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Loughborough, England, April 21, 2020 — Nemaura Medical Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, its non-invasive and flexible continuous glucose monitor (“CGM”), today announced it has secured a 24-month, $5 million non-convertible loan. The loan does not include warrants or other equity securities.
“This loan strengthens our financial position without diluting shareholders, and provides additional resources to accelerate our commercial strategy for sugarBEAT® in Europe, as well as support our planned launch of proBEAT™ in the USA, ” stated Dr. Faz Chowdhury, Nemaura’s CEO. “We appreciate the favorable terms and strong support from our lender, Chicago Venture Partners.”
About Nemaura Medical, Inc.:
Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, and proBEAT™. sugarBEAT® is a Class IIb CE marked non-invasive 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 pre-diabetes to better manage, reverse and prevent the onset of diabetes. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading. proBEAT™ comprises a prescription free non-invasive glucose monitor and a digital healthcare subscription service planned to be launched in the US as a general wellness product.
For more information 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 sugarBEAT® as a CGM / CTM in the US, 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®. There can be no assurance that the company will be able to reach a part of or any of the global market for CGM or CTM with its products/services and there can be no assurance that the foregoing repurposing can occur as planned.. 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.
Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
BEAT® platform is planned to be extended to conditions requiring continuous temperature monitoring including viral infections and poor blood circulation to feet in persons with diabetes
Loughborough, England, April 01, 2020 — Nemaura Medical Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, its non-invasive and flexible continuous glucose monitor (“CGM”), announced plans for a new product line by seeking to immediately repurpose sugarBEAT® as a CTM since its inbuilt temperature sensor is capable of continuously tracking body temperature through the skin. Nemaura is considering various options to expedite the launch of a CTM, including potential partnerships and direct to consumer sales.
CTM’s have been recognised as potentially having a key role to play in battling COVID-19, with Google’s Verily announcing plans to develop a small body worn temperature patch that transmits data to a phone application to provide timely notification of fever and support earlier diagnosis and treatment of viral infections like the flu or coronavirus1.Nemaura’s body worn skin patch designed to monitor glucose levels on the skin at 5 minute intervals also contains a thermistor which measures skin temperature as an integral part of the device, and we believe that the device could easily be repurposed for this standalone function. The CGM device is CE approved in Europe and in commercial production in the UK.
“We see a significant commercial opportunity to utilise our BEAT® platform technology specifically for CTM purposes with data being automatically sent by low energy Bluetooth to a mobile phone app from which it can then be reviewed by the user and/or sent to a family member or caregiver. We believe that there are parallels between family members and caregivers remotely monitoring glucose fluctuations in a person, and monitoring fever caused by viral infections, providing a means of remote tracking and intervention. In the current climate we see this as an opportunity to contribute to general wellbeing and patient management” stated Dr. Faz Chowdhury, Nemaura’s CEO.
Several diseases including COVID-19 are characterised by fever (an increase in body temperature) meaning that temperature monitoring can be a vital tool in the detection of such conditions and consequently a potential means of containing the spread of the disease through early self-isolation. Measuring body temperature on a continuous basis may also be used to track the course of a disease and so allow physicians to analyse the effectiveness of treatments and thus pro-actively adapt to improve outcomes.
Dr. Chowdhury further stated “body temperature can vary depending on the age of the person, their level of (recent) physical activity, the time the measurement is taken and importantly where on the body the temperature is taken. For this reason, I believe that the ability to track the temperature continuously over time and measure the rate at which it is rising or falling would be a superior form of monitoring a person than sporadic measurements taken using a more traditional thermometer.”
We believe that multiple other future uses are foreseen for a CTM including tracking ovulation to improve the chances of conception and for predicting/preventing diabetes related foot complications such as ulcers which can eventually lead to amputation if not detected early enough, whereby poor blood circulation can be rapidly detected by continuous temperature monitoring of the affected region. Further details are provided in a publication on the company’s website: View Continuous Temperature Monitoring PDF
Nemaura is establishing the regulatory framework for launching the CTM in a number of worldwide territories, including initial immediate use to provide qualitative indications without disease diagnosis.
About Nemaura Medical, Inc.:
Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT™, and proBEAT™. sugarBEAT® is a Class IIb CE marked non-invasive 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 pre-diabetes to better manage, reverse and prevent the onset of diabetes. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading. proBEAT™ comprises a prescription free non-invasive glucose monitor and a digital healthcare subscription service planned to be launched in the US as a general wellness product.
