Nevada
|
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26-3257291
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(State or other jurisdiction of
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(I.R.S. Employer
|
incorporation or organization)
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|
Identification No.)
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Avda Cortes Valencianas 58, Planta 5, Valencia, Spain
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N/A
|
(Address of principal executive offices)
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(Zip Code)
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011-34-960-454-202
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|
(Registrant's telephone number, including area code)
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Title of each class
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Name of each exchange on which registered
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None
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None
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Large Accelerated Filer [ ]
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Accelerated Filer [ ]
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Non-Accelerated Filer [ ]
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Smaller Reporting Company [ X ]
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Emerging Growth Company [ ]
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Pages
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PART I
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1
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||
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10
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16
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||
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16
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16
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16
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PART II
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17
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17
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18
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20
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20
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22
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22
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||
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22
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||
PART III
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23
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||
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24
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24
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24
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25
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||
PART IV
|
|
|
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|
26
|
|
·
|
|
Dr. Nasser Djennati, who leads the team, is a UMIST graduate with extensive experience in instrumentation design, analogue and digital electronics, IT, sensor design and specifically in nano magnetic detection applications within the medical POC device area. He has 20 years expertise in Hall Effect technology and magnetic field measurement and experience in the regulatory approvals process for Class II- a medical device products.
|
·
|
The number of heart attack survivors has doubled in the last 40 years as research and healthcare continues to improve.
|
·
|
A 2012 NHS report showed the mortality rate in England during 2002-10 fell by 50% in men and 53% in women
3
.
|
·
|
Take a resting 12-lead ECG and a blood sample for troponin I or T measurement on arrival in hospital
|
·
|
Carry out a physical examination
|
·
|
Take a detailed clinical history unless ST-Elevation Myocardial Infarction is confirmed from the resting 12-lead ECG
|
·
|
A troponin test measures the levels troponin T or troponin I proteins in the blood
12
. These proteins are released when the heart muscle has been damaged, such as occurs with a heart attack
13
.
|
·
|
The more damage there is to the heart, the greater the amount of troponin there will be in the blood.
|
·
|
Troponins are preferred over traditional markers, such as CK-MB or myoglobin, due to their greater specificity and sensitivity
14
.
|
|
|
·
|
Improve the accuracy of immunoassay biomarker detection to provide quantitative measurements of samples, effectively combining the accuracy of high sensitivity cardiac biomarker assays performed on central laboratory ("CL") analyzers with the speed and convenience of a POC, hand held device;
|
·
|
Rapid analytical time; 3 minutes for a single assay test, much faster than existing, less sensitive POC tests
19
and very much faster than CL analyzer tests;
|
·
|
Accuracy and sensitivity will permit the use, for the first time, of rapid HS cTnI tests able to rule / in rule out MI, at the POC;
|
·
|
Ability to use just a 5 ul (a small drop) of finger-stick blood for a single assay test on an easy to use microfluidic test strip, no other POC cTnI device can do this as they require venous draw
20
;
|
·
|
Ability to multiplex up to three assays on a single test strip using a <15ul finger stick blood sample in under 8 minutes; and
|
·
|
Very simple operation by relatively untrained operative - can be used very easily at first contact with patient delivering fully automated results with no requirement for expert interpretation by a highly skilled operative.
|
·
|
In the UK, around 700,000 patients attend hospital emergency departments each year with chest pains
22
.
|
·
|
A typical district general hospital will see around 6,500 patients present with chest pain of suspected cardiac origin each year
24
.
|
·
|
NHS Glasgow had reported a lower number of 3,000 patients every year who come to the hospital as an emergency with chest pain
25
.
|
|
|
·
|
Approximately 2 to 4% of patients with an ACS are mistakenly discharged
28
.
|
·
|
Around 14,000 and 50,000 patients a year are wrongly sent home by doctors having suffered a mild heart attack that has been missed by current testing methods
29
.
|
·
|
Subsequently, medical litigation arising from missed diagnosis is increasing at the rate of 20%
30
.
|
·
|
All the beads could be magnetically detected in very low quantities, including samples of beads that were previously undetectable in the last round of testing.
|
·
|
In a number of instances the current Limit of Detection of fairly standard beads appears to be already at or near to the range advised by assay consultants as prospectively suitable for a high sensitivity troponin assay, subject to the design of the assay.
|
·
|
Crucially, all the beads displayed an excellent and reliable Log2 linear response (the signal doubling with a doubled quantity of beads), which is key to accurate quantitation.
|
|
|
·
|
establishment registration and device listing;
|
·
|
QSR, which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures;
|
·
|
labeling regulations, which prohibit the promotion of products for unapproved or "off-label" uses and impose other restrictions on labeling;
|
·
|
medical device reporting regulations, which require that manufacturers report to the FDA if a 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
|
·
|
corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act that may present a risk to health.
