UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10 – Q
x
QU
ARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2008
OR
¨
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF
1934
Commission
File Number: 0-21284
STATSURE
DIAGNOSTIC SYSTEMS, INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
|
91-1549305
|
(State
or other jurisdiction)
|
|
(IRS
Employer Identification No.)
|
of
incorporation or organization)
|
|
|
1222
Avenue M, Brooklyn, NY 11230
(Address
of principal executive offices and zip code)
(347)
394-3641
(
Registrant’s
telephone number, including area code)
1881
Worcester Rd. #200, Framingham, MA. 01701
(
Former
Name or Former Address, if Changed Since Last Report)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days.
Yes
x
No
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer
¨
|
Accelerated
filer
¨
|
|
|
Non-accelerated
filer
¨
|
Smaller
reporting company
x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes
¨
No
x
Transitional
Small Business Disclosure Format (check one): Yes
¨
No
x
Indicate
by check mark whether the registrant is an accelerated filer (as defined in
Rule
12b-2 of the Exchange Act).
Yes
¨
No
x
The
number of shares outstanding of the Registrant's Common Stock as of June 30,
2008 was 39,651,096.
STATSURE
DIAGNOSTIC SYSTEMS, INC.
FORM
10-Q
INDEX
PART
I FINANCIAL INFORMATION
|
|
|
|
|
Item
1.
|
Condensed
Financial Statements
|
|
|
|
|
|
Balance
Sheets as of June 30, 2008 (unaudited) and December 31,
2007(audited)
|
3
|
|
Statements
of Operations -Three Months and Six Months Ended June 30, 2008 and
June
30, 2007 (unaudited)
|
4
|
|
Statements
of Cash Flows - Six Months Ended June 30, 2008 and 2007
(unaudited)
|
5
|
|
Notes
to Financial Statements (unaudited)
|
6-14
|
|
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition And Results of
Operations
|
15
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
19
|
|
|
|
Item
4T.
|
Controls
and Procedures
|
19
|
|
|
|
|
|
|
PART
II OTHER INFORMATION
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
20
|
|
|
|
Item
1A.
|
Risk
Factors.
|
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
20
|
|
|
|
Item
3.
|
Defaults
upon Senior Securities
|
20
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
20
|
|
|
|
Item
5.
|
Other
Information
|
20
|
|
|
|
Item
6.
|
Exhibits
|
21
|
|
|
|
Signatures.
|
22
|
PART
I FINANCIAL INFORMATION
Item
1. CONDENSED FINANCIAL STATEMENTS
STATSURE
DIAGNOSTIC SYSTEMS, INC.
CONDENSED
BALANCE SHEETS
|
|
June 30, 2008
|
|
December 31, 2007
|
|
|
|
(unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
—
|
|
$
|
43,516
|
|
Accounts
receivable, net of allowance for doubtful accounts of $3,585 (2008)
and
$2,015 (2007)
|
|
|
152,757
|
|
|
152,049
|
|
Inventories
|
|
|
15,591
|
|
|
48,256
|
|
Prepaid
expenses
|
|
|
—
|
|
|
9,795
|
|
Total
current assets
|
|
|
168,348
|
|
|
253,616
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net of accumulated depreciation of $582,058 (2008)
and
$573,765 (2007)
|
|
|
38,865
|
|
|
47,158
|
|
|
|
|
|
|
|
|
|
OTHER
ASSETS
|
|
|
|
|
|
|
|
Patents
and trademarks, net of accumulated depreciation of $170,875 (2008)
and
$163,138 (2007)
|
|
|
108,390
|
|
|
105,527
|
|
Deferred
loan costs
|
|
|
—
|
|
|
2,006
|
|
Deposits
|
|
|
2,500
|
|
|
2,500
|
|
Total
other assets
|
|
|
110,890
|
|
|
110,033
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS
|
|
$
|
318,103
|
|
$
|
410,807
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Notes
payable-shareholders
|
|
$
|
1,290,067
|
|
$
|
1,476,317
|
|
Debentures
payable, net of discount
|
|
|
206,752
|
|
|
139,194
|
|
Accounts
payable
|
|
|
190,104
|
|
|
123,516
|
|
Accrued
expenses
|
|
|
194,329
|
|
|
187,309
|
|
Accrued
interest
|
|
|
29,280
|
|
|
17,451
|
|
Accrued
interest-due to shareholder
|
|
|
510,238
|
|
|
428,775
|
|
Accrued
payroll expense to officers
|
|
|
124,999
|
|
|
124,999
|
|
Payroll
and payroll taxes payable
|
|
|
20,086
|
|
|
20,086
|
|
Cash
dividends payable to preferred shareholders
|
|
|
198,000
|
|
|
118,800
|
|
Total
current liabilities
|
|
|
2,763,855
|
|
|
2,636,447
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES
|
|
|
|
|
|
|
|
Derivative
instrument
|
|
|
151,721
|
|
|
1,010,390
|
|
TOTAL
LIABILITIES
|
|
|
2,915,576
|
|
|
3,646,837
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2006-A Convertible Preferred Stock: 2,500 shares authorized, $.001
par value, 1,980 issued and outstanding
|
|
|
2
|
|
|
2
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
DEFICIT
|
|
|
|
|
|
|
|
Series
1998-B Convertible Preferred Stock: 1,645 shares authorized, none
issued
and outstanding
|
|
|
—
|
|
|
—
|
|
Common
stock, $.001 par value, 50,000,000 shares authorized, issued and
outstanding: 39,651,096 (2008 and 2007)
|
|
|
39,651
|
|
|
39,651
|
|
Additional
paid-in capital
|
|
|
47,795,045
|
|
|
47,771,801
|
|
Accumulated
deficit
|
|
|
(50,432,171
|
)
|
|
(51,047,484
|
)
|
Total
shareholders' deficit
|
|
|
(2,597,475
|
)
|
|
(3,236,032
|
)
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
$
|
318,103
|
|
$
|
410,807
|
|
The
accompanying notes are an integral part of these financial
statements.
STATSURE
DIAGNOSTIC SYSTEMS, INC.
STATEMENTS
OF OPERATIONS
(Unaudited)
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
|
320,871
|
|
$
|
224,004
|
|
$
|
545,241
|
|
$
|
366,866
|
|
Royalty
and other income
|
|
|
—
|
|
|
176,759
|
|
|
35,800
|
|
|
187,745
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
REVENUE
|
|
|
320,871
|
|
|
400,763
|
|
|
581,041
|
|
|
554,611
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of products sold
|
|
|
73,642
|
|
|
74,173
|
|
|
122,051
|
|
|
95,902
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT
|
|
|
247,229
|
|
|
326,590
|
|
|
458,990
|
|
|
458,709
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
3,005
|
|
|
13,543
|
|
|
8,005
|
|
|
34,591
|
|
Selling,
general and administrative
|
|
|
209,585
|
|
|
275,784
|
|
|
454,164
|
|
|
706,888
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
212,590
|
|
|
289,327
|
|
|
462,169
|
|
|
741,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME
(LOSS) FROM OPERATIONS
|
|
|
34,639
|
|
|
37,263
|
|
|
(3,179
|
)
|
|
(282,770
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSES):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense-net
|
|
|
(45,384
|
)
|
|
(57,432
|
)
|
|
(93,419
|
)
|
|
(112,466
|
)
|
Interest
expense on beneficial conversion feature
|
|
|
(33,022
|
)
|
|
(36,132
|
)
|
|
(67,558
|
)
|
|
(72,442
|
)
|
Derivative
income
|
|
|
164,185
|
|
|
644,435
|
|
|
858,669
|
|
|
2,040,696
|
|
Penalties
on preferred shares
|
|
|
—
|
|
|
(29,129
|
)
|
|
—
|
|
|
(93,629
|
)
|
Contract
termination costs
|
|
|
—
|
|
|
(291,499
|
)
|
|
—
|
|
|
(291,499
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
other income (expenses):
|
|
|
85,779
|
|
|
230,243
|
|
|
697,692
|
|
|
1,470,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
before provision for income taxes
|
|
|
120,418
|
|
|
267,506
|
|
|
694,513
|
|
|
1,187,890
|
|
Provision
for income taxes
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
INCOME
|
|
|
120,418
|
|
|
267,506
|
|
|
694,513
|
|
|
1,187,890
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends
- Preferred stock series 2006-A
|
|
|
39,600
|
|
|
39,600
|
|
|
79,200
|
|
|
89,100
|
|
NET
INCOME TO COMMON SHAREHOLDERS
|
|
$
|
80,818
|
|
$
|
227,906
|
|
$
|
615,313
|
|
$
|
1,098,790
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
EARNINGS PER SHARE
|
|
$
|
0.00
|
|
$
|
0.01
|
|
$
|
0.02
|
|
$
|
0.03
|
|
DILUTED
EARNINGS (LOSS) PER SHARE
|
|
$
|
(0.00
|
)
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
$
|
(0.02
|
)
|
WEIGHTED
AVERAGE NUMBER OF SHARES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
EARNINGS PER SHARE
|
|
|
39,651,096
|
|
|
37,926,153
|
|
|
39,651,096
|
|
|
37,609,244
|
|
DILUTED
EARNINGS PER SHARE
|
|
|
43,948,596
|
|
|
46,652,612
|
|
|
43,948,596
|
|
|
46,335,703
|
|
The
accompanying notes are an integral part of these financial
statements.
