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A new generation, enhanced, corneal-birefringence-independent retinalscanning device for pediatric vision disorders using polarization modulation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EY030382-01A1
Agency Tracking Number: R41EY030382
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N
Solicitation Number: PA18-575
Timeline
Solicitation Year: 2018
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-01
Award End Date (Contract End Date): 2021-08-31
Small Business Information
30 MOUNT AUBURN ST STE B
Cambridge, MA 02138-6042
United States
DUNS: 831265967
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 BORIS GRAMATIKOV
 (813) 841-6784
 bgramat@bme.jhu.edu
Business Contact
 RACHAEL ALDRICH
Phone: (857) 600-1398
Email: raldrich@rebion.net
Research Institution
 JOHNS HOPKINS UNIVERSITY
 
3400 N. CHARLES STREET
BALTIMORE, MD 21218-2680
United States

 Nonprofit College or University
Abstract

Project Summary/Abstract
!Amblyopia is vision loss caused by neglect of a structurally normal eye due to
strabismus, asymmetric refraction (anisometropia), or deprivation. It is irreversible if not treated
by age 7, but half of all patients in the U.S. are undetected and untreated until after it is too late,
making it the leading cause of preventable vision loss. Rebion (Rebiscan, Inc) has developed
retinal birefringence scanning (RBS) into a commercial product, the RBS-based “blinq” device,
which detects amblyopia and strabismus with 94% accuracy, compared with 69% accuracy of
non-RBS methods.Although blinq effectively screens for strabismus and amblyopia by direct detection of
these conditions with very high sensitivity (97%), published “specificity” of the device is closer to
87%. Given the 5% prevalence of amblyopia and strabismus, this means that 2 normal patients
could potentially be referred for every treatable case. It is therefore essential that “specificity” of
blinq be improved if the device is to be adopted widely. One likely cause of false referrals is
corneal birefringence, which can interfere with an RBS test. Unlike retinal birefrigence, corneal
birefringence can vary greatly between patients and cause inaccurate RBS results. If corneal
birefringence could be neutralized as a factor in RBS, the specificity of the blinq device could
likely be improved to equal or exceed the deviceandapos;s 97% sensitivity.Leading researchers at Johns Hopkins University (JHU) have developed a novel,
patented approach that incorporates corneal birefringence compensation in an RBS system.
This approach can be readily optimized within blinqandapos;s current mechanical and electrical design.
In this Phase I study, we believe that by collaborating with the JHU research team, we will be
able to develop a new device that produces significant advantages over existing technologies,
including the commercially available blinq device.Applying JHUandapos;s research advancements to the FDA-cleared blinq device will allow rapid
commercial adoption of a breakthrough technology for detection of amblyopia. The improved
end result is that vision screening in the real world will immediately improve and save thousands
of children from unnecessary vision loss. Successful execution of this project will help improve
the quality of care and outcomes for thousands of children annually, while simultaneously
reducing the costs of care for all.Project Narrative
Rebion (REBIScan, Inc) has an FDA-cleared device – along with its own unique CPT
insurance billing code – that detects amblyopia and strabismus, the leading causes of
preventable vision loss in children in the United States. Researchers at Johns Hopkins
have developed a breakthrough approach for enhancing accuracy of amblyopia
detection that can be readily implemented in to the Rebion device. This collaboration will
accelerate the commercial adoption of medical and academic research that can help
save vision in tens of thousands of children nationwide.

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

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