Inside Information: Update for Bioretec's RemeOs™ Trauma Screw European Marketing Authorization
Bioretec Ltd Inside information 27 June 2024 at 10:30 p.m. EET
Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, announces that according to the information received from the Notified Body (Dekra), its European CE mark market authorization application for the RemeOs™ trauma screw has returned from the expert panel evaluation. Although the previously estimated timeline projected that the CE mark would be obtained by the end of Q2 2024, we now anticipate that it will be issued later beyond this timeline.
The duration of the expert panel evaluation was a maximum of 60 days, and with this step now completed, Bioretec continues to work diligently towards finalizing the authorization process with the Notified Body.
Further enquiries
Alan Donze, CEO, tel. +358 40 663 5011
Johanna Salko, CFO, tel. +358 40 754 8172
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Nordic Certified Adviser AB, +46 70 551 67 29
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 the CE-mark approval process is currently on-going. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical bone fracture treatment.
Better healing – Better life. www.bioretec.com
