Study Results: Rotation Medical Bioinductive Implant in Growth of New Tendinous Tissue
Study results support the biocompatibility of Rotation Medical's collagen-based bioinductive implant and its ability to promote new connective tissue with the appearance of tendon. The results are published in the journal Arthroscopy.
The retrospective study included biopsies from seven patients undergoing a subsequent arthroscopic procedure for issues unrelated to the implant at various time points (five weeks to six months) following arthroscopic rotator cuff repair with the bioinductive implant.
At six months, newly-generated tissue was observed with histologic appearance of a tendon, suggesting functional loading of the newly-generated host tissue. No evidence remained of remnants of the collagen implant, nor was there evidence of any adverse inflammatory or foreign body reaction at any timepoint.
The company received FDA 510(k) clearance of its implantable collagen scaffold technology in 2Q14 for use in arthroscopic and mini-open procedures to support tendon injuries in which there was no substantial loss of tendon tissue. A recently-announced US $12MM Series B extension financing will support U.S. commercialization of the company's repair technology.
Sources: Rotation Medical, Inc.; ORTHOWORLD Inc.