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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Nemaura Medical Inc | NASDAQ:NMRD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.1053 | 0.11 | 0.13 | 0 | 01:00:00 |
Per Share
|
Total
|
|||||||
Public offering price
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$
|
1.04
|
$
|
2,496,000
|
||||
Underwriting discounts and commissions (1)
|
$
|
0.0832
|
$
|
199,680
|
||||
Proceeds, before expenses, to us
|
$
|
0.9568
|
$
|
2,296,320
|
|
(1)
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We have agreed to pay the placement agent a commission equal to eight percent (8%) of the gross proceeds sold in the offering. In addition, we have agreed to pay the placement agent expenses of $50,000 and to issue the placement agent a unit purchase option to purchase up to five (5%) percent of the common stock and warrants sold in this offering. See section entitled "Plan of Distribution."
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ABOUT THIS PROSPECTUS SUPPLEMENT
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S-1
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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S-2
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PROSPECTUS SUPPLEMENT SUMMARY
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S-3
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THE OFFERING
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S-15
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RISK FACTORS
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S-16
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USE OF PROCEEDS
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S-18
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CAPITALIZATION
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S-19
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DILUTION
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S-20
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MANAGEMENT
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S-21
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DESCRIPTION OF COMMON STOCK
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S-22
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PLAN OF DISTRIBUTION
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S-23
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INCORPORATION BY REFERENCE OF CERTAIN DOCUMENTS
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S-26
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WHERE YOU CAN FIND MORE INFORMATION
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S-27
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LEGAL MATTERS
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S-27
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EXPERTS
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S-27
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ABOUT THIS PROSPECTUS
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1
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PROSPECTUS SUMMARY
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2
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RISK FACTORS
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4
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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5
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USE OF PROCEEDS
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6
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RATIO OF EARNINGS TO FIXED CHARGES
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7
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DESCRIPTIONS OF THE SECURITIES WE MAY OFFER
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8
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PLAN OF DISTRIBUTION
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18
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LEGAL MATTERS
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20
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EXPERTS
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20
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LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
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20
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WHERE YOU CAN FIND MORE INFORMATION
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20
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INCORPORATION BY REFERENCE OF CERTAIN DOCUMENTS
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21
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•
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any statements of the plans, strategies and objectives of management for future operations;
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•
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any statements concerning proposed new products, services or developments;
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•
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any statements regarding future economic conditions or performance;
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•
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our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
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•
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our estimates regarding the sufficiency of our cash resources and our need for additional funding; and
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•
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our intended use of the net proceeds from the offerings of shares of common stock under this prospectus supplement.
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Milestone
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Target Start Date
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Target Completion Date
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Completion of clinical studies in Type 1 and Type 2 diabetic subjects to define final device claims and for submission for CE Mark approval with final device claims.
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Completed
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Scale up of commercial sensor/patch manufacturing
(Scale up means we have started looking at larger scales - sufficient for product launch in the UK. It refers to the manufacturing process for sensors.)
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January 2017
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Initial Phase Completed
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Scale up of device (transmitter) manufacturing
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January 2017
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Ongoing
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CE Mark for body worn transmitter device
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April 2018
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December 2018/early 2019
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Commercial launch in the UK, followed by major territories in Europe
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Q4 2018
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Staggered launch post CE approval
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Clinical trial to support U.S. DeNovo Application
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May 2018
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Completed November 2018
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· |
Commercialize sugarBEAT in the United Kingdom and Republic of Ireland with Dallas Burston Pharma (Jersey) Limited, with whom we have an exclusive marketing rights agreement for these two countries.
We have also signed a full commercial agreement with Dallas Burston Ethitronix (Europe) Limited in May 2018 for all other European territories as part of an equal joint venture agreement. The joint venture intends to seek sub-license rights opportunities to one or more leading companies in the diabetes monitoring space, to leverage their network, infrastructure and resources.
