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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.
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...
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.
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Patrick McGuire is an ORTHOWORLD Contributor.
