InVivo Therapeutics Spinal Cord Injury Therapy Tod Holberton, Kent Leslie, Katie Yates

Spinal Cord Anatomy Attaches from brainstem to vertebrae Two rows of nerve roots Sensory and motor nerve fibers Three meninges

Spinal Cord Injury 10,000 people yearly Trauma damages vertebrae Vertebrae damage spinal cord Descending loss of function "Complete" and "Incomplete" injuries

Existing Treatments and Therapies 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

Drug Releasing Polymer Technology Scaffold implanted with peroxynitrite scavenger Reduces neuroinflammatory NO free radicals Addresses the issue of secondary cell death

Procedure research/

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 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

510(k) approval for two neurological devices Expected to be on the market for late Billion potential market share Future Developments