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Loughborough,England, May 29, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that it has received CE Mark approval for SugarBEAT®. With this Approval, Nemaura is permitted to commence sales of SugarBEAT® throughout the European Union.
Key Highlights:
Dr. Faz Chowdhury, CEO of Nemaura, said, “We are very pleased to report CE Mark approval in Europe for SugarBEAT®, which is the world’s first non-invasive, needle-free, continuous glucose monitor (CGM). Importantly, as a daily disposable adhesive skin-patch that sits on the surface of the skin, SugarBEAT® is painless, and versatile in terms of wear time. Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets. In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth. Due to the non-invasive nature of the sensor patch and connection to a rechargeable transmitter, SugarBEAT® will allow users the freedom to decide when, and for how long to wear the patch. Moreover, we have a unique competitive advantage, which we believe will make SugarBEAT® the lowest priced CGM device in the industry. SugarBEAT® is protected by a solid IP portfolio with over 30 issued and pending patents across multiple patent families.”
Continuous Glucose Monitoring has transformed diabetes management by providing real-time, continuous glucose readings, typically at 5 min intervals (12 per hour) which accumulate to provide an Ambulatory Glucose Profile (AGP) whereby glucose profiles over multiple days can be overlaid to observe trends, patterns, and the extent of fluctuations and out of range glucose profiles.
Dr. Chowdhury continued, “SugarBEAT® is unique in that it can be worn on non-continuous days, enhancing the flexibility and price savings. As a result, we plan to initially target the Type II diabetes market (95% of diabetics) who have traditionally relied on periodic A1c readings (every 3-6 months) to manage glucose levels. A1c measurements have significant limitations in that they are derived from a lab blood test providing a single value representing the average glucose level over the past 60-90 days. In contrast, CGM transforms glucose control by widening the focus from the limited ‘gold standard’ A1c metric to more meaningful ‘time in range’ (TIR) metric—measuring how much time per day glucose is kept within the normal range. The SugarBEAT® smartphone app displays glucose readings every five minutes for the duration of wear. Independent studies have shown that diabetes can be put into remission if glucose levels are consistently maintained in range. SugarBEAT® may also reduce the frequency of daily ‘finger prick’ tests utilized by many diabetics.”
The CE Mark approval includes recently added predictive alerts to the product design, which provide visual indication when glucose levels are falling or rising above minimum and maximum thresholds. Additional audible alerts or physical vibration of the Bluetooth-enabled mobile phone connected to SugarBEAT® occur in instances where glucose levels are deemed to fall to dangerously low levels, until switched off by the user.
“The inclusion of our new predictive alert capabilities will also have particular appeal to Type I diabetics who are at higher risk of hypoglycemia, or very low glucose levels. Insulin users can adjunctively use SugarBEAT® when calibrated with a finger-stick glucose reading. In addition, given the flexibility and non-invasive nature of the device, we look forward to targeting the growing $60 billion wearable health tech market through partnerships with leading smartphone and wearable manufacturers. Researchers, physicians and health-conscious consumers are increasingly recognizing the importance of maintaining glucose within appropriate ranges to minimize long-term health complications,” added Dr. Chowdhury.
The Company’s clinical studies were split between Type I and Type II diabetics and consisted of 75 patients over 225 patient days. The studies generated over 12,000 paired data points, with blood samples taken via catheter every 15 minutes over a 12-hour period for three non-consecutive days for each patient. The study design was based on two previous pre-sub meetings Nemaura held with the FDA, ensuring that the study would provide statistically valid results. The clinical study results indicated a MARD (Mean Absolute Relative Difference) of 11.92% (with a lower figure denoting greater accuracy), using a single point finger stick calibration. No device-related adverse events were noted. The Company remains on track to apply for FDA approval in mid-2019.
