Spinal Restoration, Inc.

Spinal Restoration, Inc. Receives FDA IDE Approval

Published in Medical Letter on the CDC and FDA, June 8th, 2008

Spinal Restoration, Inc. announced that the U.S. Food and Drug Administration has approved an Investigational Device Exemption (IDE) pilot study of the Biostat(R) Disc Augmentation 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...

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Source: Medical Letter on the CDC and FDA (2008-06-08)

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