Correction: Bioretec Ltd’s Half-year report 2025

Bioretec Ltd  Company release 31 October 2025 at 8.30 a.m. EET

Bioretec announced on 27 October 2025 that it will adjust and restate its previously reported figures for H1/2025.

The adjustment and restatement is related to the sales and distribution agreement with Tri-State Biologics (“TSB”), originally announced on 22 November 2024 (the “TSB Distribution Agreement”). The TSB Distribution Agreement was, upon its signing, based on a stocking distribution model, whereby TSB first purchases products from Bioretec for further sale and distribution by TSB to hospitals in the target geography. Following the signing of the TSB Distribution Agreement, a product repurchase addendum was added on 5 May 2025 to the TSB Distribution Agreement, whereby Bioretec would repurchase from TSB such unpaid products for which TSB was unable to procure purchasers within the payment terms ("Repurchase Addendum"). Following such repurchase under the Repurchase Addendum, Bioretec could then distribute such unpaid products directly to end-users itself, similarly to direct distribution models to which Bioretec is aiming to shift towards in an effort to move away from stocking distribution models in the United States, excluding the Orthopediatrics agreement focused solely on the pediatrics market.

In the company release dated 27 October 2025, Bioretec estimated that the corrections made in the accounting treatment related to the Repurchase Addendum and the products to be repurchased would result in a decrease of previously reported H1/2025 net sales of EUR 0.52 million, as well as an increase in costs of EUR 0.65 million. However, after further review, it was also determined that a one-time credit invoice related to the conclusion of a previous U.S. pilot distributor agreement with Spartan Medical had been incorrectly booked against net sales in Q2/2025. While the Repurchase Addendum causes a restatement of H1/2025 net sales by EUR 0.52 Million as per the company release dated 27 October 2025, the corrected accounting treatment of the aforementioned credit invoice of Spartan Medical offsets this reduction in net sales. 

In this corrected half-year report, the aforementioned one-time credit invoice related to Spartan Medical’s distribution agreement (of EUR 0.5 million), as well as the products to be repurchased worth approximately EUR 0.65 million under the TSB Distribution Agreement, are now reported in other expenses, increasing the previously reported other expenses by a total of approximately EUR 1.1 million. The previously reported total level of net sales remains mostly unchanged and represents the true volume of realized sales during the period of April-June 2025. Other minor changes detected during further review, related to changes in inventory and operating expenses, have also been adjusted

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

April–June 2025 in brief

• Bioretec successfully closed a funding round of EUR 9 million, demonstrating investor confidence in the company.
• Activa sales developed as expected, with growth particularly in China and Asia, while momentum for RemeOsTM sales builds globally. 
• First surgeries performed with RemeOs Trauma Screw in Europe mark another key event supporting the commercialization of RemeOs product line worldwide.
• Net sales decreased by 50.9% and amounted to EUR 678 thousand (4–6/2024: EUR 1,379 thousand). The comparison period included a high initial delivery to a new distributor outside the U.S.
• Sales margin (excl. other income) was EUR 486 (1,033) thousand, or 71.7% (74.9%) of net sales. Sales margin reflects preparation for commercial growth and was impacted by an increase in materials and services costs related to the shift in distribution partners, as well as the lower margin of sales to China. Sales margin during the market development and scale-up phases is planned to improve as sales increase and direct distribution channel partners are well established.
• Profit (loss) for the reporting period was EUR -4,330 (-787) thousand. The cost of the rights issue financing round arranged in June 2025 amounted to EUR 1,065 thousand. 
• Earnings per share (undiluted) were EUR -0.14 (-0.04).

January–June 2025 in brief

• Net sales amounted to EUR 2,074 thousand (1–6/2024: EUR 2,061 thousand). 
• Sales margin (excl. other income) was EUR 1,308 (1,451) thousand or 63.1% (70.4%) of net sales. The sales margin includes other income of EUR 202 (72) thousand accrued relating to received grants. 
• Profit (loss) for the reporting period was EUR -5,628 (-1,884) thousand. 
• Earnings per share (undiluted) were EUR -0.18 (-0.09).

