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24th April 17, Loughborough, UK. Nemaura Medical Inc. (OTCBB: NMRD), a medical device company has today announced the successful completion of the development and testing of its second-generation sugarBEAT® wireless skin-patch as a non-invasive, needle-free Continuous Glucose Monitoring (CGM) system for use by diabetics. The first-generation sugarBEAT® received CE approval in Q1 2016, as a wired wrist-watch based non-invasive, needle-free CGM system.
Clinical trials on the second-generation sugarBEAT® wireless skin-patch will be underway soon with a view to submitting CE approval mid-year. Nemaura Medical expects to launch sugarBEAT® in Europe later this year through its European Licensee.
The daily-disposable format of the sugarBEAT® skin-patch is expected to provide a much more flexible way for diabetics to better manage their glucose levels. Furthermore, sugarBEAT’s® cost-effective design, consisting of a reusable Bluetooth-enabled body-worn transmitter containing a low-cost disposable adhesive skin-patch will make CGM more affordable, especially for non-insulin-injecting diabetics.
Nemaura Medical CEO Dr Faz Chowdhury said: “Adopting a wireless skin-patch format has allowed us to seamlessly integrate our needle-free technology with a diabetic’s own smart device. We have also further refined and enhanced our sensor performance, and are confident that this year’s clinical trials will confirm the efficacy of sugarBEAT® in helping to improve personal healthcare management for anyone living with diabetes. ”
Alongside the sugarBEAT® wireless skin-patch, Nemaura has also successfully developed and tested the associated sugarBEAT® mobile phone application. This Medical-grade App connects by Bluetooth to the skin-patch and displays glucose readings on a continuous basis as well as providing summary Ambulatory Glucose Profile (AGP) trends. The App also allows for additional manual lifestyle inputs helping diabetics to better understand and manage their condition.
About Nemaura Medical, Inc.
Nemaura Medical is developing the daily-disposable wireless sugarBEAT® adhesive skin-patch as a non-invasive, needle-free, pain-free and affordable continuous glucose monitoring (CGM) system for adjunctive use by diabetics. Further opportunity may exist in intensive-care hospital settings, where continuous glucose monitoring is critical.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura Medical’s ongoing studies, including the safety and efficacy of Nemaura Medical’s sugarBEAT® CGM system, the failure of future development and preliminary marketing efforts, Nemaura Medical’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura Medical and its partners’ ability to develop, market and sell sugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to sugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura Medical’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura Medical undertakes no obligation to publicly update or revise any forward-looking statements.
Investors / Media contact:
Bashir Timol
Nemaura Medical Inc.
bashir.timol@nemauramedical.com
March 15th, 2016, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless continuous glucose monitoring (“CGM”) system known as sugarBEAT®, announced today that it has received notification of CE Approval for its sugarBEAT® system from its European Notified Body. The device for which CE grant notice has been approved was used in a 160 patient day study generating over 1500 paired data points, and retrospective evaluation of the glucose data. Nemaura expects the CE certificate to be received in April, upon completion of its 3-yearly ISO13485 Quality Systems recertification process, for which it was audited at the end of February 2016.
The sugarBEAT® CGM System is a body worn sensor patch designed to display real time glucose readings on a standalone reader, or smart watch or smart phone app via blue tooth, or allow retrospective evaluation of the data for glucose trending, as an adjunct device. A comprehensive 10 year study, The Diabetes Control and Complications Trial, funded by the National Institute of Diabetes and Digestive and Kidney Disease showed that maintaining better control over blood sugar levels delayed the onset and progression of complications of diabetes, including diseases of the eye, kidney and nerve damage, caused by diabetes.
Nemaura’s system is expected to empower patients to gain better control over their blood sugar levels using the minimally-invasive sugarBEAT® system, which is expected to be cost efficient compared to current marketed CGM’s as well as allow the user to decide when to wear the patch, and not have to retain the patch on the skin permanently. Nemaura are quoted as saying ‘one of the key reasons people have cited for not using current CGM’s, apart from cost, is their invasive nature and the need to retain the device on the body for long durations of up to 14 days, even at times when the patient would otherwise choose not to wear the device’.
Nemaura Medical is currently in the process of completing a second pre-submission to the US FDA to discuss their clinical strategy for the US PMA route, and expects to commence US studies by mid 2016. The European launch of the sugarBEAT® is anticipated to be by the end of 2016, with their European joint venture partner, DBJ Jersey.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT® CGM System, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the sugarBEAT® System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its sugarBEAT® System.
