Technology Overview
STR has demonstrated in functional large animal models the complete regeneration of anterior cruciate ligamentous tissue using a degradable synthetic polymeric construct. STR’s first product, the L-C Ligament®, is a biocompatible and bioresorbable synthetic scaffold which is designed to facilitate re-growth of a patient’s anterior cruciate ligament (ACL) within the knee.
The Company’s proprietary and patented technology utilizes a degradable polymer that is widely used in orthopaedic implantable devices, and addresses known risks and morbidity associated with allograft and autograft tissues. To date, STR has completed substantial large animal testing on the product, and results from one year and longer large animal studies demonstrate that the L-C Ligament can successfully regenerate a native ligament intra-articularly. The Company started a 15 patient single arm safety study at two sites in The Netherlands in June 2013. The one year follow-up has been completed for all patients and there were no revision surgeries in the first year.
In June of 2015, STR started a 60 patient randomized, prospective, two arm, non-blinded clinical trial in up to 6 sites in Europe. This trial assesses the safety and performance of the L-C Ligament against hamstring autograft.
STR is also leveraging its technology platform to develop a suite of complementary follow-on products, including the STR GRAFT™, an innovative device for which STR received FDA 510(k) clearance to market the device for soft tissue augmentation, repair of tendons and ligaments and rotator cuff repair in the United States.
The L-C Ligament® is not available for sale in the EU or United States