News Release
Spinal Restoration, Inc. Receives FDA IDE Approval
Austin, TX - May 13, 2008
Spinal Restoration, Inc. announced today that the U.S. Food and Drug
Administration has approved an Investigational Device Exemption (IDE)
pilot study of the Biostat® System. Enrollment in the
15 patient pilot study is expected to begin at three clinical sites in
July.
“IDE approval is a major milestone for our company and represents a tremendous accomplishment for our management team, business partners, and clinical and scientific advisors” said Gary Sabins, President and CEO of Spinal Restoration, Inc. “Based upon available data and results from our preclinical testing, we are confident that this clinical study will support the safety and efficacy of this new therapy and help us to advance into a larger pivotal trial of the Biostat System.”
The Biostat System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. The Biostat System has been specifically developed to address chronic low back pain resulting from degenerative cracks and fissures which form within the intervertebral disc. This condition, called Internal Disc Disruption (IDD), has been identified as the source of chronic low back pain in up to 40% of patients. Preliminary data suggest that application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate pain by sealing the painful disruptions, reducing inflammation, and enhancing tissue repair. This procedure could represent a new, minimally invasive therapy option for millions of patients suffering from chronic low back pain whose primary treatment options today are continued conservative therapy or spinal surgery.
Initial clinical results from the IDE pilot study are expected to be available in early 2009. These results will be combined with additional preclinical testing data to support an application to start a pivotal trial of the Biostat System later that year.
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.
Company Contacts:
Gary Sabins – President and CEO
512.225.0405
garysabins@spinalrestoration.com
John Wheeler – Director of Product Development and Marketing
512.225.0405
johnwheeler@spinalrestoration.com