The cruciate ligaments of the knee are vital for a wide range of activities, from bending over to pick up something on the ground to running bases at a softball game. These two ligaments—the anterior and posterior cruciate ligaments–stabilize the knee and help prevent dislocation. But they are also prone to injury. Largely associated with sports injuries, the anterior cruciate ligament (ACL) is one of the most commonly injured ligaments in the United States. Over 550,000 ACL surgeries are performed worldwide each year, with 250,000 occurring in the U.S.
To repair a torn ACL, patients typically have a reconstructive tissue graft implanted in the knee. Tissue is either harvested from the patient’s body (autograft) or from that of a cadaver (allograft) to create the graft. However, autografts may require a longer healing time and cause pain and weakness at the donor site, while allografts cannot be sterilized and are therefore associated with a higher risk of diseases such as HIV and MRSA. What’s more, only 65 to 70 percent of patients with reconstructed ACLs return to their pre-injury level of sports activity.
Orthopedic device company Soft Tissue Regeneration (STR) has developed a knee implant designed to overcome the shortcomings of conventional tissue graft replacements and promote better, faster healing. STR’s lead product, the L-C Ligament, is a biocompatible, biodegradable synthetic scaffold to encourage the regeneration of ACL ligament tissue and provide stability during the healing process. The L-C Ligament utilizes an FDA-approved polymer that is widely used in implantable orthopedic devices. As healing occurs, the implant is gradually absorbed into the body. According to STR, the L-C Ligament offers several advantages over autografts and allografts, including the potential for a faster recovery, a shorter and simpler implantation procedure, and none of the disease transmission risks associated with allografts. STR estimates its market opportunity at $2 billion.
In June of 2009, STR initiated large animal testing for the L-C Ligament. At 12, 24 and 52 weeks following the surgery, new fibrous tissue had grown and integrated at the fixation point in all animals, indicating signs of healing and a regenerative response. STR now plans to initiate a European clinical trial of the L-C Ligament in late 2011. A total of 30 patients will be enrolled in the study, which will take place in four to five sites across Europe.
STR plans to utilize its technology platform to develop a pipeline of follow-on products, including Cuff Regen, a rotator cuff augmentation device. The company is also developing a version of the L-C Ligament aimed at repairing the posterior cruciate ligament. The combined potential market for both products is estimated to be $4 billion by 2012. STR’s platform also has the potential to be expanded to other parts of the body, including the elbows, hips, wrists and ankles.
With America’s aging baby boomers desiring to maintain an active lifestyle well into old age, and with the global increase in surgical procedures in both developed and emerging markets, it seems likely that the need for ACL reconstruction–and products such as STR‘s L-C Ligament–will remain strong in the coming years.