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Nemaura Medical Inc. (OTCQB: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless disposable adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced today that it has appointed Dr. Salim Natha to the company’s Board of Directors. Dr. Natha will serve as an independent director of the company and chair the board’s Compensation Committee.
Dr. Faz Chowdhury, CEO and board member of Nemaura commented “Salim’s expertise as a serving Consultant Ophthalmologist Surgeon specialising in Diabetic Retinopathy will bring a valuable clinical perspective to our Board, and help strengthen our corporate governance as we prepare to launch sugarBEAT® later this year.”
Dr. Natha is currently practicing as an Eye Surgeon in the UK National Health Service (NHS), and is the clinical lead for a retinopathy screening programme for over 20,000 diabetics in the Ashton, Wigan and Leigh region. He has published several articles in the medical literature and is a peer reviewer for the English National Diabetic Retinopathy Screening Programme. Dr. Natha graduated with honors from the University of Liverpool Medical School.
Dr. Natha commented “Treating diabetes and its complications costs the NHS almost £10 billion (US$13 billion) a year. Breakthrough technologies like Nemaura’s sugarBEAT® have a potentially transformative role to play in helping diabetics improve their health through better management of glucose levels.”
About Nemaura Medical, Inc.
Nemaura Medical is a medical technology company developing the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. 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, 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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical 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 Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Contacts
Nemaura Medical
Bashir Timol
Director of Strategy & Corporate Development
bashir.timol@nemauramedical.com
Nemaura Medical Inc. (OTCQB: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless disposable adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced today it has signed a non-binding letter of intent with The Principals MENA DMCC (“TPM”) for an exclusive license to market and sell sugarBEAT® in the Gulf Co-operation Council region (“GCC Region”), which consists of Bahrain, Kuwait, Qatar, Saudi Arabia, Oman and United Arab Emirates.
Dr. Faz Chowdhury, Chairman and CEO of Nemaura commented “We look forward to finalizing the licensing agreement with TPM, who are a well-established market leader with the requisite market knowledge and client base to successfully commercialise sugarBEAT®.”
The GCC Region has more than 35 million diabetics in total, with data from the International Diabetes Federation showing prevalence of the disease has reached 23.9% of the adult population in Saudi Arabia, 23.1% in Kuwait and 19.8% in Qatar, which is more than twice the global average of 8.3%.
About Nemaura Medical, Inc.
Nemaura Medical is a medical technology company developing the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. 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, 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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical 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 Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Nemaura Medical
Bashir Timol
Director of Strategy & Corporate Development
bashir.timol@nemauramedical.com
Nemaura Medical Inc. (OTCQB: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless disposable adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced today that it has appointed Timothy Johnson to the company’s Board of Directors. Mr. Johnson will serve as an independent director of the company and chair the board’s Audit and Nominating and Corporate Governance Committees.
Dr. Faz Chowdhury, Chairman and CEO of Nemaura commented “Tim’s experience with managing and overseeing companies with rapid growth potential will bring a valuable perspective to our Board, and help strengthen our corporate governance and regulatory compliance as we prepare to launch sugarBEAT® later this year.”
Mr. Johnson is currently a Director at Diagnostax Advisory, a digital management consultancy, and has built up a decade of insight and experience bringing new products and technologies to established markets. He is a practicing Chartered Tax Adviser and earned his first class Masters of Science in Mathematics and Physics from the University of Manchester, UK.
Mr. Johnson commented “With the World Health Organization estimating there are over 420 million diabetics worldwide, and the number of pre-diabetics at almost three times this number, diabetes is one the world’s most pressing health challenges. Nemaura’s technology has the potential to be a game changer for better management of glucose levels, and I am very excited to part of such a transformative vision.”
About Nemaura Medical, Inc.
Nemaura Medical is a medical technology company developing the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. 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, 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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical 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 Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Investors / Media contact:
Bashir Timol
Director of Strategy & Corporate Development
Nemaura Medical Inc. (OTC: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless disposable adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced it has recently uplisted to the OTCQB Venture Market trading platform.
Dr Faz Chowdhury, CEO of Nemaura Medical commented “We are pleased to announce our uplist to the OTC Quote Board, which we expect will enhance our visibility in the marketplace, broaden and diversify our investor base, and increase the liquidity of our common stock.”
About Nemaura Medical, Inc.
Nemaura Medical is a medical technology company developing the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. 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, 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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical 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 Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Investors / Media contact:
Bashir Timol
Director of Strategy & Corporate Development
Nemaura Medical Inc. (OTC: NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless disposable adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system, today reported financial results for the full year ended March 31, 2017.
Recent Highlights and Accomplishments:
“We are pleased with the progress made over the past year culminating in the completion of the development of our second generation wireless sugarBEAT® disposable adhesive skin-patch” commented Dr Faz Chowdhury, CEO of Nemaura Medical. “We expect to commence our clinical trial programme shortly, involving up to 75 patients over 525 days, and are on track to launch sugarBEAT® before the end of 2017 in the UK.”
