Important news out today. One step after another, and never a false move":
CAMBRIDGE, Mass., Apr 04, 2013 (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 received approval for its request filed with the U.S. Food and Drug Administration (FDA) for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product.
HUD designation covers devices that treat rare, 'orphan' diseases or conditions. InVivo has received designation for the use of its biopolymer scaffolding for the treatment of recent complete spinal cord injury (no motor or sensory function) that does not involve penetrating injury or complete severing of the spinal cord.
Historically, companies that have received 'orphan' status have been able to expedite commercialization, bringing products to market several years faster than other regulatory paths would have allowed. The Company expects the device to be regulated and distributed under a Humanitarian Device Exemption (HDE) pending the results of a clinical trial for which InVivo also currently has a submission under review by the FDA. The trial will be conducted to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use.
"HUD designation is important not only for speed-to-market, but it represents a benchmark in InVivo's commitment to patients with SCI," said Frank Reynolds, InVivo Chief Executive Officer. "We are pleased that the FDA has recognized 'orphan' status for this condition and acknowledges the urgent demand for new treatment options for SCI. We've built out the team and the facility to manufacture products for human studies, and we're ready to go.
"We intend to leverage our platform to further develop treatments for chronic SCI, and expect 2013 to be a springboard year for our stakeholders as we have multiple 510(k) products targeted for market entry by the end of 2014," continued Reynolds. "Our work in 2013 will be marked by clinical SCI data and by developing treatments for additional neurotrauma conditions in the arms and legs while we engage the FDA on multiple products."
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, 2012 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.
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SOURCE: InVivo Therapeutics Holdings Corp.
CONTACT:InVivo Therapeutics Holdings Corp. Brian Luque, 617-863-5535 Director, Investor Relations bluque@invivotherapeutics.com
Copyright Business Wire 2013
