Bioretec Ltd. Forearm fractures are a common injury in children and adolescents. When operative treatment is needed, intramedullary nailing with elastic titanium nail (ESIN) is the most common surgical procedure. On many occasions, the implant is removed after fracture has healed.

Removal is needed to avoid related long-term complications such as irritations, infections or growth disturbance. The interim results of the international Post-Market Clinical Follow-up (PMCF) study show, that the use of Activa IM-Nail™ in pediatric forearm fractures with regard to various study objectives, including the clinical outcome, post-operative complications and refracture rate are equal to the standard titanium procedure but with a benefit of avoiding secondary implant removal operation. To decrease the burden of the healthcare system and the discomfort of the pediatric patient Bioretec has develop and commercialized the world's first bioresorbable elastic intramedullary nail Activa IM-Nail™, which makes implant removal operations redundant.

Activa IM-Nail™ received market authorization (CE-mark) in Europe in 2020. The PMCF study assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children between 3 and 13 years of age. A prospective multicenter study is on-going in many European countries to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail™ for patients, their parents, and other caregivers. At this stage of the study, interim results on 76 patients are analyzed and published1 in high impact rate and distinguished scientific journal: "Children".