Burst Biologics has received IRB approval to begin a multicenter prospective clinical study in spinal fusion patients. This study will be conducted using BioBurst Fluid, a cellular allograft derived from umbilical cord blood (UCB) which has shown very promising results in spinal fusion procedures. Fifteen clinical sites will participate throughout the U.S., with a total enrollment of 450 patients.
Popularity of cellular allografts has increased over the last decade. Figures show that the global spine biologics market is valued at $1.6 billion and is expected to reach $2.2 billion by 2022. This represents a significant opportunity for innovative biologic products.
Ira Fedder, M.D., Towson, Maryland, said, “As we continue to try to understand the mechanisms that lead toward successful fusion, it is critical that we consider the cellular content and activity that may contribute to positive outcomes. Patients that have compromised health and/or healing potential may stand to be the biggest benefactors of this type of technology. It is imperative that surgeons demand that companies demonstrate that their products have a positive impact on patient outcomes. A registry is a simple step in that direction.”
As Chris Jones, CEO of Burst Biologics, said, “An open registry allows us to evaluate success rates in complex cases that would otherwise be excluded from studies. Stringent inclusion-exclusion criteria narrow the patient population and usually involve only single-level procedures, not allowing previous surgery or fusion attempts, and excluding other high-risk conditions. We want to demonstrate to spine surgeons and third-party payers that BioBurst Fluid can be successful in their more challenging patients.”