Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia (Australia)

Inclusion criteria

• ✓. Child between 8 and 17 years of age (inclusive) at the time the guardian signs the ICF or adult between 18 and 29 years of age (inclusive) at the time of signing the ICF. Note, the implantations of AUR-201 will initially be staggered based on age and completion of specified DSMB evaluations (see Methodology section);
• ✓. Diagnosed with Grade II, III, or IV congenital unilateral microtia requiring complete auricular reconstruction;
• ✓. Naïve to microtia surgery or have had prior failed microtia surgery not involving the TPF flap;
• ✓. Able and willing to adhere to the post-operative wound care instructions (including, but not limited to, wearing protective devices specified by the PI) and the protocol-specified follow-up schedule;
• ✓. Willing to refrain from non-contact sports and contact sports (e.g., football, soccer, rugby, boxing, karate) for 6 and 12 weeks, respectively, following the first implantation surgery, or longer if deemed necessary for healing by the PI. If the PI opts to implant the AUR-201 wedge at a separate subcutaneous location on Day 0 and then 12 weeks later, implants the wedge in the final location, these periods of refraining from non-contact and contact sports will also apply to the second implantation surgery;
• ✓. PI deems the subject an appropriate candidate for the planned AUR-201 biopsy and implantation procedures (i.e., either the TPF flap technique or the pocket technique) and that the subject meets the following criteria:
• ✓. Healthy auricular cartilage donor site (e.g., conchal bowl site) on contralateral (non-microtic) ear available for biopsy;
• ✓. Healthy skin tissue at site of planned microtia repair;

Exclusion criteria