SBIR Phase I: Induction of therapeutic hypothermia with an esophageal cooling device

This Small Business Innovation Research (SBIR) Phase I project aims to demonstrate the feasibility and safety of inducing mild therapeutic hypothermia with an innovative esophageal cooling device. The use of mild therapeutic hypothermia to treat patients after resuscitation from cardiac arrest nearly doubles their chance of survival, but the difficulties associated with the use of existing methods for inducing hypothermia result in less than 10% of eligible patients actually receiving this treatment. The esophageal cooling device induces hypothermia through the esophagus and solves the problems of inefficiency and risk associated with existing approaches. This innovation provides high-efficiency heat transfer at the patient's core while maintaining gastric access to allow decompression, ensuring maintenance of mucosal contact and attainment of optimum heat transfer. The research objectives of the proposed activity are to demonstrate the feasibility and safety of this transformative approach in a swine model prior to developing a beta-prototype in a Phase II project. Swine will be treated with mild therapeutic hypothermia utilizing an alpha prototype device, after which histopathological analysis of the esophagus by a certified veterinarian will be undertaken to identify any adverse effects. It is anticipated that hypothermia will be induced successfully, with no adverse effects identified. The broader impact/commercial potential of this project will be the lives saved in patients suffering cardiac arrest. The commercial potential of this technology is large because up to 1 million individuals in North America suffer cardiac arrest annually, and another 3 million suffer illnesses that appear to benefit from treatment with hypothermia. Successful commercialization of this transformative technology will result in an effective new tool to enhance the scientific and technological understanding of the benefits of hypothermia in stroke, trauma, and spinal cord injury, among other indications. The device's manufacturing cost is 12 times less than competitors' devices, allowing a margin that will compete effectively in the $1 billion annual market in patient temperature control while providing significant practical advantages to physicians. Because the device is more efficient than surface devices, does not obstruct access to the patient, replaces the standard nasogastric tube, is quick and easy to place, and eliminates the risks of infections, blood clots, and needlestick injuries, adoption will be widespread, resulting in significant societal impact by improving outcomes of cardiac arrest worldwide.