Development of a POC device to guide efficient use of blood products

DESCRIPTION provided by applicant The Problem The inability of blood to coagulate properly represents a major source of preventable morbidity mortality and unnecessary costs For example over of the patients undergoing cardio pulmonary bypass CPB procedures in the US each year experience excessive bleeding which requires transfusions of blood products There are four treatment options available each corresponding to a specific hemostatic defect a fresh frozen plasma FFP to correct the plasma coagulation factors b platelet concentrate to restore platelets c cryoprecipitate to restore fibrinogen and d anti fibrinolytics to slow the activity of the clot dissolving proteins However clinical literature stongly indicates that morbidity and mortality risks as well as post operative length of stay increase in a dose dependent way with increased use of blood products Meanwhile targeted use of these products can produce savings of up to $ m year per hospital Similar reasoning can be extended to any surgical procedure at high risk for major bleeding as well as civilian military trauma care Unfortunately there is no global test of hemostasis available at the point of care POC which is able to provide rapid results about the best treatment option The tests that are available at POC canandapos t provide the required information even if used in combination Thus current clinical practice is iterative transfusion of blood products and subjective evaluation of bleeding This process is slow and prone to over transfusions resulting in increased risk of worsened outcomes and unnecessary expenses HemoSonicsandapos Solution HemoSonics LLC is developing a novel POC platform device the Global Hemostasis Analyzer GHA to diagnose and guide the treatment of excessive bleeding and overactive clotting in a variety of clinical settings The GHA is based on a patented technology able to characterize the key components of hemostasis for which a treatment is readily available coagulation factors fibrinogen platelets and fibrinolysis We believe the GHA will help i the surgical team administer the correct treatment ii the hospital save costs by reducing unnecessary transfusions iii the blood bank save valuable blood products and most importantly iv improve patient care Proposed SBIR Work With support from this SBIR program and other sources of funds including angel investors we have proven the feasibility of the technology developed and tested a fully integrated prototype of the GHA In Phase IIB we intend to complete design for manufacturing under a quality control environment complete verification and validation and submit all the necessary documents required for US and European regulatory approval This research is a collaborative effort between HemoSonics the University of Virginia Department of Biomedical Engineering and School of Medicine and Key Tech Inc Baltimore MD PUBLIC HEALTH RELEVANCE Clinical evidence strongly indicates that improved management of bleeding with targeted use of blood products can reduce morbidity and mortality risks while producing significant cost savings It has been estimated that each unit of blood products transfused increases the post operative odds of severe infection by cardiac morbidity by neurological morbidity by and overall in hospital mortality by Post operative length of stay also increases by days per unit transfused Meanwhile targeted use of these products can produce savings of up to $ m year per hospital Unfortunately management of bleeding remains suboptimal due to the limitations of current diagnostic tests The goal of this proposal is to complete the development a novel point of care POC diagnostic instrument that will improve the current management of bleeding and usage of blood products thus improving patientsandapos outcomes and generating substantial cost savings