NIA Small Business Showcase: NeuroFieldz Inc.

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The effectiveness of current vision and brain health diagnostic technologies is hampered by a lack of portability, low signal quality, long setup and measurement time, and subjective rather than objective evaluation. Current vision and brain health diagnostic tools are cart-based systems that require patients’ active participation over a 20-minute period. This can lead to misdiagnosis of age-related macular degeneration (AMD) and other age-related eye diseases. Studies forecast that more than 19 million people in the United States have intermediate or advanced AMD.

To help remedy this situation, NeuroFieldz Inc. has developed NeuroVEP, a prototype wireless sensor system that uses visual evoked potentials (VEP) by measuring brain activity — in response to visual stimuli — with a proven highly powerful neuromonitoring technique called Electric Field Encephalography (EFEG). NeuroVEP combines this with a virtual reality headset that carries an onboard smartphone, which enables custom visual stimulus patterns and state-of-the-art, artificial intelligence (AI)-powered data analysis to power a portable testing system for vision and brain disorders.

There are currently no commercially available portable VEP systems. NeuroVEP stands to provide optometrists and ophthalmologists — who are authorized to recommend and administer VEP tests — with a product that can integrate visual stimulus, neuromonitoring, and the ability to present separate stimuli to each eye in a portable automated system. Because of its portability and versatility, NeuroVEP can provide new revenue streams by reducing setup and testing times, enabling new diagnostic tests, and expanding current clinic-based practice. NeuroFieldz estimates the service obtainable market for NeuroVEP at $2.4 billion.

Beyond neuro-optical diagnostics, the NeuroVEP is expected to generate new revenues when configured for applications in field-based concussion tests, with diagnosing attention disorders, for visual testing for military personnel, and in neuromarketing.

Company Milestones

Scientific and Clinical

Business

  • 2016: National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I grant to develop the NeuroDot sensor
  • 2017: NIH SBIR Phase I grant on macular degeneration
  • 2018: NIH SBIR Phase I grant on amblyopia
  • 2020: NIH SBIR Phase II grant on macular degeneration

Financial Overview

To date, NeuroFieldz has received NSF SBIR grants that total $150,000 and NIH SBIR grants that total $2.6 million. The company is also seeking $8 million to complete manufacturing, gain U.S. Food and Drug Administration 510(K) approval, and complete an initial product launch. NeuroFieldz anticipates seeking an additional $5 million in the one to five years after product launch to sustain growth.

Intellectual Property (IP)

NeuroFieldz’s IP is protected by two approved patents (#11,083,401, #10,912,480) and one pending patent (#11,701,046) that are available for licensing from Northeastern University to NeuroFieldz.

Product Development and Regulatory Strategy

NeuroFieldz’s product development strategy for hardware design is to refine the Alpha protype and design the Beta prototype to manufacture. For software, NeuroFieldz will establish a testing infrastructure and acceptance test plan, then test and validate, then move on to usability testing. NeuroFieldz will also establish strategic partnerships for NeuroVEP, submit applications for federal grants, and maintain ongoing IP management. NeuroFieldz will seek regulatory approval for NeuroVEP under the 510(k) label as a Device: Evoked Response Photic Stimulator.

Commercialization Strategy

NeuroFieldz will use three sales options for commercialization of NeuroVEP: (1) outright purchase at $40,000, plus annual software maintenance fees of $5,000; (2) financed lease of the unit; (3) pay-per-use royalty at a fixed fee. Additional revenues, from supporting clinical trials and sales to military users, are expected.

Company Details

NeuroFieldz Inc.
Newton, Massachusetts

Industry: Remote patient monitoring for movement disorders

Management Team:

  • Srinivas Sridhar, Ph.D., Founder and Chief Executive Officer
  • Craig Versek, Ph.D., Chief Research Officer
  • Ali Banijamali, Ph.D., Principal Data Engineer

Point of Contact:
Srinivas Sridhar
sridhar@neurofieldz.com
617-755-3838