SBIR and STTR Success Story for
Synabridge Corporation

(Information Posted/Updated on 02/24/2011)

Synabridge Corporation
106 Anderson Street
Raritan, NJ  08869-1514

Contact:    George Hu
Phone:      908-725-5213
Fax:          908-725-4617
E-mail:      georgehu@synabridge.com
Web Site:  www.verisci.com

Project Title:  Instrument for Glaucoma Early Detection and Monitoring
Related Award(s):  5R44EY015015
Technology Developed:
Using visual evoked potential technique as a base, we developed a device and a testing procedure for rapid and objective assessment on visual function in the magnocellular pathway, which is affected in early-stage glaucoma and other possible diseases such as macular degeneration and diabetic retinopathy. The instrument Neucodia, with its objective, non-invasive, and user-friendly features, can be used by vision professionals for early detection of visual deficits associated with glaucoma, and for monitoring of visual function quantitatively over time.

Key Words:  VEP, Glaucoma , neural, clinical, diagnosis, screening, electrophysiology, icVEP.
Uses of Technology/Products/Service:
Neucodia is an electronic medical instrument that uses patented isolated-check VEP (icVEP) technology to detect and quantify neural deficits that result from the neuro-ophthalmic disorder – glaucoma. It is a compact, user-friendly, and noninvasive device. During the test, a stimulus with an isolated-check pattern, proprietarily designed to be sensitive to the neural pathway affected in patients with glaucoma, is presented to the patient on a CRT monitor. The VEP signals corresponding to this type of stimulus, recorded via three electrodes attached to the cortex of the patient, have been shown to be significantly different between patients with glaucoma and normal controls. After the signal is recorded, the program utilizes a novel algorithm extracts relevant frequency components and performs a statistical analysis. According to the criterion value established, a result that indicates “Pass” or “Fail” is automatically displayed on the operator’s monitor.

. Users: Ophthalmologists, optometrists, vision researchers, neurologists, and trained technicians. · Patients: Individuals at-risk for visual pathway dysfunction or with confirmed ophthalmic disorders. · Environments: Clinical offices, hospitals, and research laboratories

Benefit to Company:
The SBIR program Phase I and Phase II provided seed and early stage funds for the business growth. With the funds, we developed the prototype and the product of the instrument for quick assessment on visual function deficits including glaucoma, and we were able to collaborate with major hospitals and universities to complete the phase I and Phase II clinical trials. Both trials gave 90% and above accuracy level for detection of early stage glaucoma. We have patented the icVEP technology for the device in US and other seven countries and regions. The device received 510K clearance from FDA in May, 2009.

We successfully demonstrated the device and its application in the recent ARVO trading show at Fort Lauderdale, Florida and received attentions from the visual research and clinic communities. We have some sales and obtained potential buyers in the show.

With the technology and device developed, we expect a rapid growth of the company and to catch a significant share of the glaucoma diagnosis market that is over $500M annually in US alone.

How Product Was Commercialized:
The icVEP technology was originally developed and used in the research laboratories of Rockefeller University and New York University. It showed an efficiency to separate the group with normal vision and the group with early stage glaucoma at certain stimulus conditions - frequency, luminance, contrast, etc.

However, the problem for laboratory device is that the VEP signal is very weak and it’s embedded in the larger noise of brain activities. It’s hard to extract the useful VEP signal in a short test period that is usually required at the clinical sites. So we’ve designed a special stimulus and algorithms that strengthen the signal and reduce the background noise. An artifact rejection software was also developed to get a reliable response. The whole test now takes about 30 seconds per eye, plus the time it takes to put three electrodes on the patient’s head, which is usually less than five minutes.

Other Comments Related to Company's Success Story:
The technology and application developed also attracted media attention: The Channel 8 News in Connecticut interviewed one of our clinical testing sites Yale University Eye Center for early glaucoma detection using innovative icVEP technology. The news was broadcasted with title “Clinical trial sheds light on glaucoma”.

The president and the principal investigate of the company was also interviewed by a professional magazine “Review of Ophthalmology”. The report was published in the 2010 May issue with tile “Making Visual Evoked Potential Clinic-Friendly”.

Past R&D and/or Sales from this Project:   $0.6M
Estimated Future Annual R&D and/or Sales from this Project:   $2M