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

Inclusion criteria

• ✓. Child between 8 and 17 years of age (inclusive) at the time the parent/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;
• ✓. 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 ± 28 days 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 procedure (i.e., either TPF flap or 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