The application covers InVivo’s investigational Neuro-Spinal Scaffold, which is currently being studied in a pilot clinical trial and has been successfully implanted in three patients. Also covered is InVivo’s Neuro-Spinal Scaffold Plus Stem Cells program, which is in early stages of development for the treatment of chronic spinal cord injury. Of note, the allowed claims cover broader compositions for both products than the previously granted U.S.
Patent No. 8,858,966 issued on October 14, 2014. InVivo is the exclusive licensee of this intellectual property for spinal cord injury and other indications through a license with Boston Children’s Hospital and the Massachusetts Institute of Technology (MIT).
A notice of allowance from the USPTO is a written notification that a patent application has cleared internal review and is pending issuance.
Dr. Bob Langer, the first named inventor on the patent application, is one of 11 Institute Professors (the highest honor that can be awarded to a faculty member) at MIT and one of five living Americans to be awarded both the United States National Medal of Science and the United States National Medal of Technology and Innovation.
Dr. Langer, who is an InVivo co-founder and Scientific Advisory Board member, said, "I am pleased with the most recent patent allowance and excited to see the Neuro-Spinal Scaffold being tested in clinical trials in spinal cord injury patients. Composition flexibility for future products is important for any developing portfolio." The other named co-inventors are Dr. Rajiv Saigal and Dr. Yang Teng.
Mark Perrin, InVivo Chief Executive Officer and Chairman, said, "This notice of allowance is a significant step in the advancement of our intellectual property estate that broadens the area of our market exclusivity. We are constantly evaluating innovative materials that could provide treatments for spinal cord injury patients, and this new protection allows us to utilize a wider array of building blocks to advance this important initiative."
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury.
The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.