Developing novel 3D printed grafts for nasal reconstruction

Abstract Complex nasal reconstruction often requires significant donor cartilage to augment and reconstruct large defects. The scarcity of septal cartilage compels surgeons to resort to harvesting costochondral rib cartilage for nasal grafts. Cadaveric costochondral grafts or synthetic materials (both permanent and resorbable) are occasionally used. Each approach carries its own significant drawbacks, underscoring the unmet need among surgeons for a solution that combines the ease of use and unlimited supply of synthetic grafts, with the mechanical properties of native cartilage. Mobius Biotech has developed a novel 3D printed polycaprolactone (PCL) nasal graft the Resorb3D Spreader Graft (RSG), using Resorb3D, its innovative platform technology to produce resorbable implants for nasal and facial reconstruction. The RSG is a standardized off the shelf graft designed with a bilevel pore geometry, with smaller pores for tissue ingrowth and larger pores to accommodate cartilage tissue biopsies and engineered to mimic the mechanical properties of costochondral cartilage. By minimizing the need for cartilage harvesting surgeries, the RSG will significantly reduce the overall risk, cost, and surgical time for complex nasal reconstruction, thus benefiting a broad range of stakeholders including patients, surgeons, hospitals, and insurers. The Specific Aims of this SBIR will evaluate and test the RSG prototypes in an in vivo rabbit animal model, focusing on tissue integration, inflammation, and nasal reconstruction efficacy as compared to PDS plates. The mechanical and material properties of both RSG and PDS will also be compared to costochondral grafts to assess implant extrusion risks. Currently, PDS plates are the only available resorbable implants used by surgeons to augment septal cartilage during nasal reconstruction. Aim 1 will compare the material and mechanical properties of RSG and PDS plates to nasal septal and rib costochondral cartilage. Aim 2 will compare in vivo tissue integration, inflammatory response, and mechanical performance of the RSG vs PDS plates implanted bilaterally in a rabbit rhinoplasty model. Outcomes will determine mechanical properties and in vivo performance of RSG vs PDS plates during resorption/degradation post implantation. Aim 3 will help Mobius Biotech engage with a regulatory consultant to understand FDA requirements, start working on a Design History File (DHF) and better prepare for the SBIR Phase II.