Rubitection Inc — Department of Health and Human Services SBIR Phase I: 600

Description

DESCRIPTION provided by applicant Pressure ulcers PUs commonly referred to as bed sores affect million individuals annually in the US Treatment cost of PUs exceeded $ billion in or $ per patient To address rising expenditures associated with preventable conditions Medicare ceased reimbursement for treatment of facility acquired PUs in In response current clinical PU management protocols focus on prevention and early detection stage I PU However the standard clinical PU diagnostic test the manual Blanch Test MBT has significant limitations The MBT requires a caregiver to andquot visualizeandquot color changes to a specific area of skin when pressure is applied and andquot feelandquot changes in the properties of the skin This widely used method presents significant limitations including subjectivity low accuracy especially on dark skin tones and low of repeatability and reliability These deficiencies result in a significant unmet public health need to accurately detect the precursors of early stage PUs To address this problem Rubitection Inc andapos s long term goal is to commercialize the Rubitect Assessment System RAS a safe and low cost non invasive bed side system that includes a measurement probe and PU risk management software The RAS will allow caregivers to perform a reliable blanch test that quantitatively detects the presence of a bedsore on all skin tones or estimate the risk of a PU Preliminary bench top research has demonstrated that the RASandapos probe can reliably detect the diagnostic cues of a stage PU independent of a patientandapos s skin color This Phase SBIR proposes to achieve aims that build upon these findings complete an initial clinical validation study of the RASandapos probe to characterize its diagnostic performance on patients and investigate the feasibility of an earl risk assessment software that predicts the progression of a PU The probeandapos s sensitivity will be quantified by testing prototypes of the device on lightly and darkly pigmented patients in long term care facilities Results collected from the RAS will be compared with the standard of care MBT via patient records to calculate sensitivity using a x Contingency Table Aim will test the feasibility of a PU risk estimation software that can analyze changes in the skinandapos s properties to estimate localized risk of an impending PU The software will be bench top tested with pre classified data using a x Contingency Table to determine its sensitivity accuracy in correctly PU risk The successful completion of the Phase I SBIR will provide the initial pilot dat to demonstrate the feasibility of the RAS as a diagnostic tool for early stage bedsores and a proof of concept software platform for early PU risk assessment The follow on Phase II SBIR will refine the design of the RAS probe and software for optimized performance and clinical userability Upon completion of Randamp D the RAS will be commercialized to provide healthcare facilities with a low cost solution to early PU management The RAS will enable caregivers to reliably and safely detect PUs at their earliest stage and thus yield better patient outcomes improved documentation and lower associated costs PUBLIC HEALTH RELEVANCE Pressure ulcers PUs commonly referred to as bed sores affect million individuals annually in the US The treatment cost of PUs exceeded $ billion in or $ per patient the majority of which Medicare will not reimburse PUs most common in patients that are immobile particularly the elderly kill people each year The standard clinical PU diagnostic the manual blanch test MBT has significant limitations including subjectivity low accuracy especially on dark skin tones and lack of repeatability and reliability These deficiencies result in a significant unmet public health need to accurately detet PUs and their precursors of early stage PUs so that they can be prevented or treated at the earliest stages