Healthcare Industry News: Hydrogel
News Release - September 11, 2012
InVivo Therapeutics Announces Business Updates
CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, today 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.Highlights include:
- 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.
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.
Source: InVivo Therapeutics
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