Inside information: Bioretec updates the commercialization status of RemeOs™ DrillPin
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 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.
Bioretec Appoints Jordy Winters as Vice President of OUS Sales to Accelerate International Growth
Bioretec Appoints Jordy Winters as Vice President of OUS Sales to Accelerate International Growth
Bioretec Ltd Press release 2 September 2025 at 2:15 p.m. EST
Bioretec Ltd, a pioneer in absorbable orthopedic implants, announced today the appointment of Jordy Winters as Vice President of Sales Outside U.S. (OUS; Europe and Rest of the World) and member of the Management Team. Winters will spearhead Bioretec’s international commercial strategy, advancing the company’s expansion into key markets outside the United States and driving revenue growth.
Winters brings extensive sales leadership experience from Johnson & Johnson MedTech and Synthes, with a strong record of driving commercial adoption and building high-performing teams. Most recently, he served as Spine Lead EMEA, driving regional strategy and growth. His earlier positions included Business Lead DePuy Synthes, Sales Director Orthopaedics, and leadership roles in Joint Reconstruction, Spine and Trauma. From starting his career as a Sales Consultant to leading large-scale teams across EMEA, Jordy has consistently demonstrated a strong commitment to advancing orthopaedics and spine care solutions that positively impact patients’ lives. His appointment strengthens Bioretec’s leadership at a pivotal time for the company, as it scales operations and seizes opportunities in orthopedics with its Activa absorbable polymer platform and RemeOs™ absorbable magnesium alloy technology.
Sarah van Hellenberg Hubar-Fisher, CEO of Bioretec, states: "We are delighted to welcome Jordy Winters to our executive team. With nearly two decades of proven excellence in global orthopedic commercial leadership, his expertise and international perspective will be instrumental as we continue to expand Bioretec’s impact outside the U.S.”
"Bioretec is entering an important phase of growth, with increasing demand for innovative, sustainable solutions in orthopedics," said Jordy Winters. "I look forward to driving the company’s international commercial success and forging strategic partnerships that deliver value to patients, surgeons, and shareholders worldwide."
In parallel, Rami Ojala, previously Vice President of OUS Sales, will transition into the newly created role of Head of Global Medical Education. In this position, Ojala will lead efforts to advance surgeon training programs, develop educational initiatives, and support clinical adoption of Bioretec’s pioneering technologies worldwide.
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 Ltd: Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (W&M GmbH)
Bioretec Ltd: Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (W&M GmbH)
Bioretec Ltd Company announcement 28 August 2025 at 10:15 a.m. EET
Bioretec Ltd has on 28 August 2025 received a notification in accordance with the Securities Market Act, according to which the holdings of shares and votes of W&M GmbH in Bioretec Ltd have on 25 August 2025 crossed below the threshold of 5%.
Total position of W&M GmbH according to the notification:
|
|
% of shares and voting rights |
% of shares and voting rights through financial instruments |
Total of both in % |
Total number of shares and voting rights of the issuer |
|
Resulting situation on the date on which threshold was crossed or reached |
4.47% |
0% |
4.47% |
30,783,092 |
|
Position of previous notification (if applicable) |
|
|
|
|
Notified details of the resulting situation on the date on which the threshold was crossed:
|
|
Number of shares and voting rights |
% of shares and voting rights |
||
|
Class/type of shares |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
Direct (SMA 9:5) |
Indirect (SMA 9:6 and 9:7) |
|
FI4000480454 |
1,377,503 |
0 |
4.47% |
0% |
|
SUBTOTAL |
1,377,503 |
4.47% |
||
After 28 August 2025, W&M GmbH holds 4.47% of the shares and votes.
