CE Mark Approval for RemeOs™ Trauma Screw Product Group, featuring four product lines with over 200 individual products, drives global expansion for Bioretec
CE Mark Approval for RemeOs™ Trauma Screw Product Group, featuring four product lines with over 200 individual products, drives global expansion for Bioretec
Bioretec Ltd Press release 14 February 2025 at 6:30 p.m. EET
Bioretec Ltd., a pioneer in absorbable orthopedic implants, has achieved a pivotal milestone with the successful completion of its CE mark approval process for the RemeOs™ Trauma Screw product portfolio. With the CE mark, Bioretec can immediately start selling products in Europe through the distribution network used by the company’s Activa products. The CE mark now obtained covers a wide range of indications for both adult and pediatric patients across the upper and lower extremities, enabling Bioretec to pursue a strong market share in the European market, which already has experience with absorbable magnesium products. The broad spectrum of indications and the upcoming clinical evidence will also accelerate the expansion of the RemeOs™ Trauma Screw product group on the US market, where the current approval is more limited. Furthermore, the CE mark increases the global potential of RemeOs products, as the CE mark is also recognized as the basis for local registration in almost all countries except the United States, China and Japan.
RemeOs™ Trauma Screws, manufactured from a proprietary magnesium alloy, represent a new generation of strong, absorbable materials that enhance surgical outcomes. This product group seamlessly integrates traditional surgical techniques with the advantages of absorbable implants, promoting patient-friendly care and greater healthcare efficiency. Notably, the osteopromotive properties of RemeOs™ Trauma Screws enhance bone growth, supporting the body’s natural processes while fracture is healing. As these screws are absorbed, they obviate the need for surgical removal, delivering a cost-effective solution that aligns with the principles of value-based healthcare. The first product in from RemeOs™ magnesium alloy technology received FDA market authorization in April 2023, and its successful introduction into the U.S. market has demonstrated excellent initial patient results during its controlled launch phase.
The CE mark approval received in January 2025 opens market access across Europe, where the product now complies with the stringent MDR (Medical Device Regulation) requirements of the European Economic Area. This comprehensive approval encompasses all product lines within the RemeOs™ group, meeting diverse surgical needs across various indications for both adult and pediatric patients. The approved indications include the treatment of epi-/metaphyseal bone fractures (osteosynthesis) and the use of fixation after osteotomies for correcting deformities or malalignments in the short bones of the midfoot and hindfoot, as well as in the long bones of the upper and lower extremities, with the exception of the forefoot and hand. Specific indications examples are corrections of midfoot deformities, all ankle fractures in adults and children, and elbow fractures in children. These indications are particularly frequent, with midfoot and ankle fractures being common in both accidental injuries and sports-related traumas, while elbow fractures are among the most common fractures treated in pediatric orthopedics
The RemeOs Screw Product Group consists of four distinct product lines, each tailored to meet the specific surgical requirements and preferences of trauma and pediatric surgeons. These lines include: the cannulated headless, fully variable threaded compression screw (RemeOs FT); the partially threaded 'Herbert style' compression screws, featuring cannulation and different thread pitches in the head and shaft (RemeOs FC); and the partially threaded cannulated and non-cannulated LAG screws with a head (RemeOs FL and RemeOs LAG Solid). Available in diameters from 2 to 4 mm and lengths from 8 to 50 mm in 2 mm increments, these screws accommodate the diverse sizes and shapes of bones in both children and adults. A wide product range is essential, as fractures can occur at various locations at the same bone, and each individual’s bone dimensions and shapes are unique. The comprehensive RemeOs product portfolio facilitates precise, patient-specific treatment, covering a broad spectrum of clinical needs across both upper and lower extremities. The flexible design options of the RemeOs products meet the diverse anatomical requirements of both adult and pediatric patients, thereby enhancing surgical outcomes by providing tailored fixation solutions essential for effective recovery.
Additionally, an important factor of this approval is that almost all other countries recognize the CE mark as a basis for local registration—with the exceptions of the US, China, and Japan—further accelerating Bioretec’s global market expansion strategy. These other countries utilize the CE mark as part of their evaluation process, even though they may also require local registration and compliance checks to ensure that products meet their specific local health and safety standards. This simplifies the local registration process.
