Bioretec’s Disappearing Devices Make Lasting Impact

Bioretec is a Finnish company focused on developing fully-absorbable orthopedic implants. While the market has traditionally been slow to adopt and commercialize absorbable implants, Bioretec seeks to win over skeptics and build a new segment in orthopedics with its material science.

Bioretec’s Activa products, made of PLGA and patented self-reinforcement technologies, have been sold more than 400,000 times, and its RemeOs Screw, a proprietary osteopromotive magnesium alloy, has received FDA Breakthrough Device designation and gone through the De Novo pathway. Bioretec’s implants are sold in approximately 40 countries, and the company finished 2024 with revenue of $4.7 million, +16% from 2023.

New leadership, including the appointment of CEO Sarah van Hellenberg Hubar-Fisher, has the company focused on expanding its commercialization footprint and product approvals as it closes 2025 and eyes 2026. Bioretec’s strategy involves significantly expanding its presence in the U.S. and advancing its implant materials for new orthopedic indications.

“We remain deeply committed to staying ahead of the curve and advancing our R&D with a strong focus on material science,” Ms. van Hellenberg Hubar-Fisher said when we spoke to her earlier this month.

What differentiates your technology from other absorbable solutions on the market?

Ms. van Hellenberg Hubar-Fisher: We have two technologies: Activa and RemeOs. A main differentiator of Activa is that it’s made of a fully amorphous material that safely breaks down in the body. During healing, it gradually turns into natural substances, lactic acid and glycolic acid, that the body processes through normal metabolism and removes as carbon dioxide and water.

Previous polymer-based absorbables have had crystalline byproducts that resulted in harmful events that occurred in later stages of healing and caused hesitation in the market. That hesitation has died down with the advent of next-gen materials.

Globally, we’ve had zero adverse events reported to date on Activa implants. Much of this success is attributable to the advanced material science I described, which provides enhanced mechanical strength and malleability. Once implanted in the human body, the implant becomes shorter and thicker through controlled dimensional change, resulting in our proprietary Auto-Compression and Self-Locking SL functionality. This additional compression at the fracture site enables secure fixation within the drill hole.

RemeOs is unique in that it’s the first and only absorbable metal implant granted market authorization in the U.S. and is designated as an FDA Breakthrough Device. RemeOs delivers the mechanical strength surgeons need while following a natural degradation pathway that supports bone healing. As it degrades, it is replaced by native bone, leaving no harmful residue behind. Our focus is on providing safe products that are based on natural elements, such as magnesium, calcium and zinc, in the case of RemeOs. Other magnesium-based absorbable implants available outside of the U.S. may contain rare earth elements, which accumulate in the body over time.

What makes these products well-suited for foot and ankle indications?

Ms. van Hellenberg Hubar-Fisher: There’s limited soft tissue in the foot and ankle, so using plates or other bulky metal implants can cause irritation and discomfort for patients. Also, suppose you have secondary foot and ankle trauma in a place where you already have an implant. In that case, revision surgery can be more complex and recovery more difficult for the patient. Whenever possible, screw fixation is preferred, as it provides stable fixation with less implant prominence. In pediatric patients, traditional metal implants are almost always removed through a second surgery to avoid complications with ongoing bone development.

In the U.S., RemeOs is currently available for screw indications in the foot and ankle market, and we continue our focus on expanding the product portfolio. In Europe, the RemeOS screw portfolio already extends to most upper and lower extremity indications for both adult and pediatric use. Our Activa line includes implants for both upper and lower extremity indications in adult and pediatric patients.

Can you share an update on the development of the RemeOs Spinal Interbody Cage?

Ms. van Hellenberg Hubar-Fisher: This further demonstrates our commitment to advancing material science. It’s a next-generation material and hybrid composite engineered to regulate and control degradation speed across different indications, while providing strength retention and enhanced bone stimulation. The RemeOs Spinal Cage has also received an FDA Breakthrough Device designation, and Bioretec remains the only company with an implant portfolio carrying an osteopromotive claim.

The cage is still in the proof-of-concept phase, but through interactions with our scientific advisory board and other members of the spine community, we understand that there’s a lot of interest in spine to use our novel materials.

How important are absorbable implants to the future of healthcare?