STATSURE
DIAGNOSTIC SYSTEMS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Six
Months Ended June 30,
|
|
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
Net
income
|
|
$
|
694,513
|
|
$
|
1,187,890
|
|
Adjustments
to reconcile net income to net cash provided (used) in operating
activities:
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
16,030
|
|
|
14,749
|
|
Amortization
of deferred loan costs
|
|
|
2,006
|
|
|
9,511
|
|
Bad
debt expense
|
|
|
1,570
|
|
|
—
|
|
Options
granted to employees as compensation
|
|
|
—
|
|
|
122,604
|
|
Non-employee
share based expense
|
|
|
23,244
|
|
|
23,244
|
|
Beneficial
conversion features of convertible debts
|
|
|
67,558
|
|
|
72,442
|
|
Stocks
and warrants issued for termination penalty
|
|
|
|
|
|
291,499
|
|
Mark-to-market
gain on derivative instruments
|
|
|
(858,669
|
)
|
|
(2,040,696
|
)
|
Changes
in current assets and liabilities:
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(2,278
|
)
|
|
(53,546
|
)
|
Inventories
|
|
|
32,665
|
|
|
7,692
|
|
Prepaid
expenses
|
|
|
9,795
|
|
|
(5,064
|
)
|
Deposits
|
|
|
—
|
|
|
11,850
|
|
Accounts
payable, accrued payroll expense to officers and accrued
expenses
|
|
|
166,900
|
|
|
218,881
|
|
Deferred
rent
|
|
|
—
|
|
|
(6,287
|
)
|
Net
cash provided (used) in operating activities
|
|
|
153,334
|
|
|
(145,231
|
)
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
Acquisition
of property and equipment
|
|
|
—
|
|
|
(7,231
|
)
|
Acquisitions
of patents and trademarks
|
|
|
(10,600
|
)
|
|
(7,608
|
)
|
Net
cash (used) in investing activities
|
|
|
(10,600
|
)
|
|
(14,839)
|
)
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
Proceeds
from shareholder loans
|
|
|
175,100
|
|
|
165,000
|
|
Advances
from officer
|
|
|
0
|
|
|
25,000
|
|
Repayment
of debentures
|
|
|
0
|
|
|
(37,500
|
)
|
Repayments
of shareholder loans
|
|
|
(361,350
|
)
|
|
(93,687
|
)
|
Net
cash (used) provided by financing activities
|
|
|
(186,250
|
)
|
|
58,813
|
|
|
|
|
|
|
|
|
|
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(43,516
|
)
|
|
(101,257
|
)
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
43,516
|
|
|
109,332
|
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
|
$
|
—
|
|
$
|
8,075
|
|
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION:
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$
|
45,257
|
|
$
|
22,689
|
|
Cash
paid for taxes
|
|
$
|
3,286
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL
DISCLOSURE OF NON-CASH INFORMATION:
|
|
|
|
|
|
|
|
Common
stock issued in lieu of cash dividend payments
|
|
$
|
—
|
|
$
|
99,000
|
|
Preferred
stock dividends accrued and not paid
|
|
$
|
79,200
|
|
$
|
39,600
|
|
The
accompanying notes are an integral part of these financial statements.
STATSURE
DIAGNOSTIC SYSTEMS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
NOTE
1
.
DESCRIPTION
OF BUSINESS:
StatSure
Diagnostic Systems, Inc., a Delaware corporation ("the Company"), is primarily
engaged in the development, manufacture and marketing of rapid in-vitro assays
for use in the detection of infectious diseases and other conditions, and
medical specimen collection devices. The Company is currently marketing its
medical specimen collection devices both in the U.S. and overseas.
The
Company has signed several agreements relating to its patented barrel technology
for use in screening antibodies to HIV (Human Immunodeficiency Virus, the virus
that causes AIDS). As part of a three-way alliance with Inverness Medical
Innovations (AMEX:IMA) Chembio Diagnostics (CEMI.OB) (“Chembio”), the Company
signed a worldwide exclusive distribution deal for a rapid, point-of-care HIV
test with Inverness. In a two-way deal with Chembio, the Company granted an
exclusive license to Chembio solely to manufacture the recently FDA approved
HIV
barrel product for Inverness. This product is being marketed under the IMA
brand. In this two-way agreement (“Joint HIV Barrel Commercialization
Agreement”), a long- term strategic “partnership” was established, wherein both
companies equally split the margin dollars of the HIV barrel product once the
actual cost of manufacturing is reimbursed. The Company announced on November
5,
2007, that the HIV 1/2 Rapid Test employing the Company's patented "barrel"
technology marketed and distributed worldwide by Inverness Medical Innovations
under its Clearview® brand as "Clearview COMPLETE HIV 1 /2, received an FDA
waiver of the Clinical Laboratory Improvement Amendments of 1988(CLIA). This
CLIA waiver will allow sales of this product to a large number of markets that
do not operate under the standards of the CLIA (e.g. doctors' offices, public
health clinics). Until this waiver was obtained, marketing and sales of the
product was restricted to those laboratory settings with CLIA certification.
In
May
2008, Mr. Steve M. Peltzman, Chairman of the Board and Chief Executive Officer,
and Mr. D. Bruce Pattison, President, Chief Operating Officer and Director,
have
resigned. Messrs Peltzman and Pattison have indicated that they will enter
into
Consulting Agreements with the Company. In addition, Mr. Richard Woodrich has
resigned as Director. Concurrently, the Board elected Mr. Moshe Bodner,
currently Vice President of the Company, as Chief Executive Officer and
Director, and Mr. Leo Ehrlich, the current Chief Financial Officer and Director,
was elected as the President, Chief Operating Officer effective July 1,
2008.
NOTE
2. SUBSTANTIAL DOUBT REGARDING ABILITY TO CONTINUE AS A GOING
CONCERN
Other
than sales of the Company's collection devices, the Company has not yet
commenced any significant product commercialization. The Company incurred
significant operating losses since its inception, resulting in an accumulated
deficit of $50,432,171 at June 30, 2008. Such losses are expected to continue
for the foreseeable future and until such time, if ever, as the Company is
able
to attain revenue levels sufficient to support its operations. There can be
no
assurance that the Company will achieve or maintain profitability in the future.
In addition, the Company is in default on certain debt obligations. Despite
the
Company's financings in 2006 and October 2007, substantial additional financing
will be required in future periods.
The
Company's capital requirements have been and will continue to be significant.
The Company is dependent upon its effort to raise capital to finance its future
operations, including the cost of development, manufacturing and marketing
of
its products, to conduct clinical trials and submissions for FDA approval of
its
products and to continue the design and development of its new products.
Marketing, manufacturing and clinical testing may require capital resources
substantially greater than the resources available to the Company. The Company
intends to continue to seek public or private placement of its equity securities
in order to provide the funds necessary to meet its obligations. In addition,
Management believes that the agreements it entered into with Inverness Medical
Innovations in September 2006 (See Note 1), could enable the Company to increase
its revenues significantly during the next few years.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. The Company's significant operating losses
and
significant capital requirements, however, raise substantial doubt about the
Company's ability to continue as a going concern. The financial statements
do
not include any adjustments that might result from the outcome of this
uncertainty.
NOTE
3.
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation:
The
accompanying unaudited financial statements as of, and for the three and six
month periods ended June 30, 2008 and 2007, have been prepared in conformity
with accounting principles generally accepted in the United States of America.
