RevBio Receives FDA Approval to Conduct its Second U.S.-Based Clinical Trial for Dental Implant Stabilization
1.8.2023 20:28:00 EEST | Business Wire | Press release
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
Airship Announces Results Guarantee; Releases Commissioned Study Finding 476% ROI for Composite Organization22.7.2026 18:00:00 EEST | Press release
Airship, the mobile-first customer experience platform leader, today announced its Airship Results Guarantee, a corporate commitment to achieve predetermined business outcomes for new customers. Concurrently, the company released the results of a separate, commissioned Total Economic Impact™ (TEI) study conducted by Forrester Consulting on behalf of Airship, July 2026. The study found that a composite organization based on interviewed customers achieved a 476% Return on Investment (ROI) with a payback period of less than six months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722832535/en/ Airship has launched a new results guarantee offer to stand behind its value. Alongside this offer, the team shared the results of a new Total Economic Impact™ (TEI) study commissioned with Forrester Consulting illustrating that a composite organization achieved a 476% ROI with a payback period of less than six months. “We introduced
Arrakis Comes out of Stealth With $38M to Help Industrial Enterprises Compete in the AI Era22.7.2026 16:56:00 EEST | Press release
Arrakis, the AI deployment company helping industrial companies install AI agents for mission-critical operations, today announced a $30 million Series A led by Blossom Capital, with participation from existing investor Accel, which also led the company's $7.5 million seed round. The round brings total funding to around $38 million and includes backing from prominent technology leaders, including Olivier Pomel, founder and chief executive of Datadog, Olivier Godement, OpenAI’s Head of business products and Junaid Hussein, founder of Cambridge Aerospace. Founded in January 2026 by former Accel investor Rafael Quintanilla, together with co-founders Haroun Beltaifa, Romain Fouilland and Mikhail Galkov - alumni of Palantir, DeliveryHero, Revolut, Datadog and ASML - Arrakis helps industrial companies deploy AI into core operational workflows across aerospace, energy, logistics, manufacturing, construction and telecommunications markets. Across the US and Europe, governments and businesses a
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 16:00:00 EEST | Press release
Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Sentinel satellites to create detailed embeddings - compressed AI representations - of every 10-meter square of Earth's surface. TESSERA represents the most accurat
Omilia Appoints Ryan Kam as Chief Marketing Officer to Lead Global Brand and Growth Strategy22.7.2026 15:00:00 EEST | Press release
Omilia, a global leader in Self-Learning Agentic CX, today announced the appointment of Ryan Kam as Chief Marketing Officer (CMO). Ryan will be responsible for Omilia's global brand, demand generation, and marketing strategy as the company scales its go-to-market presence across enterprise markets. In his new role, Kam will own Omilia's global marketing function, spanning brand strategy, demand generation, product marketing, analyst relations and communications. He joins at a moment of significant commercial momentum: Omilia has seen accelerating enterprise demand across all industries and is investing in a marketing engine built to match the pace of its growth. Ryan Kam brings more than 20 years of marketing leadership across some of the most recognized names in enterprise technology. Most recently, he served as CMO at Egnyte, a leader in cloud content security and governance. Prior to that, Kam held the CMO role at LogicMonitor, where he drove growth for one of the leading infrastruc
Echodyne Announces ATAK Integration for MESA® Radar Platform22.7.2026 15:00:00 EEST | Press release
Echodyne, the radar platform company, today announced the availability of an Android Team Awareness Kit (ATAK) plugin for its MESA® radar platform. The integration enables users to configure, control, and visualize data from Echodyne radars within the ATAK environment, supporting military, public safety, and security operations that rely on TAK for shared situational awareness. The plugin extends radar management and visualization capabilities to ATAK users, allowing high-fidelity radar data and system controls to be accessed through a familiar operational interface. By integrating radar data into existing TAK workflows, organizations can streamline deployment, reduce operator workload, and improve access to real-time situational awareness. TAK is a government-developed geospatial platform used across U.S. military, federal, state, and local government organizations, as well as by U.S. partner nations. According to the U.S. Army TAK Product Center, the TAK ecosystem supports 15 Departm
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