Los Angeles, CA, July 13, 2023 — Tetrous Inc., a leading regenerative medicine company today announced that it has completed the first surgical cases in Australia using EnFix RC, a procedure-specific implant for rotator cuff repair that is specifically designed to address Enthesis Failure Syndrome. The procedures were performed successfully by Dr. Kenneth Cutbush, Dr. Ivan Popoff and Dr. Doron Sher.
“It is exciting that Tetrous is dedicated to developing new technology focused on healing the enthesis in rotator cuff surgery. For far too long, the re-tear rates following rotator cuff surgery have remained high, especially for larger tears, with little to no attention given to post-operative healing at the tendon-bone interface. The pre-clinical data is very compelling showing enthesis reformation at 12 weeks”, said Dr. Jerome Goldberg, M.B., B.S., F.R.A.C.S., F.A. Ortho A., Tetrous Clinical Advisory Board Member. “I am thrilled to be helping to bring this innovative technology to market in Australia,” he added. The EnFix™ product line is being launched in Australia in partnership with Australian Biotechnologies.
Most studies show that 20% to 70% of rotator cuff repairs fail structurally. Inadequate tendon-to-bone ingrowth results in incomplete healing, gap formation and a high risk of re-tear. Tendon reattachment is a crucial clinical need, especially in larger tears because failure rates increase linearly with tear size. While most augmentation products have been designed as “overlays” to reinforce the tendon, EnFix RC changes the paradigm by enhancing healing at the enthesis where failure often occurs. This enhanced biologic repair at the interface between tendon and bone is a significant advance.
John Bojanowski, Tetrous’ Head of Sales and Marketing said, “With first surgical cases in the U.S. two weeks ago, first cases in Australia last week and our official product launch at American Orthopaedic Society for Sports Medicine (AOSSM) annual meeting this week, things are moving fast. It is great to see this game-changing technology become available to patients.”
Tetrous’ CTO, Andy Carter, PhD, added, “I have worked for many years successfully developing and delivering multiple products using demineralized bone fibers in spine. It’s rewarding to be able to deliver technology designed for use in sports medicine specific applications such as Rotator Cuff, ACL and Achilles procedures. EnFix RC for rotator cuff repair has performed magnificently and we expect to see widespread adoption in both the U.S. and Australia.”
The EnFix RC rotator cuff implant is made from proprietary demineralized cortical bone fibers. Using Bone Textile™ technology to produce the implant yields long and strong bone fibers that promote cell wicking, cell adhesion and cell proliferation, while our FormLok™technology imparts shape retention to the device, even when immersed in liquid, as is regularly required for use in arthroscopic surgery.