Inside information: Bioretec Ltd. receives CE mark approval for RemeOs™ Trauma Screw product portfolio, allowing market launch in Europe

Bioretec Ltd    Inside information       31 January 2025 at 7:45 p.m. EET

Bioretec Ltd., a pioneer in absorbable orthopedic implants, has successfully completed its CE mark approval process and can start commercialization of its RemeOs™ Trauma Screw product portfolio within the European Union and non-European countries that recognize the CE mark market authorization. This comprehensive approval covers all cannulated and non-cannulated product designs*, with sizes ranging from diameters of 2.0mm to 4.0mm and lengths from 8mm to 50mm. Indications approved include the use of these screws for fracture and malalignment fixations in both upper and lower extremities of adult and pediatric patients, excluding the hand and forefoot.

"We are extremely pleased that the EU market approval includes all designs and a vast number of indications. We can now immediately begin offering all RemeOs™ Trauma Screws to patients across Europe. Moreover, this approval paves the way for market entry into non-European countries that recognize the CE mark, and it empowers us to collect real-world clinical evidence. This evidence will enable the expansion of indications in the U.S., where the current approval is more limited," comments Alan Donze, CEO of Bioretec.

*RemeOs FT cannulated, RemeOs FL cannulated, RemeOs FC cannulated and RemeOs LAG Solid

Further enquiries

Alan Donze, CEO, +1 619 977 5285
Johanna Salko, CFO, +358 40 754 8172

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Bioretec in brief

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 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

Proposals of the Shareholders' Nomination Board of Bioretec Ltd to the Annual General Meeting 2025

Bioretec Ltd  Company announcement  30 January 2025 at 10.30 a.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 March 21, 2025, 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 2026:

• Chairperson of the Board: EUR 3,750 per month (2024: EUR 10,000);
• Deputy Chairperson of the Board: EUR 2,500 per month if the Board of Directors elects a Deputy Chairperson e.g. to support successor planning; and
• Board members: EUR 2,000 per month (2024: EUR 1,500)

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 (2024: 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,
• MBA, M.Sc. Nutritional Epidemiology and Public Health Sarah van Hellenberg Hubar-Fisher,
• LL.M Päivi Malinen, and
• M.Sc. (Econ) Kustaa Poutiainen be re-elected as members of the Board of Directors.

Furthermore, the Nomination Board proposes that

• Doctor of Science (Technology) Antti Vasara and
• MD Justin Barad be elected as new members of the Board of Directors.

Tomi Numminen has indicated that he is unavailable for re-election to the Board of Bioretec.

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 2026.

Presentations of the current members of the Board of Directors are available at https://bioretec.com/investors/investors-suomeksi/hallinnointi/hallitus.

A brief presentation of the new candidates 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:

• Kustaa Poutiainen, Chair and Founder, Stephen Industries Inc Oy (Chair)
• Karoliina Lindroos, Head of Responsible Investment, Ilmarinen Mutual Pension Insurance Company
• Marko Berg, Investment Manager, University of Helsinki

Tomi Numminen, Chairperson of the Board, acts as an expert to the Nomination Board.

For further information:

Kustaa Poutiainen, Chairperson of the Nomination Board, +358 40 042 4506

Attachment: Presentation of new candidates

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 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 process is currently on-going. 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

-           

Bioretec_Presentation of new candidates.pdf

Bioretec Ltd’s schedule for financial reporting in 2025

Bioretec Ltd                           Company announcement                          16 December 2024 at 6.15 p.m. EET

In 2025, Bioretec will publish the following financial reports:

• financial statements bulletin for January–December 2024 on Friday 14 February 2025
• financial statements for 2024 on Friday 14 February 2025
• annual report for 2024 during week 11/2025 at the latest
• business review for January–March 2025 on Thursday 15 May 2025
• half-year report for January–June 2025 on Thursday 14 August 2025
• business review for January–September 2025 on Thursday 13 November 2025

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

Bioretec Ltd’s Annual General Meeting is planned to be held on Friday, 21 March 2025. The company's Board of Directors will convene the Annual General Meeting separately later.

