? DESCRIPTION (provided by applicant): BioSensics LLC, in collaboration with the Department of Surgery at the University of Arizona, proposes to develop, clinically validate, and commercialize the Upper-Limb Frailty Meter (UFM); a novel wearable technology for quantifying frailty in older trauma patients. It is necessary to quantify frailty in these patients to ensure tat treatment is appropriate, risk-stratified, and compatible with high function and quality of life. Despite increasing evidence that assessing frailty facilitates medical decision-making, a quick and clinically simple frailty assessment tool is not available for use in trauma. The UFM is a system of two low cost wearable sensors worn on the wrist and upper arm. It requires 20 seconds of repeated elbow flexion and extension to identify known frailty features such as slowness, weakness, inflexibility, and exhaustion. The UFM is superior to existing approaches to frailty assessment because it can be used in patients who are unable to walk, and it does not require time consuming questionnaires that are not practical in a busy clinical environment. This application is submitted as a Direct to Phase II because a prototype UFM has already been validated in our target population. Among 117 community-dwelling older adults those identified as frail by the Fried criteria were identified by the UFM with 100% sensitivity and specificity (pr-frail individuals were identified with 87% sensitivity and 82% specificity). Among 30 geriatric trauma patients there was an excellent association between the Rockwood frailty index and UFM parameters (r > 0.81, p <0.01). To commercialize the UFM we must 1) improve sensor hardware for ease of use and cost reduction, 2) demonstrate accurate diagnoses of frailty in a larger sample of non-mobile geriatric trauma patients, 3) provide further evidence that frailty affects clinical outcomes and, therefore, frailty assessment should regularly be used to guide the treatment of geriatric trauma patients, and 4) demonstrate that the UFM does not disrupt the clinical workflow. These are the objectives of the proposed project. The short-term impact of the project is a commercially available tool for more effective and efficient frailty assessment. The long-term impact of the technology and related clinical research (both proposed and in the future) is the application of frailty assessment to understand physiologic vulnerabilities among older trauma patients to improve the clinical prediction of outcomes and facilitate patient-centered communication and decision-making consistent with patients' values and preferences. There is a significant commercialization potential for the proposed technology due to 1) the size of the market, 2) the disruptive nature of our first-to- market technology, and 3) the ongoing national push towards increased reliance on frailty assessment to help guide treatment planning in geriatrics. We will have a market-ready device by the completion of Phase II with plans for a market launch during Phase III, pending FDA approval.
|Effective start/end date||6/15/15 → 3/31/17|
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