attached to this release.

"Bioretec's business is now progressing rapidly, and the future looks bright. I strongly believe in the company's long-term goals and that it has all the prerequisites to grow into a significant player internationally. It is important for me to be involved in making Bioretec the next Finnish success story. Therefore, the company under my control and Bioretec's biggest owner, Stephen Industries, fully supports this rights issue with a commitment to subscribe any shares that may not be subscribed for," states Kustaa Poutiainen, Chair of the Board of Directors of Bioretec.

"I am very excited about the market potential of RemeOs products and their absorbable metal alloy properties, which promote natural bone healing and optimize the treatment of orthopedic injuries. Bioretec is entering the next phase of its commercial journey, as the RemeOs trauma screw has, in addition to the U.S. FDA approval, recently received CE mark, which covers Europe and certain other countries that recognize this certification. To capitalize on the opportunities ahead, we will arrange this rights issue, aiming to reinforce our capital structure and secure the resources needed to successfully execute our commercial strategy," says Sarah van Hellenberg Hubar-Fisher, interim CEO of Bioretec.

General

The number of all shares in the Company may as a result of the Offering increase from the 24,626,474 Existing Shares to up to 30,783,092 shares in total. Provided that the Offering is fully subscribed, the New Shares will correspond to approximately 20.0 per cent of all shares.

Bioretec's Board of Directors has the right not to approve subscriptions received after the end of the Subscription Period. Bioretec's Board of Directors is entitled to extend the Subscription Period.

The Subscription Price is EUR 1.50 per New Share. The Subscription Price implies a customary discount for rights issues of approximately 24.8 per cent compared to the theoretical ex-rights price based on the closing price, EUR 2.12, of the Existing Shares on First North on the trading day immediately preceding the resolution on the Offering (27 May 2025). The Subscription Price for New Shares will be recorded in the fund for invested unrestricted equity of the Company.

If not all of the New Shares have been subscribed for with the Subscription Rights in the Primary Subscription, the Company's Board of Directors will resolve on the allocation of New Shares subscribed for without Subscription Rights in the Secondary Subscription as follows:

First to those who have subscribed for New Shares also with Subscription Rights in the Primary Subscription. If such subscribers oversubscribe the Offering, the allocation to such subscribers shall be determined on a per-book-entry account basis pro rata to the Subscription Rights used to subscribe for New Shares and, if this is not possible, by a drawing of lots.
Second to those who have subscribed for New Shares only without Subscription Rights in the Secondary Subscription. If such subscribers oversubscribe the Offering, the allocation to such subscribers shall be determined on a per-book-entry account basis pro rata to the New Shares subscribed for by such subscribers and, if this is not possible, by a drawing of lots.
Third to the issuer of the Underwriting Commitment.

The Company's Board of Directors will on or about 24 June 2025 (unless the Subscription Period is extended) approve subscriptions made with Subscription Rights and in accordance with the terms and conditions of the Offering and applicable law and regulations. In addition, the Board of Directors will on or about 24 June 2025 (unless the Subscription Period is extended) approve subscriptions made without Subscription Rights and in accordance with the terms and conditions of the Offering and applicable law and regulations.

The Company will on or about 24 June 2025 (unless the Subscription Period is extended) publish the final results of the Offering and the aggregate number of New Shares subscribed for by way of a company announcement.

The New Shares subscribed for with Subscription Rights will be recorded on investors' book-entry accounts as interim shares corresponding to the New Shares (the "Interim Shares") after subscriptions have been made and paid for. The ISIN code of the Interim Shares is FI4000590955 and the trading code on First North is "BRETECN0125". The Interim Shares will be freely transferable, and trading in the Interim Shares on First North as a separate share series commences on or about 6 June 2025 (provided that Nasdaq Helsinki accepts the Company's listing application). The Interim Shares will be combined with the Company's Existing Shares (ISIN code: FI4000480454 and trading code: "BRETEC") once the New Shares have been registered with the Trade Register upheld by the Finnish Patent and Registration Office. The combination will take place on or about 27 June 2025 (unless the Subscription Period is extended).

