Bioretec Oy (Bioretec), a pioneer in biodegradable orthopaedic implants, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable RemeOs DrillPin.
The designation covers the RemeOs DrillPin for fixation of bone fragments in paediatric and adult patients and for the treatment of epi-metaphyseal fractures in paediatric patients =2 years of age with an open growth plate, including transphyseal indications where fixation across the growth plate is clinically required.
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.
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).
“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 US orthopaedic market”, states Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec.
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.
Bioretec reminds investors that Breakthrough Device Designation does not change the evidentiary requirements for clinical data, FDA marketing authorization, or other regulatory approvals, nor does it guarantee that such approvals will ultimately be obtained.
Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopaedic care with fully biodegradable implant technologies. The company has built unique competencies in the?biological interface?of active implants?to enhance bone growth and accelerate fracture healing after orthopaedic surgery. |