02Jan
09Dec
RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation
RevBio, Inc., announced that it has received approval from the U.S. Food and Drug Administration to start a 20-patient pilot clinical trial to examine the safety and efficacy of the company’s bone adhesive biomaterial called TETRANITE® to immediately stabilize and fixate cranial flaps following craniotomy procedures associated with brain surgery. This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company. Read more >>
26Oct
RevBio Awarded a $2 Million Follow-On NIH Grant to Reduce Opioid Use and Addiction with TETRANITE®
RevBio, Inc., announced that it has received a grant from the National Institutes of Health through its Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, to improve strategies for the prevention and treatment of opioid misuse and addiction. This $2 million Phase II Small Business Innovation Research (SBIR) grant (2R44DE029369-02) will fund the pre-clinical development of a dental bone graft formulation that will include the release of locally acting non-opioid pain medication. This product is intended to be...
07Oct
RevBio Awarded a $3.4 Million NIH Grant for Its Novel Regenerative Bone Adhesive to Treat Complex Fractures
RevBio, Inc., announced that it has been awarded a grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), through its Commercialization Readiness Program of up to $3.4 million over the next three years (1SB1AG085803-01). This grant will enable the company to finish its late-stage product development activities and conduct a clinical trial to demonstrate the safety and efficacy of the product in comparison to the current standard of care. Read more >>
03Aug
RevBio Receives FDA Approval to Conduct its Second U.S.-Based Clinical Trial for Dental Implant Stabilization
RevBio, Inc., announced that it has received approval from the U.S. Food and Drug Administration to start a 20-patient clinical trial to examine the safety and efficacy of a more rapidly replaced, pH modified porous formulation of the company’s bone adhesive biomaterial called Tetranite® to immediately stabilize dental implants following tooth extractions. This new formulation has shown evidence of a more biologically active bone substitution. While not osteoinductive, this patent-pending version of Tetranite has shown characteristics which may be described...
09Jun
RevBio is Awarded a $2 Million Grant to Advance the Development of its Novel Dental Adhesive Bone Scaffold Product
RevBio, Inc., announced that it has been awarded a $2 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH). This funding (1R44DE032564-01) will allow the company to complete the pre-clinical research necessary to advance this product into the clinical stage of development. Read more >>
23May
RevBio Receives ISO 13485 Certification for its Quality Management System
RevBio, Inc., announced that it has received ISO 13485 certification for its quality management system. Receiving ISO 13485 certification indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical products. “Having built my career in quality management over the last 35 years, I have been through over 25 ISO 13485 audits and many FDA audits,” said Gary Bunnewith, RevBio’s Director of Quality. “None have been as exciting as developing a quality management...
15Feb
RevBio Receives a Strategic Investment from Pacific Dental Services to Support Ongoing Clinical Trials in Implant Dentistry
RevBio, Inc. announced that it has received a strategic investment from Pacific Dental Services® (PDS) to support the clinical development of its bone adhesive biomaterial for implant dentistry. Based in Irvine, California, PDS was founded in 1994 and is one of the leading dental support organizations in the U.S. with over 900 dental practices in 25 states. PDS has been on the Inc. 5000 list of the fastest growing private companies in America 14 times. RevBio is currently in the...
19Jan
RevBio Receives Approval to Start a Dental Clinical Trial in Italy for its Regenerative Biomaterial
RevBio, Inc., 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. The primary objective of this study will be to assess the time it takes for Tetranite®, the company’s adhesive biomaterial, to regenerate bone in the mandibular and maxillary dental arches. This study will be conducted at the Center for Advanced Studies and Technology (“CAST”) of the University “G.d’Annunzio” Chieti-Pescara...
10Dec