CE Mark Approval for RemeOs™ Trauma Screw Product Group, featuring four product lines with over 200 individual products, drives global expansion for Bioretec
TAMPERE, Finland, Feb. 14, 2025 /PRNewswire/ -- 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
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