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Real Time Oxygen Monitoring for Tissue Health Peripheral Artery Disease Application

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42HL127933-02
Agency Tracking Number: R42HL127933
Amount: $1,726,829.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA14-072
Timeline
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2019-05-31
Small Business Information
345 ALLERTON AVE
South San Francisco, CA 94080-4816
United States
DUNS: 830219338
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 NATALIE WISNIEWSKI
 (415) 205-9176
 natalie_ann_wisniewski@yahoo.com
Business Contact
 BRUCE SMITH
Phone: (415) 699-8670
Email: bruce.smith@profusa.com
Research Institution
 DUKE UNIVERSITY
 
2200 W MAIN ST, SUITE 820
DURHAM, NC 27705-4673
United States

 Nonprofit college or university
Abstract

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

* Information listed above is at the time of submission. *

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