|
·
|
warning letters;
|
·
|
fines and civil penalties;
|
·
|
unanticipated expenditures;
|
·
|
delays in approving or refusal to approve our applications, including supplements;
|
·
|
withdrawal of FDA approval;
|
·
|
product recall or seizure;
|
·
|
interruption of production;
|
·
|
operating restrictions;
|
·
|
injunctions; and
|
·
|
criminal prosecution.
|
·
|
MML does not control the amount and timing of resources that our strategic partners may devote to its products;
|
·
|
MML does not control the decision to pursue or amend a product, the timing of development activities, product launches and extent of marketing and sales activities;
|
·
|
MML partners and suppliers may experience financial difficulties;
|
·
|
business combinations or significant changes in a partner's business strategy may also adversely affect a collaborator's willingness or ability to complete its obligations under any arrangement;
|
·
|
a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including MML's competitors; and
|
·
|
collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing MML's products.
|
·
|
announcements of new offerings, products, services or technologies, commercial relationships, acquisitions or other events by us or our competitors;
|
·
|
price and volume fluctuations in the overall stock market from time to time;
|
·
|
significant volatility in the market price and trading volume of technology companies in general;
|
·
|
whether our results of operations meet the expectations of securities analysts or investors;
|
·
|
actual or anticipated changes in the expectations of investors or securities analysts;
|
·
|
litigation involving us, our industry, or both;
|
·
|
regulatory developments in the United States, foreign countries, or both;
|
·
|
general economic conditions and trends;
|
·
|
departures of key employees; and
|
·
|
an adverse impact on the company from any of the other risks cited herein.
|
Quarter Ended
|
|
High Bid
|
|
|
Low Bid
|
|
||
|
|
|
|
|
|
|
||
December 31, 2017
|
|
$
|
0.60
|
|
|
$
|
0.20
|
|
September 30, 2017
|
|
$
|
0.48
|
|
|
$
|
0.22
|
|
June 30, 2017
|
|
$
|
4.00
|
|
|
$
|
0.36
|
|
March 31, 2017
|
|
$
|
1.68
|
|
|
$
|
0.12
|
|
December 31, 2016
|
|
$
|
0.25
|
|
|
$
|
0.10
|
|
September 30, 2016
|
|
$
|
0.20
|
|
|
$
|
0.10
|
|
June 30, 2016
|
|
$
|
0.20
|
|
|
$
|
0.14
|
|
March 31, 2016
|
|
$
|
0.21
|
|
|
$
|
0.08
|
|
|
Page
|
F-1
|
|
|
|
F-2
|
|
|
|
F-3
|
|
|
|
F-4
|
|
|
|
F-5
|
|
|
|
F-6
|
|
December 31, 2017
|
December 31, 2016
|
||||||
Assets
|
||||||||
|
||||||||
Current assets:
|
||||||||
Cash
|
$
|
28,823
|
$
|
10,271
|
||||
Prepaid expense
|
-
|
9,375
|
||||||
Investment in joint venture
|
451,871
|
249,336
|
||||||
Total current assets
|
480,694
|
268,982
|
||||||
|
||||||||
Total assets
|
$
|
480,694
|
$
|
268,982
|
||||
|
||||||||
|
||||||||
|
||||||||
Liabilities and Stockholders' Equity (Deficit)
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
90,816
|
$
|
23,691
|
||||
Accounts payable and accrued expenses - related party
|
91,499
|
85,671
|
||||||
Convertible notes, net of discount of $561,494 and $313,846, respectively
|
284,450
|
73,319
|
||||||
Stock payable
|
67,500
|
67,500
|
||||||
|
||||||||
Total current liabilities
|
534,265
|
250,181
|
||||||
|
||||||||
|
||||||||
Stockholders' equity (deficit)
|
||||||||
Common stock, 500,000,000 shares authorized, $0.001 par value,
25,397,424 and 16,677,339, shares issued and outstanding respectively
|
25,397
|
16,677
|
||||||
Additional paid-in capital
|
2,047,718
|
1,562,516
|
||||||
Accumulated deficit
|
(2,126,686
|
)
|
(1,560,392
|
)
|
||||
Total stockholders' equity (deficit)
|
(53,571
|
)
|
18,801
|
|||||
|
||||||||
Total liabilities and stockholders' equity (deficit)
|
$
|
480,694
|
$
|
268,982
|
|
Year ended December 31, 2017
|
Year ended December 31, 2016
|
||||||
|
||||||||
|
||||||||
Revenues
|
$
|
-
|
$
|
-
|
||||
|
||||||||
|
||||||||
Expense:
|
||||||||
General and administrative expenses
|
158,912
|
134,353
|
||||||
Total expenses
|
158,912
|
134,353
|
||||||
|
||||||||
Loss from operations
|
(158,912
|
)
|
(134,353
|
)
|
||||
|
||||||||
Other expense:
|
||||||||
Interest expense
|
(252,417
|
)
|
(71,845
|
)
|
||||
Loss in equity method investment
|
(154,965
|
)
|
(43,164
|
)
|
||||
Total other expense
|
(407,382
|
)
|
(115,009
|
)
|
||||
|
||||||||
Net loss
|
$
|
(566,294
|
)
|
$
|
(249,362
|
)
|
||
|
||||||||
Net loss per common share:
|