For more information 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 sugarBEAT® as a CGM / CTM in the US, 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®. There can be no assurance that the company will be able to reach a part of or any of the global market for CGM or CTM with its products/services and there can be no assurance that the foregoing repurposing can occur as planned.. 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.
Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
Loughborough, England, March 30, 2020 — Nemaura Medical Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and digital solutions for the medical and consumer markets, announced it is planning to launch a digital healthcare subscription service in the USA under the brand name proBEAT™.
proBEAT™ is expected to be available without the need for a prescription and appeal to a broad range of adults encompassing pre-diabetic and Type 2 diabetics, numbering 88 million, and 26 million people respectively1, as well as those seeking to lose weight and/or seeking a healthier lifestyle.
proBEAT™ is expected to help users improve their knowledge of how a range of lifestyle, dietary and health and wellbeing factors impact their sugar levels by acting like a black box flight recorder. Big data about the multitude of factors that affect glucose levels will be gathered from all users and employed in developing and subsequently ‘fine-tuning’ predictive algorithms and artificial intelligence based feedback and prompts. These will then be able to both educate and provide motivational tools to the user to encourage them to lead a healthier lifestyle.
Nemaura is now prioritizing launch plans for its proBEAT™ digital health platform in the U.S. and is considering various options to expedite the launch, including potential partnering with multi-national companies.
Nemaura intends to market this device as a general wellness product as described in the FDA’s guidance document on the subject2. General Wellness Products outlined in current FDA guidance are those which have either: (1) An intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or disease conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition2. Further details are provided on Nemaura’s website: View NMRD Wellness PDF
1American Diabetes Association
2 General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff (September 27, 2019)
About Nemaura Medical, Inc.:
Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT™, and proBEAT™. sugarBEAT®, a CE mark approved Class IIb medical device, is a non-invasive 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 pre-diabetes to better manage, reverse and prevent the onset of diabetes. Nemaura is planning to submit a PMA application for sugarBEAT® during the second quarter of 2020 for FDA review of this device under medical device regulations. proBEAT™ comprises a non-invasive glucose monitor and a digital healthcare subscription service and is due to be launched in the US as a general wellness product.
For more information 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 US, 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 FDA reserves the right to re-evaluate their 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. 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.
Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
sugarBEAT® strategic global partnership(s) a step closer as Nemaura Medical enters into multiple verbal non-binding agreements
Loughborough, England, March 10, 2020 — Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, its non-invasive and flexible continuous glucose monitor (“CGM”), together with BEAT®diabetes, a planned health subscription service designed to help people with Type 2 diabetes and pre-diabetes through personalized lifestyle coaching, announced it has entered in to multiple verbal non-binding agreements for sugarBEAT® with the aim of securing regional and global partnerships.
“Collaborating with highly capable strategic partners as we seek to bring the first ever non-invasive continuous glucose monitoring system to market, is a key initiative for management. Given the importance of this initiative we thought it appropriate to share this update on the progress over the course of the last few months that has been made with potential partners for large scale collaborations that we believe will help us accelerate our speed to market by leveraging off the resources and established networks of multinational companies in this field. We have entered in to several verbal non-binding agreements covering a diverse range of potential applications for sugarBEAT® in the medical and non-medical field”stated Dr. Faz Chowdhury, CEO of Nemaura.
The verbal non-binding agreements are expected to lead to discussions for licensing and collaboration on a regional or global scale, following the appropriate mutual due diligence processes. However, there can be no assurance that the foregoing will occur as planned, or at all.
The first phase of the commercial launch of sugarBEAT® began in the UK after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company focused on scaling up its manufacturing operations. The UK licensee of sugarBEAT®, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT®.
The Company is currently planning a user study comparing sugarBEAT® directly against a highly successful major incumbent CGM sensor with the goal of positioning sugarBEAT® as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive and invasive CGM.