The financial information as of December 31, 2007 is derived from StatSure
Diagnostic Systems, Inc. financial statements included in the Company’s Annual
Report on Form 10-KSB for the year ended December 31, 2007. Certain information
or footnote disclosures in this filing that are normally included in financial
statements prepared in accordance with accounting principles generally accepted
in the United States of America have been condensed or omitted, pursuant to
the
rules and regulations of the Securities and Exchange Commission for interim
filings. In the opinion of management, the accompanying financial statements
include all adjustments necessary (which are of a normal and recurring nature)
for a fair presentation of the results of the interim periods presented. The
accompanying financial statements should be read in conjunction with the
Company’s audited financial statements for the year ended December 31, 2007, as
included in the Company’s Annual Report on Form 10-KSB for the year ended
December 31, 2007. Operating results for the three and six month period ended
June 30, 2008, are not necessarily indicative of the results that may be
expected for the entire year ending December 31, 2008, or any other portion
thereof.
Inventories
Inventory
consists of the following at:
|
|
June 30, 2008
|
|
December 31, 2007
|
|
|
|
|
|
|
|
Raw
Materials
|
|
$
|
17,993
|
|
$
|
28,884
|
|
Finished
Goods
|
|
|
6,225
|
|
|
27,999
|
|
|
|
|
24,218
|
|
|
56,883
|
|
Allowance
for obsolete inventory
|
|
|
(8,627
|
)
|
|
(8,627
|
)
|
|
|
$
|
15,591
|
|
$
|
48,256
|
|
Recent
Accounting Pronouncements:
In
September 2006, the FASB issued SFAS No. 157,
Fair
Value Measurements
,
which
defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles, and expands disclosures about fair
value measurements. This statement does not require any new fair value
measurements, but provides guidance on how to measure fair value by providing
a
fair value hierarchy used to classify the source of the information. SFAS No.
157 is effective for fiscal years beginning after November 15, 2007, and all
interim periods within those fiscal years. In February 2008, the FASB released
FASB Staff Position (FSP FAS 157-2 -
Effective Date of FASB Statement No. 157
)
which
delays the effective date of SFAS No. 157 for all nonfinancial assets and
nonfinancial liabilities, except those that are recognized or disclosed at
fair
value in the financial statements on a recurring basis (at least annually),
to
fiscal years beginning after November 15, 2008 and interim periods within those
fiscal years. The implementation of SFAS No. 157 for financial assets and
liabilities, effective January 1, 2008, did not have an impact on the Company’s
financial position and results of operations. The Company is currently
evaluating the impact of adoption of this statement on its non-financial assets
and liabilities in the first quarter of fiscal 2009.
In
December 2007, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 141 (revised 2007),
Business Combinations, which replaces SFAS No 141. The statement retains the
purchase method of accounting for acquisitions, but requires a number of
changes, including changes in the way assets and liabilities are recognized
in
the purchase accounting. It also changes the recognition of assets acquired
and
liabilities assumed arising from contingencies, requires the capitalization
of
in-process research and development at fair value, and requires the expensing
of
acquisition-related costs as incurred. SFAS No. 141R is effective for business
combinations for which the acquisition date is on or after the beginning of
the
first annual reporting period beginning on or after December 15,
2008.
In
December 2007, the FASB issued SFAS No. 160. “Noncontrolling Interests in
Consolidated Financial Statements-and Amendment of ARB No. 51.” SFAS 160
establishes accounting and reporting standards pertaining to ownership interests
in subsidiaries held by parties other than the parent, the amount of net income
attributable to the parent and to the noncontrolling interest, changes in a
parent’s ownership interest, and the valuation of any retained noncontrolling
equity investment when a subsidiary is deconsolidated. This statement also
establishes disclosure requirements that clearly identify and distinguish
between the interests of the parent and the interests of the noncontrolling
owners. SFAS 160 is effective for fiscal years beginning on or after December
15, 2008. The adoption of SFAS 160 is not currently expected to have a material
effect on the Company’s consolidated financial position, results of operations,
or cash flows.
In
March
2008, the Financial Accounting Standards Board (FASB) issued FASB Statement
No.
161,
Disclosures
about Derivative Instruments and Hedging Activities.
The new
standard is intended to improve financial reporting about derivative instruments
and hedging activities by requiring enhanced disclosures to enable investors
to
better understand their effects on an entity’s financial position, financial
performance, and cash flows. It is effective for financial statements issued
for
fiscal years and interim periods beginning after November 15, 2008, with early
application encouraged. The company is currently evaluating the impact of
adopting SFAS. No. 161 on its financial statements.
Stock
Based Compensation
:
Effective
January 1, 2006, the Company’s 2004 Stock Plan and options granted outside of
the Plan are accounted for in accordance with the recognition and measurement
provisions of Statement of Financial Accounting Standards ("FAS") No. 123
(revised 2004), Share-Based Payment ("FAS 123(R)"), which replaces FAS No.
123,
Accounting for Stock-Based Compensation, and supersedes Accounting Principles
Board Opinion ("APB") No. 25, Accounting for Stock Issued to Employees, and
related interpretations. FAS 123 (R) requires compensation costs related to
share-based payment transactions, including employee stock options, to be
recognized in the financial statements. In addition, the Company adheres to
the
guidance set forth within Securities and Exchange Commission ("SEC") Staff
Accounting Bulletin ("SAB") No. 107, which provides the Staff's views regarding
the interaction between SFAS No. 123(R) and certain SEC rules and regulations
and provides interpretations with respect to the valuation of share-based
payments for public companies.
In
adopting FAS 123(R), the Company applied the modified prospective approach
to
transition. Under the modified prospective approach, the provisions of FAS
123(R) are to be applied to new awards and to outstanding awards modified,
repurchased, or cancelled after the required effective date. Additionally,
compensation cost for the portion of awards for which the requisite service
has
not been rendered that are outstanding as of the required effective date shall
be recognized as the requisite service is rendered on or after the required
effective date. The compensation cost for that portion of awards shall be based
on the grant-date fair value of those awards as calculated for either
recognition or pro-forma disclosures under FAS 123.
While
FAS
No. 123 encouraged recognition of the fair value of all stock-based awards
on
the date of grant as expense over the vesting period, companies were permitted
to continue to apply the intrinsic value-based method of accounting prescribed
by APB No. 25 and disclose certain pro-forma amounts as if the fair value
approach of FAS No. 123 had been applied. In December 2002, FAS No. 148,
Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment
of FAS No. 123, was issued, which, in addition to providing alternative methods
of transition for a voluntary change to the fair value method of accounting
for
stock-based employee compensation, required more prominent pro-forma disclosures
in both the annual and interim financial statements. The Company complied with
these disclosure requirements for all applicable periods prior to January 1,
2006.
As
a
result of the adoption of FAS 123(R), the Company's results for the three and
six months ended June 30, 2008 and 2007 include employee share-based
compensation expense of $0, $0 and $61,680 and $122,604, respectively, recorded
in the selling, general and administrative expenses. There was no income tax
benefit recognized in the income statement for share-based compensation
arrangements as the Company has provided a 100% valuation allowance on its’
deferred tax asset
Prior
to
January 1, 2006, the Company accounted for similar transactions in accordance
with APB No. 25 which employed the intrinsic value method of measuring
compensation cost. Accordingly, compensation expense was not recognized for
fixed stock options if the exercise price of the option equaled or exceeded
the
fair value of the underlying stock at the grant date.
