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ZuluRevBio Inc., a clinical stage medical device company, announced that it has received approval from the Italian Ministry of Health and the Ethics Committee of the University “G.D’Annunzio” of Chieti-Pescara to start a 15-patient pilot clinical trial. This study’s main goal is to determine how long it takes Tetranite, an adhesive biomaterial made by the company, to rebuild bone in the mandibular and maxillary dental arches.
Tetranite capable of reabsorbing in body
The ability to bond dental implants into place while progressively resorbing and being replaced by new, natural bone is currently not possible with any materials that have been given approval in Europe or the US. These qualities have been shown in earlier studies, but the goal of this investigation is to identify how quickly the substance is reabsorbed by the body. This will help researchers decide how long future clinical trials will need to be in order to receive commercial approval.
Professor Sergio Caputi, the university’s Chancellor/Provost, will oversee the study at the Center for Advanced Studies and Technology (CAST) of the University “G.d’Annunzio” Chieti-Pescara. Professor Maurizio Piattelli, Tonino Traini, Bruna Sinjari, Gianmaria D’Addazio, and Manlio Santilli are additional members of the research group. This group works within the Department of Innovative Technologies in Medicine and Dentistry, which focuses on dental research.
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Dr. Paul Fugazzotto, an advisor to RevBio, and a noted lecturer, dental educator, and periodontist, introduced the company to the research team at the University of Chieti.
“The design of this study will answer some important questions that will help evidence the key advantages of this biomaterial,” said Dr. Fugazzotto. “I believe this technology will be transformative in the way we place dental implants.”
About RevBio
Tetranite is a patented synthetic, injectable, self-setting, osteoconductive bone adhesive biomaterial being developed and marketed by RevBio Inc. The company is initially developing this technology for uses in the dental, cranial, and larger orthopaedic markets as well as in the animal health industry. Tetranite technology from RevBio does not yet have commercial approval.
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