Further enquiries

Alan Donze, CEO, +1 619 977 5285
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 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 process is currently on-going. 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

The Finnish Financial Supervisory Authority has imposed a penalty payment on a member of Bioretec's Board of Directors for late notification of managers' transactions

Bioretec Ltd  Company announcement  12 December 2024 at 6.15 p.m. EET

The Finnish Financial Supervisory Authority (the "FIN-FSA") has imposed a penalty payment of EUR 3,000 on Michael Piccirillo, as a member of Bioretec's Board of Directors and a person discharging managerial responsibilities for the late notifications of transactions in Bioretec's share made in his own account.

The decision of the FIN-FSA is not yet legally binding and can be appealed by Michael Piccirillo.

Further enquiries

Alan Donze, CEO, +1 619 977 5285
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 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 process is currently on-going. 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

Correction: Bioretec Ltd – Managers’ transactions – Stephen Industries Inc Oy

Bioretec Ltd      Managers’ transactions 29 November 2024 at 1.30 p.m. EET

This notice corrects the Management Transaction notice published on 29 November 2024 at 7:45, in which Kustaa Poutiainen was listed as a person subject to the notification requirement. The correct person subject to the notification requirement is Stephen Industries Inc Oy.

Correction - Bioretec Oy - Managers' Transactions

_________________________________________

Person subject to the notification requirement

Name: Stephen Industries Inc Oy

Position: Closely associated person

(X) Legal person  (1):Person Discharging Managerial Responsibilities In Issuer

Name: Kustaa Poutiainen

Position: Member of the Board

Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: AMENDMENT

Reference number: 86452/4/4

Amendment comment:

This notice corrects the Management Transaction notice published on 29 November 2024 at 7:45, in which Kustaa Poutiainen was listed as a person subject to the notification requirement. The correct person subject to the notification requirement is Stephen Industries Inc Oy.

____________________________________________

Transaction date: 2024-11-28

Outside a trading venue

Instrument type: SHARE

ISIN: FI4000480454

Nature of transaction: SUBSCRIPTION

Transaction details

(1): Volume: 350000 Unit price: 2 EUR

Aggregated transactions (1):

Volume: 350000 Volume weighted average price: 2 EUR

Further enquiries

Alan Donze, CEO, tel. +358 40 663 5011

Johanna Salko, CFO, tel. +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 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 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 resorbed 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 process is currently ongoing. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

Bioretec Ltd – Managers’ transactions – Poutiainen

Bioretec Ltd      Managers’ transactions 29 November 2024 at 7.45 a.m. EET

Bioretec Oy - Managers' Transactions

_______________________________________

Person subject to the notification requirement

Name: Kustaa Poutiainen

Position: Member of the Board/Deputy member

 Issuer: Bioretec Oy

LEI: 7437008736AG7HY51K13

Notification type: INITIAL NOTIFICATION

Reference number: 86452/4/4

____________________________________________

Transaction date: 2024-11-28

Outside a trading venue

Instrument type: SHARE

ISIN: FI4000480454

Nature of transaction: SUBSCRIPTION

Transaction details

(1): Volume: 350000 Unit price: 2 EUR

Aggregated transactions (1):

Volume: 350000 Volume weighted average price: 2 EUR

Further enquiries

Alan Donze, CEO, tel. +358 40 663 5011

Johanna Salko, CFO, tel. +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 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 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 resorbed 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 process is currently ongoing. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com

Bioretec Ltd: 3,000,000 new shares registered with the trade register

Bioretec Ltd  Company announcement  28 November 2024 at 4.30 p.m. EET

THE INFORMATION CONTAINED IN THIS RELEASE IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES OR IN ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Bioretec Ltd ("Bioretec" or the "Company"), a pioneer in biodegradable orthopedic implants, announced on 27 November 2024 the result of the offering of new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing"). In the Placing, the Company issued a total of 3,000,000 Placing Shares. The Placing Shares have today been registered with the trade register maintained by the Finnish Patent and Registration Office.

