Bioretec Ltd Inside information 14 December 2025 at 5:45 p.m. EET
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.
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.
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 U.S. orthopedic 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.
Further enquiries
Sarah van Hellenberg Hubar-Fisher, CEO, +31 6 1544 8736
Certified Adviser
Nordic Certified Adviser AB, +46 70 551 67 29
About Bioretec
Bioretec is a globally operating Finnish medical device pioneer at the forefront of transforming orthopedic 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 orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries. ?
The company's latest innovation, the RemeOs product line,?is based on a high-performance magnesium alloy and hybrid composite, introducing a new generation of strong absorbable materials for enhanced surgical outcomes. The RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The first RemeOs product market authorization was received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025.
Bioretec's Activa product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.
Bioretec is shaping the future of orthopedic treatment with a focus on healing through absorption, paving the way for more effective and patient-friendly solutions.
To learn more about Bioretec, visit https://bioretec.com.
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