In Vivo Therapeutics Spinal Cord Injury Therapy Tod

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In. Vivo Therapeutics Spinal Cord Injury Therapy Tod Holberton, Kent Leslie, Katie Yates

In. Vivo Therapeutics Spinal Cord Injury Therapy Tod Holberton, Kent Leslie, Katie Yates

Spinal Cord Anatomy • • http: //www. laesieworks. com/spinal/SCIinfo 01. html Attaches from brainstem

Spinal Cord Anatomy • • http: //www. laesieworks. com/spinal/SCIinfo 01. 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

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

Existing Treatments and Therapies • • http: //www. usahockey. com Methylprednisone Surgery Immobilization or traction Occupational therapy

Scaffold Technology • PLGA Scaffold • 300 um pore size • Bioresorbable • Use

Scaffold Technology • PLGA Scaffold • 300 um pore size • Bioresorbable • Use of stem cells • Two different types of treatment for contusion vs. piercing injury http: //invivotherapeutics. com/pdf/In. Vivo_Investor_Presentation_3. 14. 13. pdf

Drug Releasing Polymer Technology • Scaffold implanted • • http: //physrev. physiology. org/content/87/1/315/F 7.

Drug Releasing Polymer Technology • Scaffold implanted • • http: //physrev. physiology. org/content/87/1/315/F 7. expansion. html with peroxynitrite scavenger Reduces neuroinflammatory NO free radicals Addresses the issue of secondary cell death

Procedure http: //www. invivotherapeutics. com/ourresearch/

Procedure http: //www. invivotherapeutics. com/ourresearch/

Effectiveness • • 2009 primate study Without treatment, loss of leg function With scaffold,

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

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

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

Future Developments • 510(k) approval for • • two neurological devices Expected to be on the market for late 2014 15 Billion potential market share

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