The global total addressable market for CGM is estimated at $82 billion per annum, consisting of $12.7 billion for Type 1 insulin users (5% of diabetes), $38.0 billion for Type 2 insulin users (15% of diabetes) and $31.4 billion for Type 2 non-insulin users (80% of diabetes). These numbers exclude the prediabetes population which is estimated at nearly three times as large as the diabetes population.1
1. PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT® and BEAT®diabetes. sugarBEAT® is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which help people with diabetes and prediabetes to better manage, reverse and prevent the onset of diabetes. BEAT®diabetes is a planned health subscription service providing 1-on-1 lifestyle coaching and behavior change recommendations driven by personalized data provided by sugarBEAT®. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading.
For more information 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’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®. 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. 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.
Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
sugarBEAT® App is now available on Play Store with iOS app planned to follow, ahead of the planned BEAT®diabetes subscription service launch
Loughborough, England, March 3, 2020 — Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, its non-invasive and flexible continuous glucose monitor (“CGM”), together with BEAT®diabetes, a planned health subscription service designed to help people with Type 2 diabetes and prediabetes through personalized lifestyle coaching, launched its sugarBEAT® App for Android devices on the Play Store in preparation for the planned launch of the Company’s BEAT®diabetes subscription based service expected for next month.1
“We believe that the launch of our app is a big step towards our commercial milestones, and we are looking forward to launching the BEAT®diabetes subscription service shortly during Type 2 Diabetes Prevention Week in the UK. This is a very exciting time in our company’s development” stated Dr. Faz Chowdhury, CEO of Nemaura.
“The sugarBEAT® app includes time-in-range profiling features which we believe is rapidly being adopted as the primary metric for managing individual daily blood glucose profiles”.
BEAT®diabetes is a subscription based service which, we believe, over time will provide both people with prediabetes and Type 2 diabetes with a number of affordable and empowering tools to better manage, prevent and potentially even reverse their condition.
The first phase of the commercial launch of sugarBEAT® began in the UK after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company focused on scaling up its manufacturing operations. The UK licensee of sugarBEAT®, DB Ethitronix, is currently in the process finalizing the launch of online sales of sugarBEAT®.
The Company is currently planning a user study comparing sugarBEAT® directly against a highly successful major incumbent CGM sensor with the goal of positioning sugarBEAT® as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive and invasive CGM.
The global total addressable market for CGM is estimated at $82 billion per annum, consisting of $12.7 billion for Type 1 insulin users (5% of diabetes), $38.0 billion for Type 2 insulin users (15% of diabetes) and $31.4 billion for Type 2 non-insulin users (80% of diabetes). These numbers exclude the prediabetes population which is estimated at nearly three times as large as the diabetes population.2
1. https://play.google.com/store/apps/details?id=com.triteq.sugarbeat
2. PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT® and BEAT®diabetes. sugarBEAT® is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which help people with diabetes and prediabetes to better manage, reverse and prevent the onset of diabetes. BEAT®diabetes is a planned health subscription service providing 1-on-1 lifestyle coaching and behavior change recommendations driven by personalized data provided by sugarBEAT®. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading.
For more information 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’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®. 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. 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.
Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
Studies planned to compare sugarBEAT® and major continuous glucose monitor sensor, seeking to position sugarBEAT® as both a possible alternative and complementary device for people with diabetes
Loughborough, England, February 25, 2020 — Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura” or the “Company”), a medical technology company focused on developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT® its non-invasive and flexible continuous glucose monitor (“CGM”), together with BEAT®diabetes, a planned health subscription service designed to help people with Type 2 diabetes and prediabetes through personalized lifestyle coaching, today, announced it’s planning to initiate a user study comparing sugarBEAT® directly against a highly successful major incumbent CGM sensor with the goal of positioning sugarBEAT® as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive invasive CGM.
“Our decision to go head-to-head vs. a hugely successful CGM sensor was based on positive feedback we received from recent meetings with public health insurers in key territories in Europe,” stated Dr. Faz Chowdhury, CEO of Nemaura. “We believe that most people with diabetes do not currently use any continuous glucose monitoring system due to the high costs and the invasiveness of current products. We believe that sugarBEAT® changes this paradigm and is the first non-invasive CGM to provide the [masses] an option for daily monitoring whenever they choose at an affordable price point. We believe that this level of flexibility is a better option than any alternative CGM devices with either 7 day, 10 day, or 14 day sensor wear time currently available.”
“We believe that sugarBEAT®’s flexibility empowers users with very powerful trend data at a lower cost compared to current CGM’s, which we believe will encourage broad adoption of the system”.