Following the registration of the Placing Shares, the total number of registered shares in the Company is 23,336,858. The Placing Shares will be issued in the book-entry system (ISIN code FI4000480454) on or about 29 November 2024. After this, and registration on the investors' book-entry accounts, they will confer shareholder rights in the Company. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Ltd on or about 2 December 2024.

Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland on or about 2 December 2024.

Bioretec Ltd
Board of directors

Further enquiries

Alan Donze, CEO, +1 619 977 5285
Tomi Numminen, Chairman of the Board, +358 40 581 2132

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 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 process is currently on-going. 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 notice

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. The information contained herein is not for publication or distribution, directly or indirectly, in or into Australia, Canada, Hong Kong, Japan, Singapore, South Africa or the United States or in any other jurisdiction in which publishing or distributing would be prohibited by applicable law. 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 does not constitute a prospectus as defined in the Prospectus Regulation ((EU) 2017/1129, 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.

This release is directed only to (A) persons who are outside the United States of America; (B) persons who are resident in a Member State of the European Economic Area and are a qualified investor (within the meaning of Article 2(1)(e) of the Prospectus Regulation)); and (C) as regards the United Kingdom, persons who are "Qualified Investors" within the meaning of Article 2(1)(e) of the Prospectus Regulation as it forms part of English law by virtue of the European Union (Withdrawal) Act 2018, who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); (ii) high net worth entities; and (iii) 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 securities mentioned herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, Relevant Persons. No one who is not a Relevant Person shall act on the basis of this release.

The securities referred to in this release have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or under the securities laws of any state of the United States, and may not be offered, sold, resold or delivered, directly or indirectly, in or into the United States absent registration except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act. Subject to certain limited exceptions, the securities referred to in this release are being offered and sold only outside the United States.

Danske Bank acts only for and on behalf of the Company in connection with the Placing. Danske Bank does not hold any other party as their client or cannot be held accountable to advise other parties than the Company with regards to the Placing or other matters referred hereto.

Information to Distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that such Placing Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the  Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to any offering of the Placing Shares. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Danske Bank as the sole bookrunner, will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Placing Shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Placing Shares and determining appropriate distribution channels.

Inside information: Bioretec Ltd successfully completes private placement raising EUR 6 million

Bioretec Ltd Inside information 27 November 2024 at 10.15 p.m. EET

THE INFORMATION CONTAINED IN THIS RELEASE IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES OR IN ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Bioretec Ltd ("Bioretec" or the "Company"), a pioneer in biodegradable orthopedic implants, hereby announces the result of the offering of new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing"). The Company announced the launch of the Placing by way of a company release published on 27 November 2024. Bioretec raises gross proceeds of EUR 6.0 million in the significantly oversubscribed Placing.

The proceeds from the Placing will be used to strengthen the commercialization of RemeOs™ Trauma Screws in the U.S. and in Europe upon the receipt of market authorization in Europe and to accelerate the product development of the RemeOs™ Spinal Interbody Cage following the Breakthrough Device Designation status granted by the US Food and Drug Administration (the FDA) on 14 March 2024 by initiating the preclinical large animal trial at the end of the year 2024.

In the Placing, the Company expects to issue a total of 3,000,000 Placing Shares in a directed share issue. The Placing Shares represent approximately 14.8 per cent of the issued shares in Bioretec prior to the Placing and approximately 12.9 per cent of the issued shares in Bioretec following the Placing. The total number of issued shares in the Company after the Placing will be 23,336,858.

The subscription price of the Placing Shares is EUR 2.00 per Placing Share, corresponding to a discount of 2.9 per cent to the closing price of EUR 2.06 on First North Growth Market Finland immediately prior to the commencement of the Placing on 27 November 2024. The subscription price shall be recorded in the invested unrestricted equity reserve.

