0001079973-19-000236.txt : 20190423 0001079973-19-000236.hdr.sgml : 20190423 20190423080235 ACCESSION NUMBER: 0001079973-19-000236 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20190423 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190423 DATE AS OF CHANGE: 20190423 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Nemaura Medical Inc. CENTRAL INDEX KEY: 0001602078 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: NV FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38355 FILM NUMBER: 19760679 BUSINESS ADDRESS: STREET 1: ADVANCED TECHNOLOGY INNOVATION CENTRE STREET 2: LOUGHBOROUGH UNIV SCIENCE & ENTERPRISE CITY: 5 OAKWOOD DRIVE, LOUGHBOROUGH STATE: X0 ZIP: LE11 3QF BUSINESS PHONE: 44-1509-222-912 MAIL ADDRESS: STREET 1: ADVANCED TECHNOLOGY INNOVATION CENTRE STREET 2: LOUGHBOROUGH UNIV SCIENCE & ENTERPRISE CITY: 5 OAKWOOD DRIVE, LOUGHBOROUGH STATE: X0 ZIP: LE11 3QF 8-K 1 nmra_8k.htm FORM 8-K


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 1934
Date of Report (Date of earliest event reported): April 23, 2019
NEMAURA MEDICAL, INC.
(Exact name of registrant as specified in charter)
Nevada
(State or other jurisdiction of incorporation)
 
000-55283
  
 
46-5027260
(Commission File Number)
  
(IRS Employer Identification No.)
     
Advanced Technology Innovation Centre,
Loughborough University Science and Enterprise Parks,
5 Oakwood Drive,
Loughborough, Leicestershire
LE11 3QF
United Kingdom
 
N/A
(Address of principal executive offices)
(Zip Code)
     
Registrant’s telephone number, including area code:
 
00 44 1509 222912
 
___________________________________________
(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 registrant under any of the following provisions:
[_]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[_]  Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b))
[_]  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))
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 [X]
 
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 8.01.  Other Events

On April 23, 2019, Nemaura Medical, Inc. issued a press release announcing it successfully completed two Summative human factors usability studies for SugarBEAT®.  A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

Item 9.01.  Financial Statements and Exhibits
(d) Exhibits

Exhibit No.
Description
 
 
 
 
   

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
  Nemaura Medical, Inc.  
       
Dated: April 23, 2019
By:
/s/ Dewan F H Chowdhury  
    Name:  Dewan F H Chowdhury  
    Title:  Chief Executive Officer  
       

 
 
 
Exhibit List

Exhibit No.
Description
99.1
Press Release, dated April 23, 2019
 
 EX-99.1 2 ex99x1.htm EXHIBIT 99.1
Exhibit 99.1
 
 
 
Nemaura Announces Successful Completion of Summative Human Factors Usability Study for SugarBEAT®
 Final step required prior to filing de novo application to the U.S. Food and Drug Administration
Loughborough, England – April 23, 2019 – Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that it has successfully completed two summative human factors usability studies for SugarBEAT®.  The usability studies were conducted according to the U.S. Food and Drug Administration (FDA) guidance on ‘Applying Human Factors and Engineering to Medical Devices,’ in preparation for submission of its medical device application to the FDA for SugarBEAT®.
The two studies consisted of 16 participants each, including both Type I and Type II diabetics.  Participants in the first and second study ranged from ages 18-50 and 51-70, respectively.  The studies were designed to ensure adequate information was captured for the diverse age groups expected to use SugarBEAT®.  The objective of the two studies was to confirm that the user interface aspects of SugarBEAT® met the FDA guidelines for medical devices.
Dr. Faz Chowdhury, CEO of Nemaura, commented, “We are pleased to have successfully completed these important studies and we are preparing our FDA filing at this time.  We anticipate broader adoption of SugarBEAT® as compared with competitive offerings given SugarBEAT® is non-invasive with flexible wear time, and will be attractively priced.”
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com