Key figures

Key events in April–June 2025

• Bioretec's Board of Directors appointed MBA Sarah van Hellenberg Hubar-Fisher as the company's interim CEO as of 15 May 2025, following the resignation of CEO Alan Donze.
• Mirva Ekman, M.Sc. (Mechanical Engineering), was appointed Quality Director and member of the Management Team as of 22 April 2025.
• Bioretec arranged a rights issue in June 2025, where shareholders were offered up to 6,156,618 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 and secondarily by other shareholders or by other persons. The objective of the rights issue was to strengthen Bioretec's capital structure and to ensure its ability to implement its RemeOs™ commercialisation strategy.  The rights issue was oversubscribed and Bioretec received gross proceeds of approximately EUR 9.2 million from the rights issue. As a result of the rights issue, the total number of shares in Bioretec increased by 6,156,618 from 24,626,474 to 30,783,092.

Sarah van Hellenberg Hubar-Fisher, Interim CEO of Bioretec Ltd:

The second quarter included the close of our successful funding round of EUR 9 million, highlighting investors’ confidence in our innovative product offering, market potential, and strategic direction. This funding round supports the needed investment in leadership resourcing for marketing and sales, global capacity building in operations, and continued R&D investment to support our robust product pipeline. Commercial traction in H1 was highlighted by continued Activa sales development with demand particularly in China and Asia, and the first surgical cases with the RemeOs Trauma Screw being performed in Europe. 

Our robust product pipeline advanced on multiple fronts, including ongoing work to advance 510(k) submissions for the RemeOs cannulated screw in the U.S., progress in our Breakthrough designated and patented hybrid composite for the RemeOs Spinal Interbody Cage program, ethical approval for first in human DrillPin clinical trials, and the commencement of post-marketing clinical follow-up for the CE-marked RemeOs line. In support of our broadened distribution network in the U.S. and the growing demand for efficiency and infection control in that market, we completed the launch of sterile, single-use instruments for our Activa cannulated screw, with the first instruments delivered and now available for use.

Sales margin reflects our commitment to prepare for commercial and operational growth namely in the U.S. market. The margin was impacted by an increase in materials and services costs, such as instrumentation and logistics costs, related to our commercial strategy to shift from using solely stocking distributors to including also direct distribution partners in the U.S.. Furthermore, the first two quarters of the year resulted in high volume demand as a percentage of revenue coming from China, with slightly lower margins.  Sales margin during the market development and scale-up phases is planned to improve as our sales increase and direct distribution channel partners are well established.

The first half of the year also marked a period of transition in the organization from a leadership perspective. It has been an honor for me to step in as interim CEO of Bioretec in mid-May, and I am proud of the oversubscribed funding round we completed in June. I want to thank our shareholders for their strong participation and continued confidence in our journey ahead.  As we continue to focus on scale and strategy refinement, I remain confident that Bioretec is well-positioned to deliver value to shareholders and patients alike.

Financial reporting in 2025

In 2025, Bioretec will publish the following financial reports:

• Business review for January–September 2025 on Thursday 13 November 2025

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

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

Tampere, 31 October 2025

Board of Directors

Bioretec Ltd

For additional information about the report:

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

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.  

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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

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Inside information: Bioretec adjusts and restates previously reported net sales FOR H1/2025 and does not expect accelerated sales in 2025

Bioretec Ltd  Inside information 27 October 2025 at 9.14 p.m. EEST

On 22 November 2024, Bioretec Ltd ("Bioretec" or the "Company"), announced through a press release a new sales and distribution agreement with Tri-State Biologics ("TSB"), enabling the sale and distribution of implants and instrument sets to hospitals within Greater New York City, Philadelphia, New Jersey, Connecticut, and Massachusetts area (the "TSB Distribution Agreement"). The TSB Distribution Agreement was, upon its signing, based on a stocking distribution model, whereby TSB first purchases products from Bioretec for further sale and distribution by TSB to hospitals in the target geography.

Following the signing of the TSB Distribution Agreement, it became evident that the sales of Bioretec's products in 2025 were not progressing in line with expectations of the TSB Distribution Agreement, and a product repurchase addendum was added on 5 May 2025 to the TSB Distribution Agreement, whereby Bioretec would repurchase from TSB such unpaid products for which TSB was unable to procure purchasers within the payment terms ("Repurchase Addendum"). Following such repurchase under the Repurchase Addendum, Bioretec could then distribute such unpaid products directly to end-users itself, similarly to direct distribution models to which Bioretec is aiming to shift towards in an effort to move away from stocking distribution models.

