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 as “osteopromotive.”
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230801379402/en/
Above are histological images of bone formation within a critical size defect after three weeks in vivo in a rabbit distal femur. On the left, the original Tetranite formulation shows very little substitution with new bone and appears white, which indicates the presence of the biomaterial. On the right, the more osteopromotive formulation shows significant bone in-growth with the red and pink areas indicating new bone substituting the Tetranite biomaterial. (Photo: Business Wire)
The clinical trial will be conducted by Paul A. Fugazzotto, DDS, a world-renowned periodontist based in Massachusetts, who has over 30 years of experience placing dental implants, and Kanyon Keeney, DDS, an oral and maxillofacial surgeon based in Virginia whose clinical practice focuses exclusively on dental implant surgery. “This product is truly transformational,” said Dr. Fugazzotto. “Tetranite will revolutionize how implant dentistry will be performed. The adhesive properties and handling characteristics of this material are incomparable to any product on the market.”
Teeth are extracted due to damage from traumatic injuries, tooth decay, or gum disease. The current standard of care consists of multiple staged surgical procedures to restore a patient’s dentition with prosthetic crowns supported by dental implants. Frequently, extraction sites are too large for dental implants to achieve primary stability through conventional mechanical engagement. Instead, patients must undergo a costly, complex, and lengthy process including a preliminary bone grafting surgery before receiving a dental implant. Based on company surveys, each year in the U.S. approximately 2.1 million implants are eventually placed into initially unstable tooth extraction sites that first must receive a bone graft. The use of Tetranite to stabilize an unstable implant will allow for the immediate placement of dental implants which otherwise could not be placed until the initial bone graft has healed to form new bone. As a result, the Tetranite® biomaterial will help reduce the duration and complexity of these dental implant procedures, lessen patient pain and recovery time, and reduce the overall cost of care thereby providing greater patient access for the treatment of tooth loss.
“We are truly excited to conduct this study with both Dr. Fugazzotto, who will initiate this study enrolling the first cases, along with Dr. Keeney,” said Alan Pollack, RevBio’s Senior Director of Dental Clinical Operations. “The improvements we have made to the technology have accelerated both the bone substitution profile and the product’s adhesive strength. Having also just recently received IRB approval, we look forward to enrolling our first patients in the coming weeks.”
About RevBio, Inc.
RevBio, Inc., is a clinical stage medical device company engaged in the development and commercialization of a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial called Tetranite®. The company is initially developing this technology for use in the dental, cranial, and broader orthopaedic markets as well as applications in the animal health market. RevBio's Tetranite technology is not yet approved for commercial use.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Esri Launches Online GIS Course for Climate Action28.9.2023 23:01:00 EEST | Press release
As the impacts of climate change increase and intensify around the world, one aspect that has become clear is the geographic nature of the issue. The ability to tackle such a wide-reaching geographic challenge requires technology that gives context, which location intelligence provides. To support the individuals working toward this goal, Esri, the global leader in geographic information system (GIS) technology, today announced it will offer a new massive open online course (MOOC) exploring the application of its software to address climate change impacts. The complimentary course will be available this fall for six weeks on the Esri Academy website and includes full access to ArcGIS Pro, ArcGIS Network Analyst, ArcGIS Online, and other ArcGIS software that uses science-based tools and authoritative data. GIS for Climate Action opens on October 25 and provides a comprehensive introduction to how GIS software is used to ingest, map, visualize, analyze, and share massive amounts of data.
Bartek Ingredients on Track with New Facility Doubling Capacity and Cutting Emissions by 80 Percent28.9.2023 22:43:00 EEST | Press release
Bartek Ingredients is pleased to provide an update on its progress on the world’s largest malic and fumaric acid manufacturing facility. The project, which broke ground in January 2023, is on schedule to deliver product to customers by the end of September 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230928870100/en/ New Bartek manufacturing facility on track to deliver product by September 2024. (Photo: Business Wire) “We’re proud to confirm that we’re progressing as expected,” Bartek CEO John Burrows said. “We’re really excited to deliver our expanded capacity by next summer, in addition to new capabilities for a variety of new products.” Bartek expects the new facility to set a new global benchmark for plant safety, efficiency, and environmental performance. Among its anticipated accomplishments is a doubling of Bartek’s production capacity and a per unit greenhouse gas emissions reduction of more than 80 percent.
Brenus Pharma unveils promising pre-clinical results extrapolating human conditions in major international congresses.28.9.2023 17:30:00 EEST | Press release
Brenus Pharma announces that pre-clinical advancements of its inaugural research program were presented at the 7th CICON (International Cancer Immunotherapy) Conference in Milan, Italy (September 20-23) and will be showcased at the 38th Annual SITC (Society for Immunotherapy of Cancer) Congress in San Diego, CA, USA (November 1-5) These communications focus on pre-clinical validation of new developments of the first product generated by the STC Platform, STC-1010, which targets colorectal cancer in a first line of treatment. CONFERENCE TITLE AUTHORS RESULTS CICON23 P119: Allogenic Tumor Cell-Based Vaccine to Treat Colorectal Cancer: Development and Preclinical Validation George ALZEEB, Scientific Project Manager, Brenus Pharma, (Ph.D) Corinne TORTORELLI, Medical Lead, Brenus Pharma, (Pharm. D., Ph.D) Corentin RICHARD, Postdoc, Centre Georges-François Leclerc, ICMUB UMR CNRS 6302, (PhD) Romain BOIDOT, Molecular biologist, Centre Georges-François Leclerc, ICMUB UMR CNRS 6302, (PhD) Tangu
BM3EAC Corp. 2023 Semi-Annual Report28.9.2023 16:15:00 EEST | Press release
BM3EAC Corp. (the “Company”), a special purpose acquisition company incorporated under the laws of the Cayman Islands as an exempted company with limited liability and listed on Euronext Amsterdam, the regulated market operated by Euronext Amsterdam N.V., today published its semi-annual report for the period 1 January 2023 to 30 June 2023. The semi-annual report can be downloaded from the Company’s website via the following link: https://www.BrigadeM3EAC.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER This announcement is not for distribution or release, directly or indirectly, and should not be distributed in or sent into, the United States, Australia, Canada, Japan, the Cayman Islands or South Africa or any other jurisdiction in which such distribution or release would be unlawful or would require registration or other measures. This announ
ASM Global and Leading Finnish Development Company Suvilahden Areena Oy to Partner in Major Helsinki Entertainment Venue Exploration28.9.2023 16:00:00 EEST | Press release
ASM Global, the world’s largest producer of entertainment experiences, and Suvilahden Areena Oy have announced an unprecedented alliance to propose serving as the lead in the future reimagination of Helsinki’s sprawling iconic and historic Hanasaari power plant built in 1909. The duo’s aim is to preserve as much of the legendary landmark building while integrating local culture and environment in combination with a state-of-the-art arena and festival area within the development. ASM Global will anchor the music and live-entertainment venue while exploring incorporating sports programming on a major scale. ASM Global Europe President Chris Bray said, “Hanasaaren voimala is a major next step for ASM Global in Finland. We already have a strong presence in Scandinavia and are now building on our recent expansion into Helsinki, which includes Kulttuuritalo. We believe that with our unrivalled global network, we will bring the world’s most sought-after concerts and artists to fans in Helsink
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom