0001079973-19-000224.txt : 20190416 0001079973-19-000224.hdr.sgml : 20190416 20190416114122 ACCESSION NUMBER: 0001079973-19-000224 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20190416 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190416 DATE AS OF CHANGE: 20190416 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: 19750281 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 16, 2019
NEMAURA MEDICAL, INC.
(Exact name of registrant as specified in charter)
Nevada
(State or other jurisdiction of incorporation)
 
001-38355
  
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 ☒
 
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 16, 2019, the Registrant issued a press release announcing the addition of new predictive alert functionality to 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 Statement 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 16, 2019
By:
/s/ Dewan F. H. Chowdhury   
    Name: Dewan F. H. Chowdhury   
    Title:  Chief Executive Officer  
       

EX-99.1 2 ex99x1.htm EXHIBIT 99.1
Exhibit 99.1
 
 

Nemaura Announces Addition of New Predictive Alert Functionality to SugarBEAT®
Enhances Product Capabilities in Advance of CE Mark Approval
Loughborough, England – April 16, 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 incorporated new predictive alert functionality into SugarBEAT®.
Alerts have been designed to provide visual indication when glucose levels are falling or rising above minimum and maximum thresholds. Additional audible alerts or physical vibration of the Bluetooth-enabled mobile phone connected to SugarBEAT® will occur in instances where glucose levels are deemed to fall to dangerously low levels, until switched off by the user.
British Standards Institute (BSI), Nemaura’s designated European Notified Body, has accepted Nemaura’s proposed plan to incorporate these alerts into the current CE Mark application, and BSI is currently reviewing the supporting verification and quality related documentation.
Dr. Faz Chowdhury, CEO of Nemaura, said, “While the non-invasive nature of SugarBEAT® opens up the CGM market to Type 2 diabetics and pre-diabetics, the inclusion of these alerts will particularly appeal to Type 1 diabetics who are at higher risk of hypoglycemia, or very low glucose levels. Adding the alerts and alarms, based on predictive algorithms, as part of the current CE review process avoids the need for a subsequent CE application thus shortening the time that it would have otherwise taken to integrate these key features in the device.  Even with these additions, we remain on track for CE Mark approval followed by our commercial launch later this year.”
Upon receiving CE Mark approval, Nemaura’s plan is to initially launch SugarBEAT® in the United Kingdom, where the addressable market for CGM is valued at over $1.3 billion. The overall global addressable market for CGM is estimated at $82 billion per year, and the U.S. market alone is estimated at $13 billion1.  Given that SugarBEAT® is  non-invasive, coupled with its affordability and flexibility, the Company expects to become a dominant player in this market.
To view a video of SugarBEAT®, please visit http://sugarbeat.com/introducing-sugarbeat/
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


1 PiperJaffray Company Note DXCM Sep 5, 2018