Search Results for: hydrogel preclinical invivo therapeutics

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today reported the financial results for the three and six months ended June 30, 2012 and provided a business update. InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovery and prognosis after a traumatic spinal cord injury. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion. The first six months of 2012 have been a time of tremendous progress for InVivo," said Frank Reynolds, InVivos Chief Executive Officer. "We are advancing multiple neurotrauma products based on our biopolymer scaffolding and hydrogel technologies. Our biopolymer scaffolding device for the treatment of acute SCI is poised to gain FDA clearance to commence human clinical studies. We recently engaged with the FDA for our hydrogel/methylprednisolone combination product and expect to submit hydrogel-based applications to the FDA for the treatments of SCI and pain later this year. Also, in July … Continue reading →

Bob Langer, co-inventor of technology used by InVivo Spinal cord injury treatment company InVivo Therapeutics Holdings Corp. (OTCBB:NVIV) reported a profit for the first quarter of 2012, and said its biopolymer scaffolding is slated to enter human clinical trials later this year. InVivo shares were up about 6 percent in mid-morning trading to $2.45. The company said it expects to start a pilot human clinical trial of the scaffolding in the second half of 2012, pending approval of an Investigational Device Exemption application by the U.S. Food and Drug Administration. Following a meeting with the FDA held in April, the company said it is expecting the product to be regulated under the Humanitarian Use Device/Humanitarian Device Exemption pathway that should accelerate commercialization. The Cambridge company uses technology co-invented by MIT Professor Robert Langer and Mass General Hospitals Dr. Joseph P. Vacanti. Langer was among the team of InVivo scientists who met with the FDA in April. The pilot test will be an open label study to evaluate the safety and efficacy in spinal cord injury patients following treatment with the biopolymer scaffolding. The study will follow promising pre-clinical studies completed in non-human primates, according to InVivo. The company also expects … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (OTCBB:NVIV.OB - News), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported the financial results for the three months ended March 31, 2012 and provided a business update. InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovery and prognosis after a traumatic spinal cord injury. Today there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion. We are off to a strong start for 2012 and the first quarter was marked by significant achievements and milestones for InVivo," said Frank Reynolds, InVivos Chief Executive Officer. We are creating a new paradigm for the treatment of neurological injuries and are at an inflection point in our growth. By the end of 2012, we expect to have several product applications under review by the FDA. Our biopolymer scaffolding device for the treatment of acute SCIs is poised to enter human clinical trials during the second half of 2012. We expect to submit … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (OTCBB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today reported the financial results for the year ended December 31, 2011 and provided a business update. InVivo has pioneered a new treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovering and prognosis after a traumatic spinal cord injury. Today, there is no effective treatment for the spinal cord for paralysis caused by SCIs, and the market potential is estimated to be over $10 billion. 2011 was a landmark year for InVivo, performing under budget for the sixth consecutive year. We made significant progress advancing the commercialization of our first product for SCI and expanding our product pipeline to the rest of the nervous system. We also laid the groundwork to have three product applications under review by FDA by the end of 2012, said Frank Reynolds, InVivos Chief Executive Officer. Our biopolymer scaffolding is poised to enter human clinical trials for SCI during the second half of 2012 and we expect to file two additional Investigational Device Exemptions for our … Continue reading →