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Loughborough, England, Nov. 11, 2019 (GLOBE NEWSWIRE) — – Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura”), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today reported financial results for the second quarter ended September 30, 2019.
Dr. Faz Chowdhury, CEO of Nemaura commented, “This has been an exciting period for Nemaura as we officially commenced the commercial rollout plans for SugarBEAT® following our recent CE approval. Towards this end, we hosted a symposia at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, in which we reported feedback from the first user experiences, demonstrating that SugarBEAT® can be an effective tool for early diagnosis of type 2 diabetes, therapy optimization, prevention, improvement and lifestyle change. As the world’s first non-invasive, safe, needle-free CGM, SugarBEAT® is uniquely positioned to target the underserved $80 billion market for Type 2 diabetics and pre-diabetics. We remain highly encouraged by the outlook for the business and look forward to providing further updates as we execute on our commercial strategy.”
Second Quarter 2019 Results:
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward-Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the United States Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Loughborough, England, Oct. 03, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ:NMRD) (“Nemaura”), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today provided an update regarding the commercial launch of SugarBEAT® and feedback from its first patient user experiences as presented at the recent symposia hosted by Nemaura at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona.
Dr. Faz Chowdhury, Chief Executive Officer, discussed key milestones in the development and plans for the commercial rollout program for SugarBEAT® in the UK, Ireland, Germany and other key European markets following its recent CE mark approval in the European Union.
Dr. Fred Schaebsdau, VP Strategic Alliances, highlighted key competitive advantages of SugarBEAT® over current invasive CGM technologies. SugarBEAT® represents the world’s first non-invasive, safe, needle-free, CGM as it does not puncture the skin to insert a sensor and allows users the freedom to decide when, and for how long to wear the patch. Dr. Schaebsdau also discussed the positive first user experiences indicating that SugarBEAT® can be an effective tool for early diagnosis of type 2 diabetes, therapy optimization, prevention, improvement and lifestyle change.
Dr. Iain Cranston, a diabetes specialist based in the UK at Portsmouth Hospital NHS Trust presented prior clinical data confirming that the SugarBEAT® is uniquely positioned to target the Type 2 diabetes and pre-diabetic markets, as well as health conscious individuals that can expect early benefits with the treatment by adopting self-management programs.
Dr. Faz Chowdhury, CEO of Nemaura commented, “With our current scale of manufacturing in United Kingdom and the first shipments of SugarBEAT® CGM devices to diabetic and pre-diabetic patients, we believe we are well positioned to move aggressively into the commercial phase of our strategy in Europe. We have established strategic partnerships in the United Kingdom and Ireland to commence sales and distribution, and are diligently working with our partners to develop the launch plan and various subscription options.”
“We are very pleased to report positive first user experiences at this premier industry conference. 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 the underserved markets for both Type 2 diabetics and pre-diabetics, which are estimated at $80 billion per year.”
Nemaura’s presentations from the European Association for the Study of Diabetes (EASD) symposia in Barcelona on September 19, 2019 are available at the Company’s website: https://nemauramedical.com/easd-symposia-2019/
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward-Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the United States Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Loughborough, England , Sept. 12, 2019 (GLOBE NEWSWIRE) — Loughborough, England – September 12, 2019 – Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura”), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that Dr. Faz Chowdhury, Chief Executive Officer, Dr. Fred Schaebsdau, VP Strategic Alliances, and Dr Iain Cranson, a diabetes specialist based in the UK, will be presenting at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) on Thursday, September 19, 2019 at 18:45 – 20:15 Central European Time at the Fira Barcelona Gran Via (Maimonides Hall) in Barcelona, Spain. The evening symposia will focus on the historic development of SugarBEAT®, its application to all categories of diabetics and diabetes management, clinical data and recent user experiences. The presentation is titled: “SugarBEAT® Non-Invasive CGM User Study Results: Diagnostic and Monitoring Applications Across Different Patient Types and Clinical Settings.”
Dr. Faz Chowdhury, CEO of Nemaura commented, “We are very pleased to be holding this symposia at this premier industry conference. We will be reporting study results from our first users, as well as sharing prior clinical data and user experiences. We also plan to discuss our commercial launch plans, including product availability in different territories. We look forward to highlighting how SugarBEAT® differs from current invasive CGM technologies and the potential to expand the addressable market to include Type 2 diabetics and pre-diabetics.”
