Development of next-generation Thrombelastographs

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DESCRIPTION (provided by applicant): Coramed is commercializing next-generation point of care instruments, the TEG 6000 series, for monitoring patient hemostasis on demand. This project includes activities to take the technology from the prototype stage completed in Phase II to FDA-cleared and CLIA-waived commercial products. The planned devices introduce a completely new technology for monitoring coagulation - one well suited for use across the continuum of care from inside the hospital to ambulatory care clinics, physician offices, ambulances, battlefields, and ultimately patient homes. A device that produces timely and equivalent results, regardless of device location or operator, can substantially enhance the standard of care for patients with a tendency to clot and can improve clinical outcomes at a reduced cost. The TEG 6000 series devices are successors to the widely accepted Thrombelastograph (R) (TEG(R)) TEG5000 Hemostasis System, which is used to measure all phases and states of patient hemostasis, including a prothrombotic state. However, despite the clinical and commercial success of the TEG5000 system, its configuration precludes general use in some point- of-care locations within and outside the hospital. The sample size and testing complexity require personnel who can perform phlebotomy, are able to pipette, and who are trained in QC and other lab procedures. Enabling use of these devices outside the hospital in sites such as physician offices will allow accessible screening for risk of heart attacks and stroke, and monitoring of anticoagulation and anti-platelet therapy. Achieving this goal requires compact and easy to use instruments such as the TEG 6000 series.