Improved Treatment Options for Vertebral Compression Fractures in Elderly Patients Using Minimally Invasive, Image-Guided Delivery of a Regenerative Bone Adhesive

Project Abstract In the U.S., about 850,000 vertebral compression fracture cases are reported annually, with Medicare-related expenses estimated at $250 million. These fractures are particularly common in individuals with osteoporosis and have a significant impact on the aging population. Compression fractures affect 20% of those over the age of 70. Traditionally, these fractures are conservatively treated with pain management or surgically treated with minimally invasive vertebral augmentation procedures involving the injection of polymethylmethacrylate (PMMA) into the vertebrae. Vertebral augmentation has shown benefits in vertebral stabilization, leading to significant pain relief and improved quality of life in up to 90% of treated patients. However, the use of PMMA in spinal surgeries has raised concerns due to its potential short-term and long-term complications. These include thermal necrosis of adjacent bone tissue, risk of fractures in adjacent vertebrae, and difficulties in revision surgeries due to PMMA's stiffness and lack of biodegradability. Most notably, cement leakage, or extravasation, has been reported in up to 75% of cases, leading to serious complications like pulmonary embolisms in up to 23% of patients. Consequently, the prevalence of these procedures has decreased by more than 70% since the emergence of these risks, leading to a decline in surgical interventions for osteoporotic spine fractures after 2009. This situation underscores the need for safer, more effective treatments for spinal fractures in vulnerable populations. To address this problem, RevBio has developed Tetranite® (TN), a novel mineral-organic bone adhesive that can fill gaps in bone, bond bone fragments together, adhere metal to bone, and accelerate healing through its osteoconductive effects. TN’s proven percutaneous injectability, low exothermal temperature, biodegradability, intrinsic mechanical strength, regenerative capabilities, and lack of toxicity make it a good candidate for replacing PMMA to treat elderly patients with vertebral fractures. There is no other material on the market to address unmet needs in the orthopaedic space of vertebral fractures for the aging U.S. population. The results from the summative user handling cadaver study (Aim 1) and the pivotal large animal study (Aim 2) will be submitted to FDA in an IDE application to initiate clinical studies. Long term, RevBio's mission is to commercialize TN to revolutionize approaches to minimally invasive spinal care, especially for aging patients with osteoporosis or poor bone quality. We aim to offer surgeons and patients a safer, more effective alternative treatment that is designed to reduce pain, accelerate return to function, and significantly decrease the complication rates associated with current vertebral fracture procedures.