Levisonics Inc. — Department of Health and Human Services SBIR Phase I: NIBIB

Description

PROJECT SUMMARYMore than 5 million U.S. patients take oral anticoagulants daily for the prevention and treatment of thromboembolic events. Most of them are outpatients in need of frequent at‐home monitoring of anticoagulant therapy. According to the National Action Plan for Adverse Drug Event (ADE) Prevention, anticoagulants are “the most common causes of ADEs across health care settings”. 33% of all emergent hospitalizations among older adults are the result of unintentional anticoagulant overdose. Yet despite these significant problems in anticoagulation therapy management, available devices for home‐use monitoring of oral anticoagulant therapy are not only poor predictors of coagulation status, but also not sensitive to dosage effects of oral anticoagulants.The long‐term objective of this SBIR Phase I project is to develop a prototype device for home‐use monitoring of anticoagulant therapy. Levisonics Inc. has developed a unique lab‐in‐a‐drop technology for blood coagulation analysis, referred to as “quasi‐static acoustic tweezing thromboelastometry” or QATT. In QATT, temporal changes in clot firmness are assessed from a single drop of blood (4‐6 microliters in volume) levitating in air under the acoustic radiation force. QATT addresses the issues of home point‐of‐care coagulation testing through the following disruptive features: 1) small sample volume requirement; 2) increased reliability and accuracy due to non‐contact measurement; and 3) rapid assessment of blood coagulation status.The objective of this SBIR proposal will be accomplished in three tasks. First, the existing laboratory research apparatus will be miniaturized and refined to a form factor suitable for home use (Specific Aim 1), with a simplified user interface for the target population. Second, a finger‐to‐device sample delivery method will be implemented (Specific Aim 2) requiring only a single finger‐prick drop of blood. Third, the feasibility of the home use prototype developed in Specific Aim 1 will be established by testing both capillary and venous blood from normal volunteers (Specific Aim 3) exposed to controlled variations of heparin and oral anticoagulant doses.PROJECT NARRATIVEEvery day millions of people, many of whom are enjoying an active retirement and leading otherwise normal lives, must take oral medications to control their risk of blood clots due to heart disease or other conditions. However, because there is no reliable home test to provide current information on their blood clotting status, many of these patients will require hospitalization because of an unintentional (and avoidable) bleeding incident. The rapid, low‐ volume blood coagulation analysis platform developed and validated in this proposal promises to give these patients and their doctors the assurance that their medication dosage meets their changing needs in the comfort of their home as frequently as needed.