0001079973-22-001319.txt : 20221012 0001079973-22-001319.hdr.sgml : 20221012 20221012125145 ACCESSION NUMBER: 0001079973-22-001319 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20221012 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221012 DATE AS OF CHANGE: 20221012 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Nemaura Medical Inc. CENTRAL INDEX KEY: 0001602078 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 465027260 FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38355 FILM NUMBER: 221306210 BUSINESS ADDRESS: STREET 1: 57 WEST 57TH STREET CITY: MANHATTAN STATE: NY ZIP: 10019 BUSINESS PHONE: 44-1509-222-912 MAIL ADDRESS: STREET 1: 57 WEST 57TH STREET CITY: MANHATTAN STATE: NY ZIP: 10019 8-K 1 nmra_8k-101222.htm FORM 8-K
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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): October 12, 2022

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.)

 

57 West 57th Street

Manhattan, NY

10019

(Address of principal executive offices) (Zip Code)
     
Registrant’s telephone number, including area code:  

+1 (646) 416-8000

 

N/A

(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)) 

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

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock NMRD The Nasdaq Stock Market LLC

 

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 October 12, 2022, Nemaura Medical, Inc. (the “Company”) issued a press release announcing receipt of a provisional purchase order from TPMENA, the Company’s Middle East/North Africa licensee for the Company’s sugarBEAT® system. TPMENA issued the provisional purchase order following its regulatory registration submission for sugarBEAT® in the Kingdom of Saudi Arabia (“KSA”). Registration in KSA is anticipated in the first quarter of 2023. The purchase order is contingent on receipt of KSA registration.

 

The information included in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth under this Item 7.01 shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.

 

DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS

 

Certain statements contained in this Current Report on Form 8-K, including on Exhibit 99.1, that are not historical facts constitute forward-looking statements. Reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which may cause actual results, performance, or achievements to differ materially from those expressed or implied. Any forward-looking statement speaks only as of the date made. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which they are made.

 

The words "believe," "anticipate," "design," "estimate," "plan," "predict," "seek," "expect," "intend," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the Company’s actual results to vary materially from those indicated by such forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors the Company believes are appropriate in the circumstances. Factors which could cause actual results to differ from expectations, many of which are beyond the Company’s control, include, but are not limited to, obtaining regulatory approval for our sugarBEAT device, conducting successful clinical trials, executing agreements required to successfully advance the Company's objectives; retaining the management and scientific team to advance the product; overcoming adverse changes in market conditions and the regulatory environment; obtaining and enforcing intellectual property rights; obtaining adequate financing in the future through product licensing, public or private equity or debt financing or otherwise; dealing with general business conditions and competition; and other factors referenced in the Company’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2022, as the same may be updated from time to time. There can be no assurance that the KSA will approve the registration. Except as required by law, we do not assume any obligation to update any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

 

 
 
 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

     

Exhibit No.    

  

Description

   
99.1  

Press release issued by the registrant on October 12, 2022.

104   Cover Page Interactive Data File - the cover page XBRL tags are embedded with the Inline XBRL document

 

 

 
 
 

 

SIGNATURE

 

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

 

  NEMAURA MEDICAL INC.
   
  By: /s/ Dewan F. H. Chowdhury
    Dewan F. H. Chowdhury
Chief Executive Officer

 

Date: October 12, 2022

 

  

 EX-99.1 2 ex99x1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

 

Nemaura Receives Provisional Purchase Order from Middle East Licensee TPMENA

 

LOUGHBOROUGH, ENGLAND, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (NASDAQ: NMRD)(“Nemaura” or the “Company”), a medical technology company focused on developing and commercialising noninvasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, today announced it has received a provisional purchase order from TPMENA, its MENA (Middle East/North Africa) licensee for the Company’s sugarBEAT® system.

 

TPMENA issued the provisional purchase order with Nemaura following its regulatory registration submission for sugarBEAT® in the Kingdom of Saudi Arabia (KSA). Registration in KSA is anticipated in the first quarter of 2023. The provisional purchase order is for 17,500 devices, and 1.7 million sensors, with 7,500 devices and 700,000 sensors in the first year following launch in KSA and 10,000 units and 1 million sensors in the second year. The purchase order is contingent on receipt of KSA registration.

 

“We believe the Middle East, and Saudi Arabia in particular, represents a significant opportunity for Nemaura and its partner TPMENA, given the high rates of Type II diabetes in the region,” said Nemaura CEO, Dr. Faz Chowdhury. “We have worked closely with TPMENA over the past year to get all language translations and packaging ready and are eager to launch our affordable and patient-friendly monitoring solution for diabetes in the region.”

 

Based in Dubai, TPMENA is a full-service distributor that markets premium international brands in the Middle East region and brings significant expertise in logistics, marketing, distribution, and sales. Founded in 2011, it has built a reputation as a reliable partner in growing brands across a number of categories. According to the International Diabetes Federation there were over 4.1 Million people with diabetes in Saudi Arabia alone in 2021, a number predicted to grow to 5.6 Million by 2030.

 

About Nemaura Medical, Inc.

Nemaura Medical Inc. is a medical technology company developing and commercialising noninvasive wearable diagnostic devices. The company is currently commercialising sugarBEAT® and proBEAT™. sugarBEAT®, a CE mark approved Class IIb medical device, is a noninvasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and prediabetes to better manage, reverse, and prevent the onset of diabetes. Nemaura has submitted a PMA (Premarket Approval Application) for sugarBEAT® to the U.S. FDA. proBEAT™ combines noninvasive glucose data processed using artificial intelligence and a digital healthcare subscription service that has been launched in the U.S. as a general wellness product as part of its BEAT® diabetes program that is currently undergoing pilot studies.

 

The Company sits at the intersection of the global Type 2 diabetes market that is expected to reach nearly $59 billion by 2025, the $50+ billion pre-diabetic market, and the wearable health-tech sector for weight loss and wellness applications that is estimated to reach $60 billion by 2023.

 

For more information, please visit www.NemauraMedical.com.

 

 

 
 
 

Cautionary Statement Regarding Forward-Looking Statements:

The statements in this press release that are not historical facts 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, the launch of proBEAT™ in the U.S., risks related to regulatory status and 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 proBEAT™, 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 both proBEAT™ digital health, and sugarBEAT®. There can be no assurance that the company will be able to reach a part of or any of the global market for CGM with its products/services. The U.S. Food and Drug Administration (the “FDA”) reserves the right to re-evaluate its decision that proBEAT™ qualifies as a general wellness product should it become aware of any issues such as skin irritation or other adverse events from the device, as well as any misuse impacting patient safety, and any other reason as the FDA may see fit at its discretion to determine the product does not fit the definition of a general wellness product. There can be no assurance that the KSA will approve the registration for sugarBEATÒ in Saudi Arabia.These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the United States Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal 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:

 

Jules Abraham

CORE IR

+1 917-885-7378

julesa@coreir.com

 

 

 

 

 

 

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