New Shares subscribed for without Subscription Rights will be recorded on the subscriber's book-entry account as shares on or about 27 June 2025 (unless the Subscription Period is extended). Trading in the New Shares will commence on First North on or about 27 June 2025 (unless the Subscription Period is extended).

Subscription and Underwriting Commitments

Bioretec has received a Subscription 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 them. The Subscription Commitment represents a total of approximately EUR 1.0 million and 10.4 per cent of the New Shares provided that the Offering will be fully subscribed. In addition, Bioretec has received an Underwriting Commitment from Stephen Industries Inc Oy to subscribe for any and all New Shares remaining after allocation according to the Secondary Subscriptions has been made. 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 on the Subscription Commitment or the Underwriting Commitment.

In addition to the Subscription and Underwriting Commitment, the Company's shareholders, including but not limited to Ilmarinen Mutual Pension Insurance Company, Handelsbanken Fonder AB, Sijoitusrahasto Säästöpankki Pienyhtiöt, Varma Mutual Pension Insurance Company, Danske Invest, VR Pension Fund, eQ Finland and Aktia Fund Management Company Ltd for and on behalf of mutual funds managed by it who together hold approximately 38.1 per cent of the Existing Shares in the Company (including the Subscription Commitment by Stephen Industries Inc Oy), have indicated that they intend to subscribe for New Shares in the Offering on the basis of all Subscription Rights to be recorded to them.

Important dates

30 May 2025	First trading date without subscription rights
2 June 2025	Record date of the Offering
5 June 2025	The Subscription Period for the Offering commences
5 June 2025	Trading in the Subscription Rights commences on First North
6 June 2025	Trading in the Interim Shares commences on First North
12 June 2025	Trading in the Subscription Rights ends on First North
19 June 2025	The Subscription Period for the Offering ends and unused Subscription Rights become void
23 June 2025	Announcement of the initial results of the Offering (estimated)
24 June 2025	Announcement of the final results of the Offering (estimated)
26 June 2025	Trading in the Interim Shares ends on First North (estimated)
26 June 2025	The New Shares subscribed for in the Offering are registered in the Trade Register (estimated)
27 June 2025	Interim shares are converted into New Shares (estimated)
27 June 2025	Trading in the New Shares commences on First North (estimated)

In connection with the Offering, Bioretec will prepare the Exemption Document in accordance with Article 1.4 db) of the Prospectus Regulation. The Exemption Document will be available at Bioretec's website at https://investors.bioretec.com/fi/osakeanti_2025 on or about 4 June 2025. In addition, the Exemption Document will be available on the website of Danske Bank A/S, Finland Branch at https://danskebank.fi/bioretec on or about 4 June 2025.

The unofficial English-language translation of the Exemption Document will be available at Bioretec's website at https://investors.bioretec.com/en/offering_2025 on or about 4 June 2025 and on the website of Danske Bank A/S, Finland Branch at https://danskebank.fi/bioretec-en on or about 4 June 2025.

DNB Carnegie Investment Bank AB, Finland Branch and Danske Bank A/S, Finland Branch are acting as the Joint Global Coordinators and the Joint Bookrunners of the Offering. Krogerus Attorneys Ltd is acting as the legal counsel to the Company. Borenius Attorneys Ltd is acting as the legal counsel to the Joint Global Coordinators. Bravura Ltd is acting as the communications adviser to the Company.

Bioretec Ltd
The Board of Directors

Further enquiries

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

Johanna Salko, CFO, +358 40 754 8172

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. 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. 

Bioretec is commercializing and developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite - a new generation of strong biodegradable 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better healing - Better life. www.bioretec.com

IMPORTANT INFORMATION

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 the United States, Australia, Canada, Hong Kong, Japan, New Zealand, South Africa or Singapore or any other jurisdiction in which publication or distribution would be unlawful. 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.

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 has not been approved by any competent authority. This release neither describes nor purports to describe risks (direct or indirect) that may be associated with an investment in the Company's securities. In connection with the offering, the Company will prepare an exemption document in accordance with Article 1.4 db of the Prospectus Regulation. The exemption document will be prepared in accordance with the requirements of Annex IX to the Prospectus Regulation. The exemption document does not constitute a prospectus under the Prospectus Regulation and will neither be reviewed nor approved by the Finnish Financial Supervisory Authority.

