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ExoSOUND:An Acoustofluidic Device for Exosome Isolation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44GM125439-01
Agency Tracking Number: R44GM125439
Amount: $1,868,869.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA18-591
Solicitation Year: 2017
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
State College, PA 16803-6602
United States
DUNS: 078612328
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (814) 387-8887
Business Contact
Phone: (814) 387-8887
Research Institution

Project Summary
Exosomes are extracellular vesiclesnmfound in nearly all biological fluidsincluding bloodurinesalivaand cerebrospinal fluidIn recent years they have emerged as a potentially powerful tool for biomedical
researchbiomarker discoverydisease diagnosticsand health monitoringExosomes perform diverse cellular
functions such as intercellular communicationantigen presentationand transfer of proteinsmRNAand
miRNAThe proteins found inside of exosomes are characteristic of their cell of origin and many exosomal
proteins are linked to diseases such as Alzheimerandapos scancerand diseases of the kidneyliverand placentaExosomes possess advantages over other circulating biomarkers in that they are highly abundantthousands
to billions per microliter of biofluidcan be collected noninvasively during early stages of disease developmentand are very durablepreserving their content through multiple freeze and thaw cyclesWhile many discoveries
have been made in identifying new exosomal protein biomarkersthe difficulties involved in the isolation of
exosomes have prevented their widespread use in biomedical research and clinical applicationsAs a resultthere exists a critical need in the research and clinical communities for a simplerapidbiocompatibleand
effective approach for isolating exosomes form biological fluids or in vitro cell cultureIn this SBIR projectwe
will address this unmet need by developing and commercializing acoustofluidici ethe fusion of acoustics
and microfluidicstechnologies for point of careautomated exosome isolationWe name our acoustofluidic
exosome solation technology ExoSOUNDIn our Phase I type Randamp D effortsAscent has successfully
demonstrated the utility and feasibility of the proposed devices by meeting or exceeding the target values of
each of the three key parameters identified in the Measures of SuccessIn Phase IIour commercialization
activities will improve performance of the disposable ExoSOUND chipsdevelop self containedbeta testingready prototypesand validate their performance with end usersThe proposed ExoSOUND technology will
have the following featuresAutomated exosome isolationwhich enables excellent biohazard containment
and short processing timee gandltmin to isolate exosomes directly fromL undiluted bloodwhich is
significantly less than that of the benchmark technologieshoursHigh exosome yieldandgtin
comparison to the benchmark technologiesBetter ability to isolate biologically active and
morphologically intact exosomes than the benchmark technologiesLow driving voltageandltVwhich
simplifies electronics and power requirementsandLow costCOGS for permanent equipmentandlt $in
comparison to the benchmark technologiesequipment cost$$With these featureswe
expect that once demonstratedthe proposed ExoSOUND technology will not only become a more compactaffordableconvenient to use replacement to the existing exosome isolation approachesbut also fulfill many
unmet needs in fundamental biomedical research and clinical applications Project Narrative
Cell derived vesicles such as exosomes are present in almost all biological fluidsThey have
been recognized to be valuable for both biomedical research and clinical applicationsThe
proposed project is to develop point of care devices that can perform automatedhigh yieldhigh purityhigh biocompatibility exosome isolationThese devices will help expedite exosomerelated biomedical research and aid in the discovery of new exosomal biomarkers

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

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