RevBio, Inc. announced that it has received FDA approval to expand its ongoing clinical trial to use TETRANITE®, its bone adhesive biomaterial, for immediate cranial flap fixation. Additionally, the company has secured reimbursement coverage from the Centers for Medicare and Medicaid Services (CMS) for TETRANITE’s use in replacing metal plates and screws in cranial procedures. This approval marks a significant milestone for RevBio’s innovative technology.
RevBio, Inc. recently announced that it has received FDA approval to expand its clinical trial for TETRANITE®, its innovative bone adhesive biomaterial, to include a wider range of cranial procedures. Previously, the company had received FDA approval to initiate a first-in-human clinical study involving an initial cohort of five patients. This study focused on using TETRANITE to restore cranial flaps after craniotomy and repair extradural use cases where intentional durotomies (incisions in the dura mater) were not required. The approval for expanding this clinical trial follows the successful demonstration of TETRANITE’s safety in the initial five patients treated with the product.
With this expanded approval, the neurosurgeon investigators involved in the study will now be able to use TETRANITE for more complex intradural use cases, such as tumor resection surgeries and other cranial procedures that require intentional durotomies. These expanded indications represent a significant step forward for the company’s technology and its potential impact on cranial surgery.
Dr. Kevin T. Foley, a leading expert in neurosurgery and a member of RevBio’s Board of Directors and Chief Medical Officer, highlighted the key advantages of TETRANITE over traditional methods for cranial flap fixation. He explained, “Metal plates and screws can produce radiographic artifacts, making it difficult to accurately interpret patient imaging after surgery. Additionally, traditional cranial flap closure methods do not fully reintegrate the bone flap with the surrounding skull, which can lead to flap movement, patient pain, and potential post-surgical infection.” Dr. Foley emphasized that TETRANITE addresses these issues by eliminating radiographic artifacts and facilitating osseous (bone) union between the flap and the skull, potentially setting a new standard of care for cranial surgeries.
In addition to the clinical trial expansion, RevBio has also received approval from the Centers for Medicare and Medicaid Services (CMS) for reimbursement when TETRANITE is used to replace metal plates and screws in cranial flap fixation. This is a significant development for the company, as it allows RevBio to charge hospitals for TETRANITE use in clinical procedures. Private insurance companies typically follow CMS’s lead, offering reimbursement for products approved by the agency, which will further facilitate the adoption of TETRANITE in clinical practice.
Grayson Allen, CFO and COO of RevBio, expressed excitement about the reimbursement approval, stating, “We are pleased to receive reimbursement approval from CMS during our IDE clinical trial. This approval enables us to establish pricing with healthcare providers, a critical step in the overall commercialization process for our product.”
RevBio is a clinical-stage medical device company focused on developing and commercializing TETRANITE®, a patented, synthetic, injectable, self-setting, and osteoconductive adhesive biomaterial. TETRANITE has broad potential applications in dental, cranial, and orthopedic surgery, as well as in animal health. While the product is not yet approved for commercial use, these recent developments mark important milestones toward its eventual market availability.
About RevBio, Inc.
RevBio, Inc. is a clinical-stage company that is advancing TETRANITE®, an innovative biomaterial designed to address the challenges of cranial flap fixation and other orthopedic and dental applications. The company is committed to developing technologies that improve patient outcomes and reduce complications in surgical procedures.