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.

The Joint Global Coordinators are acting exclusively for the Company and no one else in connection with the offering. They will not regard any other person as their respective client in relation to the offering. The Joint Global Coordinators will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients nor for giving advice in relation to the offering or any transaction or arrangement referred to herein.

Notice to distributors

Solely for the purposes of the product governance requirements set forth in (a) Directive 2014/65/EU (as amended, "MiFID II"); (b) Articles 9 and 10 of the Commission Delegated Directive 2017/593/EU supplementing MiFID II; and (c) local implementation measures (together "MiFID II Product Governance Requirements"), and disclaiming any liability the "manufacturer" (due to MiFID II Product Governance Requirements) may otherwise have, regardless of whether the liability is based on infringement, contract or otherwise, the Subscription Rights and the New Shares have been subject to an approval process whereby each of them: (i) satisfies the target market requirements of end customers for retail investors, as well as the requirements for investors defined as professional clients and eligible counterparties, as separately defined in MiFID II (the "Target Market Assessment"); and (ii) are suitable for offering through all distribution channels, as permitted in MiFID II. Distributors should note that the value of Subscription Rights and New Shares may decline and investors may not be able to recover all or part of the amount they have invested; Subscription Rights and New Shares do not guarantee any profits or capital protection; and investments in Subscription Rights and New Shares are suitable only for investors who do not need guaranteed profits or capital protection, and who (alone or in conjunction with an appropriate financial or other advisor) are able to assess the benefits and risks of such investment and have sufficient funds from investments to cover any losses incurred. The target market assessment does not affect the sales restrictions based on agreement, law or other regulation in the Offering.

The Target Market Assessment should not be considered as (a) an assessment of appropriateness or suitability under MiFID II or (b) a recommendation to an investor or a group of investors to invest, acquire or take any other action regarding the Subscription Rights or the New Shares. Each distributor is responsible for its own Target Market Assessment of the Subscription Rights and the New Shares and for determining the appropriate distribution channels.

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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New shares of Bioretec Ltd subscribed with option rights have been registered with the trade register

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New shares of Bioretec Ltd subscribed with option rights have been registered with the trade register

Bioretec Ltd Company announcement 20 May 2025 at 2.00 p.m. EEST

An aggregate number of 60,000 new shares of Bioretec Ltd have been subscribed for with option rights under option program 2018-1A. The new shares have on 20 May 2025 been registered with the trade register maintained by the Finnish Patent and Registration Office. The total subscription price of EUR 90,000.00 will be recorded in Bioretec's reserve of invested unrestricted equity, and the company's share capital remains unchanged.

Following the registration of the new shares, the total number of shares in Bioretec is 24,626,474.

The new shares will be issued in the book-entry system on or about tomorrow 21 May 2025. The new shares will confer shareholder rights in the company as of their registration on the investors' book-entry accounts. Trading in the new shares is expected to commence on Nasdaq First North Growth Market Finland on or about 22 May 2025.

Further enquiries

Sarah van Hellenberg Hubar-Fisher, Interim CEO, +31 6 1544 8736
Johanna Salko, CFO, +358 40 754 8172

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Better healing - Better life. www.bioretec.com

by Admin

Inside information: Sarah van Hellenberg Hubar-Fisher appointed interim CEO of Bioretec

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Inside information: Sarah van Hellenberg Hubar-Fisher appointed interim CEO of Bioretec

Bioretec Ltd Inside information 15 May 2025 at 10.15 a.m. EEST

Bioretec's Board of Directors has appointed MBA Sarah van Hellenberg Hubar-Fisher as the company's interim CEO. Van Hellenberg Hubar-Fisher will take up her position effective immediately.

Van Hellenberg Hubar-Fisher will continue as a member of the company's Board of Directors and as a member of the Board's Audit Committee in addition to her role as the CEO. As a result of van Hellenberg Hubar-Fisher's appointment, the Board of Directors has decided to transfer the duties the Board's Remuneration Committee to the Board of Directors until further notice.

Bioretec's Board of Directors will continue the process of recruiting a new CEO.