Several studies are planned over the course of this year designed to demonstrate the effectiveness of sugarBEAT® to increase Time-In-Range, thus reducing HbA1C with intermittent (non-consecutive days) use over a few days per week or even month. Initial results from studies comparing the various market leading CGM devices indicates sugarBEAT’s® accuracy (MARD mean absolute relative difference), to be on par with the major incumbent invasive CGM sensors, using single finger-stick blood glucose meter calibration in real-life settings.
The first phase of the commercial launch of sugarBEAT® began in the UK after the Company received CE Mark approval in 2019. In this initial phase, devices were supplied to a limited cohort of users while the Company sought to ramp up its manufacturing operations.
The UK licensee of sugarBEAT®, DB Ethitronix, are currently finalizing the launch of online sales of sugarBEAT®. Concurrently, Nemaura is finalizing the launch of its subscription-based service, BEAT®diabetes, aimed at reversing Type 2 diabetes and preventing prediabetes from the onset of diabetes.
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company commercializing BEAT®diabetes, a health subscription service designed to help people with diabetes and prediabetes better manage diabetes and reverse Type 2 diabetes or prevent diabetes through 1-on-1 lifestyle coaching and behavior driven by real time continuous glucose monitoring (CGM) and daily glucose trend data provided by sugarBEAT®, a non-invasive and flexible CGM.
For more information 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’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 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.
Investor Contact:
Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
dave@redchip.com
Loughborough, England, Feb. 11, 2020 (GLOBE NEWSWIRE) — – Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura”), a medical technology company commercializing sugarBEAT®, a non-invasive and flexible continuous glucose monitor (CGM), together with BEAT®diabetes, a health subscription service designed to help people with diabetes and prediabetes to better manage their condition through personalized lifestyle coaching, today provided a business update and financial results for the third quarter ended December 31, 2019.
Recent milestones:
– The Company announced a partnership with the award-winning UK-based company, Changing Health, to bring digital behavior programs to improve the management, reversal and prevention of Type 2 diabetes in multiple territories commencing with the United Kingdom and Ireland. Changing Health is a provider of digital coaching services to the National Health Service England, aimed at the prevention or reversal of Type 2 diabetes.
– Made significant progress on manufacturing commercial batches of product for release for sale initially in the UK and Ireland.
– Received positive feedback from the first users of sugarBEAT® as part of the first phase of commercial launch.
Dr. Faz Chowdhury, CEO of Nemaura commented, “This has been an exciting period for Nemaura, as we officially expanded sugarBEAT® CGM capabilities by launching a new digital health offering, BEAT®diabetes (www.BEATdiabetes.life), which focuses on the prevention and reversal of people with Type 2 diabetes and prediabetes through a range of holistic app and coaching services encouraging behavioral change. Additionally we have been continuing our dialogue with reimbursement agencies, as well as several multinational companies. We expect to submit the product for registration in Germany in the coming months, as well as enter in to further collaborations in due course.”
“As the world’s first non-invasive, safe, needle-free CGM, sugarBEAT® is uniquely positioned to target the underserved $80 billion market1 for people with both Type 1 & Type 2 diabetes as well as prediabetes. We remain highly encouraged by the outlook for the business and look forward to providing further updates as we execute on our commercial strategy.”
Third Quarter 2019 Results:
• Research and development expenses increased to $516,672 for the quarter ended December 31, 2019, an increase of $73,292 for the same quarter in 2018.
• General and administrative expenses increased to $542,697 for the quarter ended December 31, 2019, compared with $489,545 for the same quarter in 2018.
• The Company’s comprehensive loss was $470,841 for the quarter ended December 31, 2019, compared with $964,515 for the same quarter in 2018. The quarter ended December 31, 2019 is inclusive of $614,362 income tax benefit resulting from reimbursement of research and development expenses tax credits.
• At December 31, 2019, the Company’s cash balance was $1,067,663. The Company is immediately able to draw down on the first $3.5 million of a Senior Debt Facility provided by investors, which is intended to help fund the Company’s European launch of SugarBEAT®.
(1) PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company commercializing sugarBEAT® and BEAT®diabetes. sugarBEAT® is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which help people with diabetes and prediabetes to better manage, reverse and prevent the onset of diabetes. BEAT®diabetes is a health subscription service providing 1-on-1 lifestyle coaching and behavior change recommendations driven by personalized data provided by sugarBEAT®. People with diabetes who take insulin can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading.
