RevBio

RevBio Issued a Key Patent for its Regenerative Bone Adhesive Technology by the United States Patent and Trademark Office

Antonette Ho2025-02-15T23:49:17-05:00The United States Patent and Trademark Office recently issued patent 12,178,937 entitled “Compositions and Methods for Adhesion to Surfaces,” which constitutes the 10th U.S. patent that covers the TETRANITE bone adhesive technology. This patent expands the protected technology to include injectable mineral-organic structural bone adhesive compositions that comprise alpha tricalcium phosphate. The issuance of this patent complements RevBio’s existing U.S. patent 11,638,777, which covers the method of repairing fractured bone using the aforementioned adhesive composition. These recently issued patents enlarge...

RevBio Receives Both FDA Approval to Expand its Clinical Trial and CMS Reimbursement for its Regenerative Bone Adhesive for Cranial Flap Fixation

Antonette Ho2025-01-23T03:08:36-05:00RevBio, Inc., announced that it has received FDA approval to expand its ongoing clinical trial to immediately fixate cranial flaps using TETRANITE®, the company’s bone adhesive biomaterial. The company also received reimbursement coverage from the Centers for Medicare and Medicaid (“CMS”) for the use of TETRANITE to replace metal plates and screws. Previously, RevBio received FDA approval to initiate a first-in-human clinical study for an initial five patients to restore cranial flaps following craniotomy procedures and to repair extradural use...

RevBio Receives a $2.4 Million NIH Grant to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation and Enrolls First Five Patients

Antonette Ho2024-09-30T02:29:10-04:00RevBio, Inc., announced that it has been awarded a $2.4 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Neurological Disease and Stroke (NINDS), part of the National Institutes of Health (NIH). This two-year grant (1R44NS135736-01A1) will allow the company to complete a 20-patient pilot clinical trial to examine the safety and efficacy of the company’s bone adhesive biomaterial called TETRANITE® which will be used to immediately fixate cranial flaps and enable bone fusion following...

Companies to Watch in 2024

Antonette Ho2024-01-02T22:47:57-05:00For the past ten years, Life Science Nation (LSN) has built a global partnering platform that matches scientist-entrepreneurs and fundraising CEOs with capital, licensing, and product collaboration partners. In that time, LSN has learned so much about what makes a compelling fit for our buy-side partners. I have had discussions with hundreds of investors. I always want to understand how their investment theme of seeking early-stage technology assets is balanced with the risk of going early. Unsurprisingly, it’s complicated, but it typically...

RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation

Antonette Ho2023-12-11T18:47:50-05:00RevBio, 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 >>

RevBio Awarded a $2 Million Follow-On NIH Grant to Reduce Opioid Use and Addiction with TETRANITE®

Antonette Ho2023-10-30T16:38:59-04:00RevBio, 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...

RevBio Awarded a $3.4 Million NIH Grant for Its Novel Regenerative Bone Adhesive to Treat Complex Fractures

Antonette Ho2023-10-08T22:48:20-04:00RevBio, 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...

RevBio Receives FDA Approval to Conduct its Second U.S.-Based Clinical Trial for Dental Implant Stabilization

Antonette Ho2023-08-14T01:03:14-04:00RevBio, 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...

RevBio is Awarded a $2 Million Grant to Advance the Development of its Novel Dental Adhesive Bone Scaffold Product

Antonette Ho2023-06-09T09:28:26-04:00RevBio, 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 >>

RevBio Receives ISO 13485 Certification for its Quality Management System

Antonette Ho2023-05-28T13:25:01-04:00RevBio, 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...