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Low cost retinal optical coherence tomography for point of care use

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44EY026480-02A1
Agency Tracking Number: R44EY026480
Amount: $499,978.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NEI
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-07-01
Award End Date (Contract End Date): 2021-06-30
Small Business Information
1312 DOLLAR AVE, Durham, NC, 27701-1120
DUNS: 079580878
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 WILLIAM BROWN
 (919) 886-1863
 william.brown@lumedicasystems.com
Business Contact
 ADAM WAX
Phone: (919) 306-5414
Email: adam.wax@lumedicasystems.com
Research Institution
N/A
Abstract
The objective of this research is to create a clinical prototype of a new optical coherence tomographyOCTsystem suitable for diagnostic retinal imaging at the point of careThe target system price will be one third the price of currently available research OCT systems while providing performance comparable to other entry level OCT imaging systemsBy breaking the $system barrier we will provide an incisive tool that will be disruptive to the market by making OCT accessible to clinics and health care professionals who previously could not afford this technologyWe have spoken with ophthalmologists and optometrists who confirm the need for a low cost portable system in the detection and monitoring of diabetic retinopathyglaucomaretinopathy of prematurityand macular degenerationIncreased access to OCT can have a profound effect in ophthalmologyBy significantly reducing instrument costthis OCT system will be affordable for retinal screening at the point of care and in a wide range of research applicationsThis price point also opens markets in developing countries where the value of clinical OCT is understoodbut currently clinical systems are too expensiveThe research planproposed herewill create a prototype of the low cost OCT instrument suitable for clinical ophthalmic useWe propose to achieve the following milestonesImprove design of low cost OCTWe will transition from off the shelf to custom parts to reduce system cost and improve performance over the Phase I prototype including increasing the A scan rate tolines per secondIntegrate OCT with handheld fundus cameraOur market research shows that this capability is important for clinical acceptabilityDevelop new software for instrument control and image analysisWe will transition our software from Windows to Linux based to increase performanceNew image analysis packages will be developed with aid of a collaboratorTest system on human subjectsClinical performance will be assessed in a small clinical feasibility trial with our collaboratorDrUlrich at the UNC Kittner eye center The objective of this research is to create a clinical prototype of a new low cost optical coherence tomographyOCTsystemThe proposed instrument will use a novel design to reduce the system price by at least a factor ofcompared to available OCT imaging systemsThis will provide access to clinics and labs that previously could not afford OCT systemsPoint of care use of OCT systems may quickly become standard with the availability of this system

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

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