The Placing was carried out based on offers received in an accelerated book building and based on the authorization granted to the board of directors by the Company's annual general meeting of 26 April 2024. The Placing Shares were allocated to long-only institutional investors. In addition, Placing Shares were allocated to Stephen Industries Inc Oy, a company controlled by Kustaa Poutiainen, a member of the board of directors of the Company, which holds more than 10 per cent of all shares in the Company. More than 10 per cent of the Placing Shares were allocated to Stephen Industries Inc Oy. Kustaa Poutiainen did not participate in the decision making regarding the Placing. The Placing was significantly oversubscribed.

The Placing Shares (ISIN code FI4000480454) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 28 November 2024. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy on or about 2 December 2024.

Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland on or about 2 December 2024.

"We are very pleased with the strong response to our share issue, which reflects the confidence investors have in our vision and strategy for the company's growth. The success of this offering not only strengthens our financial position but also enables us to accelerate key initiatives in commercialization of our RemeOs™ Trauma Screw and development of our future product pipeline. We remain committed to delivering value for our shareholders and thank both our existing and new investors for their trust and support during this pivotal moment. Together, we are poised to seize the opportunities ahead and achieve long-term success", comments Alan Donze, the CEO of the Company.

Danske Bank A/S, Finland Branch is acting as the sole bookrunner of the Placing. Krogerus Attorneys Ltd is acting as the legal counsel to the Company and Borenius Attorneys Ltd is acting as the legal counsel to the sole bookrunner.

Bioretec Ltd
Board of directors

Further enquiries

Alan Donze, CEO, +1 619 977 5285
Tomi Numminen, Chairman of the board of directors, +358 40 581 2132

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 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 process is currently on-going. 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

Forward-looking statements

This company release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Bioretec's future financial position and results of operations, the Company's strategy, objectives, future developments in the markets in which the Company participates or is seeking to participate or anticipated regulatory changes in the markets in which the Company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "guidance," "intend," "may," "plan," "potential," "predict," "projected," "should" or "will" or the negative of such terms or other comparable terminology.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The Company's actual results of operations, including the Company's financial condition and liquidity and the development of the industry in which the Company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release.

Important notice

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. The information contained herein is not for publication or distribution, directly or indirectly, in or into Australia, Canada, Hong Kong, Japan, Singapore, South Africa or the United States or in any other jurisdiction in which publishing or distributing would be prohibited by applicable law. 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 does not constitute a prospectus as defined in the Prospectus Regulation ((EU) 2017/1129, 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.

This release is directed only to (A) persons who are outside the United States of America; (B) persons who are resident in a Member State of the European Economic Area and are a qualified investor (within the meaning of Article 2(1)(e) of the Prospectus Regulation)); and (C) as regards the United Kingdom, persons who are "Qualified Investors" within the meaning of Article 2(1)(e) of the Prospectus Regulation as it forms part of English law by virtue of the European Union (Withdrawal) Act 2018, who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); (ii) high net worth entities; and (iii) 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 securities mentioned herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, Relevant Persons. No one who is not a Relevant Person shall act on the basis of this release.

The securities referred to in this release have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or under the securities laws of any state of the United States, and may not be offered, sold, resold or delivered, directly or indirectly, in or into the United States absent registration except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act. Subject to certain limited exceptions, the securities referred to in this release are being offered and sold only outside the United States.

Danske Bank acts only for and on behalf of the Company in connection with the Placing. Danske Bank does not hold any other party as their client or cannot be held accountable to advise other parties than the Company with regards to the Placing or other matters referred hereto.

Information to Distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that such Placing Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the  Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to any offering of the Placing Shares. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Danske Bank as the sole bookrunner, will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Placing Shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Placing Shares and determining appropriate distribution channels.

Inside information: Bioretec Ltd launches an accelerated book-building process to raise approximately EUR 5 million through a private placement of new shares

Bioretec Ltd  Inside information 27 November 2024 at 6:30 p.m. EET

THE INFORMATION CONTAINED IN THIS RELEASE IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, SINGAPORE, SOUTH AFRICA OR THE UNITED STATES OR IN ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Bioretec Ltd ("Bioretec" or the "Company"), a pioneer in biodegradable orthopedic implants, hereby announces its intention to issue new shares (the "Placing Shares") in a private placement to institutional and other qualified investors (the "Placing") to raise approximately EUR 5 million in gross proceeds.

