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Intrasurgical Optical Coherence Tomography

Award Number: R44EY024846
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2014
PERIOD OF PERFORMANCE END DATE: 02/28/2017

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Intrasurgical Optical Coherence Tomography - DESCRIPTION (provided by applicant): Each year, over 20 million ophthalmic surgeries are performed worldwide. Indications for ophthalmic surgery include potentially blinding diseases, such as cataracts, diabetic retinopathy, macular disease, and retinal detachment. Surgeons performing these delicate procedures are challenged by the translucent nature of tissues in the eye, making it nearly impossible to visualize microstructural changes during surgery. Optical coherence tomography (OCT) is a non-contact, optical imaging modality that provides high-resolution cross-sectional images of the various layers of the anterior and posterior eye. OCT is also commonly used to aid in ophthalmic surgical planning and post-operative assessment, and more recently, has been used perioperatively. Intraoperative OCT offers the surgeon the ability to see the microstructure of the eye in a way not possible with conventional surgical microscopes. By improving tissue visualization and providing surgical feedback, intraoperative OCT will enhance surgical precision, decrease surgical trauma, aid in surgical decision-making and ultimately improve functional and anatomical outcomes. Bioptigen is at the forefront of intrasurgical OCT imaging technology, with the only OCT system on the market with an FDA approved indication for intrasurgical imaging. Currently, intrasurgical imaging is performed using a hand-held probe, or by mounting such a probe to the surgical microscope. In this proposal, we describe the development of an intraoperative OCT system integrated directly into the optical train of the surgical microscope. In Phase I, we will complete development of the SMI and integrate it with our OCT engine technology. We will also verify the optical performance of the SMI. In Phase II, Bioptigen will focus on the development of surgery-specific software. Initial testing and evaluation of the intraoperative OCT system will also be performed in Phase II, in collaboration with the Cole Eye Institute at the Cleveland Clinic. This initial testing will includ laboratory feasibility testing, quality assessment, and ergonomic evaluation. Following initial testing, our collaborators will perform simulated surgical procedures with intraoperative OCT. Feedback from these initial tests and simulated surgeries will be used to iterate on system design in preparation for human clinical studies. Ultimately, the commercialization of intraoperative OCT technology will bring state-of-the-art OCT imaging technology to the surgical bedside, improving the quality of care for millions of patients each year.


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: 2017 ( Subtotal = $0 )
2017	2016	BIOPTIGEN, INC.	633 DAVIS DRIVE SUITE 480	MORRISVILLE	NC	27560	WAKE	USA	Vision Research	000	3	4/27/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $543,040 )
2016	2016	BIOPTIGEN INC	104 TW ALEXANDER DRIVE	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Vision Research	000	3	9/1/2016	NON-COMPETING CONTINUATION	$543,040
														Subtotal = $543,040

Issue Date FY: 2015 ( Subtotal = $955,139 )
2015	2015	BIOPTIGEN INC	104 TW ALEXANDER DRIVE	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Vision Research	000	2	2/27/2015	EXTENSION WITH OR WITHOUT FUNDS	$955,139
2015	2014	BIOPTIGEN INC	104 TW ALEXANDER DRIVE	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Vision Research	001	1	2/27/2015	NEW	$0
														Subtotal = $955,139

Issue Date FY: 2014 ( Subtotal = $225,000 )
2014	2014	BIOPTIGEN INC	104 TW ALEXANDER DRIVE	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Vision Research	000	1	9/11/2014	NEW	$225,000
														Subtotal = $225,000

Grand Total All Awards = $1,723,179

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Intrasurgical Optical Coherence Tomography

Award Number: R44EY024846

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2014

PERIOD OF PERFORMANCE END DATE: 02/28/2017

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