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:
- 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.
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.comwww.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
212-671-1021NMRD@crescendo-ir.com
RedChip Companies1-800 RED-CHIP (733-2447)Info@redchip.com
1 PiperJaffrayCompany Note DXCM Sep 5 2018
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