InVivo Therapeutics Announces Business Updates
CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, announced several business updates. The highlights are being provided in connection with the Company’s presentation today at the 14th Annual Rodman and Renshaw Healthcare Conference at the Waldorf Astoria in New York City.
Human clinical trial for “First in Man” use of biopolymer scaffolding to treat acute SCI expected to commence in early 2013 under a Humanitarian Device Exemption (HDE) pathway, pending FDA approval of the related IDE application.
The Company expects that the FDA will require five patients for the pilot study and that the product will be regulated under a Humanitarian Device Exemption pathway, both factors that InVivo believes will accelerate product commercialization.
InVivo’s 2011 non-human primate study confirms the treatment effect of the scaffold devices seen in the 2008 and 2009 non-human primate studies.
Strong financial position: InVivo raised $20 million in early 2012 from a select group of institutional investors and had $18.0 million of cash on hand at June 30, 2012, sufficient to fund operations into 2014. Exercise of warrants has potential to raise an additional $16.7 million of cash.
Filed manufacturing patents to add to InVivo’s broad patent portfolio: covers the use of any biomaterial alone for SCI or in combination with any drug, growth factor or stem cell for SCI. The patent portfolio has been expanded to include parts of the peripheral nervous system, the cranial nerve, the brain and retina, and the cavernous nerve.
Recently engaged representatives from the FDA's Office of Combination Products for InVivo's second product, a novel injectable hydrogel specifically engineered for the effective local release of drugs.
Opened global corporate headquarters: InVivo moved into a new, state-of-the-art facility in One Kendall Square, Cambridge that includes a GMP cleanroom, a vivarium and corporate offices.
Held Inaugural Langer Summit on Neurotrama that brought together the leading minds in neurotrauma to discuss recent innovations and opportunities for InVivo to advance its products into the clinic.
Presented data at key scientific meetings: InVivo presented preclinical data on the Company’s biopolymer and hydrogel technologies at two key conferences, Rick Hansen's Interdependence 2012 Conference and Clinical Outlooks for Regenerative Medicine.
Awarded MD Honors Grant: InVivo neurosurgeon Amer Khali, MD was recently awarded a grant to investigate the use of InVivo's hydrogels to reduce scarring following neurosurgery.
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.
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