InVivo Therapeutics (NASDAQ:NVIV) has already demonstrated in preclinical results that its biopolymer scaffold device (BSD) has enabled paralyzed African rats and monkeys to walk again within several weeks of treatment. The novel device is biodegradable and serves to heal a patient's injured spinal cord quickly, which prevents subsequent secondary injury from bleeding, inflammation, and scaring, the actual causes of paralysis. Company management filed the Investigational Device Exemption (IDE) to the U.S. FDA in July 2011 with plans in mid 2012 to finalize a human clinical trial design and date. The preclinical results and video on the company's website are stunning to say the least.
The Cambridge, MA, biotech further advanced its offerings by developing an Injectable Hydrogel for Local Drug Delivery that controls the release of drugs to counteract the inflammatory environment that results during secondary injury after closed-wound spinal cord injury (SCI).
Going further, the firm's Biopolymer Scaffold Seeded with Autologous Human Neural Stem Cells offering extends the biopolymer platform technology further. It is designed for doctors to treat both acute and chronic spinal cord injury patients by seeding the patient's own stem cells into the scaffold. Subsequently the scaffold acts as a synthetic extra cellular matrix.
Despite the much anticipated success and promise that the and Injectable Hydrogel models hold for patients, doctors, and investors, the firm's Biopolymer Scaffold Seeded with Autologous Human Neural Stem Cells offering has even more potential and has led InVivo to the position of being a significant and key partner with companies working in the spinal cord injury arena.
A prime example of that potential is that of the Miami Partnership. In May of 2011, InVivo dazzled executives of The University of Miami Miller School of Medicine's Miami Project to Cure Paralysis with a presentation on how its science could be used to advance and partner with The Miami Project.
The Miami Project was founded in 1985 by Barth A. Green, M.D. and NFL Hall of Fame linebacker Nick Buoniconti in response to a paralyzing college football accident incurred by Buoniconti's son Marc. The Miami Project is now headed by Dr. W. Dalton Dietrich, Scientific Director, and is one of the most comprehensive spinal cord injury research centers in the U.S. It is located in the Lois Pope LIFE Center, a Center of Excellence at the University of Miami Miller School of Medicine. With more then 250 scientists on board, the group conducts research and takes approaches innovative approaches to SCI victims.
The Miami Project's Schwann Cell Transplantation Program is especially significant to The Miami Project and to the collaboration with InVivo Therapeutics. This cell therapy involves injecting Schwann cells into the spinal cords of individuals. It is key that they are the patient's own healthy stem cells. Schwann cells are a significant component of the peripheral nervous system and function as insulators that promote the growth and regeneration of nerve fibers. Hopes are that the cells will enable mobility to occur in time. The research team at The Miami Project submitted an Investigational New Drug for human clinical transplant trial in the fall 2011, and is planning for human clinical trials after FDA approval.
InVivo figures prominently here because its bio polymer hydrogel product is the extra cellular matrix needed for stem cells and Schwann cells to survive and proliferate, and to be delivered to the spinal cord. When scientists conducted preclinical trials, they demonstrated locomotor function recovery, spared nerve function and nerve cell growth using autologous Schwann cell transplantation.
InVivo's biopolymer scaffoldings mimic the natural and protective properties of the extracellular matrix within the spinal cord to promote the proliferation and survival of implanted cells. In preclinical studies, InVivo's biopolymer devices, alone, combined with drugs, or seeded with human neural stem cells, have demonstrated the ability to minimize scarring (astrogliosis) and promote post-SCI neural survival.
InVivo was co-founded by the NY born, prolific inventor Dr. Robert S. Langer, who is the David H. Koch Institute Professor at the Massachusetts Institute of Technology. Langer received his bachelor's degree from Cornell University in chemical engineering and earned his Sc.D. in chemical engineering from MIT in 1974. He is widely regarded for his contributions to medicine and the emerging fields of biotechnology. Widely respected as a pioneer of new technologies and delivery systems, Dr. Langer has also made advances in tissue engineering and has 760 granted or pending patents. He has also been the author of over 1,100 scientific papers and has been involved in the founding of multiple technology companies.
InVivo at $2.84 has a current market capitalization of $148 million with a 52-week range of $0.60 - $2.07. Its 1-year target is $4.50. Many analysts believe that InVivo is undervalued with a miniscule market cap. It is projected that as the company continues to advance its science, and receives likely positive clinical trial results, that value will skyrocket along with the use of its science in the spinal cord injury market.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.