SAN DIEGO--(BUSINESS WIRE)--Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced results of the first study of the company’s collagen-based Bioinductive Implant on patients with large and massive rotator cuff tears. The results, which were presented at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego, showed the Bioinductive Implant induced new tissue formation in all study participants.
“Failure of large and revision rotator cuff repairs continues to be a challenging problem,” said Felix H. “Buddy” Savoie, MD, study investigator and chairman of the Department of Orthopedics at Tulane University School of Medicine in New Orleans. “This study is exciting for the field of rotator cuff repair, as it showed that the Bioinductive Implant induces new tissue formation and assists in healing for patients with large and massive rotator cuff tears.”
The study enrolled 23 patients – 11 with large (two tendon) and 12 with massive (three tendon) rotator cuff tears – 16 of whom had previous rotator cuff repairs. All patients received the Rotation Medical Bioinductive Implant via arthroscopic surgery. New tissue formation was observed in all 23 patients, and 22 successfully healed their rotator cuffs. Postoperative ultrasound was used to assess tendon thickness at three, six and 12 months, and MRIs were taken at six and 12 months to confirm healing and tendon thickness. Rotator cuff thickness ranged from 5-9 mm at most recent follow-up, and all clinical scores improved significantly over time.
“Results of this study are consistent with the biopsy study published last month in Arthroscopy showing that our Bioinductive Implant promotes the growth of tendon-like tissue,” said Martha Shadan, president and CEO of Rotation Medical. “There is a growing body of evidence demonstrating that the Rotation Medical Rotator cuff system has the potential to transform the treatment of rotator cuff disease by addressing both the biomechanics and biology required to heal a rotator cuff tendon tear.”
The study, “Preliminary Investigation of a Bio-Inductive Collagen Patch used on Large/Massive Rotator Cuff Tears,” adds to the growing body of literature supporting the use of the Bioinductive Implant as a novel and effective treatment for rotator cuff tears. Additional publications and information about the Rotation Medical rotator cuff system are available on the company’s website.
For important safety information, visit http://rotationmedical.com/our-solution/risks/.
Rotation Medical is also exhibiting at the meeting in Booth #5916.
About Rotator Cuff Tears
Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.
About the Rotation Medical Bioinductive Implant
Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address this limitation by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly.
About Rotation Medical
Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit www.rotationmedical.com.