In its unaudited half-year report covering the financial period from 1 January 2025 to 30 June 2025 published on 14 August 2025 (the "H1 Report"), Bioretec reported net sales of approximately EUR 2.06 million. The net sales in the H1 Report included the sales proceeds of the full stock of products initially sold by Bioretec to TSB in the amount of approximately EUR 0.52 million. The net sales in the H1 Report, however, did not take into account the addition of the Repurchase Addendum under the TSB Distribution Agreement and the resulting potential for Bioretec to repurchase products from TSB. As a result, the net sales reported by Bioretec in the H1 Report were reported overly optimistically without full provision for the Repurchase Addendum and without provision for the volume of products that are now being repurchased under the Repurchase Addendum, resulting in the need to make a corresponding adjustment to the net sales reported in the H1 Report. Taking into account the repurchase under the Repurchase Addendum, the adjusted and restated net sales for the period covered by the H1 Report is approximately EUR 1.54 million (instead of approximately EUR 2.06 million as previously reported). Other cost effects of products sold earlier under the TSB Distribution Agreement will equal to an additional adjustment of approximately EUR 0.65 million when compared to the H1 Report.

The adjustment and restatement of net sales reported in the H1 Report will result in the restatement of also other financial information included in the H1 Report, and Bioretec will release adjusted and restated financial information for the financial period from 1 January 2025 to 30 June 2025 as soon as practicably possible.

In connection with the publication of the H1 Report, Bioretec also stated on 14 August 2025 that it will continue to focus on building market presence and to prepare for the expected acceleration of sales through the remainder of the year. The repurchase under the Repurchase Addendum, as well as Bioretec's efforts to shift from using solely stocking distributors to also using direct distribution partners in the U.S., have removed Bioretec's expectations for the acceleration of sales through the remainder of 2025, and net sales for the full year 2025 are expected to be significantly less than what was expected in connection with the H1 Report announced on 14 August 2025.

As previously announced, the Company will also provide an updated commercialization strategy and pipeline along with its revised financial targets by the end of 2025 as it, e.g. aims to shift from stocking distributors to direct distribution partners in the U.S.

Further enquiries

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

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.  

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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

Inside information: Bioretec is revising its financial targets, deems that the current financial targets will not be met and withdraws its financial targets

Bioretec Ltd  Inside information 26 October 2025 at 10.00 a.m. EEST

On 12 September 2025, Bioretec Ltd ("Bioretec" or the "Company"), announced that the revised timeline of the planned commercialization of the DrillPin in the U.S. was then not expected to have a material effect on Bioretec's financial targets published on 4 October 2024, and that Bioretec was assessing its overall commercialization strategy and pipeline, including the commercialization of the DrillPin in the U.S., and would provide an update by the end of 2025.

The Company is currently in the process of assessing and updating its overall commercialization strategy and pipeline and will be providing an update by the end of 2025. However, in the course of its assessment, the Board of Directors of Bioretec has now concluded that the financial targets published on 4 October 2024 are unattainable and will likely not be met. In particular, the Board of Directors of Bioretec deems that the target of reaching net sales of EUR 65 million by the end of the year 2028 will need to be postponed given lengthened FDA-approval timelines, the Company's current financing needs and the strategic readjustment initiatives which are currently pending assessment. While the Board of Directors of the Company believes that the addressable market for the Company's products remains the same, the Company now withdraws its financial targets and will provide an updated commercialization strategy and pipeline along with revised financial targets by the end of 2025.

The previous financial targets, which are now withdrawn, were to:

• reach net sales of EUR 65 million by the end of the year 2028 and to reach net sales in excess of EUR 100 million by the end of the year 2030 (previous target: EUR 62 million by the end of the year 2027); and
• reach positive cash flow from operating activities by the end of the year 2027 (previous target: by the end of the year 2026)

Further enquiries

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

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.  

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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

Bioretec's RemeOs™ Screw LAG Solid Receives CMS Transitional Pass-Through Payment in the US

Tampere, Finland – October 1, 2025 – Bioretec Ltd, a pioneer in absorbable orthopedic implants, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through Payment (TPT) status for the company’s RemeOs™ Screw LAG Solid, effective October 1, 2025.

“Building on the success of Breakthrough Device Designation and FDA De Novo grant, securing CMS TPT approval represents a remarkable milestone,” said Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec. “This recognition of the value of our innovative product and the support to accelerate its adoption in the US, further empowers hospitals, surgery centers, and surgeons to utilize RemeOs™, the first-of-its-kind fixation technology that supports natural healing. With this new status, Bioretec is positioned to unlock growth opportunities as we aim to transform the standard of care in orthopedic fixation.”

