CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 14/496,742, titled “Methods and Compositions for the Treatment of Open and Closed Wound Spinal Cord Injuries”. 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.”
About the Neuro-Spinal Scaffold
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.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect" and similar expressions, and include statements regarding the Company’s expectations with respect to the anticipated issuance of the patent, as the patent may be delayed in issuing, or may not ultimately issue at all. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully build and protect its intellectual property portfolio; the Company’s ability to obtain FDA approval to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as amended, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.