Dallas Burston (Jersey) Limited was founded by Dr. Dallas Burston, MBBS, an entrepreneur who has founded and sold several companies specializing in marketing pharmaceuticals. For example, in 1999, he sold 49% of Ashbourne Pharmaceuticals to HSBC Private Equity for £32 million and Bartholomew-Rhodes to Galen Ltd. for £19.8 million. More recently, in 2015, he sold DB Ashbourne Limited, a provider of off-patent branded pharmaceuticals for the UK market, to Ethypharm. At the time of the sale, DB Ashbourne Limited was estimated to have revenue of approximately £90 million.
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· |
Establish licensing or joint venture agreements with other parties to market sugarBEAT in other geographies
. We are in detailed discussions and negotiations with several other parties worldwide for licensing or joint venture agreements for the sale of the sugarBEAT device.
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· |
Submit for De Novo 510(k) approval for sugarBEAT in the U.S.
by end of Q1 2019.
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· |
Expand the indications for which the sugarBEAT device may be used.
We believe that the sugarBEAT device may offer significant benefits as compared to those found in the non-acute setting for the monitoring of other diseases. This includes monitoring of lactic acid for performance athletics, and the monitoring of drugs. We intend to complete initial proof of concept in laboratory settings followed by a clinical program for such applications.
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· |
Expand our product pipeline through our proprietary platform technologies, acquisitions and strategic licensing arrangements.
We intend to leverage our proprietary platform technologies to grow our portfolio of product candidates for the diagnosis of diabetes and other diseases. In addition, we intend to license our product and acquire products and technologies that are consistent with our research and development and business focus and strategies. This may include drug delivery products for the improved management of diabetes, for example improved insulin injector systems, and/or combination drug products for diabetes related drugs.
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2013
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2035
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Adult population
(20-79 years, millions)
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659
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669
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Diabetes (20 – 79 years)
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||
Regional prevalence (%)
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8.5
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10.3
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Comparative prevalence (%)
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6.8
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7.1
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Number of people with diabetes
(millions)
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56.3
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68.9
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Impaired Glucose Tolerance (20 – 79 years)
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||
Regional prevalence (%)
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9.2
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11.0
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Comparative prevalence (%)
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8.1
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8.9
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Number of people with IGT (millions)
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60.6
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73.7
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Type 1 diabetes (0 – 14 years)
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||
Number of children with Type 1
diabetes (thousands)
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129.4
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-
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Number of newly diagnosed cases per year (thousands)
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20.0
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-
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Countries/Territories
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Millions
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Russian Federation
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10.9
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Germany
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7.6
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Turkey
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7
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Spain
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3.8
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Italy
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3.6
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FreeStyle Libre™
(1)
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Platinum G6®
(2)
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Platinum G5®
(3)
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Eversense™
(4)
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SugarBEAT®
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Manufacturer
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Abbott
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Dexcom
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Dexcom
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Senseonics
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Nemaura Medical
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Technology
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Inserted Sensor
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Inserted Sensor
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Inserted Sensor
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Implanted Sensor
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Non-invasive Sensor
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Reliability (Overall MARD)
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11.4%
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9.8%
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9.0%
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11.4%
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<14%*
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Reliability (Clarke Error Grid A+B zone)
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99%
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Not available
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97.0%
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99.1%
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>95.0%
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Patients Studied
|
72
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324
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97
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44
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>75
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Patient Days Studies
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14
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10
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9
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90
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1 to 4
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Warm-up Time
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1 hour
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2 hours
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2 hours
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NA
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30-60 min
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Daily Calibration
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None
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None
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2x
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2x
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1x
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Glucose Display Frequency
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On manual activation of sensor
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Every 5 min
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Every 5 min
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Every 5 min
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Every 5 min
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Patch/Senor Life
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14 days
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10 days
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7 days
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90 days
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1 day
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Regulatory Approvals
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EU
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US
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Worldwide
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EU
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EU **
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Basis for reimbursement
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Finger stick
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Not available
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CGM
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CGM
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Finger stick
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Daily Avg. Reimbursement Cost
|
$2.50 (Germany)
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Not available
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$9 (US)
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Not available
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$2.50***
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Daily Retail Cost UK (exc. VAT)
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£3.50 (Patch)
£50 (Reader)
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Not available
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£7.30 (Patch)
£475 (Hardware)
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Not available
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£2*** (Daily Patch)
£30*** (Transmitter)
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IP: Patent (Core Claim), Know-how, Trademark
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Expiration Date
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Jurisdictions in which Granted/ Issued
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Jurisdictions in which
Pending |
Ongoing Royalty or Milestone Payments
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Patent: Cumulative Measurement of an Analyte*.
