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Wednesday, October 5, 2022

MEDICAL DEVICE NEWS MAGAZINE

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Bioretec Files for CE Mark for its Bioresorbable RemeOs Magnesium Screw in the EU

Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has submitted an application for the CE mark for the first product in its new RemeOs™ product family, the RemeOs™ trauma screw.

The CE mark is a legal prerequisite in order to commercialize a medical device in the European Union. Bioretec’s target is to receive the CE mark and to introduce the bioresorbable magnesium alloy trauma screw into the markets in the European Union during 2022.

RemeOs™ bioresorbable magnesium implant helps bone to heal and is naturally replaced by bone, eliminating the need for removal operations that are in many cases required when using traditional implants. In the CE mark filing, the intended use of RemeOs™ trauma screw is for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies e.g., the correction of deformities or malalignments.

“Filing for the CE mark on schedule is an important milestone in the commercialization of our first RemeOs™ product and a great end to our first year as a listed company. I am proud of our team’s commitment and effort to reach this milestone. It follows our strategic goal of developing and commercializing innovations that increase patients’ quality of life,” says Timo Lehtonen, CEO of Bioretec.

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