"CEO Sarah van Hellenberg Hubar-Fisher starts the new growth phase for Bioretec. She brings over 23 years of global healthcare leadership and new technology introduction experience, and we are keen to leverage that expertise in bringing Bioretec to the next level with the aim of becoming a leader in absorbable orthopedic implants globally", says Kustaa Poutiainen, Chair of the Board of Directors.

"I could not be more enthusiastic about the next phases of growth for Bioretec and the opportunity to lead us there. Bioretec is poised to aim for market leadership, and our organization is ready to promote its realization for the patients who deserve and have been waiting for high-quality and reliable absorbable implants", says Sarah van Hellenberg Hubar-Fisher.

Bioretec Ltd
Board of Directors

Further enquiries

Kustaa Poutiainen, Chair of the Board, +358 40 042 4506

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Bioretec in brief

Bioretec is commercializing and developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite ‒ a new generation of strong biodegradable 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

by Admin

Bioretec Ltd´s business review Q1 2025: Strong net sales in the first quarter; CE approval with comprehensive indications received in January accelerates the future expansion of RemeOs products

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Bioretec Ltd´s business review Q1 2025: Strong net sales in the first quarter; CE approval with comprehensive indications received in January accelerates the future expansion of RemeOs products

Bioretec Ltd Company announcement 15 May 2025 at 8:00 a.m.

This announcement summarizes Bioretec Ltd’s business review for January–March 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

January – March 2025 in brief

In January, Bioretec's RemeOs™ trauma screw product family received comprehensive CE approval, allowing market launch in Europe and non-European countries that recognize the CE mark.
Commercialization efforts progressed with several new distribution agreements signed in the U.S.
The new CE-marked RemeOs products are being transferred into production, and preparations are continuing to increase the manufacturing capacity and ramp up their production.
Net sales amounted to EUR 1,396 thousand (1–3/2024: EUR 682 thousand). The increase was achieved due to strong sales to China. Scheduling Activa orders for the first quarter allows more resources to be dedicated to RemeOs for the remainder of the year.
The sales margin (excl. other income) was EUR 822 (418) thousand, or 58.9% (61.3%) of net sales. The sales margin was slightly lower due to the increased share of sales to China in the first quarter, where the volume-based procurement policies continued to impact the pricing. Furthermore, the sales margin in the comparison period was suppressed by the planned production shutdown related to the ramp-up of new production capacity.
EBITDA was EUR -1,236 (-1,112) thousand. EBITDA was burdened by increased personnel costs due to headcount growth and additional fixed costs relating to commercialization and R&D projects.
The result for the reporting period amounted to EUR -1,298 (-1,097) thousand.

This business review is unaudited.

Key figures

EUR 1,000 unless otherwise noted	1–3/2025	1–3/2024	Change	1–12/2024
Net sales	1,396	682	104.7%	4,544
Sales margin	921	478	92.6%	3,391
Sales margin (excl. other income)	822	418	96.7%	3,221
Sales margin, % of net sales	65.9%	70.1%		74.6%
Sales margin, % (excl. other income)	58.9%	61.3%		70.9%
EBITDA	-1,236	-1,112	11.2%	-4,053
EBIT	-1,287	-1,139	13.0%	-4,202
Profit/-loss for the period (+/-)	-1,298	-1,097	18.3%	-4,614
R&D expenditure, % of net sales	45.7%	61.3%		48.0%
Equity ratio, %	82.2%	74.3%		84.9%
Cash and cash equivalents at the end of the period	4,424	5,981	-26.0%	6,289
Personnel at end of the period	48	39	23.1%	47

Key events in the reporting period

In January, Bioretec's RemeOs™ trauma screw product family received comprehensive CE approval, allowing market launch in Europe and non-European countries that recognize the CE mark. The approval covers all cannulated and non-cannulated product designs with sizes ranging from 2.0 mm to 4.0 mm in diameter and 8 mm to 50 mm in length. Approved indications include the use of screws in fracture and malalignment fixations in the upper and lower extremities of adult and pediatric patients, excluding the small bones in the hand and forefoot.