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May 20, 2032
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Australia, France, Germany, Italy, Poland, Spain, Netherlands, UK
|
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Brazil, Canada, China, India, Japan, Qatar, United Arab Emirates, U.S.
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None
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Patent: Patches for Reverse Iontophoresis**
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July 1, 2029
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Australia, Germany, France, UK, Italy, Netherlands, Switzerland, China, Hong Kong, Japan.
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None
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None
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Patent: wearable sensor construct
|
November 2038 | First filed in UK | UK, to be followed by PCT | None | ||
Patent: wearable sensor construct and methods of application
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November 2038 | First filed in UK | UK, to be followed by PCT | None | ||
Know-how: Sensor Formulation
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N/A
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Trade Secret
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N/A
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N/A
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Patent: Predictive Algorithms
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To be filed
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N/A
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N/A
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N/A
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Trademark: BEAT
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Renewal due in 2026
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UK, China, EU, India, Japan, Canada
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N/A
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N/A
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Trademark: sugarBEAT
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Renewal due in 2025
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UK, Australia, Switzerland, China, Egypt, EU, Israel, India, Iran, Japan, North Korea, Morocco, Mexico, Norway, New Zealand, Russia, Singapore, Tunisia, Turkey, USA
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Canada
|
N/A
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|
●
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Class I devices present a low risk and are not life-sustaining or life-supporting. The majority of Class I devices are subject only to "general controls" (e.g., prohibition against adulteration and misbranding, registration and listing, good manufacturing practices, labeling, and adverse event reporting. General controls are baseline requirements that apply to all classes of medical devices.)
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●
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Class II devices present a moderate risk and are devices for which general controls alone are not sufficient to provide a reasonable assurance of safety and effectiveness. Devices in Class II are subject to both general controls and "special controls" (e.g., special labeling, compliance with performance standards, and post market surveillance. Unless exempted, Class II devices typically require FDA clearance before marketing, through the premarket notification (510(k)) process.)
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●
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Class III devices present the highest risk. These devices generally are life-sustaining, life-supporting, or for a use that is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices are devices for which general controls, by themselves, are insufficient and for which there is insufficient information to determine that application of special controls would provide a reasonable assurance of safety and effectiveness. Class III devices are subject to general controls and typically require FDA approval of a premarket approval ("PMA") application before marketing.
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1)
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Following the NSE (Not Substantially Equivalent) determination of a 510(k)-application due to lack of identifiable predicate, new intended use or different technological characteristics that raise different questions of safety and effectiveness, or
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2)
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A direct submission of a De Novo application where the manufacturer believes their device is appropriate for Class I or II definition and determines there is no legally marketed predicate device.
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●
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Establishment registration and device listing requirements;
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●
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Quality System Regulation ("QSR"), which governs the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices;
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●
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Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and generally require the label and package of medical devices to include a unique device identifier ("UDI"), and which also prohibit the promotion of products for uncleared or unapproved, i.e., "off-label," uses;
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|
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●
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Medical Device Reporting ("MDR") regulation, which requires that manufacturers and importers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and
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●
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Reports of Corrections and Removals regulation, which requires that manufacturers and importers report to the FDA recalls (i.e., corrections or removals) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; manufacturers and importers must keep records of recalls that they determine to be not reportable.
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●
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Untitled letters or warning letters;
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●
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Fines, injunctions and civil penalties;
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●
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Recall or seizure of our products;
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●
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Operating restrictions, partial suspension or total shutdown of production;
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●
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Refusing our request for 510(k) clearance or premarket approval of new products;
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●
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Withdrawing 510(k) clearance or premarket approvals that are already granted; and
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●
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Criminal prosecution.
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Common Stock offered by us |
2,400,000 shares of our common stock shares of common stock, par value $0.001 per share, at a purchase price of $1.04 for each share of common stock and the related warrants described below.
|
Warrants |
Warrants, exercisable for five years from the date of issuance, to purchase up to an aggregate of 2,400,000 shares of common stock, for an exercise price of $1.04 per share. Each warrant entitles the investor to purchase one share of our common stock for every share of common stock purchased by such investor in the offering.
