Announces SugarBEAT® Awaiting CE Mark Approval; On Track for FDA submission in Q2 2019
Loughborough, England, March 28, 2019 (GLOBE NEWSWIRE) --
Loughborough, England – March 28, 2019 – Nemaura Medical, Inc. (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 provided the following letter to shareholders from the Company’s CEO, Dr. Faz Chowdhury, following the Company’s recent shareholder meeting held on Friday, March 22, 2019:
To our valued shareholders,
We are off to a strong start in 2019, and I wanted to take this opportunity to provide a more detailed update on our achievements and plans for the balance of this year.
Intellectual Property Portfolio
Earlier this year, we announced the grant of U.S. Patent 10,092,224, “Cumulative Measurement of an Analyte.” We filed two new patent applications to protect intellectual property around the sensor and methods of application of the device, which will not be published for at least a further 12 months, providing us with additional protection in the interim. Our improved algorithms allow sensing to occur in sub-five-minute intervals, which, in turn, enable predictive alarms so patients or users can be alerted more frequently than if the measurements were made at less frequent intervals. We believe this predictive capability will help expand the appeal of our product to Type 1 diabetics who are at higher risk of hypoglycemia, or very low glucose levels. Overall, we continue to build an extensive intellectual property portfolio, which will position us to become a leader in the non-invasive CGM space.
Skin-patch warm-up periods have been greatly reduced from our previous warm up periods of over an hour, to a warm-up period of less than 30 minutes. This is important as patients or users will be able to observe their glucose trends very soon after application of the skin-patch, which we believe will result in increased adoption of the device.
We have progressively built on our state-of-the art platform to develop a world-first, non-invasive, Continuous Glucose Monitor (CGM), which will be priced to be affordable. SugarBEAT® uniquely offers patients or users flexibility as to when and for how long they wear the device, empowering patients or users rather than making them dependent on technology. Overall, we expect the device will help people with diabetes to better manage their glucose levels by spending more time in range. With over 420 million diabetics worldwide and the number of pre-diabetics at almost three times this number, diabetes is a global healthcare concern and we believe SugarBEAT® is positioned to become a market leader, as it is expected to allow a person with diabetes or pre-diabetics to better track how lifestyle factors can impact daily glucose level trends thereby significantly improving the amount of daily time spent within a healthy glucose range.
Approval Timelines for Anticipated Commercial Launch
We continue to make significant progress towards completion of our CE Mark. We are working closely with our designated European Notified Body, British Standards Institute (BSI), a global leader in accreditation services, on a Fast Track application. The clinical review was completed in December 2018, and based on the ongoing dialogue, we are now in the final stages of the review process, after which Nemaura expects CE approval will be issued. We have made further enhancements to the product as agreed to by BSI, and look forward to providing a comprehensive update in the coming weeks.
Regarding the U.S. Food & Drug Administration (“FDA”), we recently announced that we have successfully completed the clinical studies needed to support our FDA submission for approval of SugarBEAT® in the USA. The clinical studies used 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, ensuring that the study meet adequacy requirements to provide statistically valid results.
The clinical study results indicated a MARD (Mean Absolute Relative Difference) of 11.92% (with a lower figure denoting greater accuracy), using a single point finger stick calibration. No device-related adverse events were noted. We are currently preparing our dossier for FDA submission.
We filed a Form S-3 “shelf registration” with the Securities and Exchange Commission (SEC), whereas the previous shelf registration already on file is set to expire this month. The registration provides the Company continued flexibility to raise capital if and when needed to execute on our growth strategy. Clearly, we are very cognizant of dilution, especially with our upcoming milestones and, therefore, will be mindful and selective regarding the timing and pricing of any future capital raise.
The outlook for the business is extremely encouraging and we are confident in our ability to secure regulatory approval in the foreseeable future. Moreover, the global addressable market for CGM is estimated at $82 billion per year, and over $13 billion in the U.S. alone. Our product includes significant and unique features that the competition does not provide, in particular the non-invasive nature of the device and the flexible wear period. We believe these advantages will allow SugarBEAT® to become adopted by a very large and diverse patient and user group, thus driving shareholder value.
We highly value each of you, our shareholders, and thank you for placing your confidence in us as we move efficiently towards commercial launch of SugarBEAT®.
Dr. Faz Chowdhury, CEO, Nemaura Medical
About Nemaura Medical, Inc.
Nemaura Medical, Inc. (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.
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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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