CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today announced that a Notice of Allowance has been received from the United States Patent and Trademark Office (USPTO) for U.S. Patent Application No. 14/694,466, titled “Methods and Compositions for the Treatment of Open and Closed Wound Spinal Cord Injuries”. The application covers methods of treatment of compression or contusion spinal cord injuries with a broad array of biodegradable and/or bioabsorbable polymeric implants that includes InVivo’s Neuro-Spinal ScaffoldTM, which is currently being studied in the pivotal INSPIRE study. Of note, the allowed claims cover methods of use for a broader spectrum of polymeric compositions than claims in previously granted U.S. Patent No. 9,101,695 issued on August 11, 2015 and 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 13 Institute Professors at MIT (the highest honor that can be awarded to a faculty member) and one of four 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 that continues to enhance InVivo’s intellectual property protection. It has been incredibly rewarding to follow InVivo’s progress over the last several years, and the next year should be even more exciting as InVivo strives to complete the INSPIRE study.”
Mark Perrin, InVivo Chief Executive Officer and Chairman, said, “Broadening and strengthening our intellectual property portfolio continues to be a top priority for the company. This notice of allowance provides an additional layer of protection in our broadening intellectual property estate.”
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit 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," “designed to,” “potentially,” and similar expressions, and include statements regarding the anticipated issuance of the patent and the impact of the patent on the company’s intellectual property portfolio. 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 open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the impact of achieving the OPC on the FDA approval process; the company’s ability 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 the treatment of 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, 2015, 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.