Bioinductive Implant Helps Patients with Rotator Cuff Tears Grow New Tendinous Tissue

Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced results of a biopsy study published online in Arthroscopy that supports the biocompatibility of the company’s bioinductive implant and its ability to promote new connective tissue with the histological appearance of tendon. The Rotation Medical bioinductive implant is part of the company’s novel rotator cuff system for rotator cuff repair and a new alternative to traditional surgical repair.
 
“This is a breakthrough study, as it is the first to show that the Rotation Medical bioinductive implant promotes the rapid growth of tendon-like tissue in humans,” said Dr. Steven P. Arnoczky, lead investigator of the study and director of the Laboratory for Comparative Orthopaedic Research at Michigan State University. “While clinical studies have demonstrated evidence of new tissue generation via imaging, the histologic character of this tissue could only be inferred. The unique opportunity to evaluate biopsies from implant recipients confirms the findings of the preclinical animal study, and demonstrates that the implant is biocompatible and promotes new connective tissue with the histological appearance of tendon over the surface of the native cuff tendon.”
 
The retrospective study included biopsies from seven patients undergoing a second arthroscopic procedure for issues unrelated to the implant at various time points (five weeks to six months) following arthroscopic rotator cuff repair with the Rotation Medical bioinductive implant. The biopsy specimens were examined histologically for host-tissue ingrowth, host-tissue maturation and host-implant biocompatibility. Key observations include:
 

• Five weeks: Presence of host cells (fibroblasts) within the interstices of the porous collagen implant. Cells were aligned along the linear orientation of the collagen implant structure, and there was evidence of early collagen formation.
• Three months: Increased collagen formation, maturation and organization over the surface of the implant and evidence of the collagen implant.
• Six months: Newly generated tissue with histologic appearance of a tendon, suggesting functional loading of the new generated host tissue. No evidence of any remnants of the collagen implant.
• No evidence of any adverse inflammatory or foreign body reaction at any time point.

 
“These biopsies underscore the safety of our Rotation Medical bioinductive implant in humans, as well as its ability to promote new tissue formation in a consistent and predictable manner,” said Martha Shadan, president and CEO of Rotation Medical. “We are encouraged by the results of this study, which provides further evidence that our bioinductive implant can biologically augment torn tendons and potentially reduce re-tear and revision rates.”
 
The study, “Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant,” adds to the growing body of literature supporting the use of the Rotation Medical bioinductive implant as a novel treatment for rotator cuff injury.

Find more information on the study here.