Summary of full year 2017 results:
R&D expenses were $1,035k and $1,028k for the years ended March 31, 2017 and 2016, respectively. This amount consisted primarily of expenditure on sub-contractor activities, consultancy fees and wages and demonstrated continuing expenditure for improvements made to the sugarBEAT device.
G&A expenses were $517k and $511k for the years ended March 31, 2017 and 2016, respectively.
Despite the expenses above being similar year on year, comprehensive loss applicable to common shareholders was $2.3m in 2017 compared to $1.4m in 2016. This difference is due to the foreign translation currency adjustments from the UK operations.
As of March 31, 2017, cash and cash equivalents and fixed rate cash accounts were $7.1m compared with cash and cash equivalents of $9.4m for 2016.
There was no revenue recognized in the years ended March 31, 2017 and March 31, 2016.
About Nemaura Medical, Inc.
Nemaura Medical is a medical technology company developing the wireless sugarBEAT® disposable adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. 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, 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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical 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 Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Investors / Media contact:
Bashir Timol
Director of Strategy & Corporate Development
bashir.timol@nemauramedical.com
NEMAURA MEDICAL INC.
CONSOLIDATED BALANCE SHEETS
| As of March 31, | As of March 31, | ||
| 2017 ($) | 2016 ($) | ||
| ASSETS | |||
| Current Assets: | |||
| Cash | 911,359 | 9,403,965 | |
| Fixed rate cash account | 1,867,950 | – | |
| Prepaid expenses and other receivables | 51,086 | 148,274 | |
| Total Current Assets | 2,830,395 | 9,552,239 | |
| Other Assets: | |||
| Property and equipment, net | 9,161 | 7,649 | |
| Intangible assets, net of accumulated amortization | 203,800 | 172,895 | |
| 212,961 | 180,544 | ||
| Long Term Assets: | |||
| Fixed rate cash account | 4,358,550 | – | |
| Total assets | 7,401,906 | 9,732,783 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||
| Current liabilities | |||
| Accounts payable | 77,530 | 73,015 | |
| Liability due to related party | 687,609 | 494,145 | |
| Other liabilities and accrued expenses | 87,232 | 90,853 | |
| Total current liabilities | 852,371 | 658,013 | |
| Deferred revenue | 1,183,035 | 1,396,005 | |
| 1,183,035 | 1,396,005 | ||
| Total liabilities | 2,035,406 | 2,054,018 | |
| Commitments and contingencies | |||
| Stockholders’ equity: | |||
| Common stock, $0.001 par value, 420,000,000 shares authorized and 205,000,000 shares issued and outstanding (205,000,000 at March 31, 2016) | 205,000 | 205,000 | |
| Additional paid in capital | 12,919,672 | 12,919,672 | |
| Accumulated deficit | (7,152,633) | (5,601,367) | |
| Accumulated other comprehensive income/(loss) | (605,539) | 155,460 | |
| Total stockholders’ equity | 5,366,500 | 7,678,765 | |
| Total liabilities and stockholders’ equity | 7,401,906 | 9,732,783 |
12th June 2017, Loughborough, UK. Nemaura Medical Inc. (OTCBB: NMRD), a medical device company announced the latest version of the sensor component of it’s sugarBEAT® non-invasive wireless skin-patch has achieved a more than 300% improvement in glucose detection.
This major improvement is expected to enhance sugarBEAT® accuracy as expressed through MARD, by enabling diabetics to better detect small fluctuations in glucose levels, and for sugarBEAT® to detect glucose at very low levels.
The sugarBEAT® clinical trial program, involving up to 75 patients over 525 days, is due to commence shortly, with product launch anticipated before the end of 2017 in the UK.
The needle-free and daily-disposable format of the sugarBEAT® skin-patch is expected to provide a non-invasive and flexible way for diabetics to better manage their glucose levels.
SugarBEAT’s® cost-effective design, consisting of a reusable Bluetooth-enabled body-worn transmitter containing a low-cost disposable adhesive skin-patch will make glucose monitoring more affordable, especially for non-insulin-injecting diabetics.
Alongside the sugarBEAT® wireless skin-patch, Nemaura has also successfully developed and tested the associated sugarBEAT® mobile phone application.
This Medical-grade App connects by Bluetooth to the skin-patch and displays glucose readings on a continuous basis as well as providing summary Ambulatory Glucose Profile (AGP) trends.
The App also allows for additional manual lifestyle inputs helping diabetics to better understand and manage their condition.
About Nemaura Medical, Inc.
Nemaura Medical is developing the daily-disposable wireless sugarBEAT® adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. Further opportunity may exist in intensive-care hospital settings, where continuous glucose monitoring is critical.