To view a video of SugarBEAT®, please visit https://sugarbeat.com/introducing-sugarbeat/
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Allows 3rd Party Applications to Directly access SugarBEAT® CGM Data
Loughborough, England , May 02, 2019 (GLOBE NEWSWIRE) — – Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced it will allow third-party applications, such as diabetes management, exercise and nutrition focused apps royalty free access to SugarBEAT® CGM app data. As a result, users will be able to directly access SugarBEAT® generated glucose data through their preferred participating mobile aplications, empowering users with greater choice over when to use this data to better understand how food choices and other lifestyle factors impact glucose levels.
This development is part of the Company’s broader go-to-market strategy, which is being led by Dr. Fred Schaebsdau. Dr. Schaebsdau joined the Company earlier this year to advance the commercialization and business development of SugarBEAT®, building on his success with earlier CGM products at Abbott Diabetes Care and Dexcom Germany.”
Dr. Schaebsdau commented, “We believe integrating SugarBEAT® data into the leading health and fitness apps will help to expand our target market among health-conscious consumers, providing them with seamless access to their CGM data within a familiar environment, which will assist in understanding how diet, sleep, stress, exercise and other lifestyle factors can impact glucose levels. Given SugarBEAT® is non-invasive, we believe it is uniquely placed amongst CGMs to appeal to the health-conscious consumer market. ”
Dr. Faz Chowdhury, CEO of Nemaura, commented, “We expect this integration will also benefit diabetics and pre-diabetics by making it easier for them to access CGM data through their preferred diabetes, fitness or wellness App as well as providing insurers, healthcare providers, and fitness coaches with new tools to help their patients and clients keep their glucose levels in normal range for longer.”
To view a video of SugarBEAT®, please visit https://sugarbeat.com/introducing-sugarbeat/
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Final step required prior to filing de novo application to the U.S. Food and Drug Administration
Loughborough, England , April 23, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that it has successfully completed two summative human factors usability studies for SugarBEAT®. The usability studies were conducted according to the U.S. Food and Drug Administration (FDA) guidance on ‘Applying Human Factors and Engineering to Medical Devices,’ in preparation for submission of its medical device application to the FDA for SugarBEAT®.
The two studies consisted of 16 participants each, including both Type I and Type II diabetics. Participants in the first and second study ranged from ages 18-50 and 51-70, respectively. The studies were designed to ensure adequate information was captured for the diverse age groups expected to use SugarBEAT®. The objective of the two studies was to confirm that the user interface aspects of SugarBEAT® met the FDA guidelines for medical devices.
Dr. Faz Chowdhury, CEO of Nemaura, commented, “We are pleased to have successfully completed these important studies and we are preparing our FDA filing at this time. We anticipate broader adoption of SugarBEAT® as compared with competitive offerings given SugarBEAT® is non-invasive with flexible wear time, and will be attractively priced.”
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Enhances Product Capabilities in Advance of CE Mark Approval
April 16, 2019 – Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that it has incorporated new predictive alert functionality into SugarBEAT®.
Alerts have been designed to provide visual indication when glucose levels are falling or rising above minimum and maximum thresholds. Additional audible alerts or physical vibration of the Bluetooth-enabled mobile phone connected to SugarBEAT® will occur in instances where glucose levels are deemed to fall to dangerously low levels, until switched off by the user.
British Standards Institute (BSI), Nemaura’s designated European Notified Body, has accepted Nemaura’s proposed plan to incorporate these alerts into the current CE Mark application, and BSI is currently reviewing the supporting verification and quality related documentation.
Dr. Faz Chowdhury, CEO of Nemaura, said, “While the non-invasive nature of SugarBEAT® opens up the CGM market to Type 2 diabetics and pre-diabetics, the inclusion of these alerts will particularly appeal to Type 1 diabetics who are at higher risk of hypoglycemia, or very low glucose levels. Adding the alerts and alarms, based on predictive algorithms, as part of the current CE review process avoids the need for a subsequent CE application thus shortening the time that it would have otherwise taken to integrate these key features in the device. Even with these additions, we remain on track for CE Mark approval followed by our commercial launch later this year.”
Upon receiving CE Mark approval, Nemaura’s plan is to initially launch SugarBEAT® in the United Kingdom, where the addressable market for CGM is valued at over $1.3 billion. The overall global addressable market for CGM is estimated at $82 billion per year, and the U.S. market alone is estimated at $13 billion1. Given that SugarBEAT® is non-invasive, coupled with its affordability and flexibility, the Company expects to become a dominant player in this market.
To view a video of SugarBEAT®, please visit http://sugarbeat.com/introducing-sugarbeat/
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
1 PiperJaffray Company Note DXCM Sep 5, 2018
Announces SugarBEAT® Awaiting CE Mark Approval; On Track for FDA submission in Q2 2019
Loughborough, England, March 28, 2019 (GLOBE NEWSWIRE) —
Loughborough, England – March 28, 2019 – Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today provided the following letter to shareholders from the Company’s CEO, Dr. Faz Chowdhury, following the Company’s recent shareholder meeting held on Friday, March 22, 2019:
To our valued shareholders,
We are off to a strong start in 2019, and I wanted to take this opportunity to provide a more detailed update on our achievements and plans for the balance of this year.
Intellectual Property Portfolio
Earlier this year, we announced the grant of U.S. Patent 10,092,224, “Cumulative Measurement of an Analyte.” We filed two new patent applications to protect intellectual property around the sensor and methods of application of the device, which will not be published for at least a further 12 months, providing us with additional protection in the interim. Our improved algorithms allow sensing to occur in sub-five-minute intervals, which, in turn, enable predictive alarms so patients or users can be alerted more frequently than if the measurements were made at less frequent intervals. We believe this predictive capability will help expand the appeal of our product to Type 1 diabetics who are at higher risk of hypoglycemia, or very low glucose levels. Overall, we continue to build an extensive intellectual property portfolio, which will position us to become a leader in the non-invasive CGM space.
Technology Enhancements
Skin-patch warm-up periods have been greatly reduced from our previous warm up periods of over an hour, to a warm-up period of less than 30 minutes. This is important as patients or users will be able to observe their glucose trends very soon after application of the skin-patch, which we believe will result in increased adoption of the device.
We have progressively built on our state-of-the art platform to develop a world-first, non-invasive, Continuous Glucose Monitor (CGM), which will be priced to be affordable. SugarBEAT® uniquely offers patients or users flexibility as to when and for how long they wear the device, empowering patients or users rather than making them dependent on technology. Overall, we expect the device will help people with diabetes to better manage their glucose levels by spending more time in range. With over 420 million diabetics worldwide and the number of pre-diabetics at almost three times this number, diabetes is a global healthcare concern and we believe SugarBEAT® is positioned to become a market leader, as it is expected to allow a person with diabetes or pre-diabetics to better track how lifestyle factors can impact daily glucose level trends thereby significantly improving the amount of daily time spent within a healthy glucose range.
Approval Timelines for Anticipated Commercial Launch
We continue to make significant progress towards completion of our CE Mark. We are working closely with our designated European Notified Body, British Standards Institute (BSI), a global leader in accreditation services, on a Fast Track application. The clinical review was completed in December 2018, and based on the ongoing dialogue, we are now in the final stages of the review process, after which Nemaura expects CE approval will be issued. We have made further enhancements to the product as agreed to by BSI, and look forward to providing a comprehensive update in the coming weeks.
Regarding the U.S. Food & Drug Administration (“FDA”), we recently announced that we have successfully completed the clinical studies needed to support our FDA submission for approval of SugarBEAT® in the USA. The clinical studies used were split between Type I and Type II diabetics, and consisted of 75 patients over 225 patient days. The studies generated over 12,000 paired data points, with blood samples taken via catheter every 15 minutes over a 12-hour period for three non-consecutive days for each patient. The study design was based on two previous pre-sub meetings Nemaura held with the FDA, ensuring that the study meet adequacy requirements to provide statistically valid results.
