Bioretec has received CE certificate for Activa IM-Nail™ and ActivaScrew™ Interference TCP

PRESS RELEASE
27th of February, 2020
For immediate release

BIORETEC has received CE certificate for the world´s first bioabsorbable intramedullary nail, Activa IM-Nail™

Bioretec’s fully bioabsorbable implants have shown excellent results in repairing the growing bones of children and young people. Activa IM-Nail™ opens a new chapter in orthopaedics by introducing the world´s first fully bioabsorbable option for pediatric forearm intramedullary nailing. Thanks to the complete bioabsorption of Activa IM-Nail™, normal bone growth is allowed without long-term complications related to biostable implants. Activa IM-Nail™ offers an economical solution for hospitals and society, as the unnecessary removal operation and costs related will be avoided.

Activa IM-Nail™ is made out of the self-reinforced PLGA (poly-L-lactide-co-glycolide polymer) and has an osteoconductive tricalcium-phosphate (β-TCP) marker in the tip. This unique property allows faster mini-invasive navigation of Activa IM-Nail™ with enhanced implant visibility in the xray. Shorter versions of Activa IM-Nail™ are suitable also for intramedullary distal radius and ulna fracture fixations.

BIORETEC introduces world´s smallest biocomposite interference screw, ActivaScrew™ Interference TCP

Bioretec has received CE certificate for the bioresorbable ActivaScrew™ Interference TCP biocomposite screw intended for ligament fixations in sports medicine. The company´s proprietary self-reinforcement technology enables manufacturing of the world´s smallest, strong biocomposite interference screw. The size range starts from 4 mm, the largest being 11 mm in diameter. The implant is designed to ensure the strengths needed intra-operatively and postoperatively with improved craft fixation properties from Bioretec´s Self-Locking SL™ technology. Bioretec´s Self-Locking SL™ technology makes the implant diameter expand 1-2% in human body conditions, which presses the craft for upgraded fixation security.

ActivaScrew™ Interference TCP biocomposite screw is made of bioabsorbable self-reinforced poly(L-lactide-co-glycolide) (PLGA) mixed with β-tricalcium phosphate (TCP). The β-tricalcium phosphate is known to be an osteoconductive ceramic and has excellent biocompatibility with natural bone components.

Bioretec Ltd. is a medical device company focusing on the development of strong, safe and reliable bioabsorbable and bioresorbable implants for pediatric and adult orthopaedics, trauma and sport medicine surgeries. Bioretec products are sold in over 35 countries worldwide. Bioretec continues to further develop materials and product lines for high load-bearing clinical applications based on new materials and composites. The company´s next-generation bioresorbable metal, RemeOs™, is in clinical phase with promising interim results. RemeOs™ is based on naturally occurring essential metals in the human body: magnesium, zinc and calcium.

For more information, Timo Lehtonen,
CEO Tel. +358 50 433 8493
E-mail: timo.lehtonen [at] bioretec.com
www.bioretec.com