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 Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical 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 Medical’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 Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Investors / Media contact:
Bashir Timol
Nemaura Medical Inc.
15th February 2017, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD), (“Nemaura”), a medical device company developing a non-invasive, needle-free, pain-free, daily-disposable, and cost effective wireless CGM (Continuous Glucose Monitoring) patch known as sugarBEAT® today announced that its multicentre open label clinical study has been selected for poster exhibit at the Advanced Technologies and Treatments for Diabetes (ATTD) Conference in Paris from the 15th to 18th February 2017.
The poster will illustrate sugarBEAT®’s miniaturized wireless format, as a discreet coin sized oval device less than 10mm in height, and also showcase the sugarBEAT® mobile phone application which is designed to display blood glucose readings at any point in time and provide summary ambulatory glucose profiles (AGP).
The company expects to launch sugarBEAT® in Europe this year through its European Licensee, and following two rounds of discussions with the FDA Nemaura has completed its clinical investigation plan (CIP) for a PMA application, and expects to complete the studies for a PMA submission by the end of the year.
SugarBEAT® is expected to be cost competitive due to its non-invasive design and low-cost consumables. These consist of a reusable electronic body-worn device and daily disposable patches, linked to a smart phone app.
Nemaura Medical CEO Dr Faz Chowdhury said: “Our sugarBEAT® technology is a more flexible way for anyone living with diabetes to monitor their glucose levels. Users can choose which days to wear the patch, without having to endure long wear durations of up to 14 days”.
The 10th annual conference on Technologies and Treatments for Diabetes will attract over 2,500 delegates from all over the globe. The conference is attended by the world’s leading researchers, clinical practitioners and Industry/corporate professionals, and provides a forum for lively exchange of ideas and research relating to technologies, treatment and prevention of diabetes related illnesses.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT® System as a non-invasive, needle-free, pain-free and cost-effective wireless, continuous glucose monitoring system (CGM) for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
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® CGM 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 the sugarBEAT® System, 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 its sugarBEAT® System. 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.
Investors / Media:
Bashir Timol
Nemaura Medical Inc.
Bashir.Timol@nemauramedical.com
2nd September 2016, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura” or the “Company”), a medical device company developing a minimally invasive, needle-free, wireless CGM (Continuous Glucose Monitoring) patch known as sugarBEAT®, today announced that it has signed a letter of intent (LOI) with a Chinese Corporation, Shenzen CAS Health Corporation Limited, which is a partially owned subsidiary of the Chinese Academy of Science.
The letter of intent covers three potential joint venture arrangements relating specifically to sugarBEAT® including (a) setting up a joint venture company to distribute in China, (b) setting up a manufacturing facility in China and (c) obtaining CFDA approval. Nemaura Medical recognises the size and importance of the Chinese market. As a result, the Company has prioritized obtaining CFDA regulatory approvals as the next step in fulfilling a primary objective under the LOI.
Nemaura Medical anticipates a sugarBEAT® product launch in Europe in 2017, where it has previously obtained CE approval. In the US, Nemaura Medical has had discussions with the FDA and anticipates completing its clinical program and submitting a PMA application around mid 2017.
SugarBEAT® differs from existing CGM’s given it comprises an adhesive daily-disposable skin-patch which does not require insertion of a needle-like sensor inside the skin. SugarBEAT® also provides users with tremendous flexibility as to when and how often they choose to wear the patch. Both of these factors are expected to empower users in a way current CGM’s cannot.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, needle-free, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
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® CGM 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 the sugarBEAT® System, 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 its sugarBEAT® System. 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.
Investors / Media:
Bashir Timol
Nemaura Medical Inc.
BD@nemauramedical.com
IR@Nemauramedical.com
4th August 2016, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive, needle-free, wireless CGM (Continuous Glucose Monitoring) patch known as sugarBEAT®, today announced that it recently held a second pre-submission meeting with the FDA to discuss the clinical program for its sugarBEAT® system, for the purpose of a PMA submission in the USA. As a result of its meeting, Nemaura’s management has determined a clear direction for the clinical program and has appointed Navigant (NYSE: NCI) to develop the Investigational Device Exemption (IDE) application to submit to the FDA for approval, prior to commencement of the clinical program.
Nemaura Medical anticipates completing the clinical program and submitting the PMA application around mid 2017. SugarBEAT® differs from existing CGM’s because it’s comprised of an adhesive daily disposable skin-patch which does not require insertion of a needle-like sensor inside the skin. SugarBEAT® also provides users with tremendous flexibility as to when and how often they choose to wear the patch. Both of these factors are expected to empower users in a way current CGM’s cannot.
About Nemaura Medical, Inc.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, needle-free, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
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® CGM 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 the sugarBEAT® System, 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 its sugarBEAT® System. 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.
Investors / Media:
Bashir Timol
Nemaura Medical Inc.
BD@nemauramedical.com
IR@Nemauramedical.com
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