This Grant will Advance the Company’s Pre-Clinical Research to Demonstrate an Improvement to the Current Standard of Care for Spine Fractures.
LOWELL, Mass.–(BUSINESS WIRE)–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.
“The adhesive and structural features of this biomaterial combined with the fact that it is osteoconductive and ultimately replaced by bone make it an excellent candidate for an improved vertebroplasty procedure,” said Dr. Kevin T. Foley M.D., Professor of Neurosurgery, Orthopedic Surgery, and Biomedical Engineering at the University of Tennessee Health Science Center, Chairman of the Semmes Murphey Spinal Care Clinic, and a recognized pioneer in the development of minimally invasive spine surgery. “This regenerative, adhesive, and cohesive material delivered percutaneously could significantly improve the way these fractures are treated.”
In the United States, approximately 700,000 vertebral compression fractures (“VCF”) occur each year, costing an estimated $250 million in Medicare-related expenses. These compression fractures are most common among elderly individuals. Historically, VCFs have been primarily treated using vertebroplasty and kyphoplasty, which are techniques involving the injection of polymethylmethacrylate (PMMA) into the vertebral body through a transpedicular approach under fluoroscopy. However, more recent clinical evidence has shown that these procedures are extremely risky with significant complications. Most concerning is the risk of extravasation, or cement leakage, which has occurred in up to 75% of all reported cases in published literature with up to 23% resulting in pulmonary emboli. It is therefore not surprising that the prevalence of these procedures decreased by more than 70% from their peak since this information has come to light.
“This opportunity complements the indications we are currently pursuing in dentistry, cranial surgery, orthopaedic trauma procedures, and animal health indications,” said Brian Hess, CEO of RevBio. The successful completion of the research awarded in this Phase I grant will put RevBio on track to apply for a larger, Phase II grant which would provide approximately $2 million in follow-on funding for this project.
This research is supported by the National Institute on Aging, grant number 1R43AG079741-01A1.
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.