Austin, TX – May 8, 2012-On Sunday May 6, 2012 CBS Sunday Morning presented a story titled “A new hope for back pain sufferers?” that featured Dr. Kevin Pauza, a member of Spinal Restoration’s clinical advisory board, who discussed his use of fibrin sealant injections for the treatment of back pain. The program indirectly referenced Spinal Restoration’s Biostat System and ongoing Phase III clinical study that is investigating the safety and efficacy of the Biostat System for the treatment of chronic discogenic low back pain.
Gary Sabins, President and CEO of Spinal Restoration, commented “Spinal Restoration is excited about the progress that has been made toward developing the rigorous scientific evidence necessary to obtain regulatory approval for the Biostat System.”
Development of this evidence began with extensive preclinical studies that investigated the safety and potential mode of action of BIOSTAT BIOLOGX® Fibrin Sealant within the degenerative disc.1,2 A 15-subject Food and Drug Administration (FDA) approved Pilot/Phase II clinical trial (NCT00693784) with 2-year follow-up was completed in January 2011 and demonstrated preliminary safety and potential efficacy of the Biostat System in subjects with chronic discogenic low back pain caused by internal disc disruptions. Spinal Restoration is conducting a 260-subject Phase III randomized, placebo controlled clinical trial for the same indication at 20 centers across the US in support of a future Biologic License Application to the FDA.
Mr. Sabins went on to say, “Enrollment in this study is more than 85% complete and we look forward to learning the outcome of the study in the near future. Spinal Restoration is extremely grateful for the efforts of our advisory board members and the clinical teams at each of the participating study sites in advancing this exciting technology to this point.”
The Biostat System is being studied in subjects who suffer from chronic discogenic low back pain but do not have large disc herniations or a history of lumbar spine surgery. While surgery is an appropriate option for many patients there is a great need for an interventional treatment for patients with early disc degeneration when surgery is the least desirable option. Currently there is no conservative or interventional therapy with unequivocal efficacy for treating chronic discogenic pain in this patient population.
If successful, the Biostat System Phase III study could have an extensive, far-reaching impact on the diagnosis and treatment of chronic discogenic low back pain—a debilitating health condition that affects an estimated four million adults in the U.S. annually. The Biostat System study is the first intradiscal biologic therapy for discogenic pain to enter into a Phase III clinical trial. 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.
Copyright©2012 Spinal Restoration, Inc.
About the Biostat System
The Biostat System is an investigational new drug and is limited by federal law to investigational use only. 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 and gain regulatory approval of the Biostat System, a proprietary resorbable biologic and delivery system for the treatment of chronic disc pain, based on solid scientific and clinical evidence. Visit www.spinalrestoration.com for more information.
1 Buser Z, Keulling F, Liu J, et el. Biological and mechanical effects of fibrin injection into porcine intervertebral discs. Spine 2011 Aug 15;36(18):E1201-9.
2 Buser Z, Liu J, Thorne K, et al. Inflammatory response of intervertebral disc cells is reduced by fibrin sealant scaffold in vitro. J. Tissue Eng Regen Med 2012 (in press).
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