The approval is reflected in the October 2025 Healthcare Common Procedure Coding System (HCPCS) quarterly update, which establishes a new billing code, C1741, for absorbable anchor/screw implants. This designation makes RemeOs™ eligible for separate pass-through payment under both the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment system, providing incremental reimbursement for Medicare patients.

RemeOs™ is the first and only osteopromotive absorbable metal implant for orthopedic use in the U.S. Made from a proprietary magnesium alloy, RemeOs™ provides strong and stable fixation during healing and gradually degrades as it is replaced by bone, reducing the risks and costs associated with permanent implants and subsequent hardware removal surgeries.

Clinical investigation data with RemeOs™ demonstrate that 90% of patients achieved fracture consolidation by 6 weeks, with complete healing observed by 12 weeks. In addition, the osteopromotive properties of the implant have been shown to support bone formation at the fracture site, reducing the need for secondary surgeries and eliminating the presence of permanent metal implants.

In March 2023, the RemeOs™ Screw LAG Solid received FDA De Novo market authorization, confirming its status as a truly novel technology in orthopedic fixation. Now, with CMS TPT Pass-Through approval, Bioretec has achieved a rare dual milestone reached by only a handful of medical devices- recognition by both regulators and payors as a breakthrough technology with proven clinical and economic value.

“This approval further validates RemeOs™ as a breakthrough in material science and clinical innovation,” said Timo Lehtonen, Chief Technology Officer of Bioretec. “It represents the culmination of years of investment in world-class research, rigorous testing, and robust clinical evidence —and demonstrates our commitment to advancing faster recovery and improving outcomes for patients.”

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. RemeOs™ implants are absorbed and replaced by bone, eliminating the need for removal surgery while facilitating fracture healing. The first RemeOs™ market authorization was received in the U.S. in March 2023 (via FDA De Novo), followed by CE Mark approval in Europe in January 2025.

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

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Composition of Bioretec’s Shareholders' Nomination Board

Bioretec Ltd  Company announcement 16 September 2025 at 7.30 p.m. EEST

The following persons have been appointed to Bioretec's Shareholders' Nomination Board: Tor-Oskar Karlberg from Stephen Industries Inc Oy, Rami Vehmas from Keskinäinen Eläkevakuutusyhtiö Ilmarinen, and Heinz Moitzi from W&M GmbH.

The Nomination Board has elected Tor-Oskar Karlberg as its chairperson at its organizational meeting on September 16, 2025. The chairperson of the Board of Directors of Bioretec acts as an expert to the Nomination Board without voting rights.

In accordance with the decision taken by the 2024 Annual General Meeting, the Shareholders' Nomination Board consists of three members. Each of the three largest shareholders as of the last working day in August has the right to nominate a member.

The Shareholders’ Nomination Board is responsible for preparing and presenting to the Annual General Meeting a proposal on the members of the Board of Directors as well as proposals on the remuneration and number of members of the Board of Directors. The Shareholders’ Nomination Board will submit its proposals for the 2026 Annual General Meeting to the Board of Directors by 30 January 2026.

Further inquiries

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

Certified advisor

Nordic Certified Adviser AB, +46 70 551 6729

Bioretec in brief

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

To learn more about Bioretec, visit https://bioretec.com.Better healing – Better life. www.bioretec.com

Inside information: Anne-Mari Matikainen appointed as Interim Chief Financial Officer of Bioretec; CFO Johanna Salko to depart before year-end

Bioretec Ltd  Inside information 15 September 2025 at 5.30 p.m. EEST

Bioretec Ltd., a pioneer in absorbable orthopedic implants appoints Anne-Mari Matikainen as Interim Chief Financial Officer, effective immediately. In this role, Matikainen will report to Chief Executive Officer Sarah van Hellenberg Hubar-Fisher and will join the company's management team.

Matikainen brings over 16 years of versatile experience in finance, treasury, and management consulting, having held key positions across corporate and financial sectors, such as CFO leadership experience at Springvest Oyj.

“We are excited to welcome Anne-Mari to Bioretec. Her business acumen and leadership experience are a valuable addition to the team at this juncture of planned growth for the company,” said CEO Sarah van Hellenberg Hubar-Fisher. “I would also like to extend my gratitude to Johanna Salko for her dedication and valuable contributions to the company over the past four years. She has been an important part of Bioretec’s development, and we wish her all the best for the future.”

