Inside information: Bioretec's European market authorization for RemeOs trauma screw has proceeded to expert panel evaluation, the approval is estimated during the Q2 2024
Bioretec Ltd Inside information 8 March 2024 at 9:15 p.m. EET
Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, European market authorization application of the RemeOs™ trauma screw has, according to the information received from the Notified Body, progressed to the expert panel stage. The duration of the evaluation is a maximum of 60 days. After this step, the process returns to the Notified Body. Based on the information, the company estimates that the CE mark will be obtained during the second quarter of 2024 instead of the previous estimate of the first quarter of 2024.
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Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable 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 biodegradable 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, CE mark is expected to be received during the second quarter of 2024. Bioretec is positioning itself to enter the addressable over USD 7 billion global orthopedic trauma market and to become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