||||||||
Basic and diluted
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
||
|
||||||||
Weighted average common shares outstanding:
|
||||||||
Basic and diluted
|
21,141,883
|
12,563,806
|
||||||
|
|
Common Stock
|
|||||||||||||||||||
|
Shares
|
Amount
|
Additional Paid-in Capital
|
Accumulated Deficit
|
Stockholders' Equity (Deficit)
|
|||||||||||||||
|
||||||||||||||||||||
Balance as of December 31, 2015
|
7,087,828
|
$
|
7,087
|
$
|
1,047,798
|
$
|
(1,311,030
|
)
|
$
|
(256,145
|
)
|
|||||||||
|
||||||||||||||||||||
Shares issued for cash
|
9,589,511
|
9,590
|
140,410
|
-
|
150,000
|
|||||||||||||||
|
||||||||||||||||||||
Beneficial conversion features of convertible debt
|
-
|
-
|
374,308
|
-
|
374,308
|
|||||||||||||||
Net loss
|
-
|
-
|
-
|
(249,362
|
)
|
(249,362
|
)
|
|||||||||||||
|
||||||||||||||||||||
Balance as of December 31, 2016
|
16,677,339
|
$
|
16,677
|
$
|
1,562,516
|
$
|
(1,560,392
|
)
|
$
|
18,801
|
||||||||||
|
||||||||||||||||||||
Shares issued for conversion of debt
|
8,720,085
|
8,720
|
52,501
|
-
|
61,221
|
|||||||||||||||
|
||||||||||||||||||||
Beneficial conversion features of convertible debt
|
-
|
-
|
432,701
|
-
|
432,701
|
|||||||||||||||
|
||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(566,294
|
)
|
(566,294
|
)
|
|||||||||||||
|
||||||||||||||||||||
Balance as of December 31, 2017
|
25,397,424
|
$
|
25,397
|
$
|
2,047,718
|
$
|
(2,126,686
|
)
|
$
|
(53,571
|
)
|
|||||||||
|
|
|
Year ended December 31, 2017
|
|
|
Year ended December 31, 2016
|
|
||
|
|
|
|
|
|
|
||
Operating Activities
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(566,294
|
)
|
|
$
|
(249,362
|
)
|
Adjustment to reconcile to net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Amortization of debt discount
|
|
|
185,053
|
|
|
|
60,462
|
|
Loss in equity method investment
|
|
|
154,965
|
|
|
|
43,164
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expense
|
|
|
9,375
|
|
|
(5,208
|
)
|
|
Accounts payable and accrued expenses
|
|
|
67,125
|
|
|
(2,994
|
)
|
|
Accounts payable and accrued expenses - related party
|
|
|
5,828
|
|
|
|
35,720
|
|
Cash used in operating activities
|
|
|
(143,948
|
)
|
|
|
(118,218
|
)
|
|
|
|
|
|
|
|
|
|
Investing Activities
|
|
|
|
|
|
|
|
|
Investment in joint venture
|
|
|
(357,500
|
)
|
|
|
(292,500
|
)
|
Cash used in investing activities
|
|
|
(357,500
|
)
|
|
|
(292,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock
|
|
|
-
|
|
|
|
150,000
|
|
Proceeds from convertible notes payable
|
|
|
520,000
|
|
|
|
270,000
|
|
Cash provided by financing activities
|
|
|
520,000
|
|
|
|
420,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash
|
|
|
18,552
|
|
|
|
9,282
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of year
|
|
|
10,271
|
|
|
|
989
|
|
|
|
|
|
|
|
|
|
|
Cash, end of year
|
|
$
|
28,823
|
|
|
$
|
10,271
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flows information
|
|
|
|
|
|
|
|
|
Cash paid for income taxes
|
|
$
|
-
|
|
|
$
|
-
|
|
Cash paid for interest
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
Non-cash Investing and Financing activities:
|
|
|
|
|
|
|
|
|
Beneficial conversion features of convertible debt
|
|
$
|
432,701
|
|
|
$
|
374,308
|
|
Shares issued on conversion of convertible debt
|
$
|
61,221
|
|
|
$
|
-
|
||
|
|
|
|
|
|
|
|
|
Nature of operations
|
Going concern
|
Summary of significant accounting policies
|
Equity Method Investment
|
2017
|
2016
|
|||||||
Current assets
|
||||||||
Cash
|
$
|
179,538
|
$
|
165,334
|
||||
Prepaid expenses
|
6,545
|
5,813
|
||||||
|
186,083
|
171,147
|
||||||
Intellectual property
|
1,007,801
|
992,818
|
||||||
Total assets
|
$
|
1,193,884
|
$
|
1,163,965
|
||||
|
||||||||
Current liabilities
|
||||||||
Accounts payable - trade
|
$
|
16,227
|
$
|
3,523
|
||||
Accrued liabilities
|
25,587
|
18,286
|
||||||
Total current liabilities
|
41,814
|
21,809
|
||||||
|
||||||||
Equity
|
||||||||
Share capital
|
1,625,000
|
1,625,000
|
||||||
Other comprehensive income
|
22,394
|
(17,433
|
)
|
|||||
Subscription receivable
|
-
|
(357,500
|
)
|
|||||
Accumulated deficit
|
(495,324
|
)
|
(107,911
|
)
|
||||
Total equity
|
1,152,070
|
1,142,156
|
||||||
Total equity and liabilities
|
$
|
1,193,884
|
$
|
1,163,965
|
2017
|
2016
|
|||||||
$
|
4,158
|
$
|
-
|
|||||
General and administrative expenses
|
391,571
|
107,911
|
||||||
Net loss
|
$
|
(387,413
|
)
|
$
|
(107,911
|
)
|
Convertible Debt
|
$
|
845,944
|
|||