Given the CE mark’s comprehensive coverage of designs and indications, this approval enables the immediate gathering of real-world evidence and post-market clinical data in respected European academic centers. Guided by our prestigious global Scientific Advisory Board and key opinion leaders, these efforts support FDA registrations aimed at continually expanding indications in the U.S. to match the extensive coverage provided by the CE mark. Therefore, Bioretec is well-positioned to meet the growing global demand in both adult and pediatric indications, offering clinicians a reliable and versatile solution for a wide range of trauma cases. Currently, Bioretec has an existing and active network of distributors in approximately 40 countries worldwide, poised to implement the company’s strategy starting from the European market, then expanding globally.
“The recent CE mark approval for our entire RemeOs™ Screw Product Group marks a pivotal development in Bioretec's history. Now equipped with the CE mark, we are strategically positioned for capturing the European market and leverage this success globally. The broad scope of the CE mark significantly strengthens our capacity to gather essential real-world clinical evidence across a variety of indications. This data is instrumental as we seek to expand the range of our approved products and indications within the U.S. market. With a solid network of distributors already in place in Europe and a medical community familiar with our technologies, we are poised for the RemeOs products to revolutionize bone fracture treatment standards. This approval represents more than a milestone; it is a crucial gateway to transforming patient care and enhancing the quality of life for individuals not just in Europe, but across the globe.” , says Alan Donze, CEO of Bioretec Ltd.
The market opportunity for the RemeOs trauma screws is substantial. Globally, the orthopedic trauma product market was valued at US 9.0 billion in 2024, and within this larger healthcare sector, the orthopedic extremities market is a dynamic and quickly developing subsegment. Its primary focus is on the identification, management, and rehabilitation of musculoskeletal disorders and injuries that affect the extremities. This market includes a wide range of goods and services, including orthopedic implants, fracture fixation tools, soft tissue repair techniques, and joint replacements. The demand for orthopedic extremities treatments is still being driven by the aging population, rising sports-related injuries, and occurrence of diseases like osteoarthritis. Orthopedic extremities operations have become more widespread thanks to technological developments and minimally invasive surgical methods, which also provide patients with better results and faster recovery times. Orthopedic extremity products and services have a steady and expanding market because older people frequently seek therapies to maintain or improve their mobility and quality of life. In order to fulfill the demands of this aging population, manufacturers and healthcare providers are therefore driven to innovate and broaden their product offerings, fueling market expansion. A considerable opportunity for product growth and improvement is provided by technology breakthroughs. These developments may result in more specialized and accurate treatments, enhancing patient outcomes and speeding up rehabilitation. The growing popularity of outpatient and minimally invasive procedures opens up new business potential. Orthopedic operations for the extremities that can be carried out in ambulatory settings are becoming more popular as healthcare organizations strive to cut costs and improve patient comfort. Manufacturers and healthcare professionals can profit from this trend by creating minimally invasive procedures and equipment and by streamlining the patient flow for faster healing and shorter hospital stays.
The orthopedic extremities market is dominated by North America, especially in the United States. The area benefits from a developed healthcare system, high healthcare spending, and an elderly population that is on the rise. Additionally, cutting-edge technologies and a strong emphasis on R&D help to accelerate the introduction of novel orthopedic treatments. Ambulatory surgery centers are expanding as the popularity of minimally invasive procedures rises across North America. Cost constraints and problems with healthcare reimbursement, however, continue to be problems in this area.
Another key market in the orthopedic extremity market is Europe, which is distinguished by a strong healthcare system and an aging populace. The European market places a strong emphasis on value-based treatment and cost-effectiveness, which encourages the use of outpatient and minimally invasive procedures. The orthopedic extremities market in the area is heavily influenced by nations like Germany, the United Kingdom, and France.
