Company
Portfolio Data
Back to Company Search149 MEDICAL INC
Address
17 BRIDEN STWORCESTER, MA, 01605-2662
USA
UEI: P3CACVT5FJG6
Number of Employees: 5
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2019
1
Phase I Awards
1
Phase II Awards
100%
Conversion Rate
$149,969
Phase I Dollars
$998,872
Phase II Dollars
$1,148,841
Total Awarded
Awards
Development and evaluation of diffuse correlation spectroscopy to monitor cerebral blood flow and detect intraventricular hemorrhage in extremely premature infants
Amount: $998,872 Topic: 103
PROJECT SUMMARY/ABSTRACT Every year in the United States about 30% of the 60,000 infants born extremely premature (andlt;30 weeks gestational age and andlt;1000 g birth-weight [ELGA]) develop intraventricular hemorrhage (IVH). IVH is associated with high risk for cerebral palsy and significant intellectual disability, causing lifelong implications for affected children and their families and considerable economic burden. IVH is caused by the rupture of the fragile capillaries in the germinal matrix which cannot withstand fluctuations in cerebral blood flow (CBF). In andgt;90% of cases, these injuries occur during the first three postnatal days during a period of cardiorespiratory instability that has a direct effect on CBF, which results in periods of cerebral hypo- and hyper-perfusion. Current management strategies, such as changes in ventilation or inotrope support, are blind to the impact on CBF. Improved bedside technologies to continuously monitor CBF are urgently needed to allow the clinician to make informed decisions, to optimize current strategies and foster the development of new interventions to reduce the incidence of IVH in ELGA infants and to improve developmental outcomes. Building on 149 Medical founding team’s ten years of success measuring infants with non-invasive bedside optical methods, we propose to design and build a novel fast multi-distance diffuse correlation spectroscopy (DCS) system, optimized for continuous monitoring of CBFi in ELGA infants. DCS directly quantifies an index of cerebral blood flow (CBFi) by measuring the temporal fluctuations of light generated by the dynamic scattering of moving red blood cells. To be of use in the ELGA infant, this bedside monitor needs to be safe, continuous, precise, reliable, quantitative and gently wearable. These pre-requisites will be met by designing an optical sensor which can be gently applied to the ELGA infant. The novel DCS system will be initially tested by the 149 Medical’s team in phantoms to verify performance and demonstrate precision and accuracy of flow estimates. The system will then be tested in more mature, stable premature infants at the Brigham and Womenandapos;s Hospital (BWH) NICU to evaluate feasibility of long measurements, compatibility with the NICU environment, skin integrity after long monitoring periods, and in-vivo algorithm validation. Finally, the device will be used in 50 ELGA infants during the first 72 hours of life to test our hypothesis that DCS-measured CBFi fluctuations and pressure-passive events correlate with incidence and severity of IVH. Our goal is to provide a much-needed cerebral blood flow monitor to guide individualized treatment with the goal of reducing the risk of IVH and improving long term neurodevelopmental outcomes among ELGA infants. This study in 50 ELGA infants will set the stage for a larger trial alongside commercialization.PROJECT NARRATIVE There is a great need for a bedside, non-invasive and continuous neuromonitoring tool to provide a robust measure of cerebral blood flow in premature infants. We propose to develop a novel near-infrared diffuse correlation spectroscopy (DCS) system optimized for monitoring of the cerebral blood flow index in extremely premature infants. The successful development, validation and demonstration of clinical feasibility and effectiveness of our proposed technology will lead to new patient management approaches for reducing neurological injury, protecting neurocognitive function, and reducing the overall morbidity and mortality associated with prematurity.
Tagged as:
STTR
Phase II
2021
HHS
NIH
Development and evaluation of diffuse correlation spectroscopy to monitor cerebral blood flow and detect intraventricular hemorrhage in extremely premature infants
Amount: $149,969 Topic: 103
PROJECT SUMMARY ABSTRACT Every year in the United States aboutof theinfants born extremely prematureandltweeks gestational age and andltg birth weightELGAdevelop intraventricular hemorrhageIVHIVH is associated with high risk for cerebral palsy and significant intellectual disabilitycausing lifelong implications for affected children and their families and considerable economic burdenIVH is caused by the rupture of the fragile capillaries in the germinal matrix which cannot withstand fluctuations in cerebral blood flowCBFIn andgtof casesthese injuries occur during the first three postnatal days during a period of cardiorespiratory instability that has a direct effect on CBFwhich results in periods of cerebral hypoand hyper perfusionCurrent management strategiessuch as changes in ventilation or inotrope supportare blind to the impact on CBFImproved bedside technologies to continuously monitor CBF are urgently needed to allow the clinician to make informed decisionsto optimize current strategies and foster the development of new interventions to reduce the incidence of IVH in ELGA infants and to improve developmental outcomesBuilding onMedical founding team s ten years of success measuring infants with non invasive bedside optical methodswe propose to design and build a novel fast multi distance diffuse correlation spectroscopyDCSsystemoptimized for continuous monitoring of CBFi in ELGA infantsDCS directly quantifies an index of cerebral blood flowCBFiby measuring the temporal fluctuations of light generated by the dynamic scattering of moving red blood cellsTo be of use in the ELGA infantthis bedside monitor needs to be safecontinuousprecisereliablequantitative and gently wearableThese pre requisites will be met by designing an optical sensor which can be gently applied to the ELGA infantThe novel DCS system will be initially tested by theMedical s team in phantoms to verify performance and demonstrate precision and accuracy of flow estimatesThe system will then be tested in more maturestable premature infants at the Brigham and Womenandapos s HospitalBWHNICU to evaluate feasibility of long measurementscompatibility with the NICU environmentskin integrity after long monitoring periodsand in vivo algorithm validationFinallythe device will be used inELGA infants during the firsthours of life to test our hypothesis that DCS measured CBFi fluctuations and pressure passive events correlate with incidence and severity of IVHOur goal is to provide a much needed cerebral blood flow monitor to guide individualized treatment with the goal of reducing the risk of IVH and improving long term neurodevelopmental outcomes among ELGA infantsThis study inELGA infants will set the stage for a larger trial alongside commercialization PROJECT NARRATIVE There is a great need for a bedsidenon invasive and continuous neuromonitoring tool to provide a robust measure of cerebral blood flow in premature infantsWe propose to develop a novel near infrared diffuse correlation spectroscopyDCSsystem optimized for monitoring of the cerebral blood flow index in extremely premature infantsThe successful developmentvalidation and demonstration of clinical feasibility and effectiveness of our proposed technology will lead to new patient management approaches for reducing neurological injuryprotecting neurocognitive functionand reducing the overall morbidity and mortality associated with prematurity
Tagged as:
STTR
Phase I
2019
HHS
NIH