CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurological injuries, today announced a novel hydrogel based product for the treatment of acute and sub-acute sciatica or radicular pain of the low back and legs and/or acute and sub-acute radicular pain of the neck or arms.
On June 29, 2012 InVivo submitted a request to meet with the U.S. Food and Drug Administration’s (FDA) Office of Combination Products and the appropriate representatives from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) to discuss a novel combination product.
InVivo’s new technology is intended for the treatment of acute and sub-acute neck, back, and leg pain conditions that affect over 4.2 million patients annually in the United States. The product consists of a novel injectable hydrogel specifically engineered to allow for an effective, sustained release of a number of molecules, including methylprednisolone. A summary of the underlying research and development of this product was published in the Journal of Biomaterials in January 2011 and has led to a broad platform of neurological interventions.
“For years InVivo has been pressed by patients like myself to develop treatments for herniated disks and other neurological pain issues associated with the aging baby boomers in the United States, and now we have an answer in InVivo’s hydrogel platform,” said InVivo CEO Frank Reynolds. “We believe that the opportunity for our new treatment could exceed $22B annually, and by late 2012 we plan to partner with a global leader in pain therapies to bring this product to market.”
Said InVivo CMO Eric Woodard, MD “We feel that the hydrogel addresses several specific limitations of current therapies by allowing predictable sustained release of therapeutic molecules. Additionally, it exhibits the novel property of syneresis, or shrinkage, that significantly enhances its safety profile in neurological applications.”
Added Reynolds, “We are developing technologies to treat both acute and chronic neurological injuries, and our first product, a biomaterial based scaffold for acute spinal cord injuries, is currently under review at FDA. We look forward to receiving approval to begin human studies for that product in 2012.”
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
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. Any forward-looking statements contained herein 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 sell additional shares of common stock and warrants to purchase common stock at additional closings, 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 filings with the SEC, including our Form 10-K and Form 10-Qs and our current reports on Form 8-K. We do not undertake to update these forward-looking statements made by us.