Bioretec's RemeOs product portfolio, with its versatile range and precision-engineered designs, offers a wide spectrum of solutions for clinical challenges in both adult and pediatric populations. By providing specialized fixation options for complex cases in the wrist, elbow, lower ankle, and mid to hind foot, the system addresses critical needs in upper and lower extremity trauma care. This robust portfolio not only positions Bioretec to capture significant market share in Europe but also paves the way for expansion into global markets, where regulatory acceptance of the CE mark facilitates local registrations and expedites market entry.
Further enquiries
Alan Donze, CEO, +1 619 977 5285
Johanna Salko, CFO, +358 40 754 8172
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of absorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Bioretec Ltd’s Financial Statements 2024 published
Bioretec Ltd’s Financial Statements 2024 published
Bioretec Ltd Company announcement 14 February 2025 at 5:00 p.m. EET
Bioretec Ltd has today published its 2024 Financial Statements and Report by the Board of Directors. The publications are attached to this release and also available in Finnish and English on the company’s website at www.bioretec.com/investors/investors-in-english/reports-and-presentations.
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 absorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
Bioretec Ltd’s financial statements bulletin 2024: Foundation for future growth in 2024 – CE mark received in January 2025
Bioretec Ltd’s financial statements bulletin 2024: Foundation for future growth in 2024 – CE mark received in January 2025
Bioretec Ltd Company announcement 14 February 2025 at 8:00 a.m.
This company announcement is a summary of Bioretec Ltd’s financial statements bulletin for January–December 2024. The complete financial statements bulletin with tables is attached to this release as a pdf file and available at the company’s web pages at https://bioretec.com/investors/investors-in-english/reports-and-presentations
July–December 2024 in brief
- In the second half of the year, Bioretec achieved significant milestones in market launch preparation and product development.
- In November, the company raised EUR 6.0 million in a significantly oversubscribed share issue, reflecting strong investor confidence in Bioretec’s growth strategy.
- After the reporting period in January 2025, Bioretec received the long-waited CE mark for RemeOs™ Trauma Screw product portfolio. The CE mark enables immediate market launch of the RemeOs products in Europe and supports commercialization in non-European countries that recognize the CE mark.
- Net sales increased by 23,2% and amounted to EUR 2,482 thousand (7-12/2023: EUR 2,016 thousand).
- Sales margin (excl. other income) was EUR 1,770 (1,401) thousand or 71.3% (69.5%) of net sales.
- Net loss for the period amounted to EUR -2,730 (-1,714) thousand. The net loss of the period includes the cost of financing arrangement amounting to EUR 489 thousand.
January–December 2024 in brief
- Net sales grew 16,3% and amounted to EUR 4,544 thousand (1-12/2023: EUR 3,906 thousand).
- Sales margin (excl. other income) was EUR 3,221 (2,728) thousand or 70.9% (69.8%) of net sales. The sales margin in January-December 2024 includes other income of EUR 170 (82) thousand accrued relating to a Business Finland grant.
- Net loss for the period amounted to EUR -4,614 (-3,789) thousand. The net loss of the period includes the cost of financing arrangement amounting to EUR 489 (775) thousand.
- Earnings per share (undiluted) were EUR -0.20 (-0.19).
- The Board of Directors proposes that no dividend be distributed for the financial period 1 January–31 December 2024.
Key events in 2024
- In June, the European market authorization application for the RemeOsTM trauma screw returned from expert panel evaluation signaling market authorization was now expected later than the earlier estimate (Q2/2024).
- In March, Bioretec was granted an FDA Breakthrough Device Designation status for its RemeOs™ Spinal Interbody Cage.
- In March, Bioretec’s RemeOs™ biodegradable magnesium alloy composition was granted a patent by the U.S. Patent Office.
- In May, Alan Donze was appointed Bioretec’s CEO.
- In June, Frank Sarcone was appointed as Vice President of Sales for the U.S. and a member of the Management team.
- In June, Bioretec communicated positive clinical outcomes from the controlled launch of RemeOs™ trauma screw.
- In September 2024, the following persons were appointed to Bioretec’s Shareholders' Nomination Board: Kustaa Poutiainen, Chair and Founder of Stephen Industries Inc Oy as Chair, and Karoliina Lindroos, Head of Responsible Investment of Ilmarinen Mutual Pension Insurance Company and Marko Berg, Deputy Investment Officer of University of Helsinki, as members. The Chairman of the Board of Bioretec acts as an expert on the Nomination Board.
