FDA granted Breakthrough Device Designation for Bioretec’s magnesium alloy technology-based, biodegradable RemeOs DrillPin.
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.
The RemeOs DrillPin is the third Breakthrough Device Designation granted to Bioretec by FDA for its RemeOs product portfolio (Trauma Screw, 2021; Spinal Cage, 2024).
As previously announced, the company will publish an updated commercialization strategy and product development pipeline, along with revised financial targets by the end of 2025.
“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.
FDA granted Breakthrough Device Designation for Bioretec's magnesium alloy technology-based, biodegradable RemeOs DrillPin.
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,...
FDA granted Breakthrough Device Designation for Bioretec’s magnesium alloy technology-based, biodegradable RemeOs DrillPin.
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.
The RemeOs DrillPin is the third Breakthrough Device Designation granted to Bioretec by FDA for its RemeOs product portfolio (Trauma Screw, 2021; Spinal Cage, 2024).
As previously announced, the company will publish an updated commercialization strategy and product development pipeline, along with revised financial targets by the end of 2025.
“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.
Copy to clipboard 
