Coronary heart disease (CHD) and stroke remain 1 of the major causes of morbidity and mortality in the US, and platelets play a major role in CHD/stroke. Thus, the use of antiplatelet drugs is helpful in the prevention or treatment of such vascular disorders. Despite routine use of antiplatelet agents in a large number of patients, the efficacy of antiplatelet therapy is rarely monitored in each patient. Most patients are prescribed a fixed dose with no effort to establish therapeutic efficacy, and the lack of suitable strategies precludes individual monitoring and adjustment of dosage to ensure adequate protection. The need for monitoring antiplatelet therapy is further accentuated by the fact that as many as 30% of patients may be resistant to standard dosages of commonly used antiplatelet drugs such as aspirin and clopidogrel. The current methods for the assessment of platelet function are cumbersome and time-consuming (laboratory methods), or relatively expensive, unreliable and offer only an indirect/incomplete measure (current point-of care instruments), and therefore lack sensitivity. Thrombodyne Inc. has developed, with funding from NIH, a novel approach to assess platelet function in whole blood. A functional version of the Thrombodyne Platelet Function Analyzer (TPFA) has withstood the rigors of laboratory and limited clinical testing, and detects platelet function abnormalities and identifies patients who may be resistant to standard doses of antiplatelet agents. Through this application, the investigators request support to sustain their efforts to: 1) make TPFA a cost-effective, convenient and versatile point-of-care instrument, 2) to seek FDA approvals to prepare it for marketing, and 3) to demonstrate that individually tailored dosing of antiplatelet agent (or combination of agents) would lead to better therapeutic efficacy, reduce side effects, and result in better outcomes. The applicants are at a unique point in their development path where the requested funding would allow them to take the device to market. The introduction of this convenient, cost-effective point-of-care platelet function analyzer would make it possible to tailor antiplatelet therapy for each individual and improve outcomes.
