InVivo Therapeutics Requests Humanitarian Use Device Designation with FDA
December 14 2012 - 7:51AM
Business Wire
InVivo Therapeutics Holdings Corp. (NVIV), a developer of
groundbreaking technologies for the treatment of spinal cord
injuries (SCI) and other neurotrauma conditions, today announced
that the Company has filed a request with the U.S. Food and Drug
Administration (FDA) for Humanitarian Use Device (HUD) designation
for its biopolymer scaffolding product. InVivo is currently working
with the FDA on the final steps to seek approval to begin a
clinical trial of the scaffolding in acute SCI in early 2013.
Devices eligible for HUD designation are developed to treat rare
diseases or conditions. InVivo has requested designation for the
use of its biopolymer scaffolding in the treatment of complete
functional spinal cord injuries that do not involve penetrating
injury or the complete severing of the spinal cord.
The request comes after an April 2012 meeting in which InVivo
and the FDA discussed the requirements for the HUD designation and
the potential for the device to be regulated and distributed under
a Humanitarian Device Exemption (HDE). An HUD designation and a
subsequent approved Humanitarian Device Exemption (HDE) would
enable InVivo to commercialize the devices in the United States
faster than the Pre-Market (PMA) approval process.
Said InVivo Director of Regulatory Affairs Jack Bonasera, “The
HUD/HDE provision provides a pathway for obtaining market approval
from FDA for medical devices that may help people with rare
diseases or conditions that otherwise would be remain unmet. InVivo
is confident that the results of well designed pre-clinical studies
will satisfy the primary HDE requirements in this type of
devastating injury where no motor or sensory function is present
below the level of neurological injury.”
“HUD designation is not only important for speed-to-market but
also represents a benchmark in InVivo’s commitment to patients with
spinal cord injuries and other neurotrauma conditions. Our GMP team
is ready to go, and our clean room is humming. We expect 2013 to be
a breakout year for InVivo stakeholders as we advance additional
products into the FDA process,” said Frank Reynolds, InVivo Chief
Executive Officer.
The Company expects to receive feedback from the FDA on the HUD
request in January 2013.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is utilizing polymers as a
platform technology to develop treatments to improve function in
individuals paralyzed from traumatic spinal cord injuries. The
company was founded in 2005 based on proprietary technology
co-invented by Robert S. Langer, ScD. Professor at Massachusetts
Institute of Technology, and Joseph P. Vacanti, M.D., who is
affiliated with Massachusetts General Hospital. In 2011, the
company earned the prestigious 2011 David F. Apple Award from the
American Spinal Injury Association for its outstanding contribution
to spinal cord injury medicine. The publicly traded company is
headquartered in Cambridge, MA. For more details, visit
www.invivotherapeutics.com.
Safe Harbor Statement
Certain statements contained in this press release that are not
historical facts may constitute forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities and Exchange Act of 1934, and the
Company intends that such statements are subject to the safe harbor
created thereby. These statements include, but are not limited to,
those relating to the expected approval of the FDA to conduct human
clinical trials for the Company’s products, the expected
commencement date of any approved human clinical trials, the
expected size of the pilot study, the expectation that the scaffold
product will be regulated under a HDE pathway, and the expected
acceleration of commercialization of the Company’s products
resulting therefrom. These forward-looking statements are based on
current expectations, but are subject to a number of risks and
uncertainties. The 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 obtain FDA approval to conduct human clinical trials;
whether the human clinical trials produce acceptable results; 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, the
Company’s business, research, product development, regulatory
approval, marketing and distribution plans and strategies. These
and other factors are identified and described in more detail in
our Annual Report on Form 10-K for the year ended December 31, 2011
and subsequent filings with the SEC.
Forward-looking statements contained in this press release speak
only as of the date of this release. Subsequent events or
circumstances occurring after such date may render these statements
incomplete or out of date. The Company undertakes no obligation and
expressly disclaims any duty to update such statements.