Further enquiries
Johanna Salko, CFO, +358 40 754 8172
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 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 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 Sarah van Hellenberg Hubar-Fisher as Chief Executive Officer
Bioretec Appoints Sarah van Hellenberg Hubar-Fisher as Chief Executive Officer
TAMPERE, Finland, August 27, 2025 – Bioretec Ltd., a pioneer in absorbable orthopedic implants, announced today the appointment of Sarah van Hellenberg Hubar-Fisher as Chief Executive Officer (CEO) effective immediately. Van Hellenberg Hubar-Fisher has served as Bioretec's interim CEO since May 2025 and as a member of the company's Board of Directors since 2021. An accomplished medtech executive, she steps into the CEO role with the aim of expanding the company’s commercial footprint following key regulatory milestones.
As a result of this appointment, van Hellenberg Hubar-Fisher will be stepping down from her positions as a member of the Board of Directors, as Vice Chairperson of the Board, and from her duties on the Board's Audit Committee. The Board of Directors has also elected Antti Vasara as its new Vice Chairman and a member of the Board’s Audit Committee.
"Sarah brings extensive commercial and management experience in healthcare, including the successful global introduction of new technologies. Her leadership was clearly demonstrated during her time as interim CEO, when she advanced the company’s strategic direction,” said Kustaa Poutiainen, Chairperson of the Board of Directors of Bioretec. “We look forward to Sarah leading Bioretec towards our goal of becoming a global market leader in breakthrough absorbable orthopedic implants.”
"I am excited to lead Bioretec into its next phase of growth as we bring groundbreaking orthopedic technologies to market,” said van Hellenberg Hubar-Fisher. "Our priorities are clear: accelerate the global launch of RemeOs™, build on the strong and sustained success of Activa®, and ensure both platforms have the resources and processes required for scale. With RemeOs now CE-marked, Activa’s continuing market impact, and a robust innovation pipeline, Bioretec is well positioned to grow its market presence, deliver significant clinical impact, and create long-term value for our shareholders."
Van Hellenberg Hubar-Fisher brings over 23 years of business leadership experience in healthcare, medical technology, and global public health. She has a proven track record of transforming innovative technologies into real-world outcomes, launching new ventures, driving business development, and advancing capital solutions across global markets. In addition to her role at Bioretec, she serves on the Board of Global Surgical Initiatives, Inc., a New York-based nonprofit dedicated to delivering sustainable surgical care to underserved communities. Her career includes senior leadership positions at Johnson & Johnson, and roles as Venture Partner at Nina Capital (Spain) and Growth Science Ventures (U.S.). She holds an MBA in Entrepreneurship from Babson College and a postgraduate degree in Global Business from the University of Oxford.
For Media
In the United States
FINN Partners – Alyssa Paldo
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 Ltd’s Half-year report 2025: Strong support for future growth from a successful rights issue
Bioretec Ltd’s Half-year report 2025: Strong support for future growth from a successful rights issue
Bioretec Ltd Company announcement 14 August 2025 at 8.00 am EEST
This company announcement is a summary of 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 51.7% and amounted to EUR 665 thousand (4–6/2024: EUR 1,379 thousand). The net sales was impacted by a one-time credit invoice related to the conclusion of a U.S. pilot distribution agreement, and a shift from stocking to direct distribution partners in the U.S.. Furthermore, the comparison period included a high initial delivery to a new distributor outside the U.S. Sales to stocking distributors are lumpy and may cause quarterly variance in net sales.
- Sales margin (excl. other income) was EUR 194 (1,033) thousand, or 29.1% (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 -3,504 (-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 -0.12 (-0.04).
January–June 2025 in brief
- Net sales amounted to EUR 2,062 thousand (1–6/2024: EUR 2,061 thousand).
- Sales margin (excl. other income) was EUR 1,016 (1,451) thousand or 49.3% (70.4%) of net sales. The sales margin includes other income of EUR 202 (71) thousand accrued relating to received grants.
- Profit (loss) for the reporting period was EUR -4,801 (-1,884) thousand.
- Earnings per share (undiluted) were EUR -0.16 (-0.09).
