Spinal Restoration Initiates Patient Enrollment for Phase III Study of Company’s Biostat® System
March 16, 2010
Landmark Study May Have Broad Ramifications for Spine Physicians and Patients Suffering from Discogenic Chronic Low Back Pain
AUSTIN, TX – March 16, 2010
Spinal Restoration, Inc. announced today that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted.
If successful, the Biostat System Phase III study could have an extensive, 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 U.S. annually.
Despite the enormous economic burden associated with chronic low back pain, both the diagnosis and treatment of the condition have been challenging for spine physicians. A majority of diagnostic procedures and nonsurgical and surgical interventions have limited or conflicting data to support their utility and efficacy. An article in a 2008 special focus issue of The Spine Journal warned that “we are still in the era of buyer beware” following a detailed review of available treatment options for chronic low back pain.*
“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,” said Gary Sabins, President and CEO of Spinal Restoration. “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.”
The Biostat System study is the first intradiscal biologic therapy for discogenic pain to enter into a Phase III clinical trial.
“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,” added Dr. Kevin Pauza, lead clinical investigator for the study. “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.”
More detailed information about the Biostat System study is available at www.clinicaltrials.gov (Study Identifier: NCT01011816). Patients who are interested in finding out whether they qualify for participation in the study can visit www.lowbackstudy.com.
About the Biostat System
The Biostat System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, resorbable biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation, and enhancing tissue repair.
About Spinal Restoration
Spinal Restoration restores patients’ lives by delivering new therapies that address unmet needs in spine health management. These therapies are minimally invasive, early interventions with clinically proven results. The company is working with a diverse, highly regarded group of clinical and scientific advisors to develop the Biostat® System, a proprietary resorbable biologic and delivery system for the treatment of chronic disc pain. Visit www.spinalrestoration.com for more information.
President and CEO
Director of Product Development and Marketing
*Haldeman S, Dagenais S. What have we learned about the evidence-informed management of chronic low back pain? Spine J 2008; 8:266-277.