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® and BEAT®diabetes, 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 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:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Loughborough, England, Dec. 20, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company commercializing sugarBEAT®, a non-invasive and flexible continuous glucose monitor (CGM), together with BEAT®diabetes, a health subscription service designed to help people with diabetes and prediabetes to better manage their condition through personalized lifestyle coaching, today provided a 2019 year-end corporate update.
Dr. Faz Chowdhury, CEO of Nemaura, stated, “2019 was a transformative year for our Company as we achieved a number of major milestones. During the year, we received CE Mark approval and laid the foundation for the commercial launch of sugarBEAT® in Europe and several other key territories around the world where CE approval can be used as the basis of product registration. We also launched a subscription based package, BEAT®diabetes to complement sugarBEAT® CGM and provide users with additional digital and non-digital services for the management, reversal or prevention of diabetes”.
The company started the first phase of our commercial launch of sugarBEAT® in the United Kingdom with the first shipments of sugarBEAT® CGM devices to diabetic and pre-diabetic patients from whom positive user feedback has been received. The company is poised to move aggressively into the commercial phase of the go to market strategy in Europe with its current scale of manufacturing that is entirely carried out in the United Kingdom. Nemaura also continues to establish strategic partnerships and is diligently working with its partners to develop the launch plan and various subscription options.
Recently the company announced that it has expanded the sugarBEAT® CGM capabilities by launching a new digital health offering, BEAT®diabetes, which focuses on the prevention and reversal of Type II diabetes through a range of holistic app and coaching services encouraging behavioral change. Both BEAT®diabetes and sugarBEAT® target the underserved $69 billion market for Type 2 diabetics and $50 billion market for pre-diabetics. Nemaura is committed to adding additional services aimed at improving the management of diabetes and reversing or preventing Type 2 diabetes. Towards that end, management were pleased to announce a partnership with the award-winning UK-based Changing Health to bring digital behavior programs to improve the management, reversal and prevention of Type 2 diabetes in multiple territories commencing with the United Kingdom and Ireland. Changing Health is a provider of digital coaching services to the National Health Service England aimed at the prevention or reversal of Type 2 diabetes.
Nemaura is embarking on a number of additional initiatives to improve how people with diabetes and prediabetes can manage, reverse and prevent Type 2 diabetes through the BEAT®diabetes health subscription service coupled with the non-invasive sugarBEAT® CGM across the digital health, wearable health-tech and diabetes sectors.
The company has adequate cash on hand and secured a $8 million debt facility which was provided by an existing, long-term investor. The company is believes it is in its strongest position to date, given its cash position, credit line, expected revenues, and the significant potential value of the business offering. In the beginning of December, management decided to effect a 1-for-10 reverse split, which allowed the company to comfortably regain compliance with NASDAQ and affords Nemaura a share price that management believe will enable the company to attract a broader universe of institutional investors. Given the significant progress this year, the company believes the outlook for the business is stronger than ever and it is uniquely positioned to become a leading provider of technology and services within the underserved market for Type 2 diabetics and pre-diabetics, . Management wishes everyone happy and healthy holidays and look forward to providing additional updates as Nemaura continues to execute on its commercial strategy.”
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company commercializing sugarBEAT® and BEAT®diabetes. sugarBEAT® is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which help insulin users, type 2 diabetics and pre-diabetics respectively to better manage, reverse and prevent the onset of diabetes. BEAT®diabetes is a health subscription service providing 1-on-1 lifestyle coaching and behavior change recommendations driven by personalized data provided by sugarBEAT®. Insulin users can also adjunctively use sugarBEAT® for insulin dosage purposes when calibrated by a finger stick reading.
For more information 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’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
Loughborough, England, Dec. 05, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ:NMRD) (“Nemaura”), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for diabetics and pre-diabetics, announced that it has expanded its SugarBEAT® CGM capabilities by launching a new digital health offering, BEAT® Diabetes (www.BEATdiabetes.life), which focuses on the prevention and reversal of Type II diabetes through a range of holistic app and coaching services encouraging behavioural change. Both BEAT® Diabetes and SugarBEAT® target the underserved $69 billion market for Type 2 diabetics and $50 billion market for pre-diabetics.
