Source: Bone Future; Editor: Guan Zian
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February 2025,BioretecAnnouncing itsRemeOsTrauma Screw Product Portfolio Receives CE Mark Approval, Officially Authorized for Use in the EU and RecognizedCE Certificationnon-EU country market sales. This marksBioretecAn important step has been taken in the field of absorbable orthopedic implants.
Bioretec is an innovative medical device company focused on the research and development of bioabsorbable orthopedic implants. Its products have been widely used in approximately 40 countries worldwide.RemeOs Trauma ScrewDeveloped by Bioretec based on magnesium alloy and hybrid composite materialsNew Generation Bioabsorbable Products, with the potential to replace titanium implants, while helping clinics achieve more valuable healthcare goals.
# Product Introduction
RemeOs Trauma ScrewIt is a medical device used for fracture and deformity fixation. It is made of bioAbsorbable MaterialsMade to gradually degrade in the body, eliminating the need for a second surgery to remove it. This screw is suitable forAdultAndChildrenPatient'sFixation of Fractures and Deformities in Limbs, but does not include the hands and forefeet.The product design includes two types: with holes and without holes, with a diameter range from 2.0 mm to 4.0 mm, and a length range from 8 mm to 50 mm.It is suitable for various fractures of the upper and lower limbs, providing patients with aSafer and More ConvenientTreatment options. The design of this screw aims to promote bone healing whileReduce the Risk of Complications, providing an advanced treatment option for orthopedic surgeons and patients.# Clinical Data and Value
RemeOs™ implants have significant osteopromotive properties.Studies show that 90% of patients achieved complete ossification within 6 weeks after using RemeOs™ implants, and all patients achieved complete fracture healing within 12 weeks.This bone-promoting effect is attributed to the calcium phosphate (such as hydroxyapatite) layer formed on the surface of the implant, which can generate beneficial bioactive reactions with bone tissue.In clinical applications in the United States, the RemeOs™ Trauma Screw has been successfully used in multiple cases, with follow-up results showing successful implantation and fracture healing in all cases. Surgeons report that existing surgical techniques do not need to be altered when using RemeOs™ implants, and the bone-promoting and bioactive properties at the fracture healing site are key factors in choosing this product.
The material of RemeOs™ implants is based on essential metals naturally found in the human body, such as magnesium, zinc, and calcium, and does not contain any rare earth elements harmful to the human body.Clinical trial results show that the RemeOs™ implant has good safety and functionality, with its high mechanical properties and degradation characteristics making it highly suitable for clinical and pediatric applications. Additionally, the RemeOs™ implant has the same radiolucency as cortical bone and is magnetic resonance (MR) compatible under specific conditions.
# Executive Evaluation
BioretecThe CEO said: "We are pleased to announce that the RemeOs trauma screw, including all designs and a broad range of applications, has been approved for the EU market. This means we can immediately begin offering the product to patients across Europe. Furthermore, this approval paves the way for entry into non-European countries that recognize the CE mark and provides us with the opportunity to gather real-world clinical data. This data will support our efforts to expand the intended use in the United States, where approval is currently relatively limited.
# Company Introduction
BioretecFounded in 2003, headquartered in Tampere, Finland. The company focuses on bioAbsorbable Orthopedic ImplantsResearch and production, aimed at throughInnovative ProductsImprove the quality of life for patients.BioretecThe product line is rich, coveringVarious Orthopedic Implants, its business unit is committed to advancing medical technology. The company was listed on the Nasdaq First North Growth Market Finland on September 28, 2021.The company's goal is to enter the value$7 billionThe global orthopedic trauma market, becoming a revolutionary in the field of surgical fracture treatment. In March 2023,BioretecTheRemeOs Trauma ScrewBecomeThe FirstApproved in the United StatesBioabsorbable Metal Implants`, showcasing the company's leading position in the field of innovative medical devices.`The First Global Orthopedic Conference (Global Orthopedic Forum 2025) and Innovation Awards CeremonyTo be held in April this year. The award selection method is now announced. Companies are welcome to register for participation!Please click the link below for more details. Conference seats are limited.??Register soon??~