Key figures
|
EUR 1,000 |
4–6/2025 |
4–6/2024 |
Change, % |
1–6/2025 |
1–6/2024 |
Change, % |
1–12/2024 |
|
Net sales |
665 |
1,379 |
-51.7% |
2,062 |
2,061 |
0.0% |
4,544 |
|
Sales margin |
297 |
1,045 |
-71.6% |
1,218 |
1,523 |
-20.0% |
3,391 |
|
Sales margin (excl. other income) |
194 |
1,033 |
-81.2% |
1,016 |
1,451 |
-22.9% |
3,221 |
|
Sales margin, % of net sales |
44.6% |
75.7% |
|
59.1% |
73.9% |
|
74.6% |
|
Sales margin% (excl. other income) |
29.1% |
74.9% |
|
49.3% |
70.4% |
|
70.9% |
|
EBITDA |
-2,494 |
-752 |
231.5% |
-3,730 |
-1,864 |
100.1% |
-4,053 |
|
EBIT |
-2,547 |
-782 |
225.7% |
-3,833 |
-1,921 |
99.5% |
-4,202 |
|
Profit/-loss for the period (+/-) |
-3,504 |
-787 |
345.2% |
-4,801 |
-1,884 |
154.9% |
-4,614 |
|
R&D spend on total revenue, % |
129.4% |
31.6% |
|
77.2% |
41.4% |
|
48.0% |
|
Equity ratio, % |
80.5% |
77.9% |
|
80.5% |
77.9% |
|
84.9% |
|
Cash and cash equivalents at the end of the period |
11,467 |
3,947 |
190.5% |
11,467 |
3,947 |
190.5% |
6,289 |
|
Earnings per share (undiluted) |
-0.12 |
-0.04 |
174.1% |
-0.16 |
-0.09 |
68.4% |
-0.20 |
|
Earnings per share (diluted) |
-0.11 |
-0.04 |
198.5% |
-0.14 |
-0.08 |
87.7% |
-0.17 |
|
Shares at end of period (undiluted) |
30,783,092 |
20,336,858 |
|
30,783,092 |
20,336,858 |
|
23,336,858 |
|
Shares at end of period (diluted) |
33,821,751 |
24,908,133 |
|
33,821,751 |
24,908,133 |
|
27,515,133 |
|
Personnel at end of the period |
57 |
43 |
32.6% |
57 |
43 |
32.6% |
47 |
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 continued across our portfolio. Activa sales developed as expected, with growth particularly in China and Asia, while we built momentum for RemeOs globally. Notably, the first surgeries with the RemeOs Trauma Screw were now also performed in Europe, signaling early adoption and setting the stage for increased global utilization in the second half of the year.
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.
Net sales in the first half of the year were stable compared to the year prior as planned, reflecting market development efforts for our breakthrough technology. Net sales in the second quarter was impacted by both a one-time credit invoice related to the conclusion of a U.S. pilot distribution agreement with Spartan Medical as well as a shift in distribution partners and additional direct distribution needs. Furthermore, the comparison period included a high initial delivery to a new distributor and in general, our sales to stocking distributors are lumpy and may cause quarterly variance in net sales. We continue to focus on building market presence and to prepare for the expected acceleration of sales through the remainder of the year.
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 continued growth and long-term 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, 14 August 2025
Board of Directors
Bioretec Ltd
For additional information about the report:
Sarah van Hellenberg Hubar-Fisher Johanna Salko
Interim CEO CFO
+31 6 1544 8736 +358 40 754 8172
Certified adviser
Nordic Certified Adviser
+46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device pioneer at the forefront of redefining the future of orthopedics with breakthrough absorbable implant technologies that provide sustainable and natural bone healing. Bioretec’s Activa® and magnesium-based RemeOs™ platforms combine high strength with complete biodegradability, eliminating costly removal surgeries and enabling faster, safer recovery. The company’s products are trusted by surgeons in approximately 40 countries worldwide. With the first RemeOs U.S. market authorization received in 2023, CE mark approval in 2025, and a robust innovation pipeline, Bioretec is positioned to disrupt the USD 10+ billion orthopedic trauma and spine market by delivering value-driven solutions that meet the needs of patients, surgeons, and healthcare systems globally.
