RevBio's bone adhesive trial expansion could transform cranial surgery

In the United States, on December 11, 2024, RevBio, Inc. announced a significant advancement in cranial surgical technology with the FDA's approval to expand its clinical trial of TETRANITE, a regenerative bone adhesive designed for cranial flap fixation. This decision follows positive results from an initial human trial involving five patients, which demonstrated TETRANITE's safety and effectiveness for cranial flap restoration post-surgery. The expansion allows for the use of TETRANITE in more complex intradural cases, including tumor resections where intentional durotomies are necessary, broadening its applicability in neurosurgery. Traditional methods of cranial closure often result in complications such as flap mobility, pain, and the risk of infection; however, TETRANITE offers a solution by promoting osseous integration and eliminating radiographic artifacts, thereby serving as a potential new standard of care in cranial surgeries. The Centers for Medicare and Medicaid Services (CMS) has also approved TETRANITE for reimbursement to replace conventional metal plates and screws, bolstering RevBio's position in the healthcare market by facilitating cost coverage for hospitals. The CFO/COO of RevBio expressed optimism about this milestone, viewing CMS reimbursement as critical to establishing product pricing in collaboration with healthcare providers, ultimately supporting the commercialization efforts for TETRANITE. As of now, TETRANITE is under investigation and not yet commercially available but is anticipated for diverse applications in dental, cranial, and broader orthopedic fields as well as veterinary medicine.