UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): March 16, 2021

 

BRAIN SCIENTIFIC INC.

(Exact Name of Registrant as Specified in Charter)

 

Nevada   333-209325   81-0876714

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

125 Wilbur Place, Suite 170

Bohemia, NY 11716

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (917) 388-1578 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Not applicable Not applicable Not applicable

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 

 

Emerging Growth Company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

 

  Item 7.01 Regulation FD Disclosure.

 

On March 16, 2021, Brain Scientific Inc. (the “Company”) issued a press release announcing a collaboration with JelikaLite, a company developing CognilumTM, a non-invasive wearable photobiomodulation device that is being developed to increase the well-being of children living with autism, through a clinical trial titled “Transcranial Photobiomodulation for Reducing Autism Symptoms in Children.” In the clinical trial, brain treatments for children diagnosed with autism would be delivered through CognilumTM, while the Company’s NeuroEEG, a wireless EEG device, will monitor brain activity. The clinical trial is designed to give researchers and clinicians an opportunity to potentially uncover new treatment options for reducing the symptoms children with autism experience.

 

The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K is incorporated herein by reference. The information in this Item 7.01 and in Exhibit 99.1 of Item 9.01 is being furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be deemed an admission as to the materiality of any information in this Item 7.01 or Exhibit 99.1 of Item 9.01.

 

  Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No. Description
 99.1 Press Release

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: March 16, 2021

  BRAIN SCIENTIFIC INC.
   
  By: /s/ Boris Goldstein
  Name: Boris Goldstein
  Title: Chairman of the Board, Secretary and Executive Vice President
     

 

 

 

Exhibit 99.1 

 

Brain Scientific Announces Collaboration with JelikaLite in New Clinical Trial

 

The two neurology device companies will join forces in a clinical trial seeking to reduce the symptoms of autism in children

 

NEW YORK, March 16, 2021 -- Brain Scientific Inc. (OTCQB: BRSF), a neurology-focused medical device and software company, announces a collaboration with JelikaLite, a company developing CognilumTM, a non-invasive wearable photobiomodulation device that is being developed to increase the well-being of children living with autism, through a clinical trial titled “Transcranial Photobiomodulation for Reducing Autism Symptoms in Children.”

 

In the clinical trial, brain treatments for children diagnosed with autism would be delivered through CognilumTM, while Brain Scientific’s NeuroEEG, a wireless EEG device, will monitor brain activity. The clinical trial is designed to give researchers and clinicians an opportunity to potentially uncover new treatment options for reducing the symptoms children with autism experience.

 

Based in New York, JelikaLite was launched by a group of medical researchers and practitioners specializing in psychology, neurology and phototherapy. JelikaLite’s Cognilum™ device is being developed to deliver treatment through transcranial photobiomodulation; the science uses infrared light, delivered through LEDs, to reduce brain inflammation and increase brain connectivity while the embedded sensors collect additional physical data from the patient. JelikaLite’s software platform would then provide an assessment of the child and capture ongoing data from the wearable device. Through the use of the platform’s learning modules and input of qualitative information, along with data analysis, JelikaLite believes the platform will provide progress reports and personalized recommendations for each child’s individual treatment, including efforts to decrease symptoms such as tantrum reduction, to increase eye contact and to improve speech.

 

“JelikaLite is developing a system called Cognilum that combines a home-based therapeutic wearable device, which applies near-infrared light therapy and records physical measurements with an intelligent AI platform. It provides personalization through data collection, analysis and reporting to improve a child's autism symptoms through gains in communication and daily living skills,” said Katya Sverdlov, CEO of JelikaLite.

 

Brain Scientific’s next-generation neurology products continue to serve researchers, clinicians and others working in brain diagnostics and treatment. The NeuroEEG device to be used in the clinical trial is a portable, wireless and compact device intended to acquire, record, transmit and display electrical brain activity for patients. NeuroEEG works in conjunction with NeuroCap, a hospital-grade disposable EEG headset featuring 19 active channels and 22 electrodes. The device can perform rapid EEG testing not only at medical centers but also in private homes, which supports the joint efforts in the work towards continuous monitoring of children with autism.

 

 

 

“We are delighted to begin this collaboration with JelikaLite. Our Neuro EEG solutions have a wide range of applications, and helping to monitor children with autism to improve their well-being would be an important step towards a wider adoption of affordable and accessible EEG systems like ours,” said Irina Nazarova, Director of Marketing at Brain Scientific, Inc.

 

The “Transcranial Photobiomodulation for Reducing Autism Symptoms in Children”
clinical trial is set to begin in March 2021 and will feature 30 participants in two locations in New York City. Beyond the clinical trial, the two companies are planning to join efforts in building a wearable device for home use, featuring Brain Scientific’s technology from its disposable NeuroCap, to monitor brain activity of children with autism, including EEG measurements with near-infrared light (PBM) therapy.

 

To learn more about Brain Scientific, visit www.brainscientific.com; To learn more about JelikaLite, visit www.jelikalite.com

 

About Brain Scientific:

Brain Scientific is a commercial-stage healthcare company with two FDA-cleared products, providing next-gen solutions to the neurology market. The Company’s smart diagnostic devices and sensors simplify administration, shorten scan time and cut costs, allowing clinicians to make rapid decisions remotely and bridge the widening gap in access to neurological care. To learn more about our corporate strategy, devices or for investor relations please visit: www.brainscientific.com or email us at info@memorymd.com.

 

About JelikaLite:

JelikaLite is a biotech company developing individualized solutions to children with autism and other neurological conditions. JelikaLite believes that children on the autism spectrum can lead fulfilling and productive lives. This is why JelikaLite developed an innovative solution to permanently reduce autism symptoms. It is designed to facilitate language learning, improve communication skills and reduce anxiety. The product is a home-based system, combining a therapeutic wearable device with an AI personalization platform. More information: https://jelikalite.com/

 

Forward-Looking Statements:

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies and expectations, are generally identifiable by use of the words “may,” “should,” “would,” “will,” “could,” “scheduled,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “seek” or “project” or the negative of these words or other variations on these words or comparable terminology. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances, and may not be realized because they are based upon the Company's current projections, plans, objectives, beliefs, expectations, estimates, and assumptions, and are subject to several risks and uncertainties and other influences, many of which the Company has no control. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain additional financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company's inability to expand its business, significant government regulation of medical devices and the healthcare industry, lack of product diversification, volatility in the price of the Company's raw materials and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC. The Company does not undertake to update these forward-looking statements.