Better healing – Better life. www.bioretec.com
Appendix
Bioretec Ltd’s half year report 2025 (pdf)
René Eve appointed as Director of Operations of Bioretec Ltd.
René Eve appointed as Director of Operations of Bioretec Ltd.
Bioretec Ltd Press release 11. July 2025 at 8.00 am
Bioretec has appointed Bachelor of Technology René Eve as the company’s Director of Operations and as a member of the Management Team. Eve has over 15 years of diverse experience in production, procurement, production planning, and customer service. René Eve joins Bioretec from Next Pharma and takes up his duties on 18 August 2025. Esa Hallinen, former Director of Operations, will pursue a career outside Bioretec.
”Bioretec is significantly expanding its operations and production after obtaining both U.S. FDA approval and CE Mark approval for the RemeOs™ product family of absorbable orthopedic implants in Europe and all other countries where CE Mark is recognized. René Eve has strong expertise in the pharmaceutical industry and mass manufacturing of metal products. He will play a key role in Bioretec’s growth into the next phase of commercialisation for our RemeOs and Activa™ products globally. We are excited to welcome René Eve to our experienced management team,” Bioretec’s interim CEO Sarah van Hellenberg Hubar-Fisher says.
”It’s great to join Bioretec's innovative team and support the company's growth and international success story. I am looking forward to implementing the company's strategy and bringing the production of absorbable implants to the next level,” René Eve says.
Bioretec Ltd adjusts the terms and conditions of its stock option programs due to the completed rights issue
Bioretec Ltd adjusts the terms and conditions of its stock option programs due to the completed rights issue
Bioretec Ltd Company announcement 27 June 2025 at 8.00 am EEST
As previously announced, Bioretec Ltd ("Bioretec" or the "Company") has completed a rights issue (the "Offering"), in which a total of 6,156,618 new shares of the Company were subscribed for. The new shares subscribed for in the Offering have been registered with the trade register maintained by the Finnish Patent and Registration Office on 26 June 2025.
Under the terms and conditions of the Company's existing stock option programs, if Bioretec resolves, prior to the share subscriptions under each option program taking place, to issue new shares in accordance with the pre-emptive right of the shareholders, the holders of option rights shall be treated equally with the shareholders of the Company. Under the terms and conditions of the Company's existing stock option programs, the equal treatment shall be provided as determined by the Board of Directors, either by adjusting the number of shares to be issued or the subscription price of the shares to be issued or both. In order to ensure the equal treatment of the holders of option rights, the Board of Directors of the Company has resolved to adjust the subscription prices of the Company's new shares under the Company's existing stock option programs to account for the dilutive effect of the Offering.
The adjusted subscription prices are as follows:
|
Stock option program |
Prior subscription price (EUR) |
New subscription price (EUR) |
|
2018-1A |
1.50 |
1.42 |
|
2018-1B |
1.50 |
1.42 |
|
2018-1C |
2.25 |
2.13 |
|
2018-1D |
2.25 |
2.13 |
|
2020-1A |
2.25 |
2.13 |
|
2020-1B |
3.00 |
2.84 |
|
2020-1C |
3.75 |
3.55 |
|
2023-1 |
2.48 |
2.35 |
|
2025-1 |
2.79 |
2.64 |
|
2025-2 |
2.79 |
2.64 |
Further enquiries
Sarah van Hellenberg Hubar-Fisher, Interim CEO, +31 6 1544 8736
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The Company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is commercializing and developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite - a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 10 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
New shares of Bioretec Ltd registered with the trade register
New shares of Bioretec Ltd registered with the trade register
Bioretec Ltd Company announcement 26 June 2025 at 4.00 pm EEST
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SOUTH AFRICA OR SINGAPORE, OR ANY OTHER JURISDICTION IN WHICH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.