These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Bashir Timol
Nemaura Medical Inc.
Bashir.timol@nemaura.com
or call
+ 44 1509 222 912
December 2, 2015, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless continuous glucose monitoring (“CGM”) system known as sugarBEAT®, announced today that it has entered into an equal Joint Venture agreement with DBJ Jersey to market the sugarBEAT® system in Europe.
The sugarBEAT® CGM System is designed to display real time glucose readings on the device and on a mobile phone app via blue tooth, or allow retrospective evaluation of the data for glucose trending. Nemaura has patents that allow the device to self-calibrate using an internal standard concept, which is expected to eliminate the need for routine daily finger-prick calibrations. The company anticipates a launch in Europe during 2016, pending obtaining requisite product approvals, for which the operational aspects of the launch will be entirely managed by DBJ Jersey under the terms of the agreement, with product support from Nemaura Medical.
DBJ Jersey is headed by its founder, Dr. Dallas Burston (MBBS), a pharmaceutical entrepreneur with an outstanding track record having founded and sold companies in this field totaling over US$150M, with the most recent sale led by Cavendish Corporate Finance.
Dr. Burston stated,
“The methods of measuring blood glucose levels, and managing the longer-term complications of diabetes are expanding very quickly. The landscape is rapidly changing towards less invasive wearable devices. Europe represents a US$ 3 billion market opportunity and together with intelligent use of data, I believe that there is potential to reduce the overall healthcare burden.”
In addition, Dr. Burston purchased 5 million shares in Nemaura Medical for US$10M, and was issued a warrant to acquire an additional ten million shares at an exercise price of $0.50, subject to customary anti-dilution provisions and other conditions on exercise set forth in the warrant agreement.
Dr. Faz Chowdhury, CEO of Nemaura Medical Inc., stated,
“Nemaura’s sugarBEAT® system has been developed to provide a very cost effective and minimally invasive alternative for diabetics. We are very excited to have DBJ, with its impeccable track record of advancing the adoption of new technologies, as our partner in Europe once requisite product approvals have been obtained.”
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT® CGM System, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the sugarBEAT® System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its sugarBEAT® System.
These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Bashir Timol
Nemaura Medical Inc.
Bashir.timol@nemaura.com
or
Betsy Brod
MBS Value Partners
(212)661-2231
13th October 2015, Loughborough, UK. Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing a minimally invasive wireless CGM (Continuous Glucose Monitoring) system known as sugarBEAT®, announced today that it has submitted an application under the FDA Pre-submission Program to confirm the Classification of their CGM for the US market.
The sugarBEAT® CGM System is designed to display real time glucose readings on the device and on a mobile phone app via blue tooth, or allow retrospective evaluation of the data. Nemaura has patents covering the device’s ability to self-calibrate using an internal standard concept, eliminating the need for routine daily finger prick calibrations.
The company plans to conduct clinical studies in the first half of 2016 in the US. In light of the minimally-invasive nature of their technology, the retrospective evaluation device is anticipated to be classified as a Class II medical device, therefore potentially shortening the route to market in the US.
Nemaura Medical is developing the sugarBEAT® System as a non-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT® CGM System, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the sugarBEAT® System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its sugarBEAT® System.
These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Bashir Timol
Nemaura Medical Inc.
Bashir.timol@nemaura.com
5th October 2015, Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing the sugarBEAT® CGM System as a minimally invasive, wireless continuous glucose monitoring system, announced today that it has conducted a further interim analysis of clinical data from its ongoing 540 patient day clinical program of Type I and Type II diabetic Patients, and have determined a reduction in MARD from 18% to 11.8%. MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values; a lower MARD indicates higher accuracy.
Nemaura Medical previously reported an interim evaluation that indicated the primary endpoint of accuracy and secondary endpoint of safety had been met. The current evaluation was taken from a further 76 patient day study, consisting of 19 patients wearing the device on four separate days, for 12 hours per day. The CGM data was compared with blood finger prick analysis using the Hemocu BGM device, up to 3 times per hour. Despite the enhanced results the skin safety profile was maintained without any complaints of adverse skin irritation.