This prospectus supplement also relates to the offering of the shares of common stock issuable upon exercise, if any, of the warrants.
|
|
|
Total common stock outstanding after the offering
|
207,732,498 shares, based on 205,332,498 shares of our common stock outstanding as of December 18, 2018, excluding any shares of our common stock issuable upon exercise of outstanding warrants, preferred stock, options or other rights to purchase shares of our common stock, including the warrants to be issued in this offering.
(1)
|
|
|
|
|
Use of proceeds
|
We estimate that the net proceeds from this offering, after deducting placement agent fees and before offering expenses payable by us, will be approximately $2.3 million. We intend to use the net proceeds from this offering for general corporate purposes, which include, but are not limited to a, U.S. FDA clinical trial, product launch in Europe and the development of a second generation of sugarBeat®, as well as for general corporate and working capital purposes. See "Use of Proceeds" on page S-18.
|
|
|
Risk factors
|
An investment in our shares of common stock and warrants is highly speculative and involves a number of risks. You should carefully consider the information contained in the "Risk Factors" section beginning on page S-16 of this prospectus supplement, and elsewhere in this prospectus supplement and the base prospectus, and the information we incorporate by reference, before making your investment decision.
|
|
|
Warrant Agent
|
Island Stock Transfer, LLC
|
NASDAQ Capital Market symbol
|
Our common stock is listed on the NASDAQ Capital Market under the symbol "NMRD." There is no established public trading market for the warrants, and we do not expect a market to develop. In addition, we do not intend to apply to list any such warrants on any securities exchange.
|
(1)
|
The number of shares of common stock to be outstanding after this offering is based on 205,332,498 shares of common stock outstanding on December 18, 2018.The number of shares of common stock excludes:
|
|
●
|
|
10,000,000 shares of common stock issuable upon the exercise of warrants outstanding with a weighted average exercise price of $0.50;
|
● |
2,400,000 shares of common stock issuable upon exercise of the warrants issued in connection with this offering at an exercise price of $1.04 per share; and
|
||
● | 120,000 shares of common stock and 120,000 shares of common stock issuable upon exercise of warrants underlying the unit purchase option granted to the placement agent at an exercise price of $1.30 per unit. |
|
•
|
|
On an actual basis; and
|
|
•
|
|
on an as adjusted basis to give effect to the receipt of the estimated net proceeds of $2.1 million from the sale of the common stock in this offering, after deducting the underwriting discount and estimated offering expenses payable by us as described under "Use of Proceeds".
|
|
||||||||
|
As of September 30, 2018
|
|||||||
(In thousands, except share and per share amounts)
|
Actual(1)
|
As
Adjusted(1)
|
||||||
Cash, cash equivalents and short-term investments
|
$
|
3,786,398
|
$
|
5,882,718
|
||||
Stockholders' equity:
|
||||||||
Convertible preferred stock, $0.001 par value, 200,000 shares authorized and 0 issued and outstanding, actual and as adjusted
|
$
|
0
|
$
|
0
|
||||
Common stock, $0.001 par value, 420,000,000 shares authorized and 205,050,000 shares issued and outstanding, actual, 207,450,000 shares issued and outstanding as adjusted
|
$
|
205,050
|
$
|
207,450
|
||||
Additional paid-in capital
|
$
|
13,034,623
|
$
|
15,128,543
|
||||
Accumulated deficit
|
$
|
(10,875,510
|
)
|
$
|
(10,875,510
|
)
|
||
Accumulated other comprehensive loss
|
$
|
(313,717
|
)
|
$
|
(313,717
|
)
|
||
|
||||||||
Total stockholders' equity
|
$
|
2,050,446
|
$
|
4,146,766
|
||||
|
||||||||
Total capitalization
|
$
|
4,382,801
|
$
|
6,479,121
|
||||
|
|
●
|
|
