Around 400,000 anterior cruciate ligaments (ACLs) are surgically treated annually in the U.S., comprising a $2.2B market. In the U.S. military, 3,000 ACL reconstruction surgeries are performed annually. ACL standard of care involves reconstruction and/or use of synthetic suture to act as an internal brace to support the joint. Autografting however involves patient tissue harvest related comorbidity and is associated with early onset osteoarthritis in young patients. Overcoming these challenges, we pioneered a microfluidic extrusion-based biomanufacturing technology to create strong and stable collagen microfibers that can be engineered into therapeutic ACL repair grafts. These collagen microfibers are ordered from the molecular-through-product scale, possess native ligament mechanical properties, are stable when hydrated and promote the de novo formation of ligament-like tissue in vivo. In this work we will scale-up a robust biomanufacturing process to form collagen microfibers at commercial scale. We will determine the manufacturability of grafts suited to ACL repair and other indications using collagen fibers by forming complex 3D fiber geometries. We will conduct testing for FDA submissions, and will gather critical surgeon feedback on our product to support product development and commercialization, progressing directly towards human clinical use.