The EASD Annual Meeting is Europe’s largest and most prominent meeting on diabetes. The 55th Annual Meeting will be held September 16-20, 2019 at the Fira Barcelona Gran Via, Spain. The scientific program offers researchers and healthcare professionals the opportunity to share ideas and learn about cutting-edge research and technology, groundbreaking studies and the significant advances in diabetes research, treatment and care. Additional information is available at: https://www.easd-industry.com
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward-Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the United States Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact: Crescendo Communications, LLC 212-671-1021 NMRD@crescendo-ir.com
Loughborough, England, Aug. 09, 2019 (GLOBE NEWSWIRE) — – Nemaura Medical, Inc. (NASDAQ: NMRD) (“Nemaura”), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today reported financial results for the first quarter ended June 30, 2019.
Recent Highlights and Accomplishments:
Dr. Faz Chowdhury, CEO of Nemaura commented, “We have bolstered our financial position to better support the commercial launch of SugarBEAT®, which is underway, and we completed our FDA 510(k) submission. I personally want to thank each of our shareholders as they have patiently stood by our Company through our development cycle and our very recent transition to initiation of commercial sales. Given our cash position, our credit line, expected revenue, and the significant potential value of our business, we believe we are in our strongest financial position to date, and have voluntarily suspended the ATM with Maxim.”
First Quarter 2019 Results:
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward-Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the United States Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Loughborough, England, Aug. 07, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced the first shipments of SugarBEAT® to diabetic and pre-diabetic patients in the United Kingdom. These shipments are part of the first phase of Nemaura Medical’s rollout program for SugarBEAT® following its recent CE mark approval in Europe.
Dr. Faz Chowdhury, CEO of Nemaura Medical, stated, “We are very pleased to have commenced the first phase of our commercial launch. This represents a major achievement for the Company as we transition from product development to a full-fledged commercial organization.”
Nemaura Medical will present data from its first users as part of several presentations planned at a symposium being held by the Company at the European Association for the Study of Diabetes (EASD) conference in Barcelona on September 19, 2019.
The Company further reports that its UK licensee has already registered more than 17,000 expressions of interest from potential users in the UK on its website product page. These potential users were registered prior to launch of the formal promotional campaign, thereby demonstrating the clinical need and further validating the commercial potential for SugarBEAT®. The UK direct-to-consumer sales are expected to consist of highly competitive and flexible, subscription-based options, catering to a diverse group of end users, while the drug tariff listing process is also being evaluated.
SugarBEAT® represents the world’s first non-invasive, needle-free, CGM and given that it does not puncture the skin to insert a sensor inside the skin, differentiating SugarBEAT® from competing CGM technologies, we believe it opens the device up to a far larger population of potential users. Of particular note is that this will be the first CGM that may be worn on intermittent days, thus empowering the user in a way that no other CGM is currently able to. Specifically, the Company believes that it is uniquely positioned to target the Type 2 diabetes market, which represents approximately 90% of all diabetics, in addition to catering to the Type 1 and pre-diabetic markets. In total, the global addressable market for CGM is estimated at $82 billion per year. Moreover, the Company plans to take full competitive advantage of the non-invasive nature of SugarBEAT® and expand the applications to include health conscious individuals. Nemaura Medical is currently evaluating various collaboration opportunities to accelerate its time to market for the broader applications, which are estimated to address a total market of approximately $179 billion.
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the United States Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the most recently completed fiscal year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Loughborough, England, Aug. 01, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company focused on the commercialization of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced an $8 million (USD) senior credit facility from existing major shareholders, with the first $3.5 million available immediately, to help fund the Company’s European commercial launch plans. The non-dilutive credit facility will carry 8% interest with quarterly payments and the principal due only upon maturity in 5 years. The credit facility has no stock, warrants, or equity related instruments, or other associated expenses.