The clinical study results indicated a MARD (Mean Absolute Relative Difference) of 11.92% (with a lower figure denoting greater accuracy), using a single point finger stick calibration. No device-related adverse events were noted. We are currently preparing our dossier for FDA submission.
Corporate Finance
We filed a Form S-3 “shelf registration” with the Securities and Exchange Commission (SEC), whereas the previous shelf registration already on file is set to expire this month. The registration provides the Company continued flexibility to raise capital if and when needed to execute on our growth strategy. Clearly, we are very cognizant of dilution, especially with our upcoming milestones and, therefore, will be mindful and selective regarding the timing and pricing of any future capital raise.
Outlook
The outlook for the business is extremely encouraging and we are confident in our ability to secure regulatory approval in the foreseeable future. Moreover, the global addressable market for CGM is estimated at $82 billion per year, and over $13 billion in the U.S. alone. Our product includes significant and unique features that the competition does not provide, in particular the non-invasive nature of the device and the flexible wear period. We believe these advantages will allow SugarBEAT® to become adopted by a very large and diverse patient and user group, thus driving shareholder value.
We highly value each of you, our shareholders, and thank you for placing your confidence in us as we move efficiently towards commercial launch of SugarBEAT®.
Sincerely,
Dr. Faz Chowdhury, CEO, Nemaura Medical
About Nemaura Medical, Inc.
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Attachment
Loughborough, England , March 12, 2019 (GLOBE NEWSWIRE) — Loughborough, England – March 12, 2019 – Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that it has signed an exclusive license and supply agreement for SugarBEAT® with TPMENA in the Gulf Cooperation Council (GCC) Region, which includes Bahrain, Kuwait, Saudi Arabia, Oman and United Arab Emirates. See http://www.tpmena.com/
TPMENA is a distributor of medical devices in the GCC Region, backed by Cigalah group. See https://naghi-group.com/ . TPMENA is headquartered in Saudi Arabia, which markets and sells many of the leading brands of medicines and medical devices. The GCC Region has more than 35 million diabetics, with data from the International Diabetes Federation showing prevalence of the disease has reached 23.9% of the adult population in Saudi Arabia and 23.1% in Kuwait, which is more than twice the global average of 8.3%.
Dr. Faz Chowdhury, CEO of Nemaura Medical, commented, “The GCC Region is a key market for SugarBEAT® because the prevalence of diabetes is one of the highest in the world. We are delighted to be involved with TPMENA, which brings an extensive network and proven track record. Over the past year, we have established a strong relationship with senior management of TPMENA and have full confidence that TPMENA is an exceptional partner for SugarBEAT®. Prior to entering into the agreement, TPMENA conducted extensive market research, with very positive feedback from both consumers and key opinion leaders. We look forward to accelerating the registration processes required for an aggressive GCC commercial launch of SugarBEAT® upon receipt of CE Mark approval.”
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
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
Attachment
Loughborough, England – Nemaura Medical, Inc. (NASDAQ: NMRD) nemauramedical.com, a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, yesterday reported financial results for the third quarter ended December 31, 2018.
Recent Highlights and Accomplishments:
Nemaura Signed License and Distribution Agreement for SugarBEAT® Commercial Launch in Qatar
Nemaura Successfully Completes Clinical Studies for SugarBEAT® FDA De-Novo 510(k) Submission
Nemaura Raised Circa $2M in Public Offering
Nemaura Completed Key Stages of Technical File Review for SugarBEAT® CE Mark Approval
Nemaura Announced Improvements to SugarBEAT® Warm Up Period
Nemaura Announced Grant of U.S. Patent for SugarBEAT®
Nemaura Announced Dr. Fred Schaebsdau to Lead Strategy and Business Development
Dr. Faz Chowdhury, CEO of Nemaura Medical, commented, “Over the past quarter, we have bolstered our financial position to better support the upcoming commercial launch of SugarBEAT® and filing of our FDA 510(k) submission.”
