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RevBio Receives Approval from the U.K.’s Regulatory Authority to Initiate a Clinical Trial for an Optimized Formulation of its Dental Bone Adhesive Biomaterial

RevBio Receives Approval to Start a Clinical Trial in the United Kingdom to Study a Modified Formulation of its Bone Adhesive Biomaterial for Implant Dentistry

Excerpt from the Press Release:

LOWELL, Mass.–(BUSINESS WIRE)–RevBio, Inc., announced that it has received approval from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to start a 15-patient clinical trial to examine the safety and efficacy of immediately stabilized dental implants following tooth extractions using an optimized formulation of Tetranite®, the company’s bone adhesive biomaterial.

Dr. Michael R. Norton, BDS, FDS, RCS(Ed), a London-based oral surgeon, noted lecturer, and former President of the Academy of Osseointegration, will serve as the chief investigator for this clinical trial. “I am thrilled to be involved in this clinical trial which builds on the first one I completed earlier this year,” said Dr. Norton. “Since initiating the prior MHRA-approved study in the United Kingdom, RevBio has significantly improved the osteopromotive potential of its biomaterial.”

RevBio has optimized its bone adhesive biomaterial primarily by adjusting the pH of the material as it undergoes its self-setting reaction. In addition, the company has also increased the porosity of the material. Benchtop and animal testing has shown that these changes have improved the material’s biocompatibility with the gingival tissues that surround tooth extraction sites. These formulation changes have also increased the substitution rate of new bone formation without sacrificing the biomaterial’s ability to adhere to bone. In fact, this formulation is more adhesive than the company’s prior dental formulation.

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