InVivo Therapeutics reports net income of $3,067,000 for third quarter 2011

InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported financial results for the three and nine months ended September 30, 2011 and provided a business update.

The Company's biopolymer scaffold technology is designed to provide structural support for a damaged spinal cord to promote healing and improve functional recovery and prognosis for SCI patients. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the annual market potential is estimated to be over $10 Billion.

Financial Results

For the three months ended September 30, 2011, the Company reported net income of $3,067,000, or $0.06 per diluted share, compared with a net loss of $837,000, or $0.03 per diluted share, for the three months ended September 30, 2010. Included in net income for the three months ended September 30, 2011, was a non-cash gain of $5,276,000, or $0.10 per diluted share associated with a reduction in the fair value of the derivative warrant liability. Total operating expenses were $2,213,000 during the third quarter of 2011, compared with $749,000 in the prior year third quarter. Research and development expense was $1,017,000 in the third quarter of 2011, up from $325,000 in the third quarter of 2010 as the Company prepared to initiate a clinical trial, and broadened its portfolio of products. General and administrative expense rose to $1,196,000 in the three months ended September 30, 2011 from $424,000 in the three months ended September 30, 2010 as the Company made investments to expand infrastructure and incurred costs associated with public company practices.

For the nine months ended September 30, 2011, the Company reported a net income of $419,000 or $0.01 per diluted share, compared with a net loss of $2,261,000, or $0.08 per diluted share, in the comparable 2010 period. Included in net income for the nine months ended September 30, 2011, was a non-cash gain of $6,560,000, or $0.12 per diluted share associated with a reduction in the fair value of the derivative warrant liability. The Company had cash and cash equivalents of $3,687,000 as of September 30, 2011.

"We had a strong third quarter as we prepare for human studies to treat acute spinal cord injury," commented Frank Reynolds, Chief Executive Officer of InVivo Therapeutics. "Shortly, we'll also begin working with FDA on our second product, a drug releasing hydrogel for acute spinal cord injuries. We have leveraged our years of hydrogel research to make significant progress in advancing our FDA timeline for our peripheral nerve injury device as well. This device extends our focus to degenerative nerve conditions and we now expect to submit an application for peripheral nerve injury to FDA in the summer of 2012. We expect our system to change the paradigm for peripheral nerve treatment just as we're changing it for spinal cord injuries."

Recent Highlights:

• Submitted an IDE and awaiting FDA clearance to commence a human clinical study with the Company's proprietary biopolymer scaffolding device for acute SCI.
• Prepared primate hydrogel data for FDA review.
• Finalized peripheral nerve study to support FDA application in the summer 2012.
• Completed third primate study and will submit results to peer-reviewed journal.
• Completed preclinical study in rodent SCI contusion model with positive results confirming primate results.
• Appointed Ed Wirth, formerly Director Regenerative Medicine of Geron Corporation, as Chief Scientific Officer.
• Appointed Jonathan Slotkin, M.D. as Medical Director.
• Expanded neuroscience team including a new Laboratory Director and Research & Development Manager.

Source: InVivo Therapeutics