The sugarBEAT® device displays real time glucose readings on the device and on a mobile phone app via blue tooth. Nemaura have patents that allow the device to self-calibrate using an internal standard concept, eliminating the need for routine daily finger prick calibrations. The company plans to submit for CE approval of the device by the end of 2015 and launch in Europe and other select territories by mid 2016 via strategic partnerships and licensees. Nemaura Medical is also currently preparing to file a pre-submission application to the FDA to consolidate their US clinical roadmap and product approval process.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT® CGM System, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the sugarBEAT® System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its sugarBEAT® System.
These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Nemaura Medical Inc. (OTC BB: NMRD),(“Nemaura”), a medical device company developing the sugarBEAT® CGM System as a non-invasive, wireless continuous glucose monitoring system, announced today that it has conducted an interim analysis of clinical data from its ongoing 540 patient day clinical program of Type I and Type II diabetic Patients. Nemaura will present these findings at the Marcum Microcap Conference in New York on Thursday 28th May 2015.
The data will be presented by Nemaura’s CEO Dr. Faz Chowdhury as part of the Company’s presentation on its business development and commercialization strategy. Nemaura confirmed that the results of the interim analysis incorporates a 100-patient day study, involving 30 patients returning on 3 or 4 days, wearing the sugarBEAT® device for a period of 12 or 14 hours per day; the data shows comparable results to some currently marketed invasive CGM devices, with clinical accuracy in the Clarke error grid Zones A and B exceeding 95%.
Dr. Faz Chowdhury commented,
“A continuous glucose monitoring system that is minimally invasive, safe, accurate and user-friendly is an important clinical tool for maintaining glucose control in diabetic patients.”
Nemaura’s interim analysis has indicated that its primary endpoint of accuracy, and secondary endpoint of safety have been met.
Nemaura Medical is developing the sugarBEAT® System as a minimally-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring. Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s sugarBEAT® CGM System, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the sugarBEAT® System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its sugarBEAT® System.
These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Nemaura Medical Inc. (OTC BB: NMRD), a leading developer of minimally-invasive transdermal diagnostic technologies, announced today that Dr. D F Chowdhury, CEO, and Bashir Timol, Commercial Director, will be presenting at the 2015 Marcum Microcap Conference, which will take place May 27th to May 28th at the Grand Hyatt Hotel in New York City.
Management’s presentation will take place on Thursday, May 28th at 2:30 p.m. Eastern Time in the Imperial Room.
The Company’s presentation will cover their first product called ‘sugarBEAT’, a painless, minimally invasive Continuous Glucose Monitoring solution targeting diabetics. The sugarBEAT system consists of a disposable sensor patch that is worn around the arm or thigh, connected to a watch device and smartphone App.
The annual Marcum MicroCap Conference is a showcase for public companies with less than $500 million in market capitalization. For more information or to register, please visit the conference website at http://www.marcumllp.com/microcap.
Nemaura Medical Inc. is developing smart non-invasive medical diagnostic devices for the global healthcare market. Their first product is a painless, minimally invasive Continuous Glucose Monitoring solution targeting diabetics called ‘sugarBEAT’. The sugarBEAT system consists of a disposable sensor patch that is worn around the arm or thigh, connected to a watch device and smartphone App. SugarBEAT has completed thus far a 100 patient day clinical study and is anticipated for CE approval and launch in the UK and Saudi Arabia by early 2016. The Company is further exploring the use of its technology for use in critical care continuous glucose monitoring.
Nemaura Medical announces licensing deal with DB Pharma (Jersey) Ltd., for its unique non-invasive wireless continuous glucose monitoring Watch for the UK and Ireland.
Nemaura Medical Inc., a company developing a non-invasive, wireless, transdermal continuous glucose monitoring (CGM) Watch announced today that the Company has made a significant step towards commercializing its CGM Watch in the UK after signing a license agreement granting DB Pharma (Jersey) Ltd., sole and exclusive rights to market its CGM Watch in the UK and Republic of Ireland once the product receives CE approval which is anticipated for 2015.
DB Pharma Ltd., is part of a specialist Pharma company (group) involved in the marketing and distribution of prescription Pharmaceutical and healthcare products throughout the UK, with an excellent track record of successfully bringing new products to market, rapidly and cost-effectively. There are approximately 144,000 patients in the UK who are solely insulin dependent who rely on taking blood glucose measurements using invasive painful finger prick testing 6-8 times a day, and in addition there are in excess of 270,000 mature onset diabetics who also require insulin, and regular blood glucose monitoring. The CGM device is expected to provide patients with a pain-free user friendly and cost-effective alternative to traditional routine finger prick measurements
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