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Bioretec Achieves Milestone with FDA Breakthrough Device Designation for RemeOs™ DrillPin

Bioretec Oy, a leading name in biodegradable orthopedic implants based in Finland, has achieved a significant milestone by receiving Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its innovative RemeOs™ DrillPin. This designation is a recognition of the device's potential to provide more effective treatment options in the field of orthopedic surgery, specifically for patients with bone fractures.

The RemeOs™ DrillPin is a groundbreaking product made from magnesium alloy technology, known for its biodegradability. This device is designed to facilitate the fixation of bone fragments in both pediatric and adult patients, particularly for those struggling with epi-metaphyseal fractures in children aged two years and above. This innovative technology meets a critical clinical need where existing alternatives fall short, allowing for treatment that aligns with the complexities of bone growth in young patients.

Receiving Breakthrough Device Designation is a testament to the RemeOs™ DrillPin's potential to revolutionize fracture care. The designation facilitates a more efficient and collaborative pathway for clinical development and regulatory review. This close interaction with the FDA aims to accelerate the commercialization process while providing a safety net for the reliability of the device’s clinical effectiveness.

Notably, this designation marks the third breakthrough designation awarded to Bioretec's RemeOs™ series of products, following successful recognitions for the RemeOs™ Trauma Screw in 2021 and the RemeOs™ Spinal Cage in 2024. The consistent acknowledgment of Bioretec's innovations underscores the company’s commitment to addressing the unmet needs in orthopedic treatment.

Sarah van Hellenberg Hubar-Fisher, the CEO of Bioretec, expressed enthusiasm regarding this development. She stated, "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."

The emphasis on the osteopromotive capabilities of the RemeOs™ platform indicates its ability to enhance bone growth and accelerate fracture healing. This is particularly vital for patients who require healing without the additional burden of surgical removal of implants, providing a more patient-centered approach to orthopedic care.

Bioretec has plans to unveil an updated commercialization strategy and product development pipeline by the end of 2025, showcasing a commitment to delivering advanced solutions in orthopedic medicine. While the Breakthrough Device Designation enhances the chances for efficient market entry, Bioretec reminds investors and stakeholders that it does not alter the evidentiary requirements for clinical data or guarantee FDA marketing authorization.

As a globally operating Finnish pioneer in medical devices, Bioretec has established itself as a formidable player in advancing orthopedic care. The company has developed unique competencies focused on the biological interface of active implants, directly impacting bone growth and healing post-surgery.

The RemeOs™ product line, with its high-performance magnesium alloy and hybrid composite materials, represents the next generation of orthopedic implants designed for enhanced surgical outcomes. With a commitment to patient-centric solutions, Bioretec continually strives to shape the future of orthopedic treatment with innovations that promise healing through absorption.

To stay updated on Bioretec's innovations and developments, visit their official website at https://bioretec.com.