RevBio Receives Both FDA Approval to Expand its Clinical Trial and CMS Reimbursement for its Regenerative Bone Adhesive for Cranial Flap Fixation

RevBio, Inc., announced that it has received FDA approval to expand its ongoing clinical trial to immediately fixate cranial flaps using TETRANITE®, the company’s bone adhesive biomaterial. The company also received reimbursement coverage from the Centers for Medicare and Medicaid (“CMS”) for the use of TETRANITE to replace metal plates and screws. Previously, RevBio received FDA approval to initiate a first-in-human clinical study for an initial five patients to restore cranial flaps following craniotomy procedures and to repair extradural use cases where intentional durotomies are not required. The approval of this clinical trial expansion is a result of the successful demonstration of safety in the first five patients treated with TETRANITE. a href=”https://www.businesswire.com/news/home/20241211734903/en/RevBio-Receives-Both-FDA-Approval-to-Expand-its-Clinical-Trial-and-CMS-Reimbursement-for-its-Regenerative-Bone-Adhesive-for-Cranial-Flap-Fixation” target=”_blank”>Read more >>