The number of Placing Shares and their subscription price will be decided based on offers received in an accelerated book building. Danske Bank A/S, Finland Branch ("Danske Bank") is acting as the sole book-runner of the Placing. The result of the Placing will be published as a company announcement after the completion of the book building. The book building will be launched immediately following the publication of this company announcement. The book-building can be discontinued or extended at any time during the book-building process.

The purpose of the contemplated Placing is to raise funds to strengthen the commercialization of RemeOs™ Trauma Screws in the US and in Europe upon the receipt of market authorization in Europe and to accelerate the product development of the RemeOs™ Spinal Interbody Cage following the Breakthrough Device Designation status granted by the US Food and Drug Administration (the FDA) on 14 March 2024 by initiating the preclinical large animal trial at the end of the year 2024.

The Placing will be carried out based on the authorization granted to the board of directors by the Company's annual general meeting of 26 April 2024.

Subject to the completion of the Placing, the Placing Shares (ISIN code FI4000480454) will be registered with the trade register maintained by the Finnish Patent and Registration Office on or about 28 November 2024. The Placing Shares are expected to be ready for delivery to the investors against payment through Euroclear Finland Oy on or about 2 December 2024. Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland on or about 2 December 2024.

The Company intends to enter into customary lock-up undertaking for a period of 180 days in connection with and subject to completion of the Placing.

The Company estimates that considering its current business plan and the targeted size of the Placing, the gross proceeds raised in the Placing will be sufficient for approximately 8 months. In order to reach positive cash flow from operating activities by the end of the year 2027, in accordance with the current business plan, the Company estimates that it will require approximately EUR 18 million in total external funding. Any licensing income or milestones achieved by the Company during the upcoming commercialization stages will have an effect on the estimate above.

In preparing for the Placing, the board of directors of the Company has made an overall assessment and considered various capital raising alternatives, including the possibility to raise capital through a rights issue. After careful consideration, the board of directors has determined that a directed share issue by way of the Placing in deviation from the shareholders' pre-emptive rights is a better alternative for the Company's shareholders than a rights issue. A rights issue would entail a significantly longer execution time and thereby increased market exposure and a higher potential risk of affecting the share price negatively, particularly in a volatile and challenging market, compared to a directed share issue. The cost of carrying out a directed share issue is deemed to be lower than in a rights issue where, among other things, there would be a risk that a rights issue would not be fully subscribed and significant underwriting commitments from an underwriting syndicate would possibly have to be procured. Further, the board of directors has a positive view on an increased shareholding in the Company among institutional investors and other qualified investors because of their nature as long-term investors, who are able to offer substantial capital investments cost-effectively. Consequently, and taking into account the Company's plan to speed-up the commercialization of RemeOs™ Trauma Screw products, product development strategy and the accelerated timeline for the development of the RemeOs™ Spinal Interbody Cage, when comparing a potential rights issue and a directed share issue and their respective implications on costs and timelines for the commercialization of the products and product development strategy, the board of directors views that the Placing allows the Company to obtain financing on terms and in a timetable that will be more beneficial than terms that would otherwise be available, and therefore weighty financial reasons exist for deviating from the pre-emptive rights of the shareholders.

By determining the subscription price in the Placing through an accelerated book building, it is the assessment of the board of directors that the subscription price will be set on market terms.

Danske Bank is acting as the sole bookrunner of the Placing. Krogerus Attorneys Ltd is acting as the legal counsel to the Company and Borenius Attorneys Ltd is acting as the legal counsel to the sole bookrunner.

