LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible continuous glucose monitor (CGM) for use by people with diabetes and pre-diabetics recently reported financial results for the second quarter ended September 30, 2018.
Recent Highlights and Accomplishments:
• SugarBEAT® reported positive interim data from clinic portion of study, planned for FDA submission.
• Nemaura signed letter of intent for SugarBEAT® commercial launch in Qatar.
• SugarBEAT® reported positive data for potential zero/reduced frequency of finger stick calibration.
• Nemaura successfully developed predictive algorithms that will allow alarm functionality for sugarBEAT®.
Dr. Faz Chowdhury, CEO of Nemaura Medical commented “we have maintained our well capitalised financial position to better support the expected commercial launch of sugarBEAT® in the United Kingdom in the coming weeks. Moreover, we anticipate achieving profitability in a significantly shorter term frame, as compared to other CGM providers, given the research and development costs we have incurred to date have been substantially lower, a trend we are confident will continue as we commercialize sugarBEAT®.”
Second Quarter 2018 results:
Research and development expenses increased to $622,282 for the quarter ending September 2018, an increase of $413,195 for the same quarter in 2017.
General and administrative expenses increased to $525,075 for the quarter ended September 2018, compared with $238,429 for the same quarter in 2017.
The Company’s comprehensive loss was $1,177,758 for the quarter ending September 2018, an increase of $944,036 for the same quarter in 2017.
At September 30, 2018, the Company’s combined cash and bank fixed deposits was $3,786,398.
About Nemaura Medical Inc.
Nemaura Medical (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 to better manage their glucose levels. Insulin users can adjunctively use sugarBEAT® when calibrated with a finger-stick glucose reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals for periods up to 24 hours.
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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
RedChip Companies
Victor Roberts
407-644-4256
victor@redchip.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today announced the successful development of predictive algorithms that will allow the inclusion of alarms in its sugarBEAT® CGM.
This development is expected to make sugarBEAT® more appealing to insulin users, a Total Addressable Market valued at $50Bn. CGM adoption amongst people with diabetes is minimal and growing rapidly, with the U.S. the largest single market, with an estimated 2.6% (630,000 users) of all diagnosed diabetics using CGM in 2018, representing annualized growth of 117%.1
Over the course of the last 14 months Nemaura Medical has gathered and analysed data stemming from over 25,000 paired data points between sugarBEAT® and blood serum samples taken using a venous catheter at 15 minute intervals for 12 consecutive hours. This analysis has led to substantial algorithm improvements, including predictive functionality, allowing alarms to be incorporated into sugarBEAT®.
Results indicate the alarm functionality can predict glucose level 5 minutes in advance with 98% accuracy, 10 minutes in advance with 95% accuracy and 15 minutes in advance with 90% accuracy.
SugarBEAT® is anticipated to receive CE Mark approval in the coming weeks and launch in the United Kingdom shortly thereafter.
SugarBEAT® has the potential to expand the use of CGM amongst people with diabetes and pre-diabetics given it is non-invasive and flexible, as compared to competitor CGMs, which are invasive and designed to be continuously worn for periods of up to seven days or longer.
1 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical Inc.
Nemaura Medical (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 to better manage their glucose levels. Insulin users can adjunctively use sugarBEAT® when calibrated with a finger-stick glucose reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals for periods up to 24 hours.
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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
RedChip Companies
Victor Roberts
407-644-4256
victor@redchip.com
LOUGHBOROUGH, England – Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by persons with diabetes and pre-diabetics, will host an investor webinar and live Q&A session on Tuesday, October 23, at 11:00 a.m. EST.
The webinar will feature a presentation by Dr. Faz Chowdhury, CEO of Nemaura, who will discuss recent developments, key benefits of sugarBEAT® over existing competition, target markets, and plans for the commercial launch of sugarBEAT®, as well as key upcoming milestones.
CGM adoption is growing rapidly amongst diabetics, with the global total addressable market estimated at $82Bn annually. The U.S. is the largest single market, where CGM is being used by an estimated 2.6% (630,000 users) of all diagnosed diabetics in 2018, representing annualised growth of 117%.1
To view the webinar, please visit: https://www.redchip.com/events/32/nemaura-medical-webinar
1 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.
