Business
Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin
Bioretec Oy ("Bioretec" or the "Company"), a pioneer in biodegradable orthopedic implants, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable RemeOs™ DrillPin.
About this update from Bioretec Ltd.
[{"type":"text","content":"Bioretec Ltd Inside information 14 December 2025 at 5:45 p.m. EET","length":70,"tagName":"p"},{"type":"text","content":"TAMPERE, Finland, Dec. 14, 2025 /PRNewswire/ -- Bioretec Oy ("Bioretec" or the "Company"), a pioneer in biodegradable orthopedic implants, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable RemeOs™ DrillPin.","length":328,"tagName":"p"},{"type":"text","content":"The designation covers the RemeOs™ DrillPin for fixation of bone fragments in pediatric and adult patients and for the treatment of epi-metaphyseal fractures in pediatric patients ≥2 years of age with an open growth plate, including transphyseal indications where fixation across the growth plate is clinically required.","length":320,"tagName":"p"},{"type":"text","content":"Breakthrough Device Designation is granted to medical devices that may provide more effective treatment for life threatening or irreversibly debilitating conditions and that represent a breakthrough technology or offer significant advantages over existing approved or cleared alternatives. The designation gives Bioretec prioritized and more interactive communication with the FDA during the remaining development and review process, which is expected to support an efficient clinical and regulatory pathway for the DrillPin.","length":525,"tagName":"p"},{"type":"text","content":"The RemeOs™ DrillPin is the third Breakthrough Device Designation granted to Bioretec by the FDA for its RemeOs™ product portfolio (Trauma Screw, 2021; Spinal Cage, 2024).","length":171,"tagName":"p"},{"type":"text","content":""Securing Breakthrough Device Designation for the RemeOs™ DrillPin is a major milestone for Bioretec and for patients. It confirms that there are no equivalent solutions addressing this unmet clinical need and recognizes the potential of our osteopromotive, magnesium based platform to change the way fractures are treated. Together with the CMS pass through status already granted for our RemeOs™ Trauma Screw, this designation strengthens our ability to build a commercially attractive and patient centric portfolio in the U.S. orthopedic market", states Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec.","length":622,"tagName":"p"},{"type":"text","content":...