10,000,000 shares of common stock issuable upon the exercise of warrants outstanding with a weighted average exercise price of $0.50;
|
● |
2,400,000 shares of common stock issuable upon exercise of the warrants issued in connection with this offering at an exercise price of $1.04 per share; and
|
||
● | 120,000 shares of common stock and 120,000 shares of common stock issuable upon exercise of warrants underlying the unit purchase option granted to the placement agent at an exercise price of $1.30 per unit. |
|
||||
Offering price per share
|
$
|
1.04
|
||
Net tangible book value per share as of September 30, 2018
|
$
|
0.01
|
||
Increase per share attributable to this offering
|
$
|
0.01
|
||
As-adjusted net tangible book value per share as of September 30, 2018, after giving effect to this offering
|
$
|
0.02
|
||
Dilution per share to new investors participating in this offering
|
$
|
(1.02
|
)
|
|
●
|
|
10,000,000 shares of common stock issuable upon the exercise of warrants outstanding with a weighted average exercise price of $0.50;
|
● |
2,400,000 shares of common stock issuable upon exercise of the warrants issued in connection with this offering at an exercise price of $1.04 per share; and
|
||
● | 120,000 shares of common stock and 120,000 shares of common stock issuable upon exercise of warrants underlying the unit purchase option granted to the placement agent at an exercise price of $1.30 per unit. |
Name
|
Position
|
Date of Appointment
|
Dewan Fazlul Hoque Chowdhury.
|
Chief Executive Officer, President and Director
|
December 24, 2013
|
Bashir Timol
|
Chief Business Officer and Director
|
December 24, 2013
|
Iain Anderson
|
Chief Financial Officer
|
December 12, 2016
|
Thomas Moore (1)
|
Independent Director
|
August 3, 2017
|
Dr. Salim Natha (1)
|
Independent Director
|
July 26, 2017
|
Timothy Johnson (1)
|
Independent Director
|
July 17, 2017
|
Per share and warrant
|
Total (1)
|
|||||||
Public Offering Price
|
$
|
1.04
|
$
|
2,496,000
|
||||
Placement agent commissions
|
$
|
0.0832
|
$
|
199,680
|
||||
Proceeds to us, before expenses
|
$
|
0.9568
|
$
|
2,296,320
|
(i)
|
by operation of law or by reason of our reorganization;
|
(ii)
|
to any FINRA member firm participating in the offering and the officers or partners thereof, if all securities so transferred remain subject to the lock-up restriction set forth above for the remainder of the time period;
|
(iii)
|
if the aggregate amount of our securities held by the placement agent or related persons do not exceed 1% of the securities being offered;
|
(iv)
|
that is beneficially owned on a pro rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by the fund and the participating members in the aggregate do not own more than 10% of the equity in the fund; or
|
(v)
|
the exercise or conversion of any security, if all securities remain subject to the lock-up restriction set forth above for the remainder of the time period.
|
●
|
our Annual Report on Form 10-K for the fiscal year ended March 31, 2018, filed with the SEC on June 12, 2018;
|
●
|
our Quarterly Reports on Form 10-Q for the quarter ended June 30, 2018, filed with the SEC on August 9, 2018, and the quarter ended September 30, 2018, filed with the SEC on November 6, 2018;
|
●
|
our Current Reports on Form 8-K filed with the SEC on June 27, 2018, August 6, 2018 (as amended by
our
Current Report on Form 8-K/A filed with the SEC on August 9, 2018) and October 19, 2018;
|
●
|
the description of our common stock contained in our Form 8-A12B filed with the SEC on January 19, 2018, including any amendment or report filed for the purpose of updating that description; and
|
●
|
all documents filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, on or after the date of this prospectus supplement and before we stop offering the securities covered by this prospectus supplement and the accompanying base prospectus.
