FDA approves Bioretec's RemeOs™ trauma screw as the first bioresorbable metal implant in the U.S. market

Thursday, March 30, 2023

Bioretec Ltd., a pioneer in bioresorbable[1] orthopedic implants, has today received market authorization for its RemeOs™ trauma screw in the U.S. The RemeOs™ trauma screw is the first and currently only bioresorbable metal implant approved by the U.S. Food and Drug Administration (FDA). The approved product range and indication align with the clinical trial conducted in the ankle.[2]

The benefits of the RemeOs™ trauma screw have been validated in clinical trials and have already previously been recognized by the FDA granting the Breakthrough Device Designation. Bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants making implant removal operations redundant.

"This FDA market approval is the most important milestone in our company's history to date," comments Timo Lehtonen, CEO of Bioretec." The U.S. has the world's largest market for orthopedic implants. For the first time, that market is now offered a bioresorbable alternative to be used instead of titanium and steel implants. We are confident that RemeOs™ trauma screw is the best option for a large share of patients considering the care and clinical outcome and from a health economics viewpoint thanks to making an additional removal operation unnecessary. We are also excited about this approval opening a less burdensome regulatory pathway for future RemeOs™ product lines covering a wide array of indications."

Ankle fractures are one of the most frequently occurring fracture types among the adult patient population. There are 3.4 million[3] patients treated each year in the U.S. for ankle fractures. Single-isolated ankle (malleolar) fractures are the most common type, accounting for 70% of the yearly incidence of all ankle fractures[4]. The U.S. ankle and foot market is estimated to grow (CAGR) by 7.3% per year[5]. Bioretec will launch the RemeOs™ trauma screws in the U.S. in collaboration with several hospitals and clinical professionals specialized in ankle fractures. The company expects that RemeOs™ sales will grow gradually as the clinics gain confidence in the innovative bioresorbable metal implant, as is customary for all new orthopedic products.



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