InVivo Therapeutics Releases Letter to Shareholders

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, today released a letter to Shareholders.

To Our Shareholders and Potential Shareholders:

InVivo has been making excellent progress in the past months and we are firing on all cylinders. I wanted to use this letter as a forum to provide an important update on how we are using InVivos resources to create and capture shareholder value. We expect the next six months to mark a major inflection point in our growth. The FDA has not put up any roadblocks or requested additional information that will delay the start of the study for the use of our biopolymer scaffolding to treat spinal cord injuries (SCI). Before the end of 2012, we expect to validate our clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application. We expect FDA approval to start the clinical study in early 2013.

We are disappointed with our recent stock price performance. The 50% decline since the end of August 2012 is unwarranted and seems to have been driven by unsubstantiated internet rumors. We believe our stock is undervalued and has significant near-term catalysts that should drive valuation.

At InVivo, we have assembled a world-class team of experts to develop treatments for neurotrauma. Its been my pleasure to lead this team of scientists from over 15 fields of medicine and science. We spent the last six years working through some of the most important SCI scientific decisions in order to begin the first-ever human study to implant biomaterials into the spinal cord. Weve had over 200 team members help us move the ball forward. It has been one of the greatest challenges of every member's life, but working through the process has been well worth the wait and hard work as we are now in the final steps of preparation for our first human study.

The list of potential challenges at the FDA for a first-in-man study could have been endless, but leveraging my teams past FDA experience and track record with biomaterial-based FDA approved products, we are pleased with the progress of our meetings with the FDA. Bob Langers lab at MIT has produced over 50 products either in clinical trials or through clinical trials. Many of Bobs products are similar biomaterials to InVivos and that has helped us significantly with finalizing the FDA process. Lastly, my recent new hires have brought over 100 biomaterials products to market and theyre plugged into InVivos system to drive our products to the clinic.

We all wanted to start the human study yesterday but above all we need to make sure our first study is safe and successful and that it puts the product on the path to FDA approval. The extensive product development and regulatory processes we have implemented are thorough and will enable expedited paths through the FDA for our extended platform technologies including scaffolds and hydrogels. We are creating significant internal intellectual capital and intellectual property as we continue to expand our product portfolio.

Recent hires in biomaterials engineering, biomaterials manufacturing, regulatory affairs, quality affairs, and project management have provided us with a talented staff of FDA cGMP experienced experts required to complete all work to manufacture a safe product. Brian Hess leads our new development team. He has personally brought six biomaterial products to market in recent years. InVivo has become a leader in neuroscience and is an exciting and challenging place to work. We have employment candidates banging on our doors to join InVivo. We are in an envious position and continue to recruit the best and brightest to InVivo.

We hold exclusive and world-wide patents from MIT and Harvard covering the use of any synthetic biomaterial to treat SCI. In the process of developing our manufacturing methods, we had to ensure that the final product was non-toxic for the nervous system. Our discoveries and improvements to our manufacturing process have resulted in key patent filings in 2012. We have applied for patents related to the key processes required to make a non-toxic synthetic biomaterial for spinal cord implantation. We believe the manufacturing related patents represent additional barriers of entry into our emerging neurotrauma space.

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InVivo Therapeutics Releases Letter to Shareholders