Stasys Medical Corporation — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT SUMMARY ABSTRACT Antiplatelet medications are a critical component to manage cardiovascular diseasesCVDwhich is a prevalent affliction in the USWhile monitoring platelet therapy is of increasing importance for the identification of hypoor hyper responsive patientsthere is not a clear picture of the medical value of tailored antiplatelet therapy using currently available platelet function testsCurrentlyUS FDA cleared assays of platelet function designed to be near the patient measure platelet adhesion and aggregationStasys Medical is developing a system based on patented platelet contraction sensors to assay platelet contraction force as a biomarker for platelet dysfunctionIn the current projectthe Company will build on preliminary data to demonstrate that the force biomarker is sensitive to platelet inhibition via multiple pathwaysSpecificallyaims are designed tocorrelate the platelet contractile force measurements to inhibition of platelet activation and adhesion pathwaysandbenchmark the force assay to standard platelet function testsThe go no go criteria for moving to Phase II is demonstration that platelet force is sensitive to specific inhibitors and that the assay can identify platelet dysfunction currently missed by existing standard platelet function assaysIn the Phase II project we will leverage data generated in the current project to develop an algorithm that can automatically identify antiplatelet medicationsClinicallythis will be a valuable tool to identify medication non respondersTaken togetherthe project will be used to support the Company sksubmission to FDA with claims directed at evaluating platelet function to assess clinical conditionssuch as bleeding riskassociated with the use of antiplatelet drugsand during and following cardiovascular surgery PROJECT NARRATIVE Antiplatelet medications are a critical component to manage cardiovascular diseasesCVDwhich is a prevalent affliction in the USIn the Phase I projectStasys Medical will build on preliminary data to show that the platelet contraction force biomarker reflects platelet function as proof of concept that the force assay can identify platelet dysfunction missed by existing assaysThe Phase II project will leverage Phase I results to develop an algorithm using machine learning techniques that can automatically identify antiplatelet medications to identify medication non responders