As previously announced, Bioretec Ltd ("Bioretec" or the "Company") has completed its rights issue (the "Offering"). Bioretec announced the final results of the Offering on 24 June 2025.
A total of 6,156,618 new shares (the "New Shares") subscribed for in the Offering have been registered with the trade register maintained by the Finnish Patent and Registration Office today on 26 June 2025. Following the registration of the New Shares, the total number of outstanding shares in Bioretec is 30,783,092. Bioretec does not hold its own shares.
The New Shares confer the same rights as Bioretec's other shares, after being delivered on the investor's book-entry account, on or about 27 June 2025. Trading in the New Shares is expected to commence on Nasdaq First North Growth Market Finland on or about 27 June 2025, provided that Nasdaq Helsinki Ltd accepts the Company's listing application.
Further enquiries
Sarah van Hellenberg Hubar-Fisher, Interim CEO, +31 6 1544 8736
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The Company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is commercializing and developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite - a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 10 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.
Better healing - Better life. www.bioretec.com
IMPORTANT INFORMATION
Neither this release nor the information contained herein is for publication, distribution or release, in whole or in part, directly or indirectly, in or into the United States, Australia, Canada, Hong Kong, Japan, New Zealand, South Africa or Singapore or any other jurisdiction in which publication or distribution would be unlawful. The information contained herein does not constitute an offer of securities for sale in the United States, nor may the securities of Bioretec Ltd (the "Company") be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended, and the rules and regulations thereunder. The Company does not intend to register any portion of the offering in the United States or to offer securities to the public in the United States.
This release is not a prospectus within the meaning of the Regulation (EU) 2017/1129 of the European Parliament and of the Council (as amended, the "Prospectus Regulation") and has not been approved by any competent authority. This release neither describes nor purports to describe risks (direct or indirect) that may be associated with an investment in the Company's securities. In connection with the offering, the Company has prepared an exemption document in accordance with Article 1.4 db of the Prospectus Regulation. The exemption document has been prepared in accordance with the requirements of Annex IX to the Prospectus Regulation. The exemption document does not constitute a prospectus under the Prospectus Regulation and will neither be reviewed nor approved by the Finnish Financial Authority.
The Company has not authorised any offer to the public of securities in the United Kingdom or in any Member State of the European Economic Area other than Finland. With respect to each Member State of the European Economic Area and which applies the Prospectus Regulation (each, a "Relevant Member State"), no action has been undertaken or will be undertaken to make an offer to the public of securities requiring publication of a prospectus in any Relevant Member State. As a result, the securities may only be offered in the Relevant Member States (a) to any legal entity, which fulfils the requirements of a qualified investor as defined in the Prospectus Regulation; or (b) in any other circumstances falling within Article 1(4) of the Prospectus Regulation. For the purposes of this paragraph, the expression "offer of securities to the public" means a communication to persons in any form and by any means, presenting sufficient information on the terms of the offer and the securities to be offered, so as to enable an investor to decide to purchase or subscribe for those securities.
This communication is directed only at persons who are outside the United Kingdom or persons who are qualified investors within the meaning of the Prospectus Regulation as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 and are also (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any investment activity to which this communication relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.
No part of this release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The information contained in this release has not been independently verified. No representation, warranty or undertaking, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The Company or any of its respective affiliates, advisors or representatives or any other person, shall have no liability whatsoever (in negligence or otherwise) for any loss however arising from any use of this release or its contents or otherwise arising in connection with this release. Each person must rely on their own examination and analysis of the Company, its subsidiaries, its securities and the offering, including the merits and risks involved.
The Joint Global Coordinators are acting exclusively for the Company and no one else in connection with the offering. They will not regard any other person as their respective client in relation to the offering. The Joint Global Coordinators will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients nor for giving advice in relation to the offering or any transaction or arrangement referred to herein.
