MCLEAN, Va. (PRWEB)
November 11, 2021

Traumatic Brain Injury (TBI) is a silent epidemic. 69 million people worldwide are estimated to sustain a TBI each year, from a range of causes including traffic accidents, athletic participation, falling injuries, violence, and combat. This epidemic is called “silent” because the injuries and symptoms often go unrecognized and untreated. The problems worsen with repeat injuries, especially if the brain is not given adequate recovery time after an incident. This makes early, accurate detection and ready availability of an individual’s previous results critical for both recovery and prevention of chronic symptoms.

But early, accurate detection based on signs and symptoms is challenging: symptoms vary greatly, are not unique to TBI as a cause, and often don’t manifest until days or weeks later. CT scan, X‑ray, and MRI, are large, expensive devices only available in a hospital or clinical setting, and only minimally effective at detecting milder injuries not involving structural damage.

The common field solutions are a Q&A assessment and the “swinging light test”, both of which rely on the experience of the administering professional and vary widely in their accuracy.

In the swinging light test, a light source is rapidly switched back and forth between the two eyes to determine any difference in the pupil response between the two eyes, known as Relative Afferent Pupillary Defect (RAPD). It takes years for a person to get proficient and confident in the method, and even then, it’s a very rough tool—a simple five-point grading system. Studies show that even trained professionals are unable to detect changes below a certain threshold, and the five-point scale isn’t accurate enough to track subtle changes in an individual over time. The test attempts to make distinctions on the order of 0.15 millimeters and 30 milliseconds—or in familiar terms, the thickness of a piece of heavy copy paper in 1/5 the blink of an eye. Understandably, it’s impossible for humans to consistently perform the test with precision and accuracy.

EyeMarker Systems has developed a Phase 1 solution to this problem in the case of mild traumatic brain injury (or “mTBI”, also called “concussion”): the Brain Rapid Assessment Device (BRAD), an accurate, lightweight, portable device that automates the swinging light test, and the Brain Injury Tracker (BIT), which stores individual incident history in the cloud. The device is simple to operate and requires little training. It can be administered field-side within moments following an athletic injury, or on-scene by emergency personnel immediately upon determination of a possible head injury.

The BIT cloud storage system provides critical support to the BRAD testing. By testing athletes at the start of each season, their results can be compared to their individual baseline, rather than general population averages, detecting subtle changes that might otherwise go unnoticed. With individual tests being no additional cost, they can easily be reassessed before returning to play, helping coaches and parents protect the lifetime health of their athletes.

The device was originally developed at the West Virginia University Eye Institute, and a BRAD prototype is undergoing field trials with the West Virginia University football team. The technology was originally developed for the detection of exposure to highly toxic neurotoxins, as demonstrated with contracts from the Defense Advanced Research and Projects Agency (DARPA) and the Defense Threat Reduction Agency (DTRA).

EyeMarker Systems is poised to bring this technology to market, and today announced the details of its fundraising plan, beginning with a Rule 506(c) offering in which it is seeking to raise $4 million to be used primarily to prepare the BRAD and the BIT for regulatory submission and further develop its business model and scale up. To complete the regulatory clearance or approval process and commercialize the BRAD-BIT™ solution, EyeMarker Systems plans to conduct a subsequent Regulation A, Tier 2 (“Regulation A+”) offering seeking up to $30 million.

“This technology has been years in development and testing, and we’re eager to bring it to market,” said EyeMarker Systems CEO, Wes McGee. “It saves lives and saves minds.”

“I’m particularly excited about the application in youth sports,” McGee continues. “There are over 20 million kids participating in high-risk youth sports and the play is getting faster, more complex, and more dangerous. But public awareness campaigns, rule changes, and equipment improvements haven’t stemmed the tide on concussions. We hope to help by providing a solution to aid in faster, more accurate assessment and lifetime tracking of concussions to empower parents and coaches to make informed decisions about their young athletes’ future health.”

