Animal Study Published in Muscles, Ligaments and Tendons Journal Demonstrates use of Rotation Medical Bioinductive Implant to Induce Formation of New Tendon-Like Tissue
Plymouth, MN – November 20, 2013 – An animal study published in Muscles, Ligaments and Tendons Journal demonstrated that a new bioinductive implant technology developed by Rotation Medical, Inc. was successfully used to induce the formation of new tendon-like tissue in the infraspinatus (rotator cuff) tendon of adult sheep. Rotation Medical, a medical device company focused on developing new technologies to treat rotator cuff disease, sponsored the research.
The study was designed to determine if a porous, absorbable bioinductive implant technology would allow rapid tissue ingrowth of tendon-like tissue. Study investigators sutured bioinductive implants to the surface of the infraspinatus tendons of 23 adult sheep. Six weeks later, histology tissue samples demonstrated complete ingrowth with fibrovascular tissue. By 12 weeks, the implant had induced the formation of a layer of dense, well-integrated and regularly-oriented collagenous tissue that significantly increased the thickness of the native tendon. At 26 weeks the implant was completely absorbed leaving a stable layer of mature tendon-like tissue over the surface of the host tendon. This tissue remained present at 52 weeks. The bioinductive implant did not trigger an inflammatory response or foreign body reaction.
“The Rotation Medical Bioinductive Implant consistently increased the thickness of the rotator cuff tendon by inducing the formation of well-integrated and mature tendon-like tissue,” said Steven Arnoczky, DVM, Director of the Laboratory for Comparative Orthopaedic Research at Michigan State University. “These results suggest that the bioinductive implant may have a role in preventing tear progression in partial-thickness tears by increasing tendon thickness and decreasing intra-tendinous strain.”
Rotator cuff tears affect more than four million people annually in the U.S. and are the most common source of shoulder pain and disability. Tears that start out small, over time, often develop into larger, more painful and debilitating tears due to continuing degeneration of the torn tendon.
“There is a well-recognized clinical need for a better solution to treat rotator cuff disease, since current approaches focus on minimizing pain symptoms but often fail to promote the tendon healing needed to address the source of the pain. Our goal is to treat patients earlier and reduce disease progression,” said Martha Shadan, President and CEO of Rotation Medical. “This study represents an important milestone in our path to commercialization and we are committed to partnering with the clinical community to conduct additional studies to further demonstrate the effectiveness of our bioinductive implant technology.”
The Rotation Medical bioinductive implant was cleared by the FDA in 2011 for use in the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device is not yet commercially available in the United States. A mid-2014 launch is planned in the U.S.
About Rotation Medical
Rotation Medical was founded in 2009 and is committed to advancing the treatment of rotator cuff disease through the development of a proprietary, minimally invasive rotator cuff implant system. The system combines a bioinductive implant that is affixed to the affected tendon using disposable, arthroscopic instruments that are designed to enable quick, reproducible outcomes during both arthroscopic and mini-open procedures. The bioinductive implant offers a new surgical option to intervene earlier and address the root cause of disease progression by promoting tendon healing in patients with rotator cuff tears. For more information visit www.rotationmedical.com.