Earnings
per Share:
Basic
and
diluted earnings per common share were calculated for all periods in accordance
with the requirements of Statement of Financial Accounting Standards No. 128,
“Earnings per Share”. The following table sets forth the computation of the
diluted loss per share for the six month periods ended June 30, 2008 and 2007,
respectively:
|
|
Three Months Ended
June 30
|
|
Six Months Ended
June 30
|
|
Numerator:
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
Net
income to common
shareholders
|
|
$
|
80,818
|
|
$
|
227,906
|
|
$
|
615,313
|
|
$
|
1,098,790
|
|
(Deduct)/Add:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark-to-market
gain (loss)-derivative liability
|
|
|
(164,185
|
)
|
|
(644,435
|
)
|
|
(858,669
|
)
|
|
(2,040,696
|
)
|
Interest
on convertible debt
|
|
|
5,890
|
|
|
7,268
|
|
|
11,830
|
|
|
14,708
|
|
Dividends
on preferred
stock
payable in shares
|
|
|
39,600
|
|
|
39,600
|
|
|
79,200
|
|
|
89,100
|
|
Net
loss to common shareholders and assumed conversion
|
|
$
|
(37,877
|
)
|
$
|
(369,661
|
)
|
$
|
(152,326
|
)
|
$
|
(838,098
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
reconciliation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used for basic income (loss) per share
|
|
|
39,651,096
|
|
|
37,926,153
|
|
|
39,651,096
|
|
|
37,609,244
|
|
Effect
of dilutive items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
options
|
|
|
75,000
|
|
|
202,857
|
|
|
75,000
|
|
|
202,857
|
|
Convertible
debentures
|
|
|
262,500
|
|
|
337,500
|
|
|
262,500
|
|
|
337,500
|
|
Convertible
securities
|
|
|
3,960,000
|
|
|
8,186,102
|
|
|
3,960,000
|
|
|
8,186,102
|
|
Shares
used for diluted (loss) per share
|
|
|
43,948,596
|
|
|
46,652,612
|
|
|
43,948,596
|
|
|
46,335,703
|
|
(Loss)
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted:
|
|
$
|
(0.00
|
)
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
$
|
(0.02
|
)
|
Reclassifications:
Certain
reclassifications have been made to the June 30, 2007 financial statements
in
order to conform to the current fiscal year presentation.
NOTE
4. FINANCING FROM SHAREHOLDERS
Per
a
promissory note dated February 2003, Jules Nordlicht, a shareholder, agreed
to
advance in total or in installments, up to the amount of $1,000,000 to the
Company. In November 2003 and August 2004, agreements were executed with this
shareholder to cause additional advances in total or in installments up to
the
amount of $2,500,000 to advance the process of the FDA approval. In
consideration for the financing, the Company agreed to repay such borrowed
funds
with accrued interest at 12% per annum and the shareholder reserved the right
to
demand payment in full or in part at any time after December 31, 2006. On May
8,
2006 the shareholder agreed to extend the maturity date to December 31, 2008
provided that (i) a partial payment of $350,000 will be made by the Company
on
or prior to July 31, 2006 and (ii) accrued interest will be paid quarterly
thereafter, commencing September 30, 2006. The agreement was amended on
September 4, 2006 so that the Company need no longer pay the quarterly accrued
interest but an amount of $60,000 quarterly as a principal reduction. If the
Company should default in these payments, the promissory note reverts to the
original maturity date of December 31, 2006. As of June 30, 2008, the loan
balance to this shareholder aggregated $1,290,067. An additional amount of
$81,462 and $97,758 of interest on this note has been expensed during the six
months ended June 30, 2008 and 2007, respectively, and a total of $510,238
in
accrued interest remains owed as of June 30, 2008. The lender has filed a
Uniform Commercial Code (UCC) Lien on the Company's equipment and patents as
security for this loan. The Company was unable to make its quarterly principal
payment of $60,000 in the previous year, and therefore, the remaining principal
balance is being classified as a current liability due on demand. Since December
31, 2007, the Company has reduced the principal balance on this note by $186,250
net of advances of $175,100 received in 2008 from the shareholder. The
shareholder has not demanded payment nor has the lender taken any action to
enforce the liens associated with this note.
NOTE
5. DEBENTURE PAYABLE
On
January 19, 2005, the Company's board of directors authorized the issuance
and
sale of up to three million dollars of convertible debentures. These debentures
mature March 31, 2009, and carry an interest rate of 9% per year and are
convertible into common stock at the lower of 66.6% of the valuation of the
Company's next raise of equity or $1 per share. In accordance with EITF Issue
98-5 "Accounting for Convertible Securities with Beneficial Conversion Features
or Contingently Adjustable Conversion Ratios", the Company had evaluated that
the convertible debt had a beneficial conversion feature as the conversion
price
was less than the fair value of the Company's common stock on the measurement
date. Under EITF 98-5, the discount related to the beneficial conversion feature
would be calculated based on its intrinsic value which was $2,614,400, and
is
limited to the amount of the proceeds of $1,510,000 allocated to the convertible
debt instrument. Accordingly, the beneficial conversion feature is being
amortized using the effective interest method of accounting, resulting in a
charge to interest expense of $67,558 and $72,442 for the six months ended
June
30, 2008 and 2007, respectively and $33,022 and $36,132 for the three months
ended June 30, 2008 and 2007, respectively. In September 2005, a debenture
in
the amount of $60,000 was converted into 60,000 shares of common stock. In
May
2006, the Company issued 796,056 and 701,754 shares of common stock at $0.90
and
$0.57 per share, respectively, for the induced conversion of $1,109,607 in
convertible debentures including interest of $109,608. The debenture holders
accepted these shares as full consideration for the outstanding convertible
debentures. The Company recognized an additional expense of $403,872 in 2006
because of the induced conversion to the debenture holders pursuant to the
accounting requirements of SFAS No. 84, Induced Conversions of Convertible
Debt.
The original terms of the debentures called for them to be converted at $1.00
per share. The Company induced the debenture holders to convert at $0.90 and
$0.57 per share.
As
of
June 30, 2008, there is outstanding $262,500 of 9% Convertible Debentures due
in
January 2009. Holders of the 9% Convertible Debentures are entitled to convert
principal amounts into shares of common stock at a conversion price of $1.00.
The debentures payable balance of $206,752 at June 30, 2008, represents the
net
amount of debenture payable of $262,500 reduced by the unamortized debt discount
of $55,748.
The
Company is in default to the debenture holders for not making payments on a
timely basis. As a result, in accordance with the debenture agreements, these
debentures became payable on demand unless the default is waived by the
investors. The Company has not received any notice of default from any of the
holders of the outstanding debentures.
NOTE
6. EQUITY TRANSACTIONS
On
June
8, 2006, the Company completed a private placement of $2,150,000 with 10
institutional and accredited investors pursuant to the 2006 Series A Convertible
Preferred Stock Agreement dated June 7, 2006. Net proceeds from the placement
were approximately $1,969,000. The Company issued 2,150 shares of Series 2006-A
Convertible Preferred Stock, par value $0.001 per share (the “Convertible
Preferred Stock”), at a purchase price of $1,000 per share. Each investor also
received a Series A Warrant (a “Warrant”) to purchase up to 75% of the number of
shares of common stock issuable to him upon conversion of his Convertible
Preferred Stock. If all of the Warrants are exercised, the Company will issue
a
total of 2,015,625 shares of common stock. In addition, the Company issued
to
the placement agent 631,562 warrants valued at $645,881 and paid fees of
$181,000. All the warrants have a term of 5 years and the initial exercise
price
of $1.50 per share has been adjusted to $1.00 per share as the contingent event
stated in the agreement failed to materialize. This $1.00 exercise price is
subject to adjustments for certain corporate events such as merger,
reorganization or future sale of securities at a price below the exercise price.
As the fair value of warrants and conversion option exceeded the net proceeds
of
$2,150,000 from preferred stock, the Company deemed the fair value of the
preferred stock to be $0 at inception. The $2 reflects the minimum par value
of
the stock.
The
Convertible Preferred Stock is convertible to shares of common stock at an
initial conversion price of $0.80 per share, which has been since adjusted
to
$0.50 per share, as the contingent event stated in the agreement failed to
materialize. The conversion price of $0.50 per share is subject to adjustment
in
the event of certain corporate events such as merger, reorganization or future
sale of securities at a price below the conversion rate. Cash dividends accrue
on the Convertible Preferred Stock at the rate of 8% per annum, payable
quarterly beginning in October 2006; or, at the Company's option, dividends
are
payable in shares of the Company’s common stock, accruing at the rate of 10% per
annum based on the volume-weighted average market price for shares of common
stock for the 10 trading days preceding payment.
The
Company is required to keep the Registration Statement continuously effective
until such date as is the earlier of (x) the date when all Registerable Shares
covered by the registration statement have been sold or (y) the date on which
the Registerable Shares may be sold without any restriction pursuant to Rule
144
as determined by Counsel to the Company. The registration statement was timely
filed and declared effective. On October 13, 2006, the Company announced its
intention to restate financial statements, and suspended use of its Registration
Statement declared effective by the SEC October 4, 2006. For such time as the
Registration Statement is not effective, the Company is obligated, pursuant
to
Company’s Registration Rights Agreement with holders of the Company’s
Convertible Preferred Stock, to pay such holders an amount equal to one percent
per month of the original purchase price of the Convertible Preferred Stock
until the earlier of the date the Registration Statement is again declared
effective by the SEC, or June 2008. As of June 30, 2008, the maximum penalty
liability of $129,329 pursuant to the Registration Rights Agreement was
accrued.