Nemaura Medical (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 to better manage their glucose levels. SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five-minute intervals for periods of up to 24 hours.
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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
RedChip Companies
Victor Roberts
407-644-4256
victor@redchip.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today announced data indicating sugarBEAT® could potentially be used as an adjunctive CGM without the need for finger-stick calibration.
Nemaura retrospectively evaluated a portion of previously completed clinical data for 75 patients (337 in-clinic patient days), using a refined factory calibration constant, based upon newly developed algorithms. 66% of patches worn by 92% of the patients generating 9,863 paired data points were evaluated, with 58% of these paired data points giving a MARD of 13.61%. Nemaura further noted 73% of these paired data points gave a MARD of 17.83%.1
Nemaura is currently undertaking additional data analysis, to potentially allow sugarBEAT® to be used with zero or reduced frequency finger-stick calibration.
Nemaura previously published an interim data set on September 12, 2018, from an in-clinic portion of a FDA study which indicated a MARD of 12.19% (at 30% / 30mg / gL) was achievable (on 80% of all data) with a single finger-stick calibration, and a MARD of 10.65% was achievable (on 88% of data) with two finger-stick calibrations, over a 14 hour wear period.1
Current CGM adoption is minimal and growing rapidly amongst people with diabetes, with the global total addressable market estimated at $82Bn annually. The U.S. is the largest single market, with CGM being used by an estimated 2.6% (630,000 users) of all diagnosed diabetics in 2018, representing annualized growth of 117%.2
SugarBEAT® is anticipated to launch in the UK in the coming months, and is intended to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics.
1 Further detailed summary of the results are available on the publications page of the company’s website.
2 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical Inc.
Nemaura Medical (NASDAQ:NMRD) is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to provide people with diabetes and pre-diabetics with an Ambulatory Glucose Profile (AGP) as a superior metric to better manage their glucose levels as compared to an HbA1c reading. Insulin users can adjunctively use sugarBEAT® when calibrated with a finger-stick glucose reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals for periods up to 24 hours.
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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by persons with diabetes and pre-diabetics, today announced that it has signed a non-binding letter of intent for an exclusive licensing agreement with Al-Danah Medical Co for the commercial launch of sugarBEAT® in Qatar. A final binding license agreement between Nemaura and Al-Danah is scheduled for completion by November 16, 2018 in readiness for anticipated 2019 Qatar product launch.
Qatar has one of the world’s highest prevalence of diabetes, with 17% of the population diabetic and 23% pre-diabetic1, and also has the world’s highest GDP per capita, and is therefore a significant potential market for sugarBEAT®. Al-Danah Medical Company, part of the Almana Group, is a leading medical product distributor in Qatar, representing multiple global brands.
CGM adoption is growing rapidly amongst diabetics, with the global total addressable market estimated at $82Bn annually. The U.S. is the largest single market, where CGM is being used by an estimated 2.6% (630,000 users) of all diagnosed diabetics in 2018, representing annualised growth of 117%. 2
1 https://www.hamad.qa/EN/All-Events/mefqsh2017/presentations/Documents/Sunday/D6E6_Diabetes.pdf
2 PiperJaffray Company Note DXCM Sep 5, 2018
About Nemaura Medical, Inc.
Nemaura Medical (NASDAQ:NMRD) is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to provide persons with diabetes and pre-diabetics with an Ambulatory Glucose Profile (AGP) as a superior metric to better manage their glucose levels as compared to an HbA1c reading. Insulin users can adjunctively use sugarBEAT® when calibrated with a finger-stick glucose reading.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five-minute intervals for periods of up to 24 hours.
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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
or
The Ruth Group
Lee Roth
646-536-7012
lroth@theruthgroup.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by persons with diabetes and pre-diabetics, today reported data from an interim analysis of the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product.
The interim results consisted of 25 patients, split approximately equally between Type I and Type II diabetics1. The study was conducted in a clinic setting, and blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 75 patient days. Blood samples were measured using an Architect c8000 Laboratory Instrument.