- In October, Bioretec updated its product development strategy and announced the company will accelerate the product development of the RemeOs™ Spinal Interbody Cage. As a result, the Board of Directors of Bioretec updated Bioretec's financial targets.
- In November, Bioretec signed a new logistics agreement for U.S. operations with customer support services provider GlobalMed Logistix and a new sales and distribution agreement with Tri-State Biologics.
- In November, Bioretec arranged a private placement for institutional and other experienced investors. Through a significantly oversubscribed private placement, Bioretec raised gross proceeds totaling EUR 6.0 million, which will be used to strengthen the commercialization of the RemeOs™ Trauma Screw in the United States and Europe upon the receipt of the market authorization in Europe and to accelerate the product development of the RemeOs™ Spinal Interbody Cage.
This financial statements bulletin is unaudited.
Key figures
|
EUR 1,000 |
H2 2024 |
H2 2023 |
Change, % |
FY 2024 |
FY 2023 |
Change, % |
|
Net sales |
2,482 |
2,016 |
23.2% |
4,544 |
3,906 |
16.3% |
|
Sales margin |
1,868 |
1,483 |
26.0% |
3,391 |
2,810 |
20.7% |
|
Sales margin (excl. other income) |
1,770 |
1,401 |
26.3% |
3,221 |
2,728 |
18.1% |
|
Sales margin, % of net sales |
75.3% |
73.6 % |
|
74.6% |
71.9% |
|
|
Sales margin% (excl. other income) |
71.3% |
69.5% |
|
70.9% |
69.8% |
|
|
EBITDA |
-2,189 |
-1,703 |
28.5% |
-4,053 |
-2,833 |
43.1% |
|
EBIT |
-2,281 |
-1,801 |
26.6% |
-4,202 |
-3,034 |
38.5% |
|
Profit/-loss for the period (+/-) |
-2,730 |
-1,714 |
59.3% |
-4,614 |
-3,789 |
21.8% |
|
R&D spend on total costs, % |
32.0% |
22.7 % |
|
28.7% |
25.6% |
|
|
Equity ratio, % |
84.9% |
77.3 % |
|
84.9% |
77.3% |
|
|
Cash and cash equivalents at the end of the period |
6,289 |
6,910 |
-9.0% |
6,289 |
6,910 |
-9.0% |
|
Earnings per share (undiluted) |
-0.12 |
-0.09 |
33.3% |
-0.20 |
-0.19 |
1.9% |
|
Earnings per share (diluted) |
-0.10 |
-0.07 |
42.2% |
-0.17 |
-0.15 |
8.7% |
|
Shares at the end of the period (undiluted) |
23,336,858 |
19,536,858 |
|
23,336,858 |
19,536,858 |
|
|
Shares at the end of the period (diluted) |
27,515,133 |
24,908,133 |
|
27,515,133 |
24,908,133 |
|
|
Personnel at the end of the period |
47 |
37 |
27.0% |
47 |
37 |
27.0% |
Alan Donze, CEO of Bioretec Ltd:
For Bioretec, year 2024 was a great achievement as we managed to grow our net sales despite the delayed market approvals and significant investment in building out our U.S. infrastructure. We took pivotal strides in the implementation of our strategy. We began our second phase of the RemeOs™ Trauma Screw launch in the U.S., which was supported with the recruitment of key members of the top management and the signing of new distribution and logistics agreements. We also updated our product development strategy and achieved milestones in market approval processes and patenting. To support our growth strategy and product development, we successfully raised EUR 6 million of new capital in November. Finally, in January 2025 we received the CE mark approval for RemeOs™ Trauma Screw product portfolio, a long-awaited milestone in our pursuit for expanded commercial growth.
In 2024, our net sales increased by 16 percent from the previous year, reaching EUR 4,5 million. The net sales consisted mainly of our Activa products, as the launch of RemeOs™ Trauma Screw in the U.S. is still ongoing and the CE mark approval allowing the launch in Europe was only received in January 2025. Our net sales in Europe increased by 46 percent and in the U.S. 30 percent, while the development in the rest of the world remained relatively stable. Despite a slight dip in our sales margin influenced by China’s volume-based procurement policies earlier this year, our margins improved during the last quarter of 2024 due to increased share of sales in the US.