|
|
PAGE
|
|
ABOUT THIS PROSPECTUS
|
1
|
|
PROSPECTUS SUMMARY
|
2
|
|
RISK FACTORS
|
4
|
|
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
|
5
|
|
USE OF PROCEEDS
|
6
|
|
RATIO OF EARNINGS TO FIXED CHARGES
|
7
|
|
DESCRIPTIONS OF THE SECURITIES WE MAY OFFER
|
8
|
|
PLAN OF DISTRIBUTION
|
18
|
|
LEGAL MATTERS
|
20
|
|
EXPERTS
|
20
|
|
LIMITATION ON LIABILITY AND DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
|
20
|
|
WHERE YOU CAN FIND MORE INFORMATION
|
20
|
|
INFORMATION INCORPORATED BY REFERENCE | 21 |
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PROSPECTUS SUMMARY
This prospectus summary highlights certain information about our company and other information contained elsewhere in this prospectus or in documents incorporated by reference. This summary does not contain all of the information that you should consider before making an investment decision. You should carefully read the entire prospectus, any prospectus supplement, including the section entitled “Risk Factors” and the documents incorporated by reference into this prospectus, before making an investment decision.
THE OFFERING
This prospectus is part of a Registration Statement that we filed with the Securities and Exchange Commission (“
SEC
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common stock;
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warrants to purchase any of the securities listed above; |
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debt securities, in one or more series; and/or
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units consisting of one or more of the foregoing.
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in one or more offerings up to a total dollar amount of $87,500,000. This prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about the terms of that specific offering and include a discussion of any risk factors or other special considerations that apply to those securities. The prospectus supplement may also add, update or change information contained in this prospectus. You should read both this prospectus and any prospectus supplement together with the additional information described under the heading “Where You Can Find More Information.”
OUR COMPANY
We perform medical device research and manufacturing of a continuous glucose monitoring system (“CGM”), named ‘sugarBEAT.’ The sugarBEAT device is a non-invasive, wireless device for use by persons with Type I and Type II diabetes, and may also be used to screen pre-diabetic patients. The sugarBEAT device extracts analytes, such as glucose, to the surface of the skin in a non-invasive manner where it is measured using unique sensors and the signal is processed and converted to glucose readings using algorithms.
Our primary technology currently consists of
one CGM patch.. The original version of this technology consisted of a device designed for clinical use, which was directly connected to a patch containing a sensor. This device did not have any wireless methods of data transport and all data transport was using a USB cable. The clinical device has been further developed and is available in two variants for all future applications:
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The first of these variants consists of a patch containing a sensor that is applied to the skin. Glucose is extracted from the skin into the patch and the raw data is wirelessly sent to a reader. This reader may be a discrete hand held device specifically produced for the sugarBEAT or it may be a smart phone or smart watch. The reader processes the raw data using algorithms and presents these as glucose readings.
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The second variant consists of a watch-like device with a screen, and the device directly connects to the patch containing a sensor (using a wire) and provides direct glucose readings on the screen.
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We have undertaken a CE approval, which is the process to achieve a mandatory conformity marking for the sugarBEAT device to allow it to be legally sold in the European Union. It is a manufacturers' declaration that the product meets the requirements of the applicable European laws. In 2015 we applied to obtain the CE approval for our clinical CGM sugarBEAT system. We were advised on February 25, 2016, that the review process for the CE application had been completed and the sugarBEAT device CE certification is in order for grant.
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Our manufacturing processes are governed by ISO13485 quality systems, which also governs the sale of medical devices. Our three-year recertification audit was recently completed in February 2016. As a result of the audit, we are required to complete within 60 days, certain observations related to the quality systems, in particular in relation to the recent relocation of our laboratory facilities to a new building on the same site. Upon completion of this exercise we will receive our re-certification for ISO13485/9001. Consequently, the CE approval certificate will not be issued until the re-certification is completed. We expect to complete the recertification no later than April 30, 2016.
Since our first CE mark application for sugarBEAT, we have created a new version of the CGM, variants 1 and 2 described above. The new device iterations are as described above, as variant 1 and 2, with the two key differences being firstly the new devices are smaller than the first device produced, and secondly the new devices have wireless communication means in the form of Bluetooth. It is our intent to submit a new CE mark application by October 31, 2016 for both variants of the new device. Although at this time we may not seek to commercially market and sell the initial sugarBeat device, we may continue to use it in clinics, or sell it as an introductory product in the event there are delays in securing CE approval of the variants for the new version of the CGM.