Dr. Faz Chowdhury, CEO of Nemaura, stated, “Nemaura is at an exciting inflection point, having recently received CE Mark approval for SugarBEAT®, the world’s first non-invasive, needle-free, continuous glucose monitor. We recently submitted a De Novo 510(k) medical device application to the U.S. Food and Drug Administration for SugarBEAT®. We are now aggressively entering the commercialization phase in Europe and other markets, and access to these non-dilutive funds will allow us to accelerate our commercialization timelines. The CGM market is experiencing rapid growth as larger segments of the diabetic market have started to adopt CGM. We believe SugarBEAT® has distinct advantages as it does not puncture the skin to insert a sensor filament inside the skin and instead the sensor sits on the surface of the skin. The sensor can be worn daily or intermittently, as desired by the user, allowing us to offer a highly competitive product and target both the diabetic (insulin and non-insulin dependent) and pre-diabetic markets. In addition, we plan to target the wearable health tech and digital health markets, which are both experiencing explosive growth. Overall, we estimate the total addressable market to be roughly $179 billion, many times larger than the market addressable by the current competition. The willingness of several of our long-term investors to provide this debt facility at very favorable terms to the Company further validates our confidence in the outlook for SugarBEAT® and the tremendous market potential.”
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the current year, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.
Contact:
Crescendo Communications, LLC
212-671-1021
NMRD@crescendo-ir.com
Loughborough, England , July 18, 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 the appointment of Chris Avery as Vice President of Global Business Operations to help oversee the commercial launch of SugarBEAT®, including expansion of the Company’s global licensee and distributor relationships.
Mr. Avery brings over 30 years of senior experience in the healthcare industry with a focus on launching products, establishing distribution channels, and developing international relationships. Previously, Mr. Avery co-founded DiagnoSys Medical, a UK medical device distribution company. In this role, Mr. Avery recruited, trained, and launched a field-based sales team and was responsible for negotiating the sale of the business to Home Diagnostics. Subsequently, Mr. Avery served as European Director and UK Managing Director at Home Diagnostic Inc. During his tenure at Home Diagnostics, Mr. Avery launched the company’s glucose monitoring portfolio, Orbus Stents and Animas insulin pumps, into the UK and helped build the European distribution network. Following Home Diagnostics Inc., Mr. Avery served as European Director and UK Managing Director at Nipro Diagnostics, a company dedicated to helping people with diabetes manage their disease by providing blood glucose monitoring systems and other diabetes products. While at Nipro, he re-focused the organization, delivering a new strategic direction and leadership that increased market penetration. Additionally, Mr. Avery established and managed the sales operations for the organization within various regions and oversaw distributors within the EU and Africa. Most recently, Mr. Avery served as Senior Vice President of Business Development at Dallas Burston Ethitronix (DBE), where he was heavily involved in establishing and overseeing the Collaboration Agreement with Nemaura to commercialize SugarBEAT® in Europe. Mr. Avery oversaw the pre-launch phase for the distribution of SugarBEAT®, cultivating relationships with suppliers and diabetes key opinion leaders.
Dr. Faz Chowdhury, CEO of Nemaura, stated, “We are pleased to welcome Chris to the senior management team at Nemaura, as he brings extensive knowledge of SugarBEAT® and a proven track record within the diabetes space. In addition, to overseeing our collaboration with DBE in Europe, we look forward to Chris’ increased involvement in overseeing our global rollout through licensees and global distributors given his sector expertise and extensive relationships. Moreover, we look forward to Chris’ involvement in the launch of our related digital services.”
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
Loughborough, England , July 10, 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 has submitted its De Novo 510(k) medical device application to the U.S. Food & Drug Administration for SugarBEAT® following the successful completion of clinical studies and two summative human factors usability studies for SugarBEAT®.
The 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.
Dr. Faz Chowdhury, CEO of Nemaura, commented, “We are pleased to have submitted our De Novo 510(k) application to the FDA within our projected timelines thanks to our exemplary team of scientists and engineers. The global addressable market for CGM is estimated at $82 billion per year, and over $13 billion in the U.S. alone. However, unlike type 1 diabetics, 30% of whom use CGM, the U.S. has an additional 84 million pre-diabetics. Currently, CGM usage amongst pre-diabetics and other non-insulin using diabetics is negligible. Unlike other devices on the market, as the world’s first non-invasive CGM, SugarBEAT does not puncture the skin to insert a sensor filament inside the skin. Instead the sensor sits on top of the surface of the skin. For this reason, Nemaura believes the total addressable market for SugarBEAT is likely to be far greater at $179 billion, many times larger than the market addressable by the current competition.1 The FDA has a structured review process, which should allow the review to be expedited, and while awaiting feedback on the application, the Company has now started to enter into discussions with key global companies in this space for commercialization in the US.”
