SBIR-STTR Award

Direct to Phase II

No portable, field-deployable Thromboelastography (TEG) system exists today. Current TEG systems are large, vibration-sensitive, and labor-intensive laboratory instruments, that require up to 40-60 minutes for a complete measurement - far too complex and slow for effective decision support diagnostics and hemorrhage management in emergency medicine. In contrast, the CoagCare technology can be field-deployable and provides results in under 10 minutes from clot initiation to peak clot strength and fibrinolysis, which is 6x faster than the leading TEG systems on the market. CoagCare system utilizes a low-cost, credit-card sized plastic test disposable. The CoagCare meter is designed to be a battery-powered, portable device that delivers robust measurements in extreme, vibration-intensive environments. The impact of using CoagCare in emergency medicine would be: (1) maximizing care on-scene vs. at the hospital - extending the “golden hour” of hemorrhage/trauma survivability, (2) precisely identify & deliver fluid resuscitation, and (3) optimize use of transfusion products to enable prolonged field care.In addition to measuring standard TEG clotting parameters, Abram Scientific has innovated on the TEG detection sensitivity by orders of magnitude wherein the CoagCare platform can also extract parameters relating to fibrin maturation and platelet contraction in a single test, which enables differential diagnosis of coagulopathies to prioritize use of resuscitation products in both type and quantity. CoagCare is the first platform that can measure these fibrin & platelet activity parameters in a single test. With high sensitivity and proprietary algorithms, CoagCare is the only TEG platform capable of diagnosing and differentiating between the presence of 2 types of Direct-Acting Oral Anticoagulants (DOACs), i.e. direct-thrombin or Factor IIa inhibitors (e.g., Dabigatran) versus Factor Xa inhibitors (e.g., Rivaroxaban, Apixaban), which is necessary to identify the correct reversal agents needed, that can cost $45k on average to administer. Competitors listed in order of market size: 1) Haemonetics - TEG 5000, 6s system 2) Instrumentation Laboratory, A Werfen Company - ROTEM Delta, Sigma 3) HemoSonics, A Stago Company - Quantra. The competitive advantages offered by the CoagCare platform over current systems listed above are: 1) fast turnaround time (< 10 minutes) 2) high accuracy 3) high sensitivity for fibrin/platelet relative clot strength in a single test, 4) DOAC determination & differentiation, (5) low complexity (POC meter & disposable card format), 6) high reliability, 7) cost-effectiveness (non-CAPEX, enabling faster procurement and increased adoption).This SBIR project aims to develop a further-miniaturized prototype of the CoagCare System to a single handheld meter and disposable format, in order to meet Optimal Role I/II SWAP (Size Weight and Portability) requirements to enable extended use for far-forward surgical support scenarios.