Bioretec received FDA's Breakthrough Device Designation for its bioresorbable RemeOs™ Screws.
Bioactive alloy-based RemeOs Screws are intended for the fixation of bone fractures and correction of deformities or malalignments. They form a temporary support for healing and allow the bone to reach its normal strength as the implant resorbs, and obviate the need for an implant removal procedure.
“The approval of the RemeOs™ Screw products for the U.S. FDA’s Breakthrough Devices Program is a significant step for Bioretec in our efforts to commercialize the product in the United States. We are excited about this possible future opportunity for us to be able to offer patients and the healthcare system in the United States, a new, fully bioresorbable metal implant that will provide more effective care and improves the patient’s quality of life. Orthopedic surgeons would finally have access to a bioresorbable implant that follows current surgical techniques, and surgeons will not have to change or learn new procedures in surgeries,” said Timo Lehtonen, CEO of Bioretec.