Tag - RevBio

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...
Read more...

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 >>
Read more...

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...
Read more...

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...
Read more...

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...
Read more...

Pitt researchers’ work on bone growth heads to space

What do a dentist, a super glue, and the International Space Station have in common? Not much normally, but starting Tuesday, they’ll begin a journey together to answer questions lying deep within our bones. Dr. Giuseppe Intini, Associate Professor of Periodontics and Preventive Dentistry at the University of Pittsburgh School of Dental Medicine, is a dentist whose research at the Center for Craniofacial Regeneration focuses on skeletal stem cells — the “master cells” of the skeletal system — and their ability...
Read more...

Local company develops adhesive that could be game changer for bone fracture healing

Local researchers believe they have developed an adhesive that could help broken bones heal faster. Lowell-based RevBio told 7NEWS they hope their biomaterial, “Tetranite,” can one day be used to treat osteoporosis or spinal fractures. The adhesive is being developed to help bond fractures and fill gaps as new bone material grows. An injectable product that creates a robust bond in minutes, the company hopes Tetranite can also come in handy when it comes to healing bone lost in surgeries...
Read more...

Novel Bone Adhesive to Fly on SpaceX CRS-26

More than 200 million people worldwide are affected by osteoporosis, a crippling bone disease that decreases bone density, causing bones to weaken and become increasingly susceptible to fracture. Researchers from RevBio, a biomedical startup, are turning to the microgravity environment of the International Space Station (ISS) National Laboratory to further the development of a novel therapeutic that could help repair bone fractures. Read more >>
Read more...

RevBio Receives NIH Grant to Explore the Treatment of Vertebral Compression Fractures with Its Regenerative Bone Adhesive Technology

RevBio, Inc., announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institute on Aging, part of the National Institutes of Health. This funding will allow the company to pursue the treatment of vertebral compression fractures with its patented bone adhesive technology known as Tetranite®. Because the osteoconductive bone adhesive is injectable, the material may be delivered in a minimally invasive procedure. Read more >>
Read more...