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Neuro-Optical Diagnostic System for Macular Degeneration

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AG057250-02A1
Agency Tracking Number: R44AG057250
Amount: $961,818.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-08-15
Award End Date (Contract End Date): 2022-04-30
Small Business Information
41 ESTY FARM RD
Newton, MA 02459-3605
United States
DUNS: 078739650
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 CRAIG VERSEK
 (413) 336-3464
 cversek@gmail.com
Business Contact
 SRINIVAS SRIDHAR
Phone: (617) 755-3838
Email: neurofieldz@outlook.com
Research Institution
N/A
Abstract

Age-related macular degeneration (AMD) causes progressive loss of central vision and is the leading
cause of blindness in the developed world. People with AMD manifest delayed dark adaptation (DA) recovery.
DA tests are a FDA approved method for diagnosing AMD in which a flash illumination bleaches rod and cone
photoreceptors and the subsequent recovery is a measure of the stress response of retinal metabolism. There
is an unmet need for a rapid, practical, sensitive and objective test that will provide quantitative endpoints for
early diagnosis and monitoring response to newly developed treatments. Visual evoked potentials (VEP)
generated in response to visual stimuli, provide a quantitative objective measure of the neuro-optical pathways
and visual processes that do not require sustained attention from the patient. NeuroFieldz has developed a new
system called NeuroDotVR that combines a high-resolution sensor for scalp electric potentials and fields with a
smartphone powered headmount display and measures VEP objectively during DA recovery.In the Phase I STTR project 1R41AG057250-01, we developed custom stimuli for macular DA and
validated the VEP measurements in normal controls and patients with confirmed diagnosis of AMD, ranging in
age from 18 to 88. DA was measured simultaneously in 4 retinal locations (2 per eye) in an easy-to-
administer test lasting around 15 minutes in total. The results of the Phase I proposal establish that
DAVEP can be successfully implemented in a busy clinic on naïve patients with various levels of visual
impairment and the test is well tolerated. All Phase I performance milestones were met. In this Phase II
SBIR proposal we will further develop and validate the DA-VEPF system toward eventual 510(k) FDA approval.
The project aims are: Specific Aim 1: Develop additional tests of DA-VEPF Multi-focal stimuli will be further
developed and the DA-VEPF results will be correlated with other visual biomarkers. Aim 1.1 Study Compliance
Monitoring. Aim 1.2 Cross threshold stimulus intensity sweeps with adaptive challenge branch. Specific Aim 2:
Validate in human studies The DAVEP system will be validated in a larger cohort of 100 subjects to establish
definite diagnostic criteria for early and late stage AMD. Aim 2.1 Compliant Multi-Focal Adaptive DAVEP as a
function of AMD stage. Aim 2.2 Test-Retest Reliability of DAVEP as a function of AMD stage. Aim 2.3
Comparison of DAVEP and Behavioral estimates of Dark Adaptation Recovery. Aim 2.4– Advanced Signal
Processing and Analytical Algorithm Development. Specific Aim 3: Enabling studies for 510(K) application
In preparation for an FDA 510(k) clearance to market application, we will research: 1) Market Strategy: Customer
Discovery; Reimbursement Overview; Partner Identification. 2) Regulatory Assessment for 510(k) application.
3) Scale-up manufacturing strategy.PROJECT NARRATIVE
TITLE: Neuro-Optical Diagnostic System for Macular Degeneration
This project seeks to develop a new portable wireless system called NeuroDotVR that combines a sensor for
measurement of scalp electric potentials and fields during recovery from dark adaptation using visual stimuli
presented by a virtual reality headset powered by a smartphone, and to test them in patients with Age-related
Macular Degeneration (AMD). NeuroDotVR will address an unmet need for a practical, sensitive test that will
provide quantitative endpoints for early diagnosis and monitoring response to newly developed treatments for
AMD.

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

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