The
Company has accounted for the conversion option in the preferred stock as an
embedded derivative under the provisions of FAS 133 “Accounting for Derivative
Instruments and Hedging Activities.” EITF 00-19: “Accounting for Derivative
Financial Instruments Indexed to, and Potentially Settled in, a Company's Own
Stock” (“EITF 00-19”). The Company has initially recorded the value of the
warrants and conversion option at $2,095,930 and $3,698,316, respectively which
are reflected as derivative liabilities on the balance sheet. As the proceeds
from the issuance of preferred shares of $2,150,000 were less than the combined
fair value of the warrants and the conversion option, the difference of
$3,644,246 was charged in fiscal 2006 to financing costs in the statements
of
operations.
As
of
June 30, 2008, the Company believed that none of the events that trigger
redemption upon major corporate events were probable of occurring. The Company
believes that many of these events are within its control and accordingly the
probability of occurrence of any of such events is small. Other events that
are
not within Company’s control and which trigger redemption are lapse of
registration or unavailability of registration and suspension of listing. The
Company believes that although these events are not in its control, as of June
30, 2008, redemption was not likely and that the Company could cure within
any
cure period after receipt of a Notice of Redemption. As such, in accordance
with
paragraphs 15 of EITF Topic D-98: Classification and Measurement of Redeemable
Securities, the Preferred Stock is not currently accreted to its redemption
value,
there
is
no likelihood that it will become redeemable; accordingly, no accretion is
being
made to bring the carrying value up to its redemption value.
As
of
June 30, 2008, the liability for the value of the warrants and conversion option
was “marked to market” and the difference of $275,747 and $582,922,
respectively, totaling $858,669, has been accounted for as a decrease to the
derivative expense initially recognized in the statements of operations for
the
six months ended June 30, 2006. The liability for the value of the conversion
option and warrants will be “marked to market” in future accounting periods
until such time as the preferred shares are converted and the warrants are
exercised or they meet the criteria for equity classification. At June 30,
2008,
the derivative liability was $151,721. As of June 30, 2008, the Company used
the
Black-Scholes option pricing model to revalue the fair value of warrants and
conversion options with the following assumptions:
Stock
price
|
|
$
|
0.10
|
|
Exercise
price
|
|
$
|
0.50-1.00
|
|
Expected
life in years
|
|
|
2.92
years
|
|
Risk
free interest rate
|
|
|
2.91
|
%
|
Expected
volatility
|
|
|
96.40
|
%
|
Dividend
yield
|
|
|
0
|
%
|
On
January 7, 2007 the Company issued 81,068 shares of common stock for payment
of
accrued dividends in the amount of $49,500.
Dividends
declared to the holders of the 2006 Series A Convertible Preferred Stock for
the
six months ended June 30, 2008 were $79,200 and cumulative dividends through
June 30, 2008 amounted to $247,500. Approximately $49,500 of the dividend
obligations was settled through the issuance of 138,306 shares of the Company’s
common stock and $198,000 recorded as a liabilty as of June 30, 2008
to be settled in cash.
NOTE
7. STOCK-BASED COMPENSATION PLANS
Plan
Options
The
Company has two stock option plans, a "1992 Plan", under which 350,000 shares
of
its common stock have been reserved for issuance, and a "1994 Plan", under
which
an additional 350,000 shares of its common stock have been reserved for
issuance. Under both plans, the Company's Board of Directors may grant either
incentive stock options with an exercise price of not less than the fair market
value of the common stock at the date of grant or non-qualified stock options
with an exercise price of not less than 85% of the fair market value of the
common stock at the date of grant. The Board of Directors shall determine the
period of each option and the time or times at which options may be exercised
and any restrictions on the transfer of stock issued upon exercise of any
options. Both plans also provide for certain automatic grants to each
non-employee director at a price of 100% of fair market value of the common
stock at the time of grant. Options generally vest over a period of six months
and are exercisable over a period of five years.
Non-Plan
Options
On
March
25, 2005, 550,000 stock options were granted to one officer/employee and on
May
2, 2005, another 550,000 stock options were granted to a second officer/employee
in accordance with their employment agreements. Both employment agreements
provided for immediate vesting of 100,000 stock options at an exercise price
of
$0.10 on date of grant and then vesting of the remaining 450,000 stock options
in three equal tranches of 150,000 stock options on October 1, 2005, October
1,
2006 and October 1, 2007, at an exercise price of $1.00 per share. These options
are exercisable until June 1, 2015 and had a fair value at the date of grant
of
$2,265,050. Stock option compensation for non-plan option grants recognized
during the six months ended June 30, 2008 and 2007 amounted to $0 and $60,924,
respectively.
The
Company recognized $23,244 of share based expense for both the six months ended
June 30, 2008 and 2007 for options granted to non-employees.
In
January 2006, the Company granted options to its two outside directors, Richard
Woodrich and Joseph Levi, to purchase in the aggregate 100,000 shares of the
Company's common stock. The options vest quarterly in equal amounts over a
period of three years, and are exercisable for seven years from the vesting
date
at an exercise price equal to $1.00.
The
following table summarizes all stock option activity during the six months
ended
June 30, 2008 and 2007:
|
|
Number of
Options
|
|
Weighted
Average
Exercise Price
|
|
Outstanding
at December 31, 2007
|
|
|
1,200,000
|
|
$
|
0.85
|
|
Granted
|
|
|
—
|
|
|
—
|
|
Exercised
|
|
|
—
|
|
|
—
|
|
Forfeited/expired
|
|
|
—
|
|
|
—
|
|
Outstanding
at June 30, 2008
|
|
|
1,200,000
|
|
$
|
0.85
|
|
Exercisable
at June 30, 2008
|
|
|
1,183,335
|
|
$
|
0.85
|
|
As
of
June 30, 2008, there was $23,244 of unrecognized compensation cost related
to
non-vested awards granted, which is expected to be recognized over a
weighted-average period of less than a year. The following table summarizes
the
information about stock options outstanding at June 30, 2008:
Options Outstanding
|
|
Options Exercisable
|
|
Range of Exercise Price
Per Share
|
|
Number
Outstanding at
June 30, 2008
|
|
Weighted Average
Remaining
Contractual Life
(Years)
|
|
Weighted
Average Exercise
Price Per Share
|
|
Number
Exercisable at
June 30, 2008
|
|
Weighted
Average Exercise
Price Per Share
|
|
$0.
10-$1.00
|
|
|
1,200,000
|
|
|
6.68
|
|
$
|
0.85
|
|
|
1,183,335
|
|
$
|
0.85
|
|
The
following table summarizes the information about warrants outstanding at June
30, 2008:
|
|
Number
of
Warrants
|
|
Weighted
Average
Exercise
Price
|
|
Outstanding
at December 31, 2007
|
|
|
3,968,615
|
|
$
|
0.90
|
|
Granted
|
|
|
—
|
|
|
|
|
Exercised
|
|
|
—
|
|
|
|
|
Forfeited/expired
|
|
|
—
|
|
|
|
|
Outstanding
at June 30, 2008
|
|
|
3,968,615
|
|
$
|
0.90
|
|
Of
the
above warrants, 2,647,187 expire in 2011 and 1,321,428 expire in
2012.
NOTE
8. COMMITMENTS AND CONTINGENCIES
Economic
Dependency
2008
For
the
six months ended June 30, 2008, sales to three customers were in excess of
10%
of the Company's total sales. Sales to these customers were approximately
$230,000, $125,000 and $119,000 and accounts receivable from these customers
as
of June 30, 2008, were $135,000, $0, and $0, respectively. Royalties earned
from
Inverness Medical and Chembio Diagnostic Systems for the six months ended June
30, 2008 (See Note 1-
Description
of Business) aggregated approximately $36,000 and $0, respectively.
During
the second quarter of 2008, the Company had sales to two customers that were
in
excess of 10% of the Company's total sales. Sales to these customers were
approximately $230,000 and $59,500. The Company lost its largest customer at
the
beginning of the second quarter, but this customer was immediately replaced
by
selling directly to the end user. The loss of this customer could have a
material adverse effect on the Company. There were no royalties earned from
Inverness Medical and Chembio Diagnostic Systems for the three months ended
June
30, 2008 (See Note 1-
Description
of Business).
