Bioretec gains CE mark approval for RemeOs Trauma Screws, expanding European market reach

Bioretec Ltd., a Finnish medical device company specializing in biodegradable orthopedic implants, has secured CE mark approval for its RemeOs Trauma Screw portfolio. This regulatory milestone allows the company to begin commercialization across Europe, reinforcing its position as an innovator in fracture healing technology. The approval applies to all variations of RemeOs Trauma Screws, including both cannulated and non-cannulated designs, with diameters ranging from 2.0mm to 4.0mm and lengths from 8mm to 50mm. These implants are designed for fracture fixation in the upper and lower extremities of both adult and pediatric patients, excluding the hand and forefoot.

By obtaining this regulatory clearance, Bioretec can now introduce its biodegradable orthopedic implants not only in the European Union but also in non-European markets that recognize the CE mark. This expansion marks a significant step in the company’s mission to revolutionize trauma care by eliminating the need for secondary implant removal surgeries.

What Makes RemeOs Trauma Screws a Breakthrough in Fracture Healing?

Traditional metallic implants, while effective in stabilizing fractures, often come with long-term complications. Many patients require implant removal surgery due to adverse reactions or the risk of stress shielding, which can weaken surrounding bone structures. RemeOs Trauma Screws offer a cutting-edge alternative, leveraging biodegradable orthopedic implants that naturally integrate with the bone over time.

Developed from a unique magnesium alloy and hybrid composite, the RemeOs Trauma Screws are absorbed by the body and replaced with bone tissue, accelerating the fracture healing process. This bioabsorption eliminates the need for additional removal procedures, reducing surgical risks and improving patient outcomes.

Furthermore, Bioretec’s patented material composition—based on naturally occurring metals such as magnesium, zinc, and calcium—ensures that the implants are safe and biocompatible. Unlike conventional bioresorbable implants that rely on rare-earth elements like yttrium or gadolinium, RemeOs Trauma Screws use only essential minerals already present in the human body, reducing the risk of foreign-body reactions.

How Do RemeOs Trauma Screws Improve Patient Outcomes?

The core advantage of Bioretec’s fracture healing technology lies in its ability to match bone regeneration timelines with implant strength retention. The RemeOs Trauma Screws maintain structural integrity during the critical early stages of fracture healing but gradually dissolve as the bone regains its strength.

Clinical studies have demonstrated that in 90% of patients, full ossification occurs within six weeks, with complete fracture consolidation achieved by 12 weeks. This accelerated healing process can significantly reduce recovery times, allowing patients to regain mobility faster while minimizing post-surgical complications.

The implants also eliminate concerns associated with traditional metal screws, such as osteolysis and stress shielding. Since the biodegradable orthopedic implants dissolve naturally, they do not interfere with long-term bone density or structural integrity, offering a sustainable solution for trauma care.

How Will CE Mark Approval Expand Bioretec’s Market Reach?

With the CE mark approval in place, Bioretec is now positioned to expand its footprint in the global orthopedic trauma market, which is valued at over USD 9 billion. This regulatory clearance allows the company to immediately introduce RemeOs Trauma Screws across European healthcare facilities while also paving the way for market entry in other regions that recognize CE-marked products.

Alan Donze, CEO of Bioretec, highlighted the significance of this approval in advancing the company’s global strategy:

“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.”

Bioretec previously secured U.S. regulatory approval for its first RemeOs product in March 2023. The CE mark approval not only strengthens the company’s position in Europe but also serves as a critical stepping stone toward expanding its indications and approvals in the U.S. and other key markets.

Could Biodegradable Implants Replace Titanium in the Future?

As the demand for biodegradable orthopedic implants grows, Bioretec is positioning itself as a key player in the transition away from traditional titanium-based solutions. By developing implants that integrate seamlessly with natural bone healing processes, the company is driving innovation in fracture healing technology while contributing to the global shift towards value-based healthcare.

The potential to replace permanent metal implants with bioresorbable alternatives could significantly impact orthopedic surgery by reducing overall healthcare costs, improving patient outcomes, and streamlining post-surgical care. With Bioretec now entering the European market, its RemeOs Trauma Screws could redefine the standard of care for orthopedic trauma treatment.

As Bioretec continues its expansion, the medical community will closely monitor the adoption of biodegradable orthopedic implants in real-world clinical settings. If the results align with initial clinical trials, the shift towards bioresorbable implants could mark a turning point in trauma care, ultimately reducing the need for secondary surgeries and improving long-term patient health.