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
On track to submit FDA application for SugarBEAT in mid 2019
Loughborough, England , June 17, 2019 (GLOBE NEWSWIRE) — Nemaura Medical, Inc. (NASDAQ: NMRD), a medical technology company commercializing SugarBEAT®, a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today provided a business update for the fiscal year ending March 31, 2019 and reported on recent corporate developments.
Recent Highlights:
Dr. Faz Chowdhury, CEO of Nemaura, said, “Fiscal 2019 was a transformative year as we received CE Mark approval and laid the foundation for the commercial launch of SugarBEAT® in Europe and several other key territories around the world where CE approval can be used as the basis of product registration. According to the World Health Organization (WHO), there are about 60 million people with diabetes in Europe, and the prevalence of diabetes is increasing among all ages in the European Region.”
The CGM market in United Kingdom and Germany alone is estimated at $5B, representing an extremely significant and growing market opportunity for SugarBEAT®.1
“We have developed a highly differentiated device with distinct advantages over traditional CGMs. As the world’s first non-invasive, needle-free, continuous CGM, the fact that our device sits on the skin, is completely painless, versatile in terms of wear time, and will be the lowest priced CGM in the market, provides us major competitive advantages as we begin commercialization of SugarBEAT in Europe.”
He continued, “It is also important to note that unlike other devices on the market, our device targets both the diabetic (insulin and non-insulin dependent) and pre-diabetic markets, which means we have a much larger target audience and market opportunity than our competition, who mostly focus on Type I / insulin users who constitute a small minority of all diabetics.
We are also uniquely positioned to target the Type II diabetes market, which represents 95% of all diabetics who have traditionally relied on periodic A1c readings to manage glucose levels.
CGM transforms glucose control by widening the focus from the limited ‘gold standard’ A1c metric to a much more meaningful ‘time in range’ (TIR) metric—enabling users to modify lifestyle choices on a real time basis to increase the amount of time per day glucose is kept within the normal range. Diabetes can be placed into remission if glucose levels are persistently kept in normal range throughout the day.”
Dr, Fred Schaebsdau, who was formerly Country General Manager for Dexcom in Germany, and who is leading the strategy for the European Launch of SugarBEAT®, stated: “I joined Nemaura Medical because of their innovative and groundbreaking technology, their commitment to excellence, and their focused and disciplined approach to product development and commercialization.
We are well positioned to move aggressively into the commercial phase of our strategy in Europe as we prepare to launch SugarBEAT® in the UK in Q3 of 2019, followed by Germany and other markets. Specifically, we are establishing strategic partnerships in Europe to commence sales and distribution”.
In the United Kingdom, Nemaura’s exclusive Licensee Dallas Burston Ethitronix Ltd., has initiated launch plans drawing off a stock of 12,500 SugarBEAT® transmitters Nemaura ordered in 2018 in anticipation of CE approval, therefore minimizing lead times. This launch will initially encompass post market surveillance and key opinion leader monitoring of SugarBEAT® utility by diabetics and pre-diabetics, the results of which will be presented at Nemaura’s symposia at EASD on the 19th September 2019 in Barcelona. SugarBEAT® is intended to be offered on a phased sale basis, direct to consumers and patients on flexible subscription based models via a dedicated website. In parallel the company are planning a submission for drug tariff listing to allow SugarBEAT® to be made available on prescription in the United Kingdom.
Nemaura is in the process of strengthening its commercial team with senior appointments and plans to present at major upcoming conferences as the presence in the UK and European markets is established.
Plan to Fund European Commercialization:
While the Company ended the year with $3m in cash, positive working capital and no long-term debt, it intends to move quickly to fund its European commercialization efforts through a non-dilutive $8M debt-based credit line, which is expected to be funded from some of its existing major shareholders.