Combining apps and coaching for patients has been independently and clinically proven to enhance the impact of diabetes management. The full range of services within the BEAT® Diabetes offering, which will be available under a variety of subscription packages, will include an app to track and provide personal lifestyle recommendations to patients according to their blood glucose levels, one-on-one coaching, and routine measurement of other parameters that allow improved disease management through early monitoring. BEAT® Diabetes will track the user’s blood glucose trends and provide information about how their condition is being affected by individual lifestyle factors.
SugarBEAT® is a non-invasive daily-use CGM device, with CE mark approval in Europe, which sits on top of the skin and transmits glucose readings at five minute intervals to a phone app . The flexibility afforded by a daily use wear time allows users to selectively utilize SugarBEAT® on days they prefer. This compares to conventional CGM technologies that require penetration of the skin and extended continuous day usage for periods between 10-14 days, which significantly limits the potential user population.
By combining glucose readings and daily glucose trend data provided by SugarBEAT® with digital coaching and support services provided by BEAT® Diabetes, users will be better able to achieve lifestyle changes to potentially prevent or reverse type II diabetes. Additionally, insulin users who do not currently use any CGMs have a non-invasive flexible CGM alternative, which can empower them with glucose profile data on days of their choosing, to improve management of their glucose fluctuations and allow insulin dose adjustment using confirmatory finger stick readings.
Dr. Faz Chowdhury, CEO of Nemaura, commented, “Diabetes is a global pandemic affecting over 450 million people worldwide. This disease has a major impact not only on individuals, but also employers, healthcare providers and insurers that incur substantial long-term costs to help patients manage their condition. We believe that simple monitoring of glucose is not enough. Patients need access to a variety of methods to better manage their glucose. The combination of our self-monitoring wearable platform with digital support and prompts, as well as one-on-one coaching through the BEAT® Diabetes app is designed to provide greater optionality and flexibility to both patients and payors alike.”
The launch of the BEAT® Diabetes website is intended to allow both individuals and corporate users to register their early interest so that Nemaura can provide them with details of the various subscription packages that will be available. The holistic diabetes management service is also intended to augment sales of SugarBEAT® by its licensees. For more information on the direct-to-consumer and corporate subscription offerings click here, www.BEATdiabetes.life
About SugarBEAT®
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings every five minutes throughout the day. SugarBEAT® is expected to help a person with diabetes and pre-diabetes better track how lifestyle factors can impact daily glucose level trends (known as an Ambulatory Glucose Profile) thereby significantly improving the amount of daily time spent in range. For more information, visit www.SugarBEAT.com.
Nemaura received CE Mark approval for SugarBEAT® as a Class IIb medical device in May 2019. Subsequent to the approval, the Company commenced the first phase of the product launch and has gathered feedback from diabetic and non-diabetic users, enabling fine tuning of the user experience. These findings were reported during a symposia held by the company at the European Association for the Study of Diabetes, held in Barcelona in September 2019, and are available for viewing on the Company’s website (https://nemauramedical.com/easd-symposia-2019).
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company commercializing 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.
For more information 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’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 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:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Loughborough, England, Dec. 04, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura”), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced plans to conduct reverse stock split of the Company’s issued and outstanding common stock, par value $0.001 per share on a one 1 for 10 basis. The reverse split is expected to take effect at the market open on December 5, 2019. The new CUSIP number will be 640442208.
In accordance with the reverse split, each stockholder’s percentage ownership interest in Nemaura Medical remains unchanged. Any fractional shares resulting from the reverse stock split were rounded up to the nearest whole share of common stock. As a result, the number of outstanding shares of common stock are expected to be reduced from approximately 208.1 million to approximately 20.8 million outstanding shares and the authorized shares of common stock are expected to be reduced from 420.0 million to 42.0 million.
Dr. Faz Chowdhury, CEO of Nemaura commented, “Given the recent and exciting developments at the Company, including the commercial rollout launch of SugarBEAT® following CE approval, we decided to effect the reverse split at this time to ensure a share price that we believe will enable us to attract a broader universe of institutional investors. As the world’s first non-invasive, safe, needle-free CGM, SugarBEAT® is uniquely positioned to target the underserved $80 billion market for Type 2 diabetics and pre-diabetics. We are further encouraged by the outlook for the business based on positive feedback from key opinion leaders and end users. We look forward to providing additional updates as we execute on our commercial strategy.”
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing 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 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:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
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