SBIR Phase I: Novel Device for monitoring brain hemorrhage using radio waves.

Period of Performance: 07/01/2015 - 12/31/2015

$149K

Phase 1 SBIR

Recipient Firm

Sense Diagnostics, LLC
1776 Mentor Ave. Suite 411
Cincinnati, OH 45212
Firm POC, Principal Investigator

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the reduction of deaths and long-term disabilities in people suffering from bleeding in the brain caused by hemorrhagic stroke or traumatic brain injury. The presence of blood outside of the brain?s vessels and arteries creates a characteristic change in the radio signal used by the device. Currently, physicians are alerted to worsening bleeding only when a patient fails to respond appropriately to a clinical exam that consists of a series of questions and commands. The problem this presents is that by the time the exam uncovers the additional bleeding, much of the damage to the brain has already occurred. A large proportion of patients suffering either hemorrhagic stroke or TBI die or are left severely disabled. Each year over 70,000 people suffer hemorrhagic stroke, with over half of them dying. TBI is responsible for over 1 million emergency department visits, 225,000 hospital admissions and 50,000 deaths. Using radio waves to non-invasively detect brain bleeds will reduce the time it takes to start treatment, which will save lives, reduce disabilities and result in significant savings to the health care system. The proposed project will test the ability of the SENSE device to detect small amounts of blood (as little as 2 ml) in both a gelatin model that mimics the electrical properties of the human brain and in a well-established porcine intracranial hemorrhage model. The gelatin experiments will place blood at various locations throughout the model. The prototype device will scan both before and after blood insertion and the results will be compared to the known location and volume of blood to determine the ability of the device to accurately detect the blood. Once confirmed in gelatin models, the device will be tested in a porcine ICH model using an institution IACUC approved protocol to ensure humane treatment of the test animals. Under general anesthesia, a small volume of the pig?s own blood will be surgically infused into the brain. The device will scan the pig?s brain both before and after insertion of the blood. After the scans are complete,the animals will be euthanized. The brain will be frozen in liquid nitrogen and sectioned. The scan results will be compared to the sectioned brain to determine the device?s ability to accurately detect the location and volume of blood.