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The invention provides methods for directing a localized biological response of a mammalian body to an implant disposed within the body. In one embodiment, a delivery system is positioned outside the body and adjacent to the implant within the body. The delivery system comprises a first tissue response modifier effective for directing a localized biological response of the body to the implant. The tissue response modifier is nonsurgically delivered from the delivery system into the body in a quantity effective to direct the localized biological response of the body to the implant. The invention also provides an implant system for long-term use comprising an implant and nonsurgical means for delivering a tissue response modifier through the epidermis of the body, the tissue response modifier effective for directing a localized biological response of the body to the implant.


Patent
Profusa Inc. | Date: 2016-03-31

Tissue-integrating biosensors, systems comprising these sensors and methods of using these sensors and systems for the detection of one or more analytes are provided.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 966.53K | Year: 2016

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


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase II | Award Amount: 959.80K | Year: 2016

DESCRIPTION provided by applicant Continuous biochemical monitoring has the power to change currently accepted standards of care shifting the emphasis from treating illness to maintaining health Point in time snapshots of a patientandapos s health can miss critical fluctuations or early warning signs that might warrant early interventions or changes in disease treatment and management PROFUSAandapos s sensor platform has the promise to transform healthcare by providing real time data to physicians and patients without requiring blood samples cumbersome equipment or doctor visits The goal of this Fast Track STTR is to apply PROFUSAandapos s injectable microsensors for monitoring tissue health in peripheral artery disease PAD Continuous oxygen monitoring will be useful in the treatment and management of a variety of diseases such as asthma COPD sleep apnea compartment syndrome transplant surgery and PAD PAD is a manifestation of systemic atherosclerosis that affects million people in the U S with prevalence increasing with age PAD ranges from mild accompanied by intermittent claudication or pain with exercise to severe accompanied by critical limb ischemia and gangrene and is associated with high rates of amputation mortality and poor quality of life With the appropriate treatment and monitoring disease progression can be halted and even reversed PROFUSAandapos s long term tissue monitors can be used to continuously monitor tissue oxygen levels and temperature in PAD patients during their daily activities and thus provide timely indications of changes in disease state e g restenosis In recently completed landmark studies PROFUSAandapos s prototype oxygen sensors were shown to function months in healthy rats and months in large healthy mammals In this Fast Track STTR we propose to demonstrate sensor functionality in PAD animal models rats in Phase I and pigs in Phase II Changes in tissue oxygen in the animalsandapos healthy and ischemic legs will be monitored before during and after induction of PAD out to days a time period relevant to chronic wound healing thrombolytic drug therapy optimization and monitoring for restenosis to avoid re intervention and amputation Phase II will also involve miniaturization of PROFUSAandapos s custom optical reader system to improve the form factor for in vivo use In addition to the strong scientific and pre clinical team medical clinical regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development The proposed studies will provide valuable data for advancing PROFUSA towards clinical studies of PAD monitoring and significant investor funding to enable commercialization for widespread clinical application PUBLIC HEALTH RELEVANCE Peripheral artery disease PAD in which plaque buildup obstructs arteries leading to decreased tissue oxygen levels is estimated to affect to million people in the U S creating an economic burden of more than $ B annually Decreased tissue oxygen can lead to intermittent claudication or in more advanced cases gangrene and amputation PROFUSAandapos s continuous oxygen sensing technology can help to salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment


Some embodiments described herein relate to a reader having a distributed source of radiation and a photodetector. The photodetector can be operable to sense radiation (e.g., light) emitted by an implanted sensor. The distributed source of radiation can at least partially surrounds the photodetector. The distributed source of radiation generates a photon cloud of excitation radiation within the skin, which can substantially envelopes a sensor that is implanted within the skin at a depth that is on the order of a centimeter or less.


Patent
Profusa Inc. | Date: 2016-06-22

Oxygen sensing luminescent dyes, polymers and sensors comprising these sensors and methods of using these sensors and systems are provided.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 224.88K | Year: 2016

DESCRIPTION provided by applicant The goal of this Fast Track SBIR is to demonstrate the functionality of PROFUSAandapos s novel injectable tissue oxygen monitors in patients with peripheral arterial disease PAD and to determine the its ability to detect restenosis in critical limb ischemia CLI PAD is a manifestation of systemic atherosclerosis that affects million people in the U S with prevalence increasing with age PAD ranges from mild accompanied by intermittent claudication or pain with exercise to severe accompanied by CLI and gangrene and is associated with high rates of amputation mortality and poor quality of life With the appropriate monitoring and treatment disease progression can be halted and even reversed but easy to use accurate monitoring products to indicate when a change in therapy is needed do not exist PROFUSAandapos 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 before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear In this Fast Track SBIR we propose to confirm biocompatibility according to ISO standards to enhance user experience for commercialization by minimizing sensor size and to clinically verify the ability of PROFUSAandapos s tissue oxygen sensors to detect restenosis in PAD CLI patients In addition to the strong scientific and pre clinical teams medical clinical regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development These data will be crucial in advancing PROFUSA towards commercialization and regulatory approvals PUBLIC HEALTH RELEVANCE Peripheral arterial disease PAD in which plaque buildup obstructs arteries causing decreased tissue oxygen levels is estimated to affect to million people in the U S creating an annual economic burden of more than $ B Decreased tissue oxygen levels can lead to intermittent claudication or in more advanced cases gangrene and amputation PROFUSAandapos 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 before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear


Patent
Profusa Inc. | Date: 2016-07-12

Oxygen sensing luminescent dyes, polymers and sensors comprising these sensors and methods of using these sensors and systems are provided.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 296.35K | Year: 2015

DESCRIPTION provided by applicant Continuous biochemical monitoring has the power to change currently accepted standards of care shifting the emphasis from treating illness to maintaining health Point in time snapshots of a patientandapos s health can miss critical fluctuations or early warning signs that might warrant early interventions or changes in disease treatment and management PROFUSAandapos s sensor platform has the promise to transform healthcare by providing real time data to physicians and patients without requiring blood samples cumbersome equipment or doctor visits The goal of this Fast Track STTR is to apply PROFUSAandapos s injectable microsensors for monitoring tissue health in peripheral artery disease PAD Continuous oxygen monitoring will be useful in the treatment and management of a variety of diseases such as asthma COPD sleep apnea compartment syndrome transplant surgery and PAD PAD is a manifestation of systemic atherosclerosis that affects million people in the U S with prevalence increasing with age PAD ranges from mild accompanied by intermittent claudication or pain with exercise to severe accompanied by critical limb ischemia and gangrene and is associated with high rates of amputation mortality and poor quality of life With the appropriate treatment and monitoring disease progression can be halted and even reversed PROFUSAandapos s long term tissue monitors can be used to continuously monitor tissue oxygen levels and temperature in PAD patients during their daily activities and thus provide timely indications of changes in disease state e g restenosis In recently completed landmark studies PROFUSAandapos s prototype oxygen sensors were shown to function months in healthy rats and months in large healthy mammals In this Fast Track STTR we propose to demonstrate sensor functionality in PAD animal models rats in Phase I and pigs in Phase II Changes in tissue oxygen in the animalsandapos healthy and ischemic legs will be monitored before during and after induction of PAD out to days a time period relevant to chronic wound healing thrombolytic drug therapy optimization and monitoring for restenosis to avoid re intervention and amputation Phase II will also involve miniaturization of PROFUSAandapos s custom optical reader system to improve the form factor for in vivo use In addition to the strong scientific and pre clinical team medical clinical regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development The proposed studies will provide valuable data for advancing PROFUSA towards clinical studies of PAD monitoring and significant investor funding to enable commercialization for widespread clinical application PUBLIC HEALTH RELEVANCE Peripheral artery disease PAD in which plaque buildup obstructs arteries leading to decreased tissue oxygen levels is estimated to affect to million people in the U S creating an economic burden of more than $ B annually Decreased tissue oxygen can lead to intermittent claudication or in more advanced cases gangrene and amputation PROFUSAandapos s continuous oxygen sensing technology can help to salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 787.16K | Year: 2016

Abstract The goal of this Phase II SBIR is to convert Profusa s bulky cabled optical reader into a wearable flexible disposable bandage like format that conforms to the foot for continuous monitoring of tissue oxygen levels during revascularization and restenosis in patients with peripheral artery disease PAD is a manifestation of systemic atherosclerosis that affects million people in the U S with prevalence increasing with age PAD ranges from mild accompanied by intermittent claudication or pain with exercise to severe accompanied by CLI and gangrene and is associated with high rates of amputation mortality and poor quality of life With the appropriate monitoring and treatment disease progression can be halted and even reversed but easy to use accurate monitoring products to indicate when a change in therapy is needed do not exist A tissue oxygen monitoring tool that is minimally invasive offers high sensitivity and stability and could give rapid tissue measurements would be ideal for point of care monitoring and remote continuous measurements PROFUSA 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 before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear The development of the flexible patch reader would allow for continuous wireless monitoring giving critical patient data to doctors patients or other caregivers in real time Furthermore this technology has the potential to be transformative not just for PAD but for the broad field of continuous in vivo diagnostics and mobile health monitoring In this Phase II SBIR grant we propose to first convert Profusa s current optical reader into a flexible wearable format i e optical patch reader through component redesign using novel flexible thin film conformal electronics We will then test the redesigned flexible patch reader in vitro Lastly the project will culminate in a clinical study to test safety wearability human factors and in vivo functionality Project Narrative Peripheral arterial disease PAD in which plaque buildup obstructs arteries causing decreased tissue oxygen levels is estimated to affect to million people in the U S creating an annual economic burden of more than $ B Decreased tissue oxygen levels can lead to intermittent claudication or in more advanced cases gangrene and amputation Development of a flexible patch reader as a companion device to Profusa s oxygen sensing technology would allow for continuous wireless monitoring which could help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear

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