For
the
six months ended June 30, 2008, purchases from three suppliers were in excess
of
10% of the Company's total purchases. The purchases from these suppliers for
the
six months ended June 30, 2008 ranged from $14,000 to $40,000. The corresponding
accounts payable at June 30, 2007, to these suppliers, aggregated
$56,247.
2007
For
the
six months ended June 30, 2007, sales to two customers were in excess of 10%
of
the Company's total sales. Sales to these customers were approximately $271,000
and $52,000 and accounts receivable from these customers as of June 30, 2007,
aggregated $193,000 and $0, respectively. Royalties earned from Inverness
Medical and Chembio Diagnostic Systems for the six months ended June 30, 2007
(See Note 1-
Description
of Business) aggregated approximately $118,000 and $37,000, respectively.
During
the second quarter of 2007, the Company had sales to one customer that was
in
excess of 10% of the Company's total sales. Sales to this customer were
approximately $201,000. The loss of this customer could have a material adverse
effect on the Company. Royalties earned from Inverness Medical and Chembio
Diagnostic Systems for the three months ended June 30, 2007 (See Note
1-
Description
of Business) aggregated approximately $80,000 and $13,000,
respectively.
For
the
six months ended June 30, 2007, purchases from four suppliers were in excess
of
10% of the Company's total purchases. The purchases from these suppliers for
the
six months ended June 30, 2007 ranged from $11,000 to $44,000. The corresponding
accounts payable at June 30, 2007, to these suppliers, aggregated
$44,452.
SEGMENT
INFORMATION
Under
the
disclosure requirements of SFAS No. 131, "Segment Disclosures and Related
Information," we operate within one segment. Our products are sold principally
in the United States and the United Kingdom. Segmentation of operating income
and identifiable assets is not applicable since all of our revenues outside
the
United States are export sales. Foreign sales during the three and six month
periods ended June 30, 2008 and 2007 were approximately $163,760 and $90,220,
respectively. The following table represents total product sales revenue by
geographic area:
|
|
For the three months
ended June 30,
|
|
For the six months
ended June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
United
States
|
|
$
|
59,410
|
|
$
|
95
|
|
$
|
120,020
|
|
$
|
52,737
|
|
Europe
|
|
|
253,861
|
|
|
201,009
|
|
|
393,721
|
|
|
271,879
|
|
Other
|
|
|
7,600
|
|
|
22,900
|
|
|
31,500
|
|
|
42,250
|
|
|
|
$
|
320,871
|
|
$
|
224,004
|
|
$
|
545,241
|
|
$
|
366,866
|
|
All
of
the Company's long lived assets are located in the United States.
Employment
Contracts
In
March
and May of 2005, the Company entered into employment agreements respectively
with Steve Peltzman, Chief Executive Officer and Chairman of the Board, and
Bruce Pattison, President. Both agreements provide a minimum annual base salary
of $120,000 for a term of two years and renewable annually. The current annual
renewal period ends in May 2008 and continues to provide for a base salary
of
$120,000. Either party can terminate the agreement upon 90 days notice. The
Company is also obligated to pay health and life insurance benefits and
reimburse expenses incurred by the officers on behalf of the Company. Each
executive, if terminated by the Company without cause, would be entitled to
six
months’ severance. On May 16
th
,
2008,
the Company announced that effective July 1, 2008, Steve Peltzman, Chief
Executive Officer and Chairman of the Board, and Bruce Pattison, President,
Chief Operating Officer and Director, had resigned. Messrs Peltzman and Pattison
have indicated that they will enter into Consulting Agreements with the Company.
Related
Party Agreement
On
October 17, 2007 the Company received a $500,000 financing from Inverness
Medical Innovations, Inc. The financing consists of a purchase of 1,428,572
common shares at a price of $0.35 per share. Additionally, Inverness received
5
year warrants to purchase up to an additional 1,071,428 million shares of the
Company's stock at a price of $0.75 per share. In connection with this
financing, the Company and Inverness signed two additional agreements. First,
the two companies signed an agreement whereby Inverness acquired an option
to
the exclusive, worldwide marketing and distribution rights to certain infectious
disease diagnostic tests developed by StatSure that may utilize specified
Inverness and/or StatSure intellectual property. If exercised by Inverness,
the
option provides for StatSure and Inverness to equally share development expenses
and profits. StatSure and Inverness also entered into a license agreement
whereby Inverness granted to StatSure a license to certain Inverness lateral
flow patents for use in a rapid test to detect HIV antibodies in point-of-care
markets subject to payment of royalties to Inverness. This license pertains
to
HIV tests using formats other than the Statsure's "barrel format" which is
already being sold by Inverness. During the six month periods ended June 30,
2008 and 2007, the Company earned approximately $36,000 and $80,000
respectively, in royalty income under this license agreement.
NOTE
9. FAIR VALUE MEASUREMENTS
Effective
January 1, 2008, we adopted SFAS 157, Fair Value Measurements (SFAS 157). SFAS
157 clarifies the definition of fair value, prescribes methods for measuring
fair value, and establishes a fair value hierarchy to classify the inputs used
in measuring fair value as follows:
Level
1-Inputs are unadjusted quoted prices in active markets for identical assets
or
liabilities available at the measurement date.
Level
2-Inputs are unadjusted quoted prices for similar assets and liabilities in
active markets, quoted prices for identical or similar assets and liabilities
in
markets that are not active, inputs other then quoted prices that are
observable, and inputs derived from or corroborated by observable market
data.
Level
3-Inputs are unobservable inputs which reflect the reporting entity’s own
assumptions on what assumptions the market participants would use in pricing
the
asset or liability based on the best available information.
The
adoption of SFAS No. 157 did not have a material impact on our fair value
measurements.
The
following tables present our assets and liabilities that are measured at fair
value on a recurring basis and are categorized using the fair value hierarchy.
The fair value hierarchy has three levels based on the reliability of the inputs
used to determine fair value.
|
|
|
|
Fair Value Measurements at Reporting Date Using
|
|
Description
|
|
June 30, 2008
|
|
Quoted Prices in
Active Markets for
Identical Assets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
$
|
—
|
|
$
|
-
|
|
$
|
—
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Assets
|
|
$
|
—
|
|
$
|
-
|
|
$
|
—
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative
Instrument ( See Note 6 )
|
|
$
|
151,721
|
|
$
|
-
|
|
$
|
-
|
|
$
|
151,721
|
|
Total
Liabilities
|
|
$
|
151,721
|
|
$
|
-
|
|
$
|
-
|
|
$
|
151,721
|
|
|
|
Fair Value Measurements Using
Significant Unobservable Inputs
(Level 3)
|
|
|
|
Long-term investments available
for sale
|
|
Beginning
Balance
|
|
$
|
1,010,390
|
|
Total
gains or (losses) (realized/unrealized)
|
|
|
|
|
Included
in earnings
|
|
|
(858,669
|
)
|
Included
in other comprehensive income
|
|
|
-
|
|
Purchases,
issuances and settlements
|
|
|
-
|
|
Transfer
in and/or out of Level 3
|
|
|
-
|
|
Ending
Balance
|
|
$
|
151,721
|
|
|
|
|
|
|
The
amount of total gains or (losses) for the period included in earnings
(or
changes in net assets) attributable to the change in unrealized gains
or
losses relating to assets still held at the reporting date
|
|
$
|
-
|
|
ITEM
2.
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATION
The
following discussion of the Company's financial condition and the results of
operations should be read in conjunction with the Financial Statements and
Notes
thereto appearing elsewhere in this document.
The
Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements. In order to comply with the terms of the safe
harbor, the Company notes that in addition to the description of historical
facts contained herein, this report contains certain forward-looking statements
that involve risks and uncertainties as detailed herein and from time to time
in
the Company's other filings with the Securities and Exchange Commission and
elsewhere. Such statements are based on management's current expectations and
are subject to a number of factors and uncertainties, which could cause actual
results to differ materially from those, described in the forward-looking
statements. These factors include, among others: (a) the Company's fluctuations
in sales and operating results; (b) risks associated with international
operations; (c) regulatory, competitive and contractual risks; (d) product
development risks; (e) the ability to achieve strategic initiatives, including
but not limited to the ability to achieve sales growth across the business
segments through a combination of enhanced sales force, new products, and
customer service; and (f) pending litigation.
