The principal objective of this proposal is to commercialize a totally new endotracheal tube that provides a new means to determine the tube's position with a special sensing instrument. The long range plan of the Company is to develop and expand its basic noninvasive catheter position sensing technology as a less expensive and clinically acceptable alternative to x-ray methods. The new device offers three distinct health care benefits over existing technologies. They are: (1) reduction in x-ray exposure in pediatric patients, particularly significant in those patients who require long term intubation, (2) improvement of operating room pediatric anesthesiology procedures by providing noninvasive, real time, direct determination of endotracheal tube position in the trachea, and (3) reduction in x-ray related costs of patients requiring long term respiratory support procedures. The new tube incorporates in its wall an electromagnetic field interference element, and it is this element which is detected by the sensing instrument. The Phase II work will include: (1) Completion of the Company's product development, manufacturing scale-up and biological safety testing programs; (2) Preclinical tube/instrument product performance evaluations in cadaver studies; (3) Initial clinical studies at Boston Children's Hospital; and (4) Multi-hospital assessment of product's potential clinical utility.