9,371 data points were analysed in total, consisting of 4,630 and 4,741 paired data points analysed using 1-point and 2-point calibration respectively. The MARD (Mean Absolute Relative Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19% (80% of all data), and for the 2-point calibration the MARD was 10.65% (88% of all data)). The results are in line with the company’s expectations, and compare favorably with competitor products.
SugarBEAT® is expected to launch in the UK in the coming months, and is expected to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics. Continuous Glucose Monitoring (CGM) is estimated to have a global total addressable market worth $82Bn. The U.S. has the largest number of CGM users, where 2018 usage numbers are estimated at 630,000 insulin users, representing 2.6% of 24.6 million people who have been diagnosed with diabetes.2
Nemaura previously reported data from the home-use portion of the same study, whereby 121 matched pair points between the Blood Glucose Meter and sugarBEAT® were evaluated, which indicated 84.3% of the data points had an overall MARD of 10.63%, and an overall nominal MARD of 16.3% (compared with 14.8%, 16.3% and 18% for Eversense, Dexcom G5 and Abbott Libre Pro respectively1).
Completion of U.S. study and FDA submission is anticipated in Q1 2019, alongside poster presentation at the Advanced Technologies & Treatment for Diabetes (ATTD) conference in Berlin in February 2019 for the full in-clinic portion, which is designed to record approximately 16,000 matched data points.
1Further detailed summary of the results are available on the publications page of the company’s website.
2As stated in PiperJaffray DXCM Company Note Sep 5th 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) for use by persons with diabetes and pre-diabetics. 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 rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
or
The Ruth Group
Lee Roth
646-536-7012
lroth@theruthgroup.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive glucose trending device for use by persons with diabetes and pre-diabetics today announced it has expanded its manufacturing team with the appointments of Omar Farooq as Project Manager and David McLachlan as a Project Director, both of whom bring substantial expertise to the company.
Dr. Faz Chowdhury CEO of Nemaura Medical commented, ‘We are delighted to have Omar and David join our team, and are confident in their combined ability to support and guide the company’s manufacturing scale-up from initial launch in the United Kingdom, to a global launch in multiple territories.’
These appointments are intended to supplement Nemaura’s existing team of engineers, scientists and outsourced service providers as preparations continue for launch of sugarBEAT® in the coming months.
Omar is a chartered chemical engineer with 20 years of regulated industry experience across the full engineering lifecycle, including design, construction, commissioning, operation and process optimisation.
David will be directing the manufacturing and qualification strategy across multiple sites, to facilitate seamless transition into commercial launch and subsequently the scale up to support launches in multiple territories worldwide. David has an honours degree from Herriot Watt University, Edinburgh and over 25 years of experience in the healthcare industry. Most recently, he played a pivotal role in creating the manufacturing capability for the launch of a new blood glucose monitoring strip for a leading test strip manufacturer. This work included developing business cases for various manufacturing options, vendor selection and approval, and enhancing process throughput.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose trending device for use by persons with diabetes and pre-diabetics.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals over periods up to 24 hours.
SugarBEAT® can additionally be used by insulin using persons with diabetes as an adjunctive glucose monitoring device 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 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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
or
The Ruth Group
Lee Roth
646-536-7012
lroth@theruthgroup.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive glucose trending device for use by persons with diabetes and pre-diabetics today reported financial results for the first quarter ended June 30, 2018.
Recent Highlights and Accomplishments:
• SugarBEAT® commenced clinical trials for FDA approval and reported positive interim data from home-use portion of study.
• With its approved contract manufacturers, Nemaura commenced manufacturing scale-up in preparation for anticipated launch in the United Kingdom in the coming months.
• Nemaura placed an initial order with UK contract manufacturer for 12,500 sugarBEAT® rechargeable transmitters, which will be supplemented with approximately 100,000 skin-patches per month.
Dr Faz Chowdhury, CEO of Nemaura Medical commented “we have maintained our well capitalised financial position whilst incurring significant additional costs from commencing FDA clinical trials and scaling up our systems in readiness for anticipated UK commercial launch of sugarBEAT® later this year. This financial strength should allow us to start to generate sales revenues without requiring additional capital.”
First Quarter 2018 results:
Research and development expenses increased to $429,539 over the quarter ending June 2018, an increase from $149,198 for the same quarter in 2017.
