Late stage development and preparation of a long-term non-enzymatic continuous glucose sensor for clinical trials

Abstract Diabetes is a complex multi factorial disease that diminishes the length and quality of life of affected individualsThe use of continuous glucose monitorsCGMcan be an invaluable management tool for patients afflicted by this chronic and costly diseaseHoweverdespite years of developmentcurrently available continuous glucose monitorsCGMsstill lack good accuracy and reliability for short term and particularlylong term use in diabetes managementThe main obstacles to achieving a long termaccurate CGM are instabilities in the sensing chemistry and the body s immune response against the sensorspecifically the foreign body responseFBRleading to biofoulinginflammationavascular fibrosis and sensing chemistry degradationAdditionallycurrent CGM systems in the market and under development are either bulky percutaneous probes or implantable devices encased in hard metals or plastics that become surrounded by an avascular tissue capsule over time or are taken up by immune cellsif nano sizedProfusa has developed fluorescentnon enzymatic boronic acidBAbased glucose sensors that are produced in a tissue integrating hydrogel format that has been shown to minimize the FBRenabling long term monitoringIn this CRP SBIRwe aim to guide our successfully demonstrated injectable glucose sensors through late stage development and technical activities that are vital for commercializationClinical translation of this technology will motivate and enable diabetic and pre diabetic patients to more tightly control their glucose levels without fear of hypoglycemia and will reduce the diabetes disease burden on the healthcare systemIn this projectwe propose to prepare the path for first in human clinical testingas a first step towards commercializationTo this endwe will demonstrate production of sterilebiocompatiblepackaged sensors ready for clinical trial use in order to ensure compliance with regulatory standardsWe will perform market research analysis to determine target populationassess reimbursement potentialand develop regulatory strategies to align clinical development with business objectivesIn additionwe will complete documentation regarding investigational device exemptionFinallywe will design and plan for a first in humanFIHclinical trial by preparing all necessary documents for IRB submissionThis proposal will aid Profusa in moving its glucose sensor towards commercializationto significantly improve the health and quality of life of pre diabetic and diabetic patients Project Narrative Diabetes is a devastating and costly chronic disease affecting nearlymillion people in the US alone and amounting to $B in annual healthcare expendituresThis project will move Profusa s long term continuous glucose sensors toward first in human clinical trialsAdoption of Profusa s sensors will motivate and enable diabetic patients to more tightly control their glucose levels without fear of severe glucose lowsand will reduce the diabetes disease burden on the healthcare system