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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230801379402/en/
Contact information
Michael Tiedemann
mtiedemann@revbio.com
617-763-0923
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
NIQ Launches New Brand Traction Score Designed to Reveal How Effectively FMCG Brands Convert Shelf Presence Into Real Consumer Purchases18.11.2025 13:45:00 EET | Press release
Coca-Cola has been recognised as the top FMCG brand in Western Europe for its success in driving conversions, according to NielsenIQ (NIQ)’s Brand Traction Score, a new metric that measures how effectively brands convert their shelf presence into actual consumer purchases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118769598/en/ NIQ Brand Traction Score The NIQ Brand Traction Score combines two of NIQ’s most powerful data sources: insights from its Consumer Panel, which tracks how frequently shoppers buy a brand, and its Retail Measurement data, which captures how widely and deeply that brand is distributed across stores. This strategy saw some of the top-performing brands grow by 40% due to expanding their presence, with more than 60% of their unit growth coming from households adding these brands to their category repertoire. There was also growth (18%) from existing buyers expanding their brand and category purchas
Barilla Opens Its New Innovation Center to Drive Food Innovation Worldwide18.11.2025 13:37:00 EET | Press release
How can we bring the excellence of Italian culinary tradition into the future? How can we transform everyday products into experiences that surprise the senses, create emotions, and accompany people in moments of pleasure, sharing, and discovery? The answer for Barilla Group is the Barilla Innovation & Technology Experience (BITE) in Parma, marking the company’s most significant investment in food innovation in recent years. With almost 14,000m², more than €20 million invested and an additional €2 million per year dedicated to equipment upgrades, BITE stands as a global hub designed to foster development across the Group’s portfolio. Pasta, sauces, and bakery become a territory of exploration here, where research and technology serve Barilla's passion for good food. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118376430/en/ Guido, Paolo and Luca Barilla. © Barilla Rooted in an approach of collaboration with leading inte
HP Becomes Sisvel Wi-Fi 6 Pool Licensee, Ending Disputes with Wilus, Huawei and Philips18.11.2025 11:58:00 EET | Press release
HP Inc and Sisvel have concluded an agreement for the Palo Alto-based global technology leader to become a licensee of the Sisvel Wi-Fi 6 patent pool. The deal follows a mediation process ordered by Judge Rodney Gilstrap, of the US District Court for the Eastern District of Texas, as part of patent infringement litigation brought against HP by Wilus Institute of Standards and Technology, a licensor in the pool. The agreement not only ends the Wilus suit, but also actions launched against HP by other Sisvel Wi-Fi 6 pool licensors, Huawei and Philips. HP now has one-stop access to approximately 2,000 patents (245 patent families) recognised to date, through the pool’s process of independent patent evaluations, as essential to the 802.11ax Wi-Fi 6 standard. Close to 40 entities license the patents in the Sisvel Wi-Fi 6 patent pool. In addition to HP Inc, these include other recent additions such as Cisco, Netgear and Acer. “We are grateful to HP for the constructive way in which they enga
Europe's GetVocal raises $26m to scale trustworthy conversational agents for enterprises18.11.2025 11:00:00 EET | Press release
GetVocal, Europe’s leading provider of conversational AI agents for enterprise customer support, today announced the closing of a $26 million Series A investment round led by Creandum with participation from Elaia and Speedinvest, bringing GetVocal’s total fundraising to $30 million. GetVocal will use the funding to fuel product innovation, market expansion, and hiring across Europe as the company accelerates its mission to help enterprises build hybrid human-AI workforces. Founded in 2023 by AI entrepreneurs Roy Moussa and Antonin Bertin, GetVocal is headquartered in Paris, with a 60-strong team spread across Europe. It serves 23 markets, with a stronghold in France and Portugal, and a rapidly growing presence in the UK and DACH. The company tackles one of the biggest barriers to conversational AI adoption – the lack of trust and confidence in black-box autonomous systems – by building trustworthy, transparent, and governed AI agents that accelerate the customer experience (CX) market
Ant Group Unveils China’s First Multimodal AI Assistant with Code-Driven Outputs18.11.2025 10:05:00 EET | Press release
Ant Group today launched LingGuang, a next-generation multimodal AI assistant and the first of its kind in China that interacts with users through code-driven outputs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117438567/en/ Equipped with the capability to understand and produce language, image, voice and data, LingGuang delivers precise, structured responses to complex queries through 3D models, audio clips, charts, animations, interactive maps, and even immediately generated applications, in addition to traditional text-based conversation. Designed around three key features, LingGuang aims to make complex knowledge simpler and more intuitive, transforming how users access information and interact with AI tools. Fast Research: LingGuang responds to user questions or keywords with dynamic, multimodal content, making research on any topic clearer and more engaging. Its 3D digital modeling capability transcends traditio
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