20
Participants
Start Date
September 30, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
Magnesium-based bioresorbable DrillPin for fixation of distal radius fractures in children
This is a first-in-child clinical investigation of a bioresorbable magnesium alloy DrillPin (RemeOs™) for fixation of distal radius fractures in children aged 5 to \<14 years. The implant is investigational, not CE-marked or FDA-approved, and represents a novel alternative to traditional metallic implants. It gradually degrades in vivo, eliminating the need for removal. The study focuses on safety and feasibility in a pediatric population, supported by preclinical data from a similar Mg-based RemeOs™ Screw. The DrillPin's material and design are intended to support bone healing without growth disturbances, offering a state-of-the-art, bioresorbable solution tailored for growing patients.
Lead Sponsor
Bioretec Ltd.
INDUSTRY