Bioretec Ltd Inside information 12 September 2025 at 11:00 a.m. EEST
Bioretec Ltd., a pioneer in absorbable orthopedic implants, announces an update to the commercialization status of the RemeOs DrillPin. Following interactive discussions with the U.S. Food and Drug Administration ("FDA"), the planned commercialization of the DrillPin in the U.S. will progress on a revised timeline to reflect recent FDA guidance on data requirements specific to novel materials.
This adjustment extends the previously communicated timeline for commercialization in 2025. The revised timeline is not currently expected to have a material effect on Bioretec's financial targets published on 4 October 2024.
Bioretec is assessing its overall commercialization strategy and pipeline, including the commercialization of the DrillPin in the U.S., and will provide an update by the end of 2025.
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. ?
Bioretec's Activa® product line features fully bioabsorbable orthopedic implants made from a proprietary, self-reinforced PLGA polymer. These implants deliver secure fixation through patented innovations and naturally degrade in approximately two years, eliminating the need for costly and invasive removal surgeries while supporting optimal bone regeneration. Activa products are both CE marked and FDA cleared for a wide range of indications in adult and pediatric patients.
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. With the development of next-generation implants like RemeOs, Bioretec is shaping the future of orthopedic treatment, paving the way for more effective and patient-friendly solutions.
To learn more about Bioretec, visit https://bioretec.com.
