Preclinical Evaluation of a Biofabricated Implant for Rotator Cuff Tendon-Enthesis Regeneration

Preclinical Evaluation of a Biofabricated Implant for Rotator Cuff Tendon Enthesis Regeneration Project Summary Abstract Rotator cuff injuries are a major clinical problemleading tosurgical rotator cuff repairRCRprocedures performed annually in the U SaloneRe rupture rates following RCR are reported upwards ofwith the current standard of careAddressing the clinical need for improving rotator cuff healingthe goals of this research are to optimize the biomanufacturingpreservation and in vivo performance of a Biologically enhanced Tissue ENgineered DeviceBio TENDfor tendon and tendon to boneenthesisregenerationSupported by multiple patentsBio TEND isa wellcharacterizedanisotropicresorbable collagen microfibrous graft electrospun from a benign solventengineered for high void to promote rapid cellular ingrowth and remodelingandbiomanufactured with clinical grade stem cells primed for tendon and fibrocartilage formation to promote enthesis regenerationOur hypothesis is that Bio TEND grafts will accelerate the production of newhost generateddenseregularly oriented tendon like tissue and enthesis integration in a RCR modelWe will accomplish two specific aims necessary for progressing through FDA approval and to commercializationAimEstablish Optimal Bio TEND Biomanufacturing and Preservation StrategiesAimAssess Bio TEND in a Chronic Rat RCR ModelSuccessful completion of our SBIR Phase I work will yield biomanufacturing of a therapeutic for RCRincluding scale uppreservation and performance studiesThis work will lead to pivotal testing in large animals and Mechanism of Action studies in SBIR Phase IIand human clinical trials in Phase IIIResults of these SBIR studies will provide the data required for FDA submission and to successfully market the productThis project brings together investigators with the necessary complementary expertise in the translation of medical devices and cellular therapiesDrFrancisEmbodyand tendon biologybiomechanics and animal models for RCRDrSoslowskyPennworking together with world class surgeons to develop this critical therapeutic Preclinical Evaluation of a Biofabricated Implant for Rotator Cuff TendonEnthesis Regeneration Project Narrative This work will develop an advanced biomanufactured graft to significantly improve rotator cuff healing for thepatients with surgical rotator cuff repair annually in the U Swhich is critically needed in light of the upwards ofre rupture rates reportedThe goals of this research are to optimize the biomanufacturingpreservation and performance of a Biologically enhanced Tissue ENgineered DeviceBio TENDfor tendon and tendon to boneenthesisregenerationand to evaluate putative mechanisms of actionMOAand therapeutic potential in vivoOur hypothesis is that Bio TEND grafts will accelerate the production of newhostgenerateddenseregularly oriented tendon like tissue and enthesis integration in a rotator cuff repair model