First Patient Receives L-C Ligament® in EU Clinical Trial
NEW HAVEN, Conn., July 9, 2013 /PRNewswire/ — Soft Tissue Regeneration, Inc. announced the enrollment of its first patient in a clinical trial of the company’s L-C Ligament®, a bioresorbable scaffold for soft tissue regeneration of the anterior cruciate ligament (ACL) of the knee. The patient was implanted at Isala Klinieken in Zwolle, The Netherlands, by a team led by Dr. Kees van Egmond and supervised by Drs. Robert Arciero and Robert Stanton of the United States. The implant surgery was performed successfully and the patient is recovering.
“The surgery lasted about one hour, which is what we expected due to the straightforward nature of this procedure,” said Dr. van Egmond. “I am encouraged by the patient’s recovery and progress.”
The clinical trial is a prospective, multi-center, non-randomized trial to evaluate the safety profile of the L-C Ligament® in 15 males and females with acute ACL injuries. The primary endpoint of the study is the rate of revision surgery in treated patients. Secondary efficacy endpoints measure the patient’s radiographic, clinical, and subjective outcomes. The trial is being conducted solely in Europe. A larger, global trial in the United States and Europe is anticipated to begin in 2015.
“This is a major milestone for people who suffer through ACL injuries requiring surgery. It is the first step in a process we believe will help improve patient outcomes on so many levels,” said Joseph Reilly, CEO and co-founder of Soft Tissue Regeneration. “There is still work to be done, but we are extremely happy to have completed the first surgery with positive results.”
Invented by Cato T. Laurencin, M.D., PhD, the L-C Ligament® is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery. It is a patented and proprietary technology that uses a clinically-proven polymer called poly(L) lactide acid (PLLA), which is derived from renewable sources such as cornstarch. This degradable polymer is widely used in orthopaedic implantable devices and addresses known risks and morbidity associated with allograft and autograft tissues. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site.
“Having a scaffold that can stabilize the knee and foster the regeneration of the ligament tissues would constitute a major advancement in the treatment of ACL injuries,” said Dr. Arciero, who in addition to being one of the attending physicians, is president-elect of the American Orthopaedic Society for Sports Medicine (AOSSM). “This procedure has the potential to facilitate faster, improved healing with very little surgical morbidity for patients.”
Dr. Arciero and Dr. Stanton (a former president of AOSSM) have been members of Soft Tissue Regeneration’s Scientific Advisory Board since 2010 and have participated in the development of the device.
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 at one year and longer have demonstrated that the L-C Ligament® can successfully regenerate a native ligament intra-articularly.
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(TM), 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 www.softtissueregeneration.com.
Soft Tissue Regeneration, Inc.
SOURCE Soft Tissue Regeneration, Inc.