Readies launch of SugarBEAT® in United Kingdom and Germany following CE Mark approval
On track to submit FDA application for SugarBEAT in mid 2019
Loughborough, England , June 17, 2019 (GLOBE NEWSWIRE) -- Nemaura Medical, Inc. (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.
- Completed pivotal clinical studies for SugarBEAT®
- Received CE Mark approval for SugarBEAT®
- Hired Dr. Fred Schaebsdau, formerly the General Manager of Dexcom Germany, to lead commercialization of SugarBEAT in Europe and global strategic collaborations
- Announced that Nemaura will allow third-party applications, such as diabetes management, exercise and nutrition focused apps royalty free access to SugarBEAT® CGM app data
- Completed two summative human factors usability studies for SugarBEAT® in preparation for submission of De-Novo 510(k) to the U.S. FDA
- Incorporated new predictive alert functionality into SugarBEAT® designed to provide visual indication and alarms when glucose levels are falling or rising above minimum and maximum thresholds
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.
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.”
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. (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.
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.
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1 PiperJaffrayCompany Note DXCM Sep 5 2018