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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150622005340/en/
Copyright Business Wire 2015