Spinal Restoration has initiated patient enrollment in the Phase III study of the Biostat System for the treatment of discogenic chronic low back pain.
The Phase III study is a few multi-center, randomized, blinded, placebo-controlled trial of a nonsurgical treatment for discogenic low back pain ever to be conducted.
Spinal Restoration said that the Biostat System Phase III study, if successful, will have a far-reaching impact on the diagnosis and treatment of discogenic chronic low back pain-a debilitating health condition that affects an estimated four million adults in the US annually. Reportedly, the Biostat System study is the first intradiscal biologic therapy for discogenic pain to enter into a Phase III clinical trial.
Gary Sabins, president and CEO of Spinal Restoration, said: “There is high demand within the current healthcare environment for low back pain treatments that have clearly defined indications, unequivocal efficacy data, and the potential to lower the cost of care for patients.
“Our Phase III study of the Biostat System is designed to provide extensive data addressing each of these critical areas and, for the first time, may give spine physicians the information they need to make better, more informed decisions when treating discogenic chronic low back pain.”
Kevin Pauza, lead clinical investigator for the study, said: “The inclusion and exclusion criteria of the study are extremely rigorous, requiring not only a precise diagnosis of discogenic pain, but also the elimination of potential confounding sources of pain through diagnostic spinal injections, imaging studies and physical examination.
“The extent of diagnostic measures combined with the randomized, placebo-controlled, blinded design makes this the most ambitious study ever undertaken within the interventional spine community.”