Less discount related to beneficial conversion features
|
(716,938
|
)
|
||
Add amortization of debt discount
|
155,444
|
|||
Balance at December 31, 2017
|
$
|
284,450
|
Common stock
|
Commitments
|
Income taxes
|
Related party transactions
|
Subsequent events
|
Name
|
Age
|
Position
|
Carlos Jose Gil
|
49
|
Chief Executive Officer, Director
|
Name and Principal Position
|
Year
|
|
Salary
|
|
|
Bonus
|
|
|
Total
|
|
|||
Carlos Jose Gil
|
2017
|
|
$
|
62,696
|
|
|
$
|
-0-
|
|
|
$
|
62,696
|
|
2016
|
|
$
|
61,124
|
|
|
$
|
-0-
|
|
|
$
|
61,124
|
|
·
|
each of our directors;
|
·
|
each of our named executive officers;
|
·
|
all of our current directors and executive officers as a group; and
|
each person, or group of affiliated persons, who beneficially owned more than 5% of our common stock.
|
Name and Address of
Beneficial Owner(s)
|
Amount and Nature of
Beneficial Owner(s)
(1)
|
Percentage of Beneficial Ownership
(1)
|
Carlos José Gil, CEO and Director (2)
|
-0-
|
-0-
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All officers and directors (1 person)
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-0-
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-0-
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Valley Heights, Inc (3) | 9, 589,512 | 36.60% |
(1)
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This table is based on 26,197,536 shares of common stock issued and outstanding as of the date indicated above.
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(2)
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Mr. Gil's address is Avda Cortes Valencianas 58, Planta 5, Valencia, Spain.
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(3) | Valley Heights, Inc. address is Suite 1-A, 5, Eusebio A Morales, El Cangrego, Panama City, Republic of Panama |
Number
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Description
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10.13** | |
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ZENOSENSE, INC.
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Date: April 17, 2018
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By:
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/s/ Carlos Jose Gil
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Carlos Jose Gil
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Chief Executive Officer, Chief Accounting/Financial Officer, and Sole Director
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I have reviewed this Annual Report on Form 10-K of Zenosense, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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||
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a.
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b.
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date: April 17, 2018
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By:
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/s/Carlos Jose Gil
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Carlos Jose Gil
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Chief Executive Officer and Principal Financial Officer
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1.
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the Annual Report on Form 10-K of Zenosense, Inc. for the year ended December 31, 2017 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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2.
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the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Zenosense, Inc.
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/s/Carlos Jose Gil
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Carlos Jose Gil, Chief Executive Officer and Principal Financial Officer
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*
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A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Zenosense, Inc. and will be retained by Zenosense, Inc. and furnished to the Securities and Exchange Commission or its staff upon request. This written statement accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission, and will not be incorporated by reference into any filing of Zenosense, Inc. under the Securities Act of 1933 or the Securities Exchange Act of 1934, irrespective of any general incorporation language contained in such filing.
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