Third Quarter 2018 results:
Research and development expenses increased to $443,380 for the quarter ended December 2018, an increase of $88,080 for the same quarter in 2017.
General and administrative expenses increased to $489,545 for the quarter ended December 2018, compared with $121,053 for the same quarter in 2017.
The Company’s comprehensive loss was $964,515 for the quarter ended December 2018, an increase of $534,791 for the same quarter in 2017.
At December 31, 2018, the Company’s cash was $5,040,661.
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
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:
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
Dr. Schaebsdau to Advance European Launch of SugarBEAT® Continuous Glucose Monitor
Nemaura Preparing U.S. FDA 510(k) Submission
Loughborough, England – February 11, 2019 – Nemaura Medical, Inc. (NASDAQ: NMRD) nemauramedical.com, a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that Dr. Fred Schaebsdau, MD, PhD, MBA has joined Nemaura to lead strategy and business development. Dr. Schaebsdau will advance Nemaura’s commercial strategy for its planned launch of SugarBEAT® in Europe, and advise regarding its upcoming 510(k) submission to the United States Food and Drug Administration. He will also be named to Nemaura’s Scientific Advisory Board.
Dr. Schaebsdau has over 15 years of executive level experience in the CGM, Blood Glucose Monitoring (BGM) and insulin delivery industries, which started in 2004 during his tenure with Abbott Diabetes Care, where he was a member of the M&A and post-merger integration teams responsible for the acquisition of TheraSense and its FreeStyle Navigator CGM. From September 2016 until January 2019, he was the General Manager of Dexcom Germany, which during his leadership became the fastest growing organization in Dexcom’s history achieving triple digit revenue and new patient growth every year. Two generations of CGM, G5 and G6, were successfully launched and negotiations with public insurers completed, which resulted in full reimbursement for >85% of the German population. From 2009 until August 2015, at Roche Diabetes Care, he was Senior Vice-President, Head of Global Strategy and Business Development, completing several strategic acquisitions, partnerships and licensing deals. In September 2015, he founded his own firm as exclusive distributor in Europe, the Middle East and Africa for UniStrip®, the world’s first generic blood glucose test strip. Since September 2015, he is a member of the Advisory Board of Peppermint Venture Partners.
Dr. Schaebsdau studied Medicine at the University of Giessen and completed residencies in urology and surgery at the University of Chicago, University of Hannover and University of Freiburg. He is licensed to practice medicine in the U.S. and Germany. During his residency at the University of Hannover, he conducted primary research in neurophysiology with a grant from the DFG (Deutsche Forschungsgemeinschaft) and completed his PhD. In 1993, he received an MBA from The Wharton School of the University of Pennsylvania.
Commenting on the appointment, Dr. Faz Chowdhury, CEO of Nemaura, stated, “We are moving rapidly towards launch of SugarBEAT® in Europe and we are looking to accelerate our entrance into the United States market and are planning our submission to the FDA Human Factors Premarket Evaluation Team and we are honored that Dr. Schaebsdau has agreed to lead our European launch and assist us with the FDA 510(k) process as a Member of our Scientific Advisory Board. We are confident that Dr. Schaebsdau will help us advance our sales platform in Europe and that his oversight will help us to expedite our FDA submission. We look forward to leveraging his expertise and knowledge as we move towards commercialization and as we navigate the scientific and regulatory environments, and connect to the broad network of respected leaders in the Diabetes space.”
“The non-invasive, flexible and affordable nature of SugarBEAT® has the potential to really open up the CGM market to all diabetics, pre-diabetics and non-diabetics seeking to better manage their diet, weight and physical fitness,” said Dr. Schaebsdau. “Nemaura’s approach is truly innovative and the addressable market is global and enormous. I am honored to be involved in Nemaura’s important mission.”
