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San Francisco, CA, United States

Patent
Profusa Inc. | Date: 2014-08-15

Tissue-integrating electronic apparatuses, systems comprising such apparatuses and methods of using these apparatuses and systems for the detection of one or more signals are provided.


Patent
Profusa Inc. | Date: 2014-03-13

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


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: | Program: SBIR | Phase: Phase I | Award Amount: 994.86K | Year: 2011

DESCRIPTION (provided by applicant): Currently available continuous glucose sensors are inaccurate and prone to failure, making the goal of an artificial pancreas elusive. Furthermore, their designs are not patient-friendly and they require frequent user input (e.g. calibration). The largest hurdle in developing implantable glucose sensors is the foreign body response (FBR). In this Phase I SBIR, we propose a syringe-injectable, tissue-integrating, glucose sensor to mitigate the foreign body response and enable accurate glucose monitoring for a minimum of 3 weeks in the body. PROFUSA's long- term goal is to develop a self-calibrating, implantable CGM with a minimum operational life of 3 months and a longer-term goal of 12 months that will be sufficiently accurate so as to enable an artificial pancreas. Tiny, soft and porous tissue-integrating biosensors that encourage capillaries to grow in and throughout the entire cross section of the sensor are being developed to allow reliable sensor function and thus overcome limitations of the FBR. Prototype sensors will be produced by integrating luminescent sensing nanospheres (glucose-responsive and reference nanospheres) into previously developed vascularizing hydrogel scaffolds (developed by PROFUSA and collaborators through currently active grants). The near infrared sensor signals are read through the skin with a miniaturized Continuous Optical INterrogation (COIN) patch reader that utilizes novel micro-optics to significantly decrease background noise. The goal ofthis Phase I SBIR is to demonstrate in vivo sensor functionality with the sensor and reader prototypes. Advancements towards a thin-film patch reader that will continuously and discretely monitor blood glucose will improve patient compliance. Clinical translation of this technology will motivate and enable diabetic patients to more tightly control their glucose levels without fear of hypoglycemia, and will reduce the diabetes disease burden on the healthcare system. PUBLIC HEALTH RELEVANCE: Diabetesis a devastating and costly chronic disease affecting nearly 25 million people in the US alone and amounting to 200B in annual healthcare expenditures. Upon successful proof-of- concept demonstration of our novel sensing approach in this SBIR Phase I, PROFUSA is poised to develop and commercialize a self-calibrating, implantable continuous glucose monitor (CGM) that will be embraced by patients and will enable an artificial pancreas. Adoption of the PROFUSA 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.

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