The National Institutes of Health (NIH) has awarded a $2.2 million grant to RevBio Inc. to advance its bone graft product (TETRANITE) for use in minimally invasive spine fracture treatment.

The company received the Phase II Small Business Innovation Research (SBIR) grant from the NIH’s National Institute on Aging (NIA). This two-year grant builds upon the work that was completed in a prior Phase I award and will enable the company to complete preclinical product testing—a key step in obtaining U.S. Food and Drug Administration approval 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.

Roughly 850,000 vertebral fractures are reported in the United States annually. These fractures are most prevalent in the elderly, with 20% of those older than 70 suffering from fractures due to osteoporosis. Vertebral fracture surgical treatment 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 but PMMA can potentially cause thermal necrosis in bone, and its non-biodegradability and stiffness can lead to complications including adjacent vertebral fractures. 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 more than 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 properties address the limitations which led to the rapid decline in the use of PMMA for spinal fractures,” stated Eric Woodard, M.D., chief of Neurosurgery at the New England Baptist Hospital.

TETRANITE is an injectable, self-setting biomaterial that is highly cohesive, enabling it to be placed into a wet surgical environment without being washed away during its application. The material hardens within minutes and, during its curing process, forms adhesive bonds to both bone and metallic surfaces. As a result, the material is capable of withstanding separation forces when used to adhere bone fragments together or to fixate metallic implants to bone when there is insufficient existing bone contact. Given its structural properties, RevBio is developing applications both to augment the fixation strength of existing metal implant devices and also applications for its stand-alone use with possible load-bearing applications.

“Kyphoplasty, developed by Kyphon, Inc., was extremely successful in treating chronic pain, which lead to Kyphon’s sale to Medtronic for $3.9 billion,” commented 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.”

RevBio Inc. is a clinical stage medical device company developing and commercializing 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 orthopedic markets as well as applications in the animal health market. RevBio’s TETRANITE technology has not been approved for commercial use.