General and Administrative expenses increased to $342,424 for the quarter ending June 2018, compared to $268,122 for the same quarter in 2017.
The Company’s comprehensive loss was $997,763 for the quarter ending June 2018, an increase of $792,731 for the same quarter in 2017.
At June 30, 2018, the Company’s combined cash and bank fixed deposits was $4,941,042.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose trending device for use by persons with diabetes and pre-diabetics.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals over periods up to 24 hours.
SugarBEAT® can additionally be used by insulin using persons with diabetes as an adjunctive glucose monitoring device 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 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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
or
The Ruth Group
Lee Roth
646-536-7012
lroth@theruthgroup.com
LOUGHBOROUGH, England. Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive glucose trending device for use by persons with diabetes and pre-diabetics today announced it has initiated the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product, and further announced positive interim results from the home-use portion of this initial study.
The interim results evaluated data from 25 patients, split approximately equally between Type I and Type II diabetics, each wearing sugarBEAT whilst going about their daily home/work routine for 1 or 2 non-consecutive days, for a total of 36 patient days. Each patient recorded up to 5 finger prick readings per day, at approximately equal intervals, over periods up to 14 hours. Readings were measured using the Abbott Freestyle Optimum neo Blood glucose meter (BGM).
The results analysed 121 matched pair points between the BGM and sugarBEAT®, and indicated 84.3% of the data points had an overall MARD (Mean absolute relative deviation) of 10.63%, and an overall nominal MARD of 16.3% (compared with 14.8%, 16.3% and 18% for Eversense, Dexcom G5 and Abbott Libre Pro respectively*). It is the first time the company has published data from a home use study, which replicates all the challenges of real-world usage, and the data compares favorably to existing CGMs.
The initial U.S. study is expected to enroll a total of 75 patients wearing the device over a 7-day period, including 3 days in a clinical setting (525 total patient days; 225 total in-clinic days). Initial U.S. study completion and FDA submission is anticipated in Q1 2019, alongside poster presentation at ATTD in Berlin in February 2019 for the in-clinic portion, which is designed to record approximately 16,000 matched data points.
SugarBEAT® is expected to launch in the UK, followed by other territories upon achieving CE approval, which is anticipated in the coming months.
*Further detailed summary of the results are available on the publications page of the company’s website.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose trending device for use by persons with diabetes and pre-diabetics.
SugarBEAT® consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
SugarBEAT® can additionally be used by insulin using persons with diabetes as an adjunctive glucose monitoring device 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 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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
or
The Ruth Group
Lee Roth
646-536-7012
lroth@theruthgroup.com
LOUGHBOROUGH, England–(BUSINESS WIRE)–Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing the wireless sugarBEAT® non-invasive glucose monitoring system for adjunctive use by persons with diabetes, today announced it has placed an initial order with its designated UK-based contract manufacturer for 12,500 sugarBEAT® rechargeable transmitters, which will be supplemented with approximately 100,000 skin-patches per month, also manufactured in the UK, in preparation for the anticipated sugarBEAT® product launch in the coming months.
SugarBEAT® consists of a daily-disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals, and is expected to launch initially in the United Kingdom, upon CE Mark approval.
Dr Faz Chowdhury, CEO and chair of Nemaura Medical commented ‘We expect this initial order will support the successful launch of sugarBEAT® in the UK later this year, and also develop the capacities needed for subsequent scale up and launch in other countries which accept the CE Mark.’
Nemaura Medical recently completed a sugarBEAT® European three-stage clinical trial program consisting of 75 patients over 525 patient days in total, and have used this data to support their CE Mark application. A predecessor sugarBEAT® device, based on a wired wrist-watch form factor, received CE Mark approval in 2016.
About Nemaura Medical, Inc.
Nemaura Medical Inc. (NASDAQ: NMRD), is a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible glucose monitoring system for adjunctive use by persons with diabetes.
SugarBEAT® consists of a daily-disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
For more information, please visit www.NemauraMedical.com and 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 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.
Contacts
Nemaura Medical Inc.
Bashir Timol
Chief Business Officer
bashir.timol@nemauramedical.com
or
The Ruth Group
Lee Roth
646-536-7012
lroth@theruthgroup.com
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