CHAIR OF THE BOARD’S COMMENTS

Ramping up for sustainable growth

The first quarter of 2025 marked a pivotal phase in our commercialization journey, setting the stage for accelerated global growth. High volume orders from China contributed significantly to topline performance, reflecting both customer confidence and our readiness to scale. At the same time, we achieved record production output and signed the highest number of new U.S. distribution agreements in a single quarter, further expanding our commercial footprint. Amid macroeconomic uncertainty, the differentiated clinical and economic value of our RemeOs™ bioabsorbable implants continues to set us apart.

Net sales in the first quarter of 2025 reached EUR 1.4 million—up by 105 per cent from the previous year. Growth was primarily driven by the Activa product line sales in China, supported by our broad portfolio and established customer base. Momentum is accelerating for a successful U.S. rollout of RemeOs, with early clinical adoption, expanding distributor coverage, and growing surgeon interest validating market demand.

Our U.S. expansion gained momentum by signing eight new distribution agreements in the quarter, now spanning 14 states and more than 80 representatives. These partners were carefully selected to cover major metropolitan areas with dense hospital networks and high surgical volumes. In parallel, the Activa product line continues its successful introduction into the U.S. market. To further support adoption, we are preparing to launch a line of single-use instruments in the second half of 2025 – an essential step in addressing efficiency and safety demands in high-volume surgical environments.

The CE mark approval for RemeOs™ Trauma Screws received in January enables immediate commercialization in Europe and other CE-recognizing markets, unlocking significant new opportunities. The CE mark encompasses all implant designs and a broad range of indications. It enables immediate European launch and lays the foundation for real-world clinical data collection, which will support both local market expansion and broader U.S. indication expansions. We are actively onboarding and training our distributor and direct sales teams across Europe, with early commercial activity already underway.

On the innovation front, we continued to advance our pipeline. The RemeOs Spinal Interbody Cage program achieved a key milestone with successful large-animal proof-of-concept implantations. The RemeOs DrillPin study has initiated site selection and training to commence patient enrollment. In the U.S., the 510(k) process for our cannulated screw is progressing, while the CE-approved RemeOs line has entered post-market clinical follow-up (PMCF) trials in adult and pediatric cases across upper and lower extremities. We also started developing single-use instruments tailored to the US customer needs.

Manufacturing capacity will be further increased in the coming months, with the scaling-up of the production of the RemeOs portfolio already underway. To support the next phase of commercialization, product development, and clinical validation, we contemplate launching a new funding round by the third quarter of this year at the latest.

While global headwinds persist, we remain confident and focused on our strategy and execution. With the CE mark approval secured and momentum building across key markets, we are well-positioned to deliver growth and long-term value.

Kustaa Poutiainen, Chair of the Board

KEY EVENTS AFTER THE REPORTING PERIOD

On May 8, the Board of Directors of Bioretec Ltd announced that the company's CEO, Alan Donze, will resign from his position and will remain available for the company until July 7, 2025. The Board of Directors will immediately initiate the process of recruiting a new CEO.

COMMERCIALIZATION STATUS

Milestones achieved:

RemeOs™ Trauma Screw received FDA approval in the U.S. in March 2023. Bioretec announced 100% healing rate with the patients treated during the initial focused product launch phase of RemeOs™ Trauma Screw in the U.S. in June 2024.
In 2024, Bioretec strengthened its marketing and sales experience and know-how by appointing key leaders in the U.S. and Europe.
In January 2025, Bioretec received a comprehensive CE mark approval for RemeOs products, allowing market launch in Europe and non-European countries that recognize the CE mark.
To support direct sales of both RemOs and Activa products, Bioretec has entered into new distribution agreements in the U.S. in the past few months covering currently 14 states with over 80 individual representatives. Earlier in 2024, Bioretec entered into logistics agreements both in the U.S. and Europe to ensure seamless operations and customer service support in both continents.
Bioretec commenced the development of single-use instrumentation for the RemeOs and Activa products, which is favored in the U.S market due to its efficiency and risk mitigation.

