About the Company
Soft Tissue Regeneration, Inc. is a medical device company focused on the application of resorbable polymer scaffold technology to regenerate and repair ligament and tendon tissue. The Company’s devices are based on proprietary fiber, braid and mesh designs comprised of poly (L) lactic acid (“PLLA”), a resorbable polymer with a long and proven history of use in implantable medical devices. The STR device designs are ideally suited for tendon, ligament, and other soft tissue injuries when an implantable scaffold is required for the reinforcement and/or regeneration of functional tissue.
The first STR device to reach the clinical stage is the L-C Ligament®, which is currently in clinical trials in Europe. This device has the potential to advance the surgical repair of torn ACL’s by obviating the need to utilize either the patient’s own tissue (“autograft”) with the pain and morbidity of a second surgical site, or the use of cadaver tissue (“allograft”) with the risks of infection and sub-optimal healing. Following four years of animal testing that has demonstrated the ability of the L-C Ligament to remodel and regenerate functioning ligament, STR has initiated a 15 patient Phase I clinical study in Europe. The first patient was treated in June 2013 in Zwolle, The Netherlands and the fifteenth patient was implanted in April 2014.
In June of 2015, the Company started a new 60 patient randomized, prospective, two arm, non-blinded clinical trial in up to 6 sites in Europe for the L-C Ligament This trial assesses the safety and performance of the L-C Ligament against hamstring autograft, and will help further our advancement towards qualifying for CE Mark in Europe.
The L-C Ligament is not approved for sale in Europe, the USA or elsewhere in the world. It is an investigational product exclusively in Europe and can only be implanted as part of this clinical trial.
The Company has also developed a soft tissue augmentation device for rotator cuff repair called the STR GRAFT. In November 2012, the Company received 510(k) clearance to market the STR GRAFT for soft tissue augmentation and rotator cuff repair in the USA.
The Company is developing a 3 dimensional braided surgical mesh for breast reconstruction and hernia repair.
STR was founded in 2008 by Cato T. Laurencin and Joseph W. Reilly.