LOWELL, Mass.–(BUSINESS WIRE)–RevBio, Inc., announced that it has been awarded a $2.2 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH). This two-year grant (1R44AG097243-01) builds upon the work that was completed in a prior Phase I grant (1R43AG079741-01A1) and will enable the company to complete preclinical product testing which is a key development step for obtaining approval from the U.S. Food & Drug Administration to initiate a human clinical trial.
“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 Kevin T. Foley M.D., Professor of Neurosurgery, Orthopedic Surgery, and Biomedical Engineering at the University of Tennessee Health Science Center, and Chairman of the Semmes Murphey Clinic. Dr. Foley is a globally recognized pioneer in the development of minimally invasive spine surgery instruments and techniques.
In the United States, around 850,000 vertebral fractures are reported each year. These fractures are most prevalent in the elderly, with 20% of those over the age of 70 experiencing these fractures due to osteoporosis. The surgical treatment of vertebral fractures has historically involved vertebroplasty and kyphoplasty techniques which rely upon the injection of polymethylmethacrylate (PMMA) to augment and stabilize fractured vertebrae. These methods have been successful in relieving pain and improving the quality of life for many patients. However, PMMA’s clinical use has raised concerns due to its potential to cause thermal necrosis in bone, its non-biodegradability, and its stiffness which can lead to complications including fractures in adjacent vertebrae. Cement leakage, or extravasation, has been reported in up to 75% of cases, leading to severe consequences such as pulmonary embolisms in about 23% of patients. These risks have led to a significant decline in these procedures, which have decreased by over 70% since 2009, leaving many elderly patients without a way to alleviate their chronic back pain.
“Having been involved in the Phase I preclinical testing of this product, TETRANITE’s game changing properties address the limitations which led to the rapid decline in the use of PMMA for spinal fractures,” said Eric Woodard, M.D., Chief of Neurosurgery at the New England Baptist Hospital.
“Kyphoplasty, developed by Kyphon, Inc., was extremely successful in treating chronic pain, which lead to Kyphon’s sale to Medtronic for $3.9 billion,” said Jonathan Slotkin, M.D., practicing neurosurgeon and General Partner at Scrub Capital, which recently made a seed-stage investment in RevBio. “The biomimetic characteristics of TETRANITE provide a much better product profile than PMMA which could make it become the new standard of care—and a blockbuster product—for treating chronic pain associated with spine fractures.”
About RevBio, Inc.
RevBio, Inc., is a clinical stage medical device company engaged in the development and commercialization of TETRANITE®, a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive. 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.