TAMPERE, Finland, Jan. 31, 2025 /PRNewswire/ -- Bioretec Ltd., a pioneer in absorbable orthopedic implants, has successfully completed its CE mark approval process and can start commercialization of its RemeOs Trauma Screw product portfolio within the European Union and non-European countries that recognize the CE mark market authorization. This comprehensive approval covers all cannulated and non-cannulated product designs*, with sizes ranging from diameters of 2.0mm to 4.0mm and lengths from 8mm to 50mm. Indications approved include the use of these screws for fracture and malalignment fixations in both upper and lower extremities of adult and pediatric patients, excluding the hand and forefoot.
"We are extremely pleased that the EU market approval includes all designs and a vast number of indications. We can now immediately begin offering all RemeOs Trauma Screws to patients across Europe. Moreover, this approval paves the way for market entry into non-European countries that recognize the CE mark, and it empowers us to collect real-world clinical evidence. This evidence will enable the expansion of indications in the U.S., where the current approval is more limited," comments Alan Donze, CEO of Bioretec.
*RemeOs FT cannulated, RemeOs FL cannulated, RemeOs FC cannulated and RemeOs LAG Solid
Further enquiries
Alan Donze, CEO, +1 619 977 5285
Johanna Salko, CFO, +358 40 754 8172
Certified adviser
Nordic Certified Adviser AB, +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of biodegradable orthopedic implants. 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 is?developing?the new RemeOs?product line?based on a magnesium alloy and hybrid composite, introducing a new generation of strong biodegradable 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 combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on?value for patients through efficient healthcare. The first RemeOs product market authorization has been received in the U.S. in March 2023, and in Europe, the CE mark approval was received in January 2025. Bioretec is positioning itself to enter the addressable over USD 9 billion global orthopedic trauma and spine market and to become a game changer in surgical bone fracture treatment.
Better healing - Better life. www.bioretec.com
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