PROFUSA, INC. — Department of Health and Human Services SBIR Phase II: 200

Description

Project Summary Abstract Despite years of development currently available continuous glucose monitors CGMs still lack good accuracy and reliability for short term and particularly long term use in diabetes management While insulin pumps work well CGM remains the single largest hurdle to closing the loop of an artificial pancreas The main obstacles to achieving a long term accurate CGM are instabilities in the sensing chemistry and the body s immune response against the sensor specifically the foreign body response FBR leading to biofouling inflammation avascular fibrosis and sensing chemistry degradation Additionally current 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 cells if nano sized In this Phase II SBIR we propose to demonstrate the safety and feasibility of a minimally invasive long term non enzymatic glucose sensor produced using our novel tissue integrating smart hydrogels that become part of the tissue they are sensing to overcome the FBR The near infra red NIR fluorescence of the smart hydrogel modulates based on the glucose concentration and is detected non invasively through the skin with an optical reader The long term vascularizing nature of these hydrogel sensors provides exquisite capillary proximity to more than times greater sensor surface area compared to traditional electrochemical sensors thereby overcoming the FBR and enhancing accuracy and longevity of glucose detection The proposed CGM system contains no implanted electronics or hardware in the body Profusa s long term goal is to develop a self calibrating injectable soft hydrogel CGM with a minimum operational life of months and a longer term goal of months with sufficient accuracy to enable an artificial pancreas Moreover because of the platform nature of this technology sensing moieties specific to other analytes e g oxygen lactate can also be incorporated within the hydrogel matrix Profusa s tissue integrating sensor platform has been demonstrated to be stable in the body for months to years and to provide superior sensing performance compared to solid non tissue integrating sensors The overall focus of this proposal is to transition the day in vitro success from Phase I to an in vivo pre clinical model over days In addition to demonstrating safety and feasibility we aim to improve human factors of our glucose sensors by engineering a significant reduction in sensor size less volume to minimize materials placed in the body and injection needle size cut in half to minimize sensation upon injection The ultimate objective is to achieve stable sensor response over months with an error comparable to leading percutaneous continuous glucose monitors Refinement of fluorescent tissue intergrating sensors promises to open a whole new sensing modality for diabetes management and health monitoring Project Narrative Diabetes is a devastating and costly chronic disease affecting nearly million people in the US alone and amounting to $ B in annual healthcare expenditures Upon successful pre clinical testing of a novel long term low cost glucose sensor in this Phase II SBIR Profusa Inc is poised to undergo human trials in order to demonstrate day in vivo longevity and accuracy to lay the groundwork for inclusion into an artificial pancreas Adoption of Profusa s CGM will motivate and enable diabetic patients to more tightly control their glucose levels without fear of severe glucose lows and will reduce the diabetes disease burden on the healthcare system