The company has engaged Medical Funding Professionals (MFP), a registered investment advisor firm, to guide them through the process, following their Capital Planning Valuation Strategy™ (CPVS). MFP CEO Stephen Brock explains:

“This stepping stone approach offers multiple advantages for the company and investors,” says Brock. “The current Reg D 506(c) offering will provide EyeMarker Systems capital to begin the regulatory process and further develop its business model and processes such as brand awareness and financial reporting. After achieving certain milestones, the intended subsequent Regulation A+ offering would fund the completion of the regulatory process and their go-to-market strategy, with the added advantage of significant exposure to potential customers and strategic partners, as well as a broader base of potential investors.”

“A potential future Regulation A+ offering also provides an incentive for early-stage investors in a Reg D 506(c) offering who may be looking to monetize a portion of their investment as the company grows and achieves certain milestones,” Brock explains. “Regulation A+ allows shareholders to sell a limited amount of their shares subject to state Blue Sky laws and other requirements. All of that while EyeMarker System’s principals retain control of their company when following our CPVS.”

The Rule 506(c) offering consists of up to 1,000,000 shares priced at $4.00 per share, for a total of up to $4 million. Purchasers must be accredited investors and meet certain SEC verification requirements for validation of their “accredited investor” status. For additional details of the offering, visit https://EyeMarkerSystems.com/investors.

ABOUT EYEMARKER SYTEMS, INC.

Incorporated in Delaware and based in McLean, Virginia, EyeMarker Systems is an emerging, start-up med-tech company focused on the research, development and commercialization of solutions to aid in the assessment and lifetime tracking of mild traumatic brain injury (or “mTBI”, also called “concussion”). These devices are urgently needed in a range of markets, including youth sports, emergency vehicles, hospital emergency rooms and elder care. EyeMarker Systems’ products have not received regulatory clearance or approval, and until such time, they are for investigational use only and not available for commercial sale in the U.S.

Contact: Wes McGee, Wes.McGee@EyeMarkerSystems.com

Website: https://EyeMarkerSystems.com

ABOUT MEDICAL FUNDING PROFESSIONALS

Medical Funding Professionals is a registered investment advisor firm providing capital planning solutions to the medical industry, including life sciences, biotech, medtech, and pharmaceutical sectors. Their Capital Planning Valuation Strategy™ (CPVS) helps founders and key executives maintain control of their companies as they raise capital and grow.

Contact: Stephen Brock, Stephen.Brock@MedicalFundingPro.com

Website: https://MedicalFundingPro.com

FORWARD-LOOKING STATEMENTS

Certain statements in this press release constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995 and “forward-looking information” as such ‎term is ‎defined in applicable US and Canadian securities legislation. The words “may,” “would,” “could,” ‎‎“should,” “potential,” ‎‎“will,” “seek,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “expect” and ‎similar expressions as they relate ‎to the Company. Such statements reflect the ‎Company’s current views and intentions with respect to future ‎events, and current information ‎available to the Company, and are subject to certain risks, uncertainties and ‎assumptions, including, ‎without limitation: the conditions to closing of the transaction being satisfied, including obtaining all necessary approvals for the transaction. Should any factor affect the Company in an unexpected manner, ‎or should assumptions underlying the forward-‎looking information or statements prove incorrect, the actual ‎results or events may differ materially from the results or events ‎predicted. Any such forward-‎looking information or statement is expressly qualified in its entirety by this cautionary statement. ‎Moreover, the ‎Company does not assume responsibility for the accuracy or completeness of such forward-looking ‎‎information or statement. The forward-looking information and/or statements included in this press release are made as of the date of ‎this press ‎release and EyeMarker Systems undertakes no obligation to publicly update or revise any ‎forward-looking information, ‎other than as required by applicable law.

REGULATION A DISCLAIMER

The information contained in this press release neither constitutes an offer for nor a solicitation of interest in an offering pursuant to Regulation A. This press release may be deemed to be a so-called “testing the waters” communication under Regulation A under the Securities Act of 1933, in which case the following apply:

• 
  No money or other consideration is being solicited, and if sent in response, will not be accepted;
• No offer to buy the securities can be accepted and no part of the purchase price can be received until the offering statement is qualified, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time before notice of its acceptance given after the qualification date;
• Your indication of interest involves no obligation or commitment of any kind; and
• Eye Marker Systems, Inc. has not yet filed an offering statement, which would include a preliminary offering circular, with the SEC.