The initial controlled launch of RemeOs™ Trauma Screws in the U.S. yielded excellent patient results and excellent post-healing follow-ups. This success established a strong foundation for entering the second phase of commercialization for RemeOs products in the U.S. In this phase, we will focus on expanding the distribution of the RemeOs™ Trauma Screw beyond the initial selected group of hospitals to a broader network. In addition to RemeOs products, we are also launching the Activa product line to the U.S. market.
To support these efforts, we successfully signed two important new cooperation agreements. In November, we entered into a new logistics agreement with GlobalMed Logistix (GMLx), a leader in healthcare logistics, that operates its own logistics center on the east coast of the United States with a has a nationwide network. This agreement ensures high service levels for customers throughout the U.S. market with seamless import and distribution of implants and instrument sets to hospitals. Additionally, we signed an important agreement with Tri-State Biologics (TSB), a leading distributor of medical and surgical products based in New Jersey. This partnership will enable the efficient sales and distribution of implants and instrument sets to hospitals in one of the most populated areas of the United States.
In addition to the commercial progress of the trauma screw, we are excited about the positive results of the RemeOs™ Spinal Interbody Cage, which received FDA’s Breakthrough Device Designation status. To speed-up the commercialization of RemeOs™ Trauma Screw products and overall product development strategy, including the RemeOs™ Spinal Interbody Cage, we organized a successful and significantly oversubscribed share issue in November, raising EUR 6 million of funds. We were very pleased with the strong response to the share issue, which reflects the confidence investors have in our vision and strategy.
We are extremely pleased that in January 2025, we finally received the CE mark approval for RemeOs™ Trauma Screws, which not only allows immediate product launch in Europe, but also enables commercialization in non-European countries that recognize the CE mark. The CE mark received includes all RemeOs designs, and a broad indication set. The approval will accelerate the collection of real-world clinical evidence, which will enable the expansion of indications in the U.S., where the current approval is more limited.
With the receipt of the CE mark approval in 2025, we will focus on the launch of the full line of the RemeOs products to our customers and existing network of European distributors. In the U.S., we wait for new market approvals and maintain a focus on creating market demand with hospitals and surgeons as well as adding additional distributor partners for the U.S. infrastructure. To keep up with the growth and future potential, we will need to further scale up our manufacturing capacity and workforce. To accomplish these plans and achieve our target of generating positive cash flow from operating activities by the end of 2027, we anticipate requiring new funding in 2025.
In summary, I am extremely proud of our progress and excited about the unique opportunities that lie ahead. With the CE mark now received, we are entering a new phase in our growth strategy, and I have full trust in our capabilities to deliver the results. With the support of our dedicated personnel, owners and investors, we are well-positioned to achieve our growth targets and strengthen Bioretec’s position as a leader in innovative medical solutions.
Board of Directors’ dividend proposal
On 31 December 2024, the parent company’s distributable funds totaled EUR 6,364,318.67. The Board of Directors of the company proposes that the loss of EUR 4,669,883.08 for the financial period from 1 January to 31 December 2024 be credited in the equity as Profit(loss) for previous accounting periods and that no dividend be distributed.
Financial reporting and Annual General Meeting in 2025
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.
Tampere, 14 February 2025
Board of Directors
Bioretec Ltd
For additional information about the report
Alan Donze Johanna Salko
CEO CFO
+1 619 977 5285 +358 40 754 8172
alan.donze@bioretec.com johanna.salko@bioretec.com
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 absorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs™ implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.
Better Healing – Better Life. www.bioretec.com
Appendix
Bioretec Ltd’s financial statements bulletin January–December 2024 (pdf)
Inside information: Bioretec Ltd. receives CE mark approval for RemeOs™ Trauma Screw product portfolio, allowing market launch in Europe
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
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
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Bioretec Ltd’s schedule for financial reporting in 2025
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
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
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 – 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: 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.