RevBio, Inc. has been awarded a $2.2 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) to advance development of TETRANITE, a synthetic bone adhesive designed to treat vertebral compression fractures through minimally invasive procedures. The two-year grant (1R44AG097243-01) builds upon previous Phase I research and will enable the clinical-stage medical device company to complete preclinical testing necessary for FDA approval to initiate human clinical trials.
Addressing Critical Unmet Medical Need
Vertebral compression fractures represent a significant healthcare burden, with approximately 850,000 cases reported annually in the United States. These fractures disproportionately affect elderly patients, with 20% of individuals over age 70 experiencing such fractures due to osteoporosis.
Current surgical interventions rely on vertebroplasty and kyphoplasty techniques that inject polymethylmethacrylate (PMMA) to stabilize fractured vertebrae. While these methods have provided pain relief and improved quality of life for many patients, PMMA's clinical limitations have led to serious safety concerns and a dramatic decline in procedure utilization.
"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," according to the company's announcement. Cement leakage, or extravasation, occurs in up to 75% of cases, resulting in severe consequences such as pulmonary embolisms in approximately 23% of patients.
These safety issues have contributed to a greater than 70% decline in vertebroplasty and kyphoplasty procedures since 2009, leaving many elderly patients without effective treatment options for chronic back pain.
TETRANITE's Differentiated Properties
TETRANITE represents a fundamentally different approach to vertebral fracture treatment. The patented biomaterial is synthetic, injectable, self-setting, and osteoconductive, meaning it promotes bone growth and is ultimately replaced by natural bone tissue.
"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 recognized as a pioneer in minimally invasive spine surgery development.
Preclinical testing has demonstrated TETRANITE's suitability for percutaneous injection using image guidance for controlled delivery into vertebrae. The biomaterial's radiopacity allows surgeons to visualize its placement using standard radiographic monitoring equipment during spine procedures.
Clinical and Commercial Potential
Eric Woodard, M.D., Chief of Neurosurgery at the New England Baptist Hospital, who participated in Phase I preclinical testing, emphasized the technology's transformative potential: "TETRANITE's game changing properties address the limitations which led to the rapid decline in the use of PMMA for spinal fractures."
The commercial opportunity for improved vertebral fracture treatments is substantial, as evidenced by the historical success of kyphoplasty technology. Jonathan Slotkin, M.D., a practicing neurosurgeon and General Partner at Scrub Capital, which recently made a seed-stage investment in RevBio, noted: "Kyphoplasty, developed by Kyphon, Inc., was extremely successful in treating chronic pain, which lead to Kyphon's sale to Medtronic for $3.9 billion."
Dr. Slotkin added: "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."
Development Timeline and Regulatory Path
The Phase II grant represents a critical milestone in TETRANITE's development pathway. The funding will support completion of preclinical product testing required to obtain FDA approval for human clinical trials. This follows successful completion of work under a prior Phase I grant (1R43AG079741-01A1).
RevBio is developing TETRANITE technology across multiple applications, including dental, cranial, and broader orthopedic markets, as well as animal health applications. The company notes that TETRANITE technology is not yet approved for commercial use, with regulatory approval pending completion of clinical development programs.
