FDA Clears RevBio® to Begin Clinical Trial of Regenerative Bone Glue in Dentistry
RevBio, a biomedical company focused on developing regenerative biomaterials, announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pilot dental clinical trial evaluating the safety and effectiveness of its proprietary regenerative bone adhesive, TETRANITE®. The study will assess the use of the product in dental ridge augmentation procedures, with the goal of enabling bone regeneration without the need for traditional ancillary containment devices such as membranes, meshes, or fixation hardware including tacks and screws.
The FDA approval marks a significant milestone for RevBio as it advances TETRANITE® into clinical evaluation for dental applications. The pilot trial is designed to explore how the adhesive bone scaffold performs in real-world clinical settings, particularly in patients who require bone regeneration prior to receiving dental implants. Ridge augmentation procedures are commonly required in dentistry to restore bone that has been lost due to tooth extraction, trauma, periodontal disease, or prolonged tooth absence.
TETRANITE® is engineered to adhere directly to the surrounding bony walls of a graft site, a property that differentiates it from conventional particulate bone graft materials. By forming a stable, adhesive interface with native bone, the product is intended to remain securely in place during the healing process, potentially eliminating the need for secondary fixation or containment strategies that add complexity, cost, and procedural time to dental surgeries.
“The ability for the product to adhere to the surrounding bony walls of a site that needs to be grafted is a fundamentally unique attribute of TETRANITE,” said Rahul Jadia, Ph.D., RevBio’s Research and Development Manager of Technology Development, who has led the development of the adhesive bone scaffold. “Equally impressive is the fact that the material is substituted with bone in a clinically relevant timescale without significant loss of volume or adhesive and mechanical strength. These characteristics are expected to help accelerate the course of complex dental procedures while supporting predictable, high-quality clinical outcomes.”
Dental ridge augmentation is a critical step in implant dentistry, as sufficient bone volume is necessary to properly anchor dental implants. Industry data indicate that approximately 44% of patients who receive a dental implant begin treatment with at least one missing tooth, often accompanied by varying degrees of bone loss. The extent of bone resorption typically increases with the length of time a tooth has been missing, making reconstruction more challenging.
In current clinical practice, ridge augmentation commonly involves the placement of particulate-based bone graft materials. These grafts require additional containment measures—such as collagen membranes, titanium meshes, or polymer barriers—to prevent graft migration and protect the material during healing. Fixation aids, including tacks or screws, are often used to secure these devices in place. While effective in many cases, these approaches increase surgical complexity and introduce additional risks, including infection, inflammation, membrane exposure, and patient discomfort.
Despite advances in grafting materials and techniques, clinical outcomes remain inconsistent. In more than 30% of ridge augmentation cases, existing bone graft materials fail to achieve the desired increase in bone volume or density, necessitating additional grafting procedures. These repeat interventions can significantly extend treatment timelines, increase costs for patients and providers, and delay implant placement.
RevBio’s TETRANITE® technology aims to address these limitations by offering a bone graft solution that combines mechanical stability, adhesive fixation, and regenerative performance in a single material. By adhering directly to bone and maintaining structural integrity during the healing process, the adhesive scaffold is designed to support predictable bone regeneration without reliance on external containment systems.
The pilot clinical trial approved by the FDA will evaluate both the safety profile and the regenerative performance of TETRANITE® in dental ridge augmentation procedures. Investigators will assess clinical outcomes such as bone volume maintenance, integration with native bone, handling characteristics, and overall procedural efficiency. Data from the trial will inform future clinical development and broader studies intended to support regulatory submissions and potential commercialization.
The development of TETRANITE® has been supported by substantial federal and institutional funding, reflecting strong confidence in the technology’s potential to address unmet clinical needs. Since its inception, the product development program has received $1.8 million in grant funding from the Translational Resource Center (TRC), a research consortium funded by the National Institute of Dental and Craniofacial Research (NIDCR) under grant number U24-DE029462. The TRC is dedicated to advancing promising tissue engineering and regenerative medicine technologies from the laboratory to clinical application.
RevBio’s progress was further accelerated by a $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the NIDCR (grant number 1R44DE032564-01). This funding supported the completion of preclinical studies required to demonstrate safety, performance, and translational readiness, ultimately enabling the company to advance TETRANITE® into human clinical trials.
“The Translational Resource Center is excited about RevBio’s unique and compelling technology that addresses a critical unmet clinical need,” said David H. Kohn, Ph.D., Natalie C. Roberts Endowed Professor in the Departments of Biologic and Materials Sciences and Biomedical Engineering at the University of Michigan and Director of the Translational Resource Center. “We are pleased to support RevBio and to provide translational guidance that has helped shepherd this product to regulatory approval and into first-in-human clinical trials.”
The approval to begin clinical testing underscores the growing interest in regenerative solutions that simplify surgical workflows while improving patient outcomes. As dental implant procedures continue to rise globally, driven by aging populations and increased demand for restorative dentistry, the need for reliable, efficient bone regeneration technologies has become increasingly urgent.
By eliminating the need for membranes, meshes, and fixation hardware, TETRANITE® has the potential to reduce operative time, minimize surgical trauma, and lower the risk of complications associated with multi-component grafting systems. These advantages may translate into shorter treatment timelines, reduced costs, and improved patient experiences.
RevBio believes that success in dental applications could also open the door to broader uses of its adhesive bone technology across other areas of orthopedic and craniofacial surgery. The company continues to explore additional indications where strong adhesion, structural stability, and regenerative performance are essential.
As the pilot trial begins, RevBio will work closely with clinical investigators and regulatory partners to collect robust data supporting the safety and effectiveness of TETRANITE®. The company views this study as a foundational step toward establishing a new category of regenerative bone adhesives capable of transforming how bone grafting procedures are performed.
With FDA approval secured and clinical evaluation underway, RevBio is positioned to advance its mission of delivering innovative, science-driven solutions that improve surgical outcomes and address long-standing challenges in regenerative medicine and dentistry.
