04 Jan Bioretec files for CE mark for its bioresorbable RemeOs magnesium screw in the EU
HELSINKI, Dec. 31, 2021 /PRNewswire/ — 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.
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Certified Adviser: Nordic Certified Adviser AB, p. +46 70 551 67 29
Information about Bioretec
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable 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 bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed 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. With the U.S. and EU market authorization for the first RemeOs™ product expected in 2022, Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical possibilities. Better Healing – Better Life. www.bioretec.com.
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