GENERAL
StatSure
Diagnostic Systems, Inc., (“SDS”), a Delaware corporation (the “Company” or
“StatSure”), is primarily engaged in commercializing two product platforms:
first, the development, manufacturing and marketing of oral-fluid collection
devices to provide physiologic samples to screen for the presence of
drugs-of-abuse or infectious diseases; second, the development of point-of-care
(POC), rapid, immunoassays for use in the detection of infectious diseases.
These immunoassays incorporate SDS’ patented “barrel” technology, designed to
provide speed, safety and convenience which are considered critical factors
in
point-of-care markets. In the oral fluid collection market, the Company’s
platform has a patented internal quality control that indicates sufficient
volume of the oral fluid sample (“volume adequacy indicator”).
The
Company's principal executive offices are located at 1222 Ave M, Brooklyn,
NY
11230.
On
September 29, 2006, the Company announced it had signed several agreements
relating to its patented barrel technology for use in screening antibodies
to
HIV (Human Immunodeficiency Virus, the virus that causes AIDS). As part of
a
three-way alliance with Inverness Medical Innovations (AMEX:IMA) and Chembio
Diagnostics (CEMI.OB) (“Chembio”), StatSure signed a worldwide, exclusive
distribution deal for a rapid, point-of-care HIV test with Inverness. In a
two-way deal with Chembio, the Company granted an exclusive license to Chembio
solely to manufacture their recently FDA approved HIV barrel product for
Inverness Medical Innovations (“IMA” or “Inverness”). This product is being
marketed under the IMA brand. In this two-way agreement (“Joint HIV Barrel
Commercialization Agreement”), a long- term strategic “partnership” was
established, wherein both companies equally split the margin dollars of the
HIV
barrel product once the actual cost of manufacturing is reimbursed.
On
November 5, 2007 the Company announced that the U.S. Food and Drug
Administration ("FDA"), through its Center for Devices and Radiological Health,
had approved a waiver under the Clinical Laboratory Improvements Amendments
of
1988 ("CLIA") for the HIV
1/2
Rapid
Test marketed by Inverness, as per the aforementioned agreement.
On
October 17, 2007 the Company received a $500,000 financing from Inverness
Medical Innovations, Inc. The financing consisted of a sale of 1,428,571 common
shares at a price of $0.35 per share. Additionally, Inverness received 5 year
warrants to purchase up to an additional 1,071,428 shares of the Company's
stock
at a price of $0.75 per share.
In
connection with this financing, the Company and Inverness signed two additional
agreements. First, the two companies signed an agreement whereby Inverness
acquired an option to the exclusive, worldwide marketing and distribution rights
to certain infectious disease diagnostic tests that may be developed by StatSure
that may utilize specified Inverness and/or StatSure intellectual property.
If
exercised by Inverness, the option provides for StatSure and Inverness to
equally share development expenses and profits. StatSure and Inverness also
entered into a license agreement whereby Inverness granted to StatSure a license
to certain Inverness lateral flow patents for use in a rapid test to detect
HIV
antibodies in point-of-care markets subject to payment of royalties to
Inverness. This license pertains to HIV tests using formats other than the
Statsure's "barrel format" which is already being sold by
Inverness.
The
Company announced that effective July 1, 2008, Mr. Steve M. Peltzman, Chairman
of the Board and Chief Executive Officer, and Mr. D. Bruce Pattison, President,
Chief Operating Officer and Director, have resigned. Messrs Peltzman and
Pattison have indicated that they will enter into Consulting Agreements with
StatSure. In addition, Mr. Richard Woodrich has resigned as
Director. Concurrently, the Board elected Mr. Moishe Bodner, currently Vice
President of the Company, as Chief Executive Officer and Director, and Mr.
Leo
Ehrlich, the current Chief Financial Officer and Director, was elected as the
President, Chief Operating Officer effective July 1, 2008.
The
Company has incurred significant operating losses since its inception, resulting
in an accumulated deficit of $50,432,171at June 30, 2008. Such losses are
expected to continue for the foreseeable future and until such time, if ever,
as
the Company is able to attain sales levels sufficient to support its operations.
The Company's independent certified public accountants have included an
explanatory paragraph in their report on the December 31, 2007 financial
statements, stating that the Company's significant operating losses and
significant capital requirements raise substantial doubt about the Company's
ability to continue as a going concern. There can be no assurance that the
Company will be able to obtain the additional capital resources necessary to
continue its business, or that such financing will be available on commercially
reasonable terms or at all. (See note 2 of notes to financial
statements.)
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
The
preparation of financial statements and related disclosures in conformity with
accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect the amounts reported
in
the unaudited Financial Statements and accompanying notes. Estimates are used
for, but not limited to, the accounting for the allowance for doubtful accounts,
inventories, income taxes and loss contingencies. Management bases its estimates
on historical experience and on various other assumptions that are believed
to
be reasonable under the circumstances. Actual results could differ from these
estimates under different assumptions or conditions.
RESULTS
OF OPERATIONS
Second
Quarter and First Six Months of 2008 Compared to Second Quarter and First Six
Months of 2007
Revenues.
The
Company's revenues consist of product sales and royalties. Revenues decreased
to
$320,871 in the second quarter of 2008 from revenues of $400,763 in the second
quarter of 2007. Revenues increased to $581,041 in the first six months of
2008
from $554,611 in the first six months of 2007. The decrease in revenues in
the
second quarter of 2008, from revenues in the second quarter of 2007, is due
to
the decrease in royalties and equipment rental income from Inverness Medical
and
Chembio Diagnostic Systems. In 2007 Inverness overstocked when launching its
Complete HIV test for which the Company receives royalties. In 2008, Inverness
was working through their excess inventory which resulted in a decrease in
royalties and equipment rental income. The Company expects to realize royalty
revenues throughout the remainder of 2008.
The
increase in revenue for the first six months of 2008 from the first six months
of 2007 was due to increased orders from new clients in 2008. Royalties and
equipment rental income earned from Inverness Medical and Chembio Diagnostic
Systems for the six months ended June 30, 2008 and 2007 aggregated approximately
$35,800 and $188,000, respectively. In 2007 Inverness overstocked when launching
its Complete HIV test for which the Company receives royalties. In 2008,
Inverness was working through their excess inventory which resulted in a
decrease in royalties and equipment rental income. The Company expects to
realize royalty revenues throughout the remainder of 2008.
The
Company's revenues are primarily generated from sales of its patented saliva
collection devices. Specimens collected with the device are sent to and
processed at laboratories. For the six months ended June 30, 2008, sales to
three customers were in excess of 10% of the Company's total sales. Sales to
these customers were approximately $230,000, $125,000 and $119,000,
respectively. During this period the Company lost its largest customer for
the
past several years. The Company was able to replace lost sales with another
customer but is uncertain at this time if these orders will continue. The loss
of this customer will have a material adverse effect on the
Company.
Cost
of products sold
:
Costs
of products sold decreased to $73,642 (23% of product sales) in the second
quarter of 2008 from $74,173 (33% of product sales) in the second quarter of
2007, and increased to $122,051 (23% of product sales) in the first six months
of 2008 from $95,902 (26% of product sales) in the first six months of 2007.
The
cost of products sold percentage (%) will vary depending on our selling price
and product mix.
Research
and development expenses:
Research
and development expenses decreased to $3,005
in
the
second quarter of 2008 from $13,543
in
the
second quarter of 2007 and decreased to $8,005 in the first six months of 2008
from $34,591 in the first six months of 2007. The decrease in 2008 is due to
the
completion of projects during 2007 calendar year. The expenses for research
and
development are expected to continue at current levels until such time as the
Company has sufficient funds to implement a new research and development
program.
Selling,
general and administrative expenses
:
Selling, general and administrative expenses decreased to $209,585 in the second
quarter of 2008 from $275,784 in the second quarter of 2007, and decreased
to
$454,164 in the first six months of 2008 from $706,888 in the first six months
of 2007. For the second quarter 2008, the Company’s decrease in selling, general
and administrative expenses was primarily the result of the decrease in payroll
expense and payroll related expense of approximately $61,400, a decrease in
directors fees of approximately $18,600, a decrease in legal and accounting
fees
of approximately $5,500, net of increases in consulting expenses of
approximately $11,600 and freight expense of approximately $7,400. The decrease
in the first six months was mainly due to the decreases in director’s fees of
approximately $37,000, legal and accounting of approximately $93,000, rent
of
approximately $8,000 and payroll and payroll related expenses of approximately
$124,000.