Bioretec’s current Chief Financial Officer Johanna Salko will support the company during the transition phase until 30 November 2025. The recruitment process for a new permanent Chief Financial Officer has been initiated.

Further enquiries

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

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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

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

Bioretec Ltd Company announcement 15 September 2025 at 3.15 p.m. EEST

An aggregate number of 5,000 new shares of Bioretec Ltd have been subscribed for with option rights under option program 2018-1A. The new shares have on 15 September 2025 been registered with the trade register maintained by the Finnish Patent and Registration Office. The total subscription price of EUR 7,100.00 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 30,788,092.

The new shares will be issued in the book-entry system on or about tomorrow 16 September 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 17 September 2025.

Further enquiries

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

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.  

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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

Inside information: Bioretec updates the commercialization status of RemeOs™ DrillPin

Bioretec Ltd  Inside information 12 September 2025 at 11:00 a.m. EEST

Bioretec Ltd., a pioneer in absorbable orthopedic implants, announces an update to the commercialization status of the RemeOs™ DrillPin. Following interactive discussions with the U.S. Food and Drug Administration ("FDA"), the planned commercialization of the DrillPin in the U.S. will progress on a revised timeline to reflect recent FDA guidance on data requirements specific to novel materials.

This adjustment extends the previously communicated timeline for commercialization in 2025. The revised timeline is not currently expected to have a material effect on Bioretec's financial targets published on 4 October 2024.

Bioretec is assessing its overall commercialization strategy and pipeline, including the commercialization of the DrillPin in the U.S., and will provide an update by the end of 2025.

Further enquiries

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

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.  

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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

Bioretec Appoints Dr. Christopher W. DiGiovanni to Scientific Advisory Board

Bioretec Ltd Press Release 4 September 2025 at 3 p.m. EET

Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, today announced the appointment of Dr. Christopher W. DiGiovanni to its Scientific Advisory Board (SAB).

Dr. DiGiovanni is an internationally recognized foot and ankle surgeon who has dedicated nearly three decades to advancing clinical care, surgical innovation, and medical education. He currently serves as Professor of Orthopaedic Surgery at Harvard Medical School in the Department of Orthopaedic Surgery and Chief Emeritus of Foot and Ankle Services at Massachusetts General Hospital (MGH) / Newton-Wellesley Foot & Ankle Center. He is a Past President of both the American Orthopaedic Foot and Ankle Society and the North American Orthopaedic Foot Club, co-founder of the MGH Foot & Ankle Research and Innovation Lab (FARIL) and has been consistently recognized as one of Castle Connolly Top Doctors® and Boston’s Top Doctors.

In addition to his clinical practice, Dr. DiGiovanni has published over 250 articles, edited five medical textbooks, and contributed to numerous global innovations in foot and ankle surgery, including FDA-approved technologies. He has served on multiple editorial boards, consulted for athletes from collegiate to Olympic levels, and advised leading orthopedic companies, worldwide.

“Patient-centric advancements in orthopedic surgery continue to accelerate at a remarkable pace, including contributions specific to the foot and ankle subspecialty,” said Dr. DiGiovanni. “Novel absorbable implants represent one of the greatest areas of technological innovation and hold a tremendous promise for patients. Bioretec is at the forefront of surgical device evolution with its novel biocompatible implants, and I look forward to joining the Scientific Advisory Board to help advance these exciting technologies.”

Bioretec’s SAB provides strategic clinical insights as the company advances commercialization of its breakthrough implant platforms, including Activa and RemeOs™. Dr. DiGiovanni’s appointment advances Bioretec’s mission to engage world-class clinical leaders to guide product innovation and ensure its solutions meet the highest standards of safety, efficacy, and real-world applicability.

“We are honored to welcome Dr. DiGiovanni to our Scientific Advisory Board,” said Timo Lehtonen, Chief Technology Officer of Bioretec. “Dr. DiGiovanni brings unparalleled expertise in foot and ankle surgery, further strengthening our commitment to excellence in patient care and innovation. His proven expertise in advancing clinical care and research, coupled with his leadership in the orthopedic community, will be instrumental as we expand adoption of Activa and RemeOs in the U.S. and global markets.”

About Bioretec

Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic care with fully biodegradable implant technologies. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.

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

The company’s latest innovation, the RemeOs™ product line, is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.

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