Ms. van Hellenberg Hubar-Fisher: If you look at the sales trajectory of trauma, or orthopedics in general, market factors like an aging population are influencing growth. However, the CAGR for most of these markets is not astoundingly high. Absorbables, however, are achieving double-digit growth.

People are much more aware of what health means to them. They prefer not to have foreign objects in their bodies if they can be avoided. Those patient-driven elements speak to absorbable products. Value-based healthcare is also a major driver of growth. Absorbable implants that perform, help avoid secondary surgeries and lower the risk of hospital-acquired infections- for example, infections that can occur around protruding K-wires in pediatric patients. Absorbable products, including our forthcoming RemeOs DrillPin, are buried under the skin and gradually disappear without the need for removal. This reduces the risk of complications and supports a more solid economic story.

Absorbables have been discussed for years as an important next step in orthopedic care, but traditionally commercialization and adoption have been slow. Why are we seeing more interest now?

Ms. van Hellenberg Hubar-Fisher: The Breakthrough designation has helped support the adoption of our RemeOs line. It has facilitated a more interactive regulatory pathway and provides the opportunity for improved reimbursement.

There is also a new recognition of next-generation absorbable materials. Industry is a bit smarter about what to look for in an absorbable implant today than it was when the first generation came out on the market, which ended up having legacy issues over time. The clinical community is also more well-informed about high performing absorbables and understands and can see the clinical and economic benefits.

What challenges and barriers do you still see for your technologies?

Ms. van Hellenberg Hubar-Fisher: Anyone who works in medtech knows that training and education go hand in hand and are needed to overcome the normal barriers to adoption. It’s really important to properly train and educate your commercial representatives and your clinical stakeholders.

When you’re working with novel materials, the regulatory hurdle is quite a heavy lift for a small company like ours. One could argue that our ability to get a product from the starting line, through internal development, to a market authorization via the De Novo pathway and Breakthrough Device Designation within less than five years is pretty astounding progress. I don’t know many big companies that could achieve those goals in that time frame. It demonstrates the commitment of our R&D teams and our CTO to achieve a level of excellence.

Of course, growth capital is also required to achieve targets. Our approach has been to lead with science and then accelerate with marketing and commercialization efforts that drive home our demonstrated excellence in materials science and therefore, patient outcomes.

This article was first published by Orthoworld on September 21, 2025.

by Admin

Composition of Bioretec’s Shareholders' Nomination Board

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

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

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

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

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

Further inquiries

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

Certified advisor

Nordic Certified Adviser AB, +46 70 551 6729

Bioretec in brief

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

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

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

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

by Admin

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

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

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

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

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

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

Further enquiries

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

Certified Adviser

Nordic Certified Adviser AB, +46 70 551 67 29

About Bioretec

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

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

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

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

by Admin

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

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

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

An aggregate number of 5,000 new shares of Bioretec Ltd have been subscribed for with option rights under option program 2018-1A. The new shares have on 15 September 2025 been registered with the trade register maintained by the Finnish Patent and Registration Office. The total subscription price of EUR 7,100.00 will be recorded in Bioretec's reserve of invested unrestricted equity, and the company's share capital remains unchanged.

Following the registration of the new shares, the total number of shares in Bioretec is 30,788,092.

The new shares will be issued in the book-entry system on or about tomorrow 16 September 2025. The new shares will confer shareholder rights in the company as of their registration on the investors' book-entry accounts. Trading in the new shares is expected to commence on Nasdaq First North Growth Market Finland on or about 17 September 2025.

Further enquiries

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

Certified adviser

Nordic Certified Adviser AB, +46 70 551 67 29

Information about Bioretec

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

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.

by Admin

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

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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.  

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.

by Admin

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

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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’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.

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

by Admin

Bioretec Appoints Jordy Winters as Vice President of OUS Sales to Accelerate International Growth

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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:

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

by Admin

Bioretec Ltd: Notification in accordance with chapter 9, section 10 of the Securities Market Act on a change in holdings (W&M GmbH)

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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 ISIN code	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.

by Admin

Bioretec Appoints Sarah van Hellenberg Hubar-Fisher as Chief Executive Officer

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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

alyssa.paldo@finnpartners.com

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.  

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.

by Admin

Bioretec Ltd’s Half-year report 2025: Strong support for future growth from a successful rights issue

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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)

wkr0006.pdf

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