Interest
expense:
Interest
expense decreased to $45,384 in the second quarter of 2008 from $57,432 in
the
second quarter of 2007, and decreased to $93,419 in the first six months of
2008
from $112,466 in the first six months of 2007. The decrease in interest expense
for both periods was due to lower principal balances on debentures and notes
payables to shareholders which resulted in lower interest expense.
Interest
expense on beneficial conversion feature:
Interest expense on beneficial conversion feature decreased to $33,022 in the
second quarter of 2008 from $36,132 in the first quarter of 2007 and decreased
to $67,558 in the first six months of 2008 from $72,442 in the first six months
of 2007. The decrease of this non-cash expense was due to the conversion of
$400,000 of debentures and a reduction in the beneficial conversion
feature.
Derivative
income:
Derivative
income of $164,185 was recorded in the second quarter of 2008 from derivative
income of $644,435 which was recorded in the second quarter of 2007, and
derivative income of $858,669 was recorded in the first six months of 2008
as
compared to $2,040,696 in the first six months of 2007. The fluctuation was
due
to the mark-to market adjustment on embedded derivatives principally driven
by
the decrease in our common stock price from $0.249 to $0.10.
LIQUIDITY
AND CAPITAL RESOURCES
|
|
June 30, 2008
|
|
December 31, 2007
|
|
Cash
and cash equivalents
|
|
$
|
0
|
|
$
|
43,516
|
|
Working
capital deficit
|
|
$
|
(2,595,507
|
)
|
$
|
(2,382,831
|
)
|
Net
cash
provided by operating activities in the first six months of 2008 was $153,334
compared to $145,231 used during the same period 2007. In 2008, the increase
in
cash provided by operations was primarily due to net income, a decrease in
inventories and prepaid expenses, combined with the increase in accounts
payable, accrued payroll and accrued expenses.
Cash
used
in investing activities in the six months ended June 30, 2008 was $10,600 as
compared to $14,839 during the six months ended June 30, 2007. The Company
incurred no patent and trademark costs in 2008.
Cash
used
in financing activities for the six months ended June 30, 2008 was $186,250
compared to cash provided of $58,813 for the same period in 2007. During 2008
the Company repaid shareholder loans of $361,350 compared to $93,687 of
repayments for the same period in 2007.
As
of
June 30, 2008, there is outstanding $262,500 of 9% Convertible Debentures due
in
January 2009. Holders of the 9% Convertible Debentures are entitled to convert
principal amounts into shares of common stock at a conversion price of $1.00.
The Company is in default to these debenture holders for not making payments
on
a timely basis. As a result, in accordance with the debenture agreements, these
debentures became payable on demand unless the default is waived by the
investors. The amount of debentures at June 30, 2008 of $262,500 plus accrued
interest of $29,280 has therefore been reflected as a current liability.
Accordingly, debentures payable-net of discount in the amount of $206,752,
is
the net of amount of debenture payables of $262,500 reduced by unamortized
debt discount of $55,748 and is shown on the balance sheet as a current
liability. The Company has not received any notice of default from any of the
holders of the outstanding debentures.
The
following table lists the future cash payments required on debt and any other
contractual obligations of the Company as of June 30, 2008.
Obligations
|
|
Total
|
|
Less
than 1
year
|
|
1-3
years
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt
|
|
$
|
1,496,819
|
|
$
|
1,496,819
|
|
$
|
0
|
|
Operating
leases
|
|
|
14,166
|
|
|
14,166
|
|
|
0
|
|
In
June
2007, the Company decided to move its offices to nearby premises also in
Framingham, MA. The Company is leasing its new premises on a month to month
basis at a rent of $1,800 per month. The Company also occupies premises in
Brooklyn, New York. The lease has a three-year term ending August 30, 2008
and a
base annual rental rate through maturity of approximately $16,000 per
annum.
Since
inception, the Company has financed its capital requirements through the
proceeds from its public offering of common stock in March 1993 and the exercise
of common stock purchase warrants pursuant to such offering, proceeds from
sales
of convertible debentures, proceeds from private placements of common stock
and
preferred stock, the exercise of common stock purchase warrants and stock
options and loans.
There
can
be no assurance that the Company will be able to obtain the additional capital
resources necessary to implement or continue its programs, or that such
financing will be available on commercially reasonable terms or at all. The
Company will continue to seek public or private placement of its equity
securities and corporate partners to develop products. There can be no assurance
that the Company will be able to sell its securities on commercially reasonable
terms or to enter into agreements with corporate partners on favorable terms
or
at all. The Company's future capital needs will depend upon numerous factors,
including the progress of the approval for sale of the Company's products in
various countries, including the U.S., the extent and timing of the acceptance
of the Company's products, the cost of marketing and manufacturing activities
and the amount of revenues generated from operations, none of which can be
predicted with certainty. The Company's significant operating losses and capital
requirements raise substantial doubt about the Company's ability to continue
as
a going concern.
Recent
Accounting Pronouncements
See
Note 3 "Recent Accounting Standards Affecting the Company” in the Notes to
Condensed Consolidated Financial Statements in Item 1 for a full
description of recent accounting pronouncements, including the expected dates
of
adoption and estimated effects on results of operations and financial condition,
which is incorporated herein.
OFF-BALANCE
SHEET ARRANGEMENTS. The Company does not have any off-balance sheet
arrangements, as defined in Item 304(a) (4) (ii) of Regulation S-K under the
Securities Exchange Act of 1934, as amended.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Not
applicable
ITEM
4T. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
As
of
June 30, 2008, the Company’s management, including our Chief Executive Officer
(CEO) and Chief Financial Officer (CFO), have conducted an evaluation of
the
effectiveness of our disclosure controls and procedures pursuant to Rule
13a-15(b) of the Exchange Act. Based on the evaluation, our CEO and CFO
concluded that our disclosure controls and procedures are not effective as
a
result of an unremediated material weakness associated with a lack of
segregation of duties, resulting from the Company’s continued lack of
resources.
Changes
in Internal Control Over Financial Reporting
There
were no changes in the Company’s internal control over financial reporting
during the first six months ended June 30, 2008 or subsequent to the date
the
Company completed its evaluation, that have materially affected or reasonably
likely to materially affect, the Company’s internal control over financial
reporting.
PART
II. OTHER INFORMATION
Item
1
.
LEGAL PROCEEDINGS
Item
2.
UNREGISTERED
SALES OF EQUITY SECURITIES
None
ITEM
3.
DEFAULTS
UPON SENIOR SECURITIES
The
Company is in default on a total of $291,780 of convertible debentures. The
amount of principal payments in arrears was $262,500, with an additional amount
of $29,280 of interest due at June 30, 2008. These defaults are the result
of a
failure to pay in accordance with the terms agreed. No notice of default has
been received.
The
Company is in default on a total of $1,800,305 of shareholder loans. The amount
of principal payments in arrears was $1,290,067, with an additional amount
of
$510,238 of interest due at June 30, 2008. The default is
the
result of a failure to pay in accordance with the agreed upon terms. On
September 22, 2007, the Company advised the shareholder, Mr. Nordlicht, that
in
consideration of his forbearing from calling the Company in default on the
loan
outstanding of principal and all accrued interest, the Company agrees to pay
him
no later than December 31, 2008, an amount totaling $2,600,000 as full payment
of the loan (principal and interest). Any payments made during the interim
period between January 1, 2007 and December 31, 2008 will be deducted from
this
total amount. As of the date of this filing, Mr. Nordlicht has not sent the
Company a default notice.
ITEM
4.
SUBMISSION
OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM
5.
OTHER
INFORMATION
None
ITEM
6. EXHIBITS
(a)
Exhibit
index
Exhibit
|
|
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a)
under the Securities Exchange Act of 1934, as amended.
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a)
under the Securities Exchange Act of 1934, as amended.
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer required by Rule 13a-14(b) or Rule 15d-14(b)
under the Securities Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act
of 2002.
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b)
under the Securities Exchange Act of 1934, as amended, and 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act
of 2002.
|
(b)
Reports
on Form 8-K
Date
|
Items
Reported
|
|
|
5/16/07
|
5.02
|
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
Dated:
August 14, 2008
STATSURE
DIAGNOSTIC SYSTEMS, INC.
|
/s/
Moshe Bodner
|
|
|
Moshe
Bodner
|
|
|
Chief
Executive Officer
|
|
|
(principal
executive officer)
|
|
|
|
|
|
/s/
Leo Ehrlich
|
|
|
Leo
Ehrlich
|
|
|
Chief
Financial Officer
|
|
|
(principal
financial officer)
|
|
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