By minimizing secondary injuries and successfully promoting functional recovery, NVIV’s technologies have the potential to bring unquantifiable quality of life improvements for numerous traumatic back-injury patients and very well could pave the way to a more ubiquitous set of solutions for back injuries. NVIV is helping to move the entire state of the art forward with their innovative products and continued commitment to partnerships within the larger spine care sector.
The beauty of the NVIV approach is that because the BSD is a medical device, the FDA-approval process that normally takes years for a drug can be largely avoided. An IDE (Investigational Device Exemption) was filed with the FDA in July of 2011 and an anticipated meeting this April should suffice for a finalization of clinical trial design.
The BSD is designed to take full advantage of the research done on conducting polymers, which not only perform well for transmission of electrical signals from the CNS, but also may promote neural tissue repair, thanks to the ability of the material to integrate with CNS tissues successfully.
The reason these properties are so important is that the BSD is also designed to be commercialized in a version seeded with autologous human neural stem cells (hNSCs), with the patient’s own stem cells kick-starting the process of tissue recovery. Such partnerships as that with The Miami Project to Cure Paralysis (the most comprehensive spinal cord injury research center in the world), whose work involving Schwann cell transplantation takes full advantage of this product vector, will be key to fully leveraging the potential of the BSD framework.
The Miami Project’s initiative using injected Schwann cells also benefits significantly from NVIV’s third major offering, a biopolymer hydrogel, which is the perfect growth factor for stem cells and Schwann cells, allowing highly-localized/controlled drug release.
Needless to say this is an impressive array of acute/chronic SCI offerings in a massively underserved space for the Cambridge, MA based NVIV, who recently signed a multi-year lease on their 21k sq. ft. HQ (set to house significant lab space and cGMP cleanroom for manufacturing and packaging, in addition to the corporate offices).
Founder, CEO, CFO and Chairman of the NVIV Board, Frank Reynolds (scheduled to appear on San Antonio’s Fox News First at 7AM CST and San Antonio Living at 11AM CST tomorrow), is not only co-inventor of four of the company’s patents, with over two decades of industry management experience, he suffered a spinal injury himself in 1992 and is a tireless, dedicated researcher in the field. Additionally, David H. Koch Institute Professor at the Massachusetts Institute of Technology (MIT is another partner of the company), Robert S. Langer, widely renown in medicine, biotech, and tissue engineering science, is a key member of NVIV’s Scientific Advisory Board.
A one-year $4.50 price target for NVIV (closed February 17 at $2.18, $113M market cap), with pending human trials of potentially break-away technologies, essentially unopposed by any clear competitor in the same space, makes the opportunity look significantly undervalued. Potential to strike deeply into an estimated $10B annual global SCI market ($39B spent on larger care market associated with spinal cord injury in U.S. alone in 2011), means NVIV technologies could achieve revenues of more than a billion dollars by only capturing 10% of a market where clearly as many as half of all the approximately 2M SCI patients worldwide could benefit.
For more information on InVivo Therapeutics Corp., or to stay up to date on the latest news and information, please visit the company’s website at: www.InVivoTherapeutics.com
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