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InVivo Therapeutics Spinal Cord Injury Therapy Tod Holberton, Kent Leslie, Katie Yates Spinal Cord Anatomy • • • • http://www.laesieworks.com/spinal/SCIinfo01.html Attaches from brainstem to vertebrae Two rows of nerve roots Sensory and motor nerve fibers Three meninges Spinal Cord Injury • • • • • http://www.michaelwaks.com/spinal-cord-injury-attorney.html 10,000 people yearly Trauma damages vertebrae Vertebrae damage spinal cord Descending loss of function "Complete" and "Incomplete" injuries Existing Treatments and Therapies • • • • http://www.usahockey.com Methylprednisone Surgery Immobilization or traction Occupational therapy Scaffold Technology • PLGA Scaffold • 300um pore size • Bioresorbable • Use of stem cells • Two different types of treatment for contusion vs. piercing injury http://invivotherapeutics.com/pdf/InVivo_Investor_Presentation_3.14.13.pdf Drug Releasing Polymer Technology • Scaffold implanted • • http://physrev.physiology.org/content/87/1/315/F7.expansion.html with peroxynitrite scavenger Reduces neuroinflammatory NO free radicals Addresses the issue of secondary cell death Procedure http://www.invivotherapeutics.com/ourresearch/ Effectiveness • • • • 2009 primate study Without treatment, loss of leg function With scaffold, animal is able to run on a treadmill and use its toes to grip and climb a ladder Greater injury recovery Clinical Study • • • • • Hoping to begin clinical trials in 2013 Received HDE status from the FDA in April 2012 5 acute SCI patients at Brigham & Women's and Geisinger Hospital (PA) Rehab at Shepherd Center (GA) One-year followup Cost, Complications, and Recovery Process • • • • • $60,000 - $100,000 Uncertainty of coverage No current recovery procedures for humans Technology still in the early developmental phase Only known complications thus far are those associated with invasive surgery Future Developments • 510(k) approval • • for two neurological devices Expected to be on the market for late 2014 15 Billion potential market share