Burst Biologics to launch spinal fusion trial

Burst Biologics said today that it won regulatory approval to begin a clinical trial evaluating its BioBurst Fluid cellular allograft in spinal fusion patients.

The company’s cellular allograft is derived from umbilical cord blood and has yielded promising results in spinal fusion procedures, according to the Boise, Idaho-based company. The prospective trial is slated to enroll 450 patients across 15 sites in the U.S.

“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,” Dr. Ira Fedder said in prepared remarks. “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.”

Burst Biologic’s BioBurst Fluid was designed to support vasculogenesis and the bone consolidation process, the company said, and it’s cytokine profile helps to recruit a patient’s own stem cells into the fusion bed.

“An open registry allows us to evaluate success rates in complex cases that would otherwise be excluded from studies,” CEO Chris Jones added. “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.”

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