InVivo Therapeutics Submits Updated IDE to FDA to Begin Spinal Cord Injury Human Study
CAMBRIDGE, Mass.--(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 the Company has submitted an updated Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) requesting permission to begin human studies in order to test its biopolymer scaffolding for the treatment of acute SCI.
The updated IDE submission is in response to exchanges since InVivo's April 12, 2012 meeting with the FDA. The filing contains additional information regarding the manufacturing and pre-clinical testing of the scaffolding device. Once approved, the IDE will allow InVivo to conduct an open-label human study to collect safety and efficacy data to support FDA approval of the first in-cord treatment for SCI. The Company is also working with the FDA in order to have the scaffolding device designated as a Humanitarian Use Device (HUD), a designation that InVivo expects will create a faster path to market.
"We are prepared to safely treat acute SCI patients, and in the coming months we hope to have the first opportunity to translate to humans the positive effect from the scaffold that we observed in our 2008, 2009, and 2011 non-human primate studies," said Frank Reynolds, InVivo Chief Executive Officer. "Our technology remains the only treatment to have demonstrated functional recovery when applied to non-human primates with SCI, and this first study has the potential to change the treatment options for neurotrauma patients forever.
"We've all heard that 'an ounce of prevention is worth a pound of cure,' and over a hundred people on the InVivo team have worked tirelessly since 2008 to bring this 'ounce of prevention' to patients. We intend to intervene shortly after injury to minimize the advancement of scarring and to provide functional recovery within weeks of treatment." Continued Reynolds, "I want to thank our Chief Medical Officer, Dr. Eric Woodard, and our Chief Technology Officer, Brian Hess, along with their teams, for their deep and never ending commitment to SCI patients. We look forward to receiving feedback from the FDA and to getting started on this historical first-in-man clinical trial."
Said Brian Hess, InVivo Chief Technology Officer, "We appreciate the collaborative dialogue we have had with the FDA. Since our April 2012 meeting, we've established regulatory processes to treat neurotrauma with biomaterials, and we've completed knowledge transfer with the FDA that we believe will benefit all of our additional products in development. We expect to bring a wide range of neurotrauma treatments to patients as quickly as possible with the potential for two new 510(k) products to hit the market in late 2014. In addition to the scaffolding device for SCI, we are developing products for conditions such as pain, fibrosis, and drug delivery, and we continue to make excellent progress in these applications as well."
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 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.
InVivo Therapeutics Holdings Corp.
Director, Investor Relations
KEYWORDS: United States North America Massachusetts
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