Notice to distributors
Solely for the purposes of the product governance requirements set forth in (a) Directive 2014/65/EU (as amended, "MiFID II"); (b) Articles 9 and 10 of the Commission Delegated Directive 2017/593/EU supplementing MiFID II; and (c) local implementation measures (together "MiFID II Product Governance Requirements"), and disclaiming any liability the "manufacturer" (due to MiFID II Product Governance Requirements) may otherwise have, regardless of whether the liability is based on infringement, contract or otherwise, the Subscription Rights and the New Shares have been subject to an approval process whereby each of them: (i) satisfies the target market requirements of end customers for retail investors, as well as the requirements for investors defined as professional clients and eligible counterparties, as separately defined in MiFID II (the "Target Market Assessment"); and (ii) are suitable for offering through all distribution channels, as permitted in MiFID II. Distributors should note that the value of Subscription Rights and New Shares may decline and investors may not be able to recover all or part of the amount they have invested; Subscription Rights and New Shares do not guarantee any profits or capital protection; and investments in Subscription Rights and New Shares are suitable only for investors who do not need guaranteed profits or capital protection, and who (alone or in conjunction with an appropriate financial or other advisor) are able to assess the benefits and risks of such investment and have sufficient funds from investments to cover any losses incurred. The target market assessment does not affect the sales restrictions based on agreement, law or other regulation in the Offering.
The Target Market Assessment should not be considered as (a) an assessment of appropriateness or suitability under MiFID II or (b) a recommendation to an investor or a group of investors to invest, acquire or take any other action regarding the Subscription Rights or the New Shares. Each distributor is responsible for its own Target Market Assessment of the Subscription Rights and the New Shares and for determining the appropriate distribution channels.
FORWARD-LOOKING STATEMENTS
Certain statements in this release are "forward-looking statements." Forward-looking statements include statements concerning plans, assumptions, projections, objectives, targets, goals, strategies, future events, future revenues or performance, capital expenditures, financing needs, plans or intentions relating to acquisitions, the Company's competitive strengths and weaknesses, plans or goals relating to financial position, future operations and development, its business strategy and the anticipated trends in the industry and the political and legal environment in which it operates and other information that is not historical information. In some instances, they can be identified by the use of forward-looking terminology, including the terms "believes," "intends," "may," "will" or "should" or, in each case, their negative or variations on comparable terminology.
Forward-looking statements in this release are based on assumptions. Forward-looking statements involve inherent risks, uncertainties and assumptions, both general and specific, and the risk exists that the predictions, forecasts, projections, plans and other forward-looking statements will not be achieved. Given these risks, uncertainties and assumptions, you are cautioned not to place undue reliance on such forward-looking statements. Any forward-looking statements contained herein speak only as at the date of this release. Save as required by law, the Company does not intend to, and does not assume any obligation to, update or correct any forward-looking statement contained in this release.
Bioretec Ltd – Managers’ transactions – Stephen Industries Inc Oy
Bioretec Ltd – Managers’ transactions – Stephen Industries Inc Oy
Bioretec Ltd Managers’ transactions 25 June 2025 at 11.45 a.m. EET
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: INITIAL NOTIFICATION
Reference number: 113197/4/6
____________________________________________
Transaction date: 2025-06-24
Outside a trading venue
Instrument type: SHARE
ISIN: FI4000480454
Nature of transaction: SUBSCRIPTION
Transaction details
(1): Volume: 500000 Unit price: 1.5 EUR
Aggregated transactions (1):
Volume: 500000 Volume weighted average price: 1.5 EUR
Further enquiries
Sarah van Hellenberg Hubar-Fisher, Interim CEO, +31 6 1544 8736
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is commercializing and developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite - a new generation of strong biodegradable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and enhance bone remodeling, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential make implant removal operations 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 10 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