Soft Tissue Regeneration, Inc. (STR), the developer of resorbable polymer scaffolds for the repair of soft tissue injuries, today announced it has initiated a randomized and controlled clinical study in Europe for its L-C Ligament® device for the reconstruction of a ruptured anterior cruciate ligament (ACL).
The results of this clinical study will be submitted to regulatory authorities to obtain approval (CE mark) for STR to market the L-C Ligament® in most European markets. On September 24, 2015, the first three patients of this clinical study were enrolled and treated at the Isala Klinieken in Zwolle, The Netherlands, by a team led by Dr. Kees van Egmond and supported by Drs. Peter Indelicato and Robert Stanton of the United States, both members of the STR Scientific Advisory Board. All three patients were treated successfully, including the two patients who received the L-C Ligament® device and one patient who was treated with tendon harvested from the patient’s own hamstring (autologous hamstring tendon).
“The repair of a ruptured ACL typically involves the surgical harvesting of the patient’s own hamstring or patellar tendon tissue, often resulting in pain, donor-site morbidity, impaired function, and additional operating time,” said Dr. van Egmond. “With few options to autograft available, the L-C Ligament® may fulfill a significant clinical need for a device that will regenerate a functioning ACL while avoiding the morbidity associated with autograft reconstructions and saving a considerable amount of operating time.”
Dr. van Egmond also performed the first-in-man L-C Ligament® implant procedure in June 2013, and was the primary investigator of STR’s earlier 15-patient safety and feasibility study.
The L-C Ligament® clinical trial is a prospective, multi-center, randomized controlled trial that will compare the L-C Ligament® to the hamstring autograft in 60 patients requiring a surgical reconstruction for an acute ACL injury. The primary endpoint of the study is the absence of revision surgery for graft failure and the function of the reconstruction as measured by established orthopedic evaluation scores for patients following knee surgery. The trial is being conducted in Europe to obtain a CE mark to allow STR to go to market in Europe. A larger global trial in the United States and Europe is anticipated to begin in late 2016.
“This is another major milestone for Soft Tissue Regeneration and the hundreds of thousands of people who suffer ACL injuries annually requiring surgery,” said Joseph Reilly, CEO and co-founder of STR. “It is another step that will help improve patient outcomes on so many levels. Other European sites are beginning the recruitment process and we expect up to six sites to be recruiting by year end.”
The L-C Ligament® is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery and regenerate the ACL. It is manufactured in a patented and proprietary process utilizing a clinically proven polymer called poly (L-lactic acid) or PLLA. This degradable polymer is widely used in orthopaedic implantable devices, and breaks down into naturally occurring lactic acid, which is also a byproduct of exercise.
The L-C ligament® addresses known risks and morbidity associated with allograft and autograft tissues for ACL reconstruction. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site. The L-C Ligament® is anticipated to encourage the regeneration of the patient’s own ligament tissue. To date, results from large-scale animal testing and a European safety study have demonstrated that the L-C Ligament® can successfully regenerate a native ligament in the intra-articular space.
STR is privileged to have the support of a prestigious and committed Scientific Advisory Board, two of whose members, Drs. Robert Stanton and Peter Indelicato, attended and advised on the surgeries of these first three patients enrolled in the CE Mark Study. Another member of the STR Scientific Advisory Board, Dr. Robert Arciero also has attended a patient surgery during the STR Safety and Feasibility Study. Drs. Arciero, Stanton, and Indelicato are each past Presidents of the leading academic sports medicine society, the American Orthopedic Society of Sports Medicine (“AOSSM”).
The L-C Ligament® is an investigational device and is not available for use or sale in the European Union or the United States. It is only available as part of the clinical trial.
About Soft Tissue Regeneration, Inc.
Soft Tissue Regeneration, Inc. (STR) is a medical device company whose aim is to apply its patented and proprietary technology comprised of PLLA, a degradable polymer, in orthopedic implant devices for regeneration and augmentation of soft tissue. In addition to the L-C Ligament®, STR is also leveraging its technology to develop a suite of complementary follow-on products and surgical meshes, including the STR GRAFT™, a FDA 510(k)-cleared innovative device for soft tissue augmentation, repair of tendons and ligaments and rotator cuff repair in the United States. To learn more about the company or about investing in the company, visit http://www.softtissueregeneration.com.