Next steps:

First RemeOs screws to be shipped to distributors and hospitals in Europe, and first surgeries with RemeOs products to be performed in Europe.
Bioretec shall further strengthen the commercialization efforts of both the RemeOs and Activa products in the
U.S. by entering into additional local sales and distribution agreements with partners acting as agents.
To keep up with the growth and future potential, Bioretec will further scale up the manufacturing capacity and focus on building excellence in sales and marketing capabilities. The company plans to capitalize on the broad indication coverage of the CE mark and collect real-world clinical evidence in order to expand indications in the U.S., where current approvals are more limited.
In the U.S., an FDA 510(k)-registration application process to widen the product range of the RemeOs Trauma Screw is ongoing.
Preparing to launch the first single-use instrumentation sets for the RemeOs and Activa products in the second half of 2025.

Financial reporting in 2025

In 2025, Bioretec will publish the following financial reports:

half-year report for January–June 2025 on Thursday 14 August 2025
business review for January–September 2025 on Thursday 13 November 2025

Tampere, 15 May 2025

Board of Directors

Bioretec Ltd

For additional information:

Kustaa Poutiainen Johanna Salko

Chair of the Board CFO

+358 40 042 4506 +358 40 754 8172

kustaa.poutiainen@stephenindustries.com johanna.salko@bioretec.com

Certified advisor:

Nordic Certified Adviser AB, p. +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of absorbable orthopedic implants. 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.

Bioretec is commercializing and developing the new RemeOs™ product line based on a 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

Appendix

Bioretec Ltd’s business review January–March 2025 (pdf)

wkr0006.pdf

by Admin

Inside information: Bioretec´s CEO Alan Donze to resign

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Inside information: Bioretec´s CEO Alan Donze to resign

Bioretec Ltd Inside information 8 May 2025 at 6:45 p.m. EET

The Board of Directors of Bioretec Ltd announces that the company's CEO, Alan Donze, will resign from his position and will remain available for the company until July 7, 2025.

The Board of Directors of Bioretec would like to thank Alan Donze for his work as CEO.

The Board of Directors will immediately initiate the process of recruiting a new CEO.

Further enquiries

Kustaa Poutiainen, Chair of the Board, +358 40 042 4506

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Bioretec in brief

Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

by Admin

Bioretec Ltd – Managers’ transactions – Alan Donze

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Bioretec Ltd – Managers’ transactions – Alan Donze

Bioretec Ltd Managers’ transactions 9 April 2025 at 17.15 p.m. EET

Bioretec Oy - Managers' Transactions

__________________________________________

Person subject to the notification requirement

Name: Alan Donze

Position: Chief Executive Officer

Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: INITIAL NOTIFICATION

Reference number: 103643/7/6

____________________________________________

Transaction date: 2025-04-08

Outside a trading venue

Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT

Name of the instrument: Bioretec Ltd, Option program 2025-2

Nature of transaction: ACCEPTANCE OF A STOCK OPTION

(X) Linked to stock option programme

Transaction details

(1): Volume: 610105 Unit price: 0 EUR

Aggregated transactions (1):

Volume: 610105 Volume weighted average price: 0 EUR

Further enquiries

Johanna Salko, CFO, tel. +358 40 754 8172

Certified adviser: Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is developing the new RemeOs™ product line based on a 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

by Admin

Bioretec Ltd – Managers’ transactions – Justin Barad

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Bioretec Ltd – Managers’ transactions – Justin Barad

Bioretec Ltd Managers’ transactions 9 April 2025 at 17.00 p.m. EET

Bioretec Oy - Managers' Transactions

__________________________________________

Person subject to the notification requirement

Name: Justin Barad

Position: Member of the Board/Deputy member

Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: INITIAL NOTIFICATION

Reference number: 103639/6/6

____________________________________________

Transaction date: 2025-04-08

Outside a trading venue

Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT

Name of the instrument: Bioretec Ltd, Option program 2025-1

Nature of transaction: ACCEPTANCE OF A STOCK OPTION

(X) Linked to stock option programme

Transaction details

(1): Volume: 25000 Unit price: 0 EUR

Aggregated transactions (1):

Volume: 25000 Volume weighted average price: 0 EUR

Further enquiries

Johanna Salko, CFO, tel. +358 40 754 8172

Certified adviser: Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Better healing – Better life. www.bioretec.com

by Admin

Bioretec Ltd – Managers’ transactions – Antti Vasara

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Bioretec Ltd – Managers’ transactions – Antti Vasara

