MARKET AND OPPORTUNITY
Osteoporosis leads to 1.5 million fractures each year in the United States, of which 750,000 are vertebral compression fractures (VCFs).
Painful and disfiguring, VCFs often do not respond to conservative treatment such as medication or physical therapy. In the United States, more than 100,000 VCFs are treated with Bone Cement injection (vertebroplasty and kyphoplasty procedures). Unfortunately, cement leaking outside the vertebral body is common and reported to occur in up to 70%. In approximately 4% of cases, cement leakage leads to serious adverse effects. Cement leakage of bone cement into the blood vessels (embolism) may lead to heart attack, cardiac arrest and stroke.
Cement leakage of bone cement into the tissue surrounding the spinal cord may lead to nerve injury that can, in rare instances, cause paralysis.
Cement leakage into disc space increases risk of new fracture of adjacent vertebral bodies.
The market seeks a safer and more effective Bone Cement for VCFs.