Other Highlights:
Preparation of FDA Application:
The Company remains on track to submit its FDA application for approval of SugarBEAT® in mid 2019, having successfully completed two summative human factors usability studies for SugarBEAT®. The objective of the two studies was to confirm that the user interface aspects of SugarBEAT® met the FDA guidelines for medical devices and were designed to ensure adequate information was captured for diverse age groups expected to use SugarBEAT®. The Company is pursuing the De-Novo 510(k) pathway.
Predictive Alert Feature Developed:
The Company continues to advance the product through continued R&D, incorporating a new predictive alert functionality into SugarBEAT®. These alerts have been designed to provide visual indications when glucose levels are falling or rising above minimum and maximum thresholds. While the non-invasive nature of SugarBEAT® opens up the CGM market to pre-diabetics and Type 2 diabetics, especially the 80% of diabetics who do not inject insulin on a daily basis, the inclusion of these alerts will particularly appeal to Type 1 diabetics who are at higher risk of hypoglycemia, or very low glucose levels.”
Lactate Monitoring:
The Company is also actively pursuing a number of important product extensions based on its BEAT technology platform. Specifically, it is developing patches using the BEAT technology platform to measure alternative analytes, including lactate, uric acid, lithium and drugs. In particular, lactate monitoring is currently used to determine the relative fitness of professional athletes and the company completed preliminary studies demonstrating the application of the BEAT technology for continuous lactate monitoring. The Company expects its second product to be the world’s first non-invasive skin patch for continuous lactate monitoring, and is designed to help the user determine the appropriate training intensity levels and monitor and improve performance accordingly.
To view a video of SugarBEAT®, please visit http://sugarbeat.com/introducing-sugarbeat/
Summary of full year 2019 financial results:
Research and development expenses were approximately $2,297,000 and $994,000 for the years ended March 31, 2019 and 2018, respectively. The additional spend was driven by the increased level of activity as the Company draws closer to commercialization and related to clinical trials and improvements made to SugarBEAT®, and expenditures included sub-contractor activities and consultants’ fees and wages.
General and administrative expenses were approximately $2,180,000 and $915,000 for the years ended March 31, 2019 and 2018, respectively. Additional costs mostly relate to insurance, legal and professional fees, audit fees and wages.
Comprehensive loss applicable to common shareholders was $4.8m in 2019 compared to $1.3m in 2018. Spending in 2019 was higher than in 2018 on research & development, general & administrative expenses as explained above, together with foreign currency translation adjustment.
As of March 31, 2019, cash and cash equivalents and fixed rate cash accounts were $3.7m compared with cash and cash equivalents of $5.7m for 2018.
About Nemaura Medical, Inc.:
Nemaura Medical, Inc. (NASDAQ: NMRD), is a medical technology company commercializing SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) designed to help people with diabetes and pre-diabetics better manage their glucose levels by spending more time in range. Insulin users can adjunctively use SugarBEAT® when calibrated by a finger stick reading. SugarBEAT® consists of a daily, disposable adhesive skin-patch connected to a small form factor rechargeable transmitter, connected via Bluetooth to a specially designed mobile application, which displays glucose readings at five-minute intervals throughout the day.
For more information visit:
www.NemauraMedical.com
www.SugarBEAT.com
Cautionary Statement Regarding Forward Looking Statements:
The statements in this press release that are not historical facts, and may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s SugarBEAT® system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell SugarBEAT®, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to SugarBEAT®. These and other risks and uncertainties are identified and described in more detail in Nemaura’s filings with the 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
RedChip Companies
1-800 RED-CHIP (733-2447)
Info@redchip.com
1 PiperJaffrayCompany Note DXCM Sep 5 2018
Loughborough, England, June 14, 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 an interview with its CEO, Dr. Faz Chowdhury, will air on The RedChip Money Report television program. The interview will air Sunday, June 16, on Bloomberg International, available in 149 million homes across Europe, the Middle East, and Africa. Check local listings for times in your area.
In the exclusive interview, Dr. Chowdhury discusses the global market opportunity for the company’s innovative SugarBEAT® CGM product, CE Mark approval, near-term sales strategy, and plans for FDA approval.
To view the interview segment, please visit: https://youtu.be/GwlEO5C8Wvs
“The RedChip Money Report” delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.
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
RedChip Companies:
Victor Roberts
407-644-4256
victor@redchip.com
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