SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF
THE
SECURITIES EXCHANGE ACT OF 1934
Date
of
Report (Date of earliest event reported): March 21, 2008 (March 17,
2008)
CHEMBIO
DIAGNOSTICS, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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0-30379
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88-0425691
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(State
or other jurisdiction
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(Commission
File Number)
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(IRS
Employer
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of
Incorporation)
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Identification
Number)
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3661
Horseblock Road
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Medford,
NY 11763
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(Address
of principal executive offices)
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631-924-1135
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(Registrant’s
Telephone Number)
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N/A
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
3.02 Unregistered Sales of Equity Securities.
On
March
20, 2008, Chembio Diagnostics, Inc. (the “Company”) issued James D. Merselis
options to purchase 9,000 shares of the Company’s common stock, exercisable at
$0.15 per share, which was the closing price of the Company’s common stock on
March 20, 2008. No cash was exchanged in this issuance, and these
shares were issued to Mr. Merselis in consideration for his service as a member
of the Company’s Board of Directors. This issuance was granted based
on exemptions from registration under the Securities Act of 1933, as amended
(the “Securities Act”), and applicable state laws pursuant to Section 4(2) of
the Securities Act and Rule 506 of Regulation D. This issuance
qualified for this exemption from registration because (i) the Company did
not
engage in any general solicitation or advertising to market the
securities; (ii) all the Company's reports filed under the Securities
Exchange Act of 1934 were made available to Mr. Merselis; (iii) Mr. Merselis
was
provided the opportunity to ask questions and receive answers from the Company
regarding the issuance; (iv) Mr. Merselis has knowledge and experience in
financial and business matters so that he was capable of evaluating the merits
and risks of an investment in the Company; and (v) Mr. Merselis received
“restricted securities” that include a restrictive legend on the
certificate.
ITEM
5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
(d) Effective
March 17, 2008, the Company’s Board of Directors (the “Board”) elected James D.
Merselis to become a member of the Board. From 2002 to
2007, Mr. Merselis served as the President, Chief Executive Officer, and
Director of Hemosense, Inc. (AMEX: HEM), a company that develops, manufactures,
and sells handheld blood coagulation monitoring systems. During his
tenure at Hemosense, Inc., Mr. Merselis led the company through multiple rounds
of private financing, an initial public offering, and a sale to Inverness
Medical Innovations. From 1998 to 2002, Mr. Merselis served as
President, Chief Executive Officer, and Director of Micronics, Inc., a Redmond,
WA, based company that develops in vitro diagnostic products for disease
diagnosis, prognosis, and treatment monitoring. Under the leadership
of Mr. Merselis, Micronics, Inc., raised substantial venture capital