SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project will facilitate technological development of a point-of-care device to measure the forces of platelets from whole blood during clotting. Trauma accounts for nearly 5 million deaths per year worldwide and 17 deaths per hour in the U.S. These deaths arise from an extensive loss of blood due to trauma-induced coagulopathy (TIC), which is a systemic impairment of hemostasis (blood clotting) caused by severe injury. The current SBIR Phase I award will fund a feasibility study on the ability to measure platelet forces during coagulation by a magnetic-based sensor. The specific technical goal of this SBIR Phase I proposal is to improve the signal detection of our magnetic-based sensor. Successful completion of these objectives will enable a Phase II project that will demonstrate the ability of this technology to detect clotting dysfunction in trauma patients on a personalized basis, as well as patients on anti-platelet and or anti-coagulation medications. The broader impact/commercial potential of this project will be to reduce preventable deaths of often young, productive members of society. Trauma is the most imporatn cause of death among young people (age group 1-45 years) and costs $135B in healthcare dollars annually. Excessive bleeding in a trauma patient is a major reason for deaths and medical costs. Excessive bleeding is often made worse by coagulopathy, which is the inability of a patient?s blood to coagulate and properly seal bleeding wounds. Currently, acute trauma-induced coagulopathy (TIC) occurs in 1 in 4 severe trauma cases, but is hard to detect and treat. As a consequence, an emergency department physician must make a semi-blind decision on which transfusion products or drugs to administer to a patient in order to stop the bleeding based upon their training, past experience, and vague clinical guidelines and must act upon their decision within the ?golden hour? (i.e. roughly 60 minutes after injury) to have the best likelihood to save lives, reduce morbidity, and reduce hospital costs.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to create a medical device capable of rapidly guiding treatment to stop bleeding in trauma patients. Trauma can affect the body's ability to form clots to stop bleeding. Of the more than 2 million severe cases of trauma in the U.S., approximately one third will develop a condition: trauma-induced coagulopathy (TIC), which increases mortality 4-fold. TIC can be corrected; however, current tests to identify TIC take too long to effectively guide treatment. This leads to sub-optimal care and increased mortality and morbidity. The current standard-of-care to correct TIC is the transfusion of blood products. A patient should only be transfused if necessary because unnecessary transfusions can lead to complications resulting in longer hospital stays and even death. A rapid assay that can evaluate a trauma patient's coagulation status can help guide treatment of their injuries, resulting in improved standard-of-care that can both save lives and healthcare dollars. Yearly trauma rates unfortunately remain stable, and with an addressable market of more than $400M per year in the U.S., the commercial impact for such an assay is significant.The proposed project is to develop a rapid assay that provides an individualized assessment of a trauma patient's coagulation status. A significant subset of trauma patients develop impairment to the normal coagulation process as a result of their injuries. Current assays to identify this impairment take too long to effectively guide treatment. Therefore, successful completion of this project will yield a disposable microfluidic card (microcard) that has multiple advantages over current assays, which are slow and non-specific. The microcard will measure clot characteristics currently used by emergency room physicians to guide treatment, but will do so in less than five minutes. This is a critical feature as it quickly guides treatment, meaning that there is time for re-evaluation to determine if treatment is effective. The microcard will also include on-board positive and negative controls that indicate a patient?s individual coagulation profile. This will result in personalized and more accurate treatments that can reduce complications and mortality. The rapid and specific microcard assay will significantly improve care of injured patients while conserving resources and time, ultimately saving money for the U.S. healthcare system.