InVivo Therapeutics Engages FDA With Second Product, A Novel Drug Releasing Hydrogel For Chronic Pain Treatment

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 Administrations (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.

InVivos 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 InVivos 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 thatthe hydrogel addresses several specific limitations of current therapies by allowing predictable sustained release of therapeutic molecules. Additionally, itexhibits 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 http://www.invivotherapeutics.com.

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InVivo Therapeutics Engages FDA With Second Product, A Novel Drug Releasing Hydrogel For Chronic Pain Treatment