STTR Phase II: Intraventricular Cooling Catheter

Period of Performance: 01/01/2009 - 12/31/2009

$500K

Phase 2 STTR

Recipient Firm

CoolSpine LLC
188 Hoop Pole Hill Road
Woodbury, CT 06798
Principal Investigator

Research Institution

Yale University
PO Box 208047
New Haven, CT 06520
Institution POC

Abstract

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). This Small Business Innovation Research Phase II project will build upon the success demonstrated in the Phase I program and further develop the Intraventricular Cooling Catheter, whose purpose is to induce localized therapeutic hypothermia while maintaining systemic normothermia and thus to act as a neuroprotective modality to mitigate brain injury in traumatic brain injury, and stroke, and post-cardiac arrest brain injury in humans. In Phase II our primary objectives are: 1) design and development of commercially viable prototypes of the system components (Controller and Catheter); 2) determination of system's range of effectiveness in cooling tissue in various regions of the brain (cooling map of brain); and 3) determination of system's safety and efficacy profile. Improvements will be developed to both the catheter and the controller based on our Phase I experience. Animal trials using a sheep model will be conducted to determine the system's performance and efficacy in brain application. Finally, an IDE safety trial will be conducted (in spine application). We anticipate that the results of this work will provide the foundation for this intraventricular cooling catheter to be used as an adjunct modality to other treatments for