Bioretec Ltd Managers’ transactions 9 April 2025 at 17.00 p.m. EET

Bioretec Oy - Managers' Transactions

__________________________________________

Person subject to the notification requirement

Name: Antti Vasara

Position: Member of the Board

Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: INITIAL NOTIFICATION

Reference number: 103634/7/6

____________________________________________

Transaction date: 2025-04-07

Outside a trading venue

Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT

Name of the instrument: Bioretec Ltd, Option program 2025-1

Nature of transaction: ACCEPTANCE OF A STOCK OPTION

(X) Linked to stock option programme

Transaction details

(1): Volume: 25000 Unit price: 0 EUR

Aggregated transactions (1):

Volume: 25000 Volume weighted average price: 0 EUR

Further enquiries

Johanna Salko, CFO, tel. +358 40 754 8172

Certified adviser: Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Better healing – Better life. www.bioretec.com

by Admin

Bioretec Ltd – Managers’ transactions – Päivi Malinen

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Bioretec Ltd – Managers’ transactions – Päivi Malinen

Bioretec Ltd Managers’ transactions 9 April 2025 at 17.00 p.m. EET

Bioretec Oy - Managers' Transactions

__________________________________________

Person subject to the notification requirement

Name: Päivi Malinen

Position: Member of the Board/Deputy member

Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: INITIAL NOTIFICATION

Reference number: 103640/7/6

____________________________________________

Transaction date: 2025-04-08

Outside a trading venue

Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT

Name of the instrument: Bioretec Ltd, Option program 2025-1

Nature of transaction: ACCEPTANCE OF A STOCK OPTION

(X) Linked to stock option programme

Transaction details

(1): Volume: 25000 Unit price: 0 EUR

Aggregated transactions (1):

Volume: 25000 Volume weighted average price: 0 EUR

Further enquiries

Johanna Salko, CFO, tel. +358 40 754 8172

Certified adviser: Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Better healing – Better life. www.bioretec.com

by Admin

Bioretec Ltd – Managers’ transactions – Michael Piccirillo

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Bioretec Ltd – Managers’ transactions – Michael Piccirillo

Bioretec Ltd Managers’ transactions 9 April 2025 at 17.00 p.m. EET

Bioretec Oy - Managers' Transactions

__________________________________________

Person subject to the notification requirement

Name: Michael Piccirillo

Position: Member of the Board/Deputy member

Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: INITIAL NOTIFICATION

Reference number: 103630/9/8

____________________________________________

Transaction date: 2025-04-07

Outside a trading venue

Instrument type: FINANCIAL INSTRUMENT LINKED TO A SHARE OR A DEBT INSTRUMENT

Name of the instrument: Bioretec Ltd, Option program 2025-1

Nature of transaction: ACCEPTANCE OF A STOCK OPTION

(X) Linked to stock option programme

Transaction details

(1): Volume: 25000 Unit price: 0 EUR

Aggregated transactions (1):

Volume: 25000 Volume weighted average price: 0 EUR

Further enquiries

Johanna Salko, CFO, tel. +358 40 754 8172

Certified adviser: Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Better healing – Better life. www.bioretec.com

by Admin

Press Release

Inside information: Bioretec Ltd's Board of Directors resolved on a rights issue of approximately EUR 9.2 million and publishes the terms and conditions of the fully guaranteed rights issue

New shares of Bioretec Ltd subscribed with option rights have been registered with the trade register

Inside information: Sarah van Hellenberg Hubar-Fisher appointed interim CEO of Bioretec

Bioretec Ltd´s business review Q1 2025: Strong net sales in the first quarter; CE approval with comprehensive indications received in January accelerates the future expansion of RemeOs products

Inside information: Bioretec´s CEO Alan Donze to resign

Bioretec Ltd – Managers’ transactions – Alan Donze

Bioretec Ltd – Managers’ transactions – Justin Barad

Bioretec Ltd – Managers’ transactions – Antti Vasara

Bioretec Ltd – Managers’ transactions – Päivi Malinen

Bioretec Ltd – Managers’ transactions – Michael Piccirillo