Tissue Oxygen Monitoring in Peripheral Vascular Disease

DESCRIPTIONprovided by applicantThe goal of this Fast Track SBIR is to demonstrate the functionality of PROFUSAandapos s novel injectable tissue oxygen monitors in patients with peripheral arterial diseasePADand to determine the its ability to detect restenosis in critical limb ischemiaCLIPAD is a manifestation of systemic atherosclerosis that affectsmillion people in the U Swith prevalence increasing with agePAD ranges from mildaccompanied by intermittent claudication or pain with exerciseto severeaccompanied by CLI and gangreneand is associated with high rates of amputationmortality and poor quality of lifeWith the appropriate monitoring and treatmentdisease progression can be halted and even reversedbut easy to useaccurate monitoring products to indicate when a change in therapy is needed do not existPROFUSAandapos s oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb beforeduringand after treatmentthus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appearIn this Fast Track SBIRwe proposeto confirm biocompatibility according to ISOstandardsto enhance user experience for commercialization by minimizing sensor size andto clinically verify the ability of PROFUSAandapos s tissue oxygen sensors to detect restenosis in PAD CLI patientsIn addition to the strong scientific and pre clinical teamsmedicalclinicalregulatory and business personnel will be an integral part of this project to provide early strategy for successful product developmentThese data will be crucial in advancing PROFUSA towards commercialization and regulatory approvals PUBLIC HEALTH RELEVANCEPeripheral arterial diseasePADin which plaque buildup obstructs arteries causing decreased tissue oxygen levelsis estimated to affecttomillion people in the U Screating an annual economic burden of more than $BDecreased tissue oxygen levels can lead to intermittent claudication orin more advanced casesgangrene and amputationPROFUSAandapos s oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb beforeduringand after treatmentthus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear