FDA Approves RevBio’s Second U.S. Clinical Trial for Advanced Dental Implant Stabilization

RevBio, Inc. is thrilled to announce that it has been granted approval from the U.S. Food and Drug Administration for a 20-patient clinical trial to evaluate the effects of the company’s bone adhesive biomaterial – Tetranite®. This newest version, a patent-pending formulation with pH-modified and rapidly replaced porous elements, has displayed characteristics that could be considered “osteopromotive”, providing greater potential for biologically active bone replacement. With great anticipation, the clinical trial will examine the safety and efficacy of this revolutionary material for immediately stabilizing dental implants after tooth extractions.

Revolutionize the way implant dentistry is performed with Tetranite, a transformational new product on the dental market. With unmatched adhesive properties and handling characteristics, this unique material has captured the attention of Paul A. Fugazzotto, DDS and Kanyon Keeney, DDS, two of the world’s leading periodontists and oral surgeons, who are conducting a clinical trial to further explore the potential of Tetranite. With Fugazzotto’s 30 years of experience in placing dental implants and Keeney’s clinical practice exclusively dedicated to dental implant surgery, Tetranite is intent on changing the game for dental implant procedures.

Tetranite® biomaterial will revolutionize dental implant procedures by providing an innovative solution to stabilize unsable implants, enabling their immediate placement after tooth extraction. This cutting-edge material saves time, money, and pain for patients, giving them faster and easier access to optimal oral care.

Each year, over 2.1 million unstable implants are restored in the U.S. with conventional bone grafting surgeries, but with Tetranite, that number could be drastically reduced. By providing a simple, convenient solution to a complex and costly problem, Tetranite is sure to make a positive difference for dental patients everywhere.

We are thrilled to announce that Dr. Fugazzotto and Dr. Keeney are officially on board to help us conduct a promising study exploring the bone substitution profile and adhesive strength of our new technology. With the recent IRB approval, our first patients will be enrolling soon. Thanks to the recent technological improvements, we are anticipating accelerated results in the bone substitution profile and the increased adhesive strength of the product.

About RevBio, Inc.

RevBio, Inc. is revolutionizing the medical device industry with its patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial – Tetranite®. This game-changing biotechnology is expected to revolutionize treatment for dental, cranial, orthopaedic, and animal health applications. While Tetranite is not yet ready for commercial use, RevBio is working hard to make stimulating medical advancements a reality.

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