About Nemaura Medical, Inc.
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
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:
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
Loughborough, England – February 7, 2019 – Nemaura Medical Inc. (NASDAQ: NMRD) nemauramedical.com, a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (“CGM”) for use by diabetics and pre-diabetics, today announced the grant of U.S. Patent 10,092,224, Cumulative Measurement of an Analyte.
SugarBEAT® CGM utilizes a proprietary, daily disposable adhesive skin-patch system 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.
SugarBEAT®️ utilizes an ultra-sensitive glucose oxidase-based sensor to detect actual glucose concentrations, which are then processed by the algorithm on the mobile application. Previously, a notable sensor limitation was that it required glucose depletion and therefore fifteen minute intervals between readings.
The newly granted patent allows sensing to occur in sub-five-minute intervals by allowing for cumulative measurements to be taken and processed by the algorithm rather than waiting for complete depletion of glucose concentrations. This allows better utility of predictive alarms as patients or users can be alerted more frequently than if the measurements were made at intervals of fifteen minutes or more. This patent, which has filed in multiple jurisdictions worldwide and has now been granted in the U.S., builds on Nemaura’s robust intellectual property portfolio.
Globally, there are more than 400M diabetics and 1B pre-diabetics. The annual addressable market for CGM for diabetics (excluding pre-diabetics) is estimated at $82B, with the U.S. market estimated at $13B. CGM adoption among diabetics is growing rapidly; the U.S. market saw 117% growth in 2018. To date, the measurable CGM market pertains mostly to insulin-using diabetics, a potential population of approximately 20% of all diabetics. Therefore, while the U.S. is the largest single market for CGM globally, it is estimated that the 630,000 diagnosed diabetics using CGM in the U.S. in 2018 represent just 2.6% of that total addressable market. (1)
1 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (“CGM”) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
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® 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 most recently filed Annual Report on Form 10-K, 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.
Contact
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
Loughborough, England –Nemaura Medical, Inc. (NASDAQ: NMRD) nemauramedical.com a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that it has substantially advanced the use-case for SugarBEAT® to improve management of glucose levels by spending more time in range.
SugarBEAT® CGM utilizes a proprietary daily disposable adhesive skin-patch system 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.
Nemaura has previously achieved industry-leading, skin-patch warm-up periods of less than one hour meaning that reliable glucose readings can be expected one hour after application of the skin-patch. Following optimization, Nemaura is now confident that in commercial application, this warm-up period can be halved to 30 minutes.
This is significant because it provides users with greater flexibility, for instance, for users who wish to wear the skin-patch for a few hours daily. By comparison, the leading CGM on the market requires a two-hour warm-up period (or delay before reliable reporting of glucose levels) and is designed to be worn continuously for 10 days.
“We are very proud of these latest improvements in warm-up times for SugarBEAT®, which enable a CGM solution for the 80% of diabetics that are not insulin-users as well as pre-diabetics,” commented Doctor Faz Chowdhury, CEO of Nemaura. “The flexibility of SugarBEAT® will be a key differentiating factor with the potential to reach the largest number of diabetics and provides Nemaura with the opportunity to expand into new markets.”
Globally, there are more than 400M diabetics and 1B pre-diabetics. The annual addressable market for CGM for diabetics (excluding pre-diabetics) is estimated at $82B, with the U.S. market estimated at $13B. CGM adoption among diabetics is growing rapidly; the U.S. market saw 117% growth in 2018. To date, the measurable CGM market pertains mostly to insulin-using diabetics, a potential population of approximately 20% of all diabetics. Therefore, while the U.S. is the largest single market for CGM globally, it is estimated that the 630,000 diagnosed diabetics using CGM in the U.S. in 2018 represent just 2.6% of that total addressable market. (1)
1 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
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® 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.
Contact
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
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