Corporate Fact Sheet

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Market Snapshot

OTC.BB ticker symbol NVIV    Stock price (2/23/12) $2.33    Inception range $0.60-$3.23

Market capitalization $148.6 M    Common shares outstanding 63.8 M    Fiscal year end Dec. 31  Insider ownership 38%

Company Profile

InVivo Therapeutics Holdings Corp is a Cambridge, Mass. medical device company focused on utilizing polymers as a platform technology to develop and commercialize groundbreaking treatments for spinal cord injuries (SCI). The company was founded in 2005 on the basis of proprietary technology co-invented by Robert Langer, Sc.D., Institute Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who is affiliated with Mass. General Hospital in Boston.

Investment Highlights

InVivo’s platform technology includes products intended as nervous system therapies, with initial focus on spinal cord injuries, a $10+ billion market opportunity for which there are no successful treatment options. The financial impact of SCI, as reported by the National Spinal Cord Injury Statistical Center, is staggering. First year, “cost of care” ranges from $321,720 to $985,774, depending on severity of injury. However, only a very small percentage of patients ever regain full function as current medical interventions address only the symptoms of SCI rather than the underlying neurological pathology. There are 12,000 new cases in the U.S. of spinal cord injury each year, and approximately 1,275,000 people are currently living with paralysis due to SCI.

Robust animal studies suggest that InVivo’s novel approach to SCI will be effective in humans. Instead of focusing exclusively on regeneration, InVivo concentrates on neuroprotection: protecting the spinal cord by mitigating the bleeding, inflammation, and further cell death that result from the body’s immune response to SCI. By minimizing these secondary injury processes, and by supporting subsequent repair and recovery, the body can locally reorganize toward functional recovery through the spared healthy tissue. This process, known as neuroplasticity, may result in partial functional recovery. Rodent and primate studies have demonstrated success, and data from a 40-animal primate study will be submitted to a peer-reviewed journal.

Near-term path to $500+ million U.S. market with human pilot study expected to begin in the 2nd half of 2012. InVivo has filed an Investigational Drug Exemption with the U.S. Food and Drug Administration (FDA) to begin a 10-patient pilot study at three sites in the U.S. with its first product, a proprietary biopolymer scaffold to treat acute SCI. With 12,000 SCI per year in the U.S. and no effective treatment options, the product could potentially be cleared under a Humanitarian Device Exemption, speeding the path to market.

Pipeline of products to treat chronic SCI, pain and inflammation using InVivo’s platform technology.

1. Biopolymer Scaffold to Treat SCI: A novel surgical device designed for implantation into an acute SCI lesion. The scaffold is developed from a biodegradable and biocompatible polymer approved by the FDA for surgical sutures. The device degrades naturally inside the body over a desired time period to maximize efficacy without requiring subsequent removal.
2. Injectable Hydrogel for Local Drug Delivery: An injectable hydrogel designed for local controlled release of drugs to counteract the inflammatory environment that results during secondary injury after SCI and peripheral nerve injuries.
3. Biopolymer Scaffold Seeded with Autologous Human Neural Stem Cells: Extends the biopolymer platform technology to treat both acute and chronic SCI by seeding the patient’s own stem cells into the scaffold, which acts as a synthetic extracellular matrix.

Extraordinary management and advisors. Frank Reynolds, founder and CEO, has 25 years of experience including being responsible for new business in 132 countries as the former Director of Global Business Development at Siemens Corp. Dr. Richard J. Roberts, PhD, director, was awarded the 1993 Nobel Prize in Physiology or Medicine. George Nolen, director, is the former CEO of Siemens Corp.

Ironclad patent protection. 11 issued US patents, 3 pending US patents, 34 international patents and 23 international patents pending stemming from over a decade of research. The patents cover the use of any biomaterials to treat SCI alone or in combination with any drugs or cells.

Sources: Christopher & Dana Reeve Foundation, “One Degree of Separation: Paralysis and Spinal Cord Injury in the United States” 2010 and National Spinal Cord Injury Statistical Center, “Spinal Cord Injury Facts and Figures at a Glance” 2011.