Bioretec Ltd
Board of directors

Further enquiries

Alan Donze, CEO, +1 619 977 5285
Tomi Numminen, Chairman of the Board, +358 40 581 2132

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 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 process is currently ongoing. 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

Forward-looking statements

This company release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Bioretec's future financial position and results of operations, the Company's strategy, objectives, future developments in the markets in which the company participates or is seeking to participate or anticipated regulatory changes in the markets in which the company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "guidance," "intend," "may," "plan," "potential," "predict," "projected," "should" or "will" or the negative of such terms or other comparable terminology.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The Company's actual results of operations, including the Company's financial condition and liquidity and the development of the industry in which the Company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release.

Important notice

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. The information contained herein is not for publication or distribution, directly or indirectly, in or into Australia, Canada, Hong Kong, Japan, Singapore, South Africa or the United States or in any other jurisdiction in which publishing or distributing would be prohibited by applicable law. 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 does not constitute a prospectus as defined in the Prospectus Regulation ((EU) 2017/1129, 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.

This release is directed only to (A) persons who are outside the United States of America; (B) persons who are resident in a Member State of the European Economic Area and are a qualified investor (within the meaning of Article 2(1)(e) of the Prospectus Regulation)); and (C) as regards the United Kingdom, persons who are "Qualified Investors" within the meaning of Article 2(1)(e) of the Prospectus Regulation as it forms part of English law by virtue of the European Union (Withdrawal) Act 2018, who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); (ii) high net worth entities; and (iii) 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 securities mentioned herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, Relevant Persons. No one who is not a Relevant Person shall act on the basis of this release.

The securities referred to in this release have not been, and will not be, registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or under the securities laws of any state of the United States, and may not be offered, sold, resold or delivered, directly or indirectly, in or into the United States absent registration except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act. Subject to certain limited exceptions, the securities referred to in this release are being offered and sold only outside the United States.

Danske Bank acts only for and on behalf of the Company in connection with the Placing. Danske Bank does not hold any other party as their client or cannot be held accountable to advise other parties than the Company with regards to the Placing or other matters referred hereto.

Information to Distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that such Placing Shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the  Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to any offering of the Placing Shares. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Danske Bank as the sole bookrunner, will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Placing Shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Placing Shares and determining appropriate distribution channels.

Bioretec signed a new sales and distribution agreement to accelerate the commercialization of RemeOs™ Trauma Screw in the U.S. civilian hospital market

Bioretec Ltd                   Press release             22 November 2024 at 9:30 a.m.EET

Bioretec Ltd, a pioneering company dedicated to advancing biodegradable orthopedic implants, is moving ahead with the next phase of the commercialization of its innovative RemeOs™ Trauma Products in the U.S. market. As a continuation to the previously signed logistics agreement with GlobalMed Logistix, Bioretec strengthens now its commercialization efforts by signing a new sales and distribution agreement with Tri-State Biologics (TSB), which is a distributor of medical and surgical products based in New Jersey. TSB is a leading medical solutions provider with 18 sales representatives dedicated to breaking the mold of traditional medical device distribution. Signing of the agreement will enable the smooth sales and distribution of implants and instrument sets to hospitals within Greater New York City, Philadelphia, New Jersey, Connecticut, and Massachusetts area covering one of the most populated areas of the United States.

 As part of the next phase of the RemeOs™ Trauma Screw commercialization, Bioretec aims to sign more new local sales and distribution agreements to serve civilian hospitals in the U.S. while Spartan Medical continues to serve the military and veteran hospitals.

“We are happy to announce this sales and distribution agreement with a partner who is innovative in forming medical product distribution streams in the U.S. The initial controlled launch of RemeOs™ Trauma Screws in the U.S. yielded excellent patient results, with a notable number of surgeries and successful post-healing follow-ups. This success lays the groundwork for entering the second phase of commercialization for RemeOs™ products in the U.S. and driving demand within the surgeon community”, says Alan Donze, CEO of Bioretec Ltd.

Further enquiries

Alan Donze, CEO, tel. +358 40 663 5011

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

Bioretec in brief

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 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 resorbed 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 process is currently ongoing. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and become a game changer in surgical bone fracture treatment.

Better healing – Better life. www.bioretec.com