Orthopedic

Regenerating Spinal Discs - Biostat System

Spinal Restoration, Inc. is currently trailing their Biostat® System which is a non-surgical procedure for chronic low back pain. It consists of BIOSTAT BIOLOGX® Fibrin Sealant, which is a human derived, resorbable biologic tissue sealant. and an application system for delivering the biologic to the intervertebral disc. Application of the Sealant to the disc may alleviate pain by sealing the disc disruptions, reducing inflammation, and enhancing tissue repair.

A Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. Its the first 'intradiscal biologic therapy' for discogenic pain to enter into a Phase III clinical trial. If successful, the system could have an extensive, impact on the diagnosis and treatment for sufferers of discogenic 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 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.”

Based on news release from http://www.spinalrestoration.com/newsroom/news_3-16-2010.html

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