Our Business Strategy
We intend to lead in the discovery, development and commercialization of innovative and targeted diagnostic medical devices that improve disease monitoring, management and overall patient care. We plan to take the following steps to implement our broad business strategy. Our key commercial strategies post- CE approval of the new variants 1 and 2 of the sugarBEAT will be as follows:
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Develop our own specialty sales and marketing teams to market the sugarBEAT device in the European Union
. We intend to develop specialty sales teams with our Joint Venture partner for the EU territory, for the distribution of our product in the European Economic Area, excluding the UK, Channel Islands, the Isle of Man and Republic of Ireland. We have a marketing license agreement for the UK and Republic of Ireland with DB Pharma (Jersey) Ltd. This agreement is in addition to the 50/50 joint venture agreement with the same party for product launch in all territories in the EU outside of the UK, Channel Islands, the Isle of Man and the Republic of Ireland.
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Develop a Clinical and Commercialization Strategy for Product launch in the USA
. In October 2015 we held a pre-submission meeting with the FDA and expect to hold a second meeting by mid June 2016 with the objective of ensuring that the FDA concurs with our proposed clinical strategy for a
Premarket Approval Application, or PMA
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submission
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Expand the indications for which the sugarBEAT device may be used.
We believe that the sugarBEAT device may offer other significant benefits other than those found in the non-acute setting for the monitoring of other diseases. This includes monitoring of lactic acid for performance athletics as well as critical care, and the monitoring of drugs for clinical study programs. Initial proof of concept will be completed in laboratory settings followed by a clinical program.
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Expand our product pipeline through our proprietary platform technologies, acquisitions and strategic licensing arrangements.
We intend to leverage our proprietary platform technologies to grow our portfolio of product candidates for the diagnosis of diabetes and other diseases. In addition we intend to license our product and acquire products and technologies that are consistent with our research and development and business focus and strategies.
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Principal Executive Office
Our principal executive offices were located at Charnwood Building Holywell Park, Ashby Road, Loughborough, Leicestershire, United Kingdom. In August 2015 we relocated to a new-build facility within the same Science Park, The Advanced Technology Centre, Oakwood Drive, Loughborough, Leicestershire, LE113QF, UK. Our website is located at http://www.nemauramedical.com and our telephone number is +44 1509 222912 . Information found on, or accessible through, our website is not a part of, and is not incorporated into, this prospectus, and you should not consider it part of this prospectus or part of any prospectus supplement. Our website address is included in this document as an inactive textual reference only.
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shares of our common stock;
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warrants to purchase any of the securities listed above;
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debt securities, in one or more series; and/or | ||
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units consisting of one or more of the foregoing.
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the offering price and aggregate number of warrants offered;
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if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such security;
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if applicable, the date on and after which the warrants and the related securities will be separately transferable;
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in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise;
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in the case of warrants to purchase common stock, the number or amount of shares of common stock, purchasable upon the exercise of one warrant and the price at which and currency in which these shares may be purchased upon such exercise;
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the manner of exercise of the warrants, including any cashless exercise rights;
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the warrant agreement under which the warrants will be issued;
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the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants;
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anti-dilution provisions of the warrants, if any;
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the terms of any rights to redeem or call the warrants;
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any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the dates on which the right to exercise the warrants will commence and expire or, if the warrants are not continuously exercisable during that period, the specific date or dates on which the warrants will be exercisable;
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the manner in which the warrant agreement and warrants may be modified;
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the identities of the warrant agent and any calculation or other agent for the warrants;
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federal income tax consequences of holding or exercising the warrants;
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the terms of the securities issuable upon exercise of the warrants;
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any securities exchange or quotation system on which the warrants or any securities deliverable upon exercise of the warrants may be listed or quoted; and
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any other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture; or
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in the case of warrants to purchase common stock, the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
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the title;
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the principal amount being offered, and, if a series, the total amount authorized and the total amount outstanding;
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any limit on the amount that may be issued;
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whether or not we will issue the series of debt securities in global form and, if so, the terms and who the depositary will be;
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the maturity date;
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whether and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a U.S. person for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts;
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the annual interest rate, which may be fixed or variable, or the method for determining the rate, the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates;
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the terms of the subordination of any series of subordinated debt, if applicable;
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the place where payments will be payable;
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restrictions on transfer, sale or other assignment, if any;
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our right, if any, to defer payment of interest and the maximum length of any such deferral period;
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the date, if any, after which, the conditions upon which, and the price at which we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions, and any other applicable terms of those redemption provisions;
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the date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;
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whether the indenture will restrict our ability and/or the ability of our subsidiaries to, among other things:
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incur additional indebtedness;
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issue additional securities;
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create liens;
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pay dividends and make distributions in respect of our capital stock and the capital stock of our subsidiaries;
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redeem capital stock;
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place restrictions on our subsidiaries’ ability to pay dividends, make distributions or transfer assets;
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make investments or other restricted payments;
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sell or otherwise dispose of assets;
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enter into sale-leaseback transactions;
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engage in transactions with stockholders and affiliates;
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issue or sell stock of our subsidiaries; or
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effect a consolidation or merger;
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whether the indenture will require us to maintain any interest coverage, fixed charge, cash flow-based, asset-based or other financial ratios;
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information describing any book-entry features;
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provisions for a sinking fund purchase or other analogous fund, if any;
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whether the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount” as defined in paragraph (a) of Section 1273 of the Internal Revenue Code;
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the procedures for any auction and remarketing, if any;
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the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof;
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if other than dollars, the currency in which the series of debt securities will be denominated; and
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any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, including any events of default that are in addition to those described in this prospectus or any covenants provided with respect to the debt securities that are in addition to those described above, and any terms that may be required by us or advisable under applicable laws or regulations or advisable in connection with the marketing of the debt securities.
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if we fail to pay interest when due and payable and our failure continues for 90 days and the time for payment has not been extended or deferred;
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if we fail to pay the principal, sinking fund payment or premium, if any, when due and payable and the time for payment has not been extended or delayed;
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if we fail to observe or perform any other covenant contained in the debt securities or the indentures, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we receive notice from the debenture trustee or holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and
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if specified events of bankruptcy, insolvency or reorganization occur.
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the direction so given by the holder is not in conflict with any law or the applicable indenture; and
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subject to its duties under the Trust Indenture Act of 1939, the debenture trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding.
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the holder has given written notice to the debenture trustee of a continuing event of default with respect to that series;
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the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made written request, and such holders have offered reasonable indemnity, to the debenture trustee to institute the proceeding as trustee; and
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the debenture trustee does not institute the proceeding and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 90 days after the notice, request and offer.
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to fix any ambiguity, defect or inconsistency in the indenture;
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to comply with the provisions described above under “
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Consolidation, Merger or Sale”;
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to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act of 1939;
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to evidence and provide for the acceptance of appointment by a successor trustee;
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to provide for uncertificated debt securities and to make all appropriate changes for such purpose;
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to add to, delete from, or revise the conditions, limitations and restrictions on the authorized amount, terms or purposes of issuance, authorization and delivery of debt securities or any series, as set forth in the indenture;
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to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided under “
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General” to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities;
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to add to our covenants such new covenants, restrictions, conditions or provisions for the protection of the holders, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default, or to surrender any of our rights or powers under the indenture; or
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to change anything that does not materially adversely affect the interests of any holder of debt securities of any series.
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extending the fixed maturity of the series of debt securities;
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reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any debt securities; or
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reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver.
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register the transfer or exchange of debt securities of the series;
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replace stolen, lost or mutilated debt securities of the series;
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maintain paying agencies;
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hold monies for payment in trust; and
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appoint any successor trustee;
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recover excess money held by the debenture trustee; and
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compensate and indemnify the debenture trustee.
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issue, register the transfer of, or exchange any debt securities of any series being redeemed in part during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or
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register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part.
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the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;
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any unit agreement under which the units will be issued;
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any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; and
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whether the units will be issued in fully registered or global form.
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· | Our Annual Report on Form 10-K for the fiscal year ended March 31, 2015; |
· | Our Quarterly Report on Form 10-Q for the fiscal quarters ended June 30, 2015, September 30, 2015 and December 31, 2015; and |
· | Our Current Reports on Form 8-K as filed on December 2, 2015 and March 17, 2015. |
1 Year Nemaura Medical Chart |
1 Month Nemaura Medical Chart |
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