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Clinical evaluation and development of a diagnostic multi-modal intravascular imaging system

Award Number: R44HL129496
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2020

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Clinical evaluation and development of a diagnostic multi-modal intravascular imaging system - ¿ DESCRIPTION (provided by applicant): Understanding that not a single imaging technique can alone address needs of all vascular diagnosis, OCT medical imaging Inc. (OCTMI) propose to develop a clinical multimodal intravascular imaging system encompassing ultra-high resolution optical coherence tomography(OCT) and IVUS. This Combined multimodal vascular imaging system will permit cross-sectional visualization of vascular artery with unprecedented resolution and depth not possible with any of these technologies alone. This multi-modal imaging strategy in a single system permits use of a single disposable guide wire, thereby reducing cost to hospital, patients and improving prognosis by early detection. We believe these technologies together will provide 1) critical 3D and cross-sectional details & functional information necessary for identifying vulnerable plaques 2) inside-out view of vessel necessary for stent sizing 3) extent of mal-apposition of stent struts in artery 4) extent of post-stent thrombosis. In a multi-institutional effort, we plan to create this multi-modal probe and necessary hardware in Phase I, followed by extensive clinical trials in phase II before seeking FDA approval and marketing in Phase III


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = -$1 )
2021	2018	OCT MEDICAL IMAGING, INC.	1002 HEALTH SCIENCES RD	IRVINE	CA	92617	ORANGE	USA	Cardiovascular Diseases Research	000	3	1/26/2021	NON-COMPETING CONTINUATION	-$1
														Subtotal = -$1

Issue Date FY: 2018 ( Subtotal = $1,243,556 )
2018	2018	OCT MEDICAL IMAGING, INC.	1002 HEALTH SCIENCES RD	IRVINE	CA	92617	ORANGE	USA	Cardiovascular Diseases Research	001	3	7/25/2018	NON-COMPETING CONTINUATION	$1,243,556
2018	2015	OCT MEDICAL IMAGING, INC.	1002 HEALTH SCIENCES RD	IRVINE	CA	92617	ORANGE	USA	Cardiovascular Diseases Research	000	1	7/19/2018	NEW	$0
														Subtotal = $1,243,556

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	OCT MEDICAL IMAGING, INC.	1002 HEALTH SCIENCES RD BECKMAN LASER INSTITUTE	IRVINE	CA	92617	ORANGE	USA	Cardiovascular Diseases Research	000	2	7/21/2017	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $1,252,899 )
2016	2016	OCT MEDICAL IMAGING INC	1002 HEALTH SCIENCES ROAD	IRVINE	CA	92612	ORANGE	USA	Cardiovascular Diseases Research	000	2	7/15/2016	EXTENSION WITH OR WITHOUT FUNDS	$1,252,899
														Subtotal = $1,252,899

Issue Date FY: 2015 ( Subtotal = $350,430 )
2015	2015	OCT MEDICAL IMAGING INC	1002 HEALTH SCIENCES ROAD	IRVINE	CA	92612	ORANGE	USA	Cardiovascular Diseases Research	000	1	8/17/2015	NEW	$350,430
														Subtotal = $350,430

Grand Total All Awards = $2,846,884

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Clinical evaluation and development of a diagnostic multi-modal intravascular imaging system

Award Number: R44HL129496

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2020

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