Spinal Restoration, Inc. announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for claims concerning the delivery device and method of use of the Biostat System for the treatment of discogenic low back pain.
The Biostat System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, biologic tissue sealant, and the Biostat® Delivery Device, a unique application system specifically designed for safe delivery of biologic materials to the intervertebral disc. The allowed claims are directed to the Biostat Delivery Device as well as kits and methods for using the Biostat System to treat the intervertebral disc.
President and CEO Gary Sabins commented, "We believe that the design of the Biostat System overcomes significant hurdles to safe delivery of biologic materials to the intervertebral disc. The allowance of these claims strengthens Spinal Restoration's broad intellectual property portfolio and helps to fortify our leadership position in the field of intradiscal biologic therapies."
In March of 2010, Spinal Restoration became the first company to initiate a Phase III study of a biologic therapy for discogenic low back pain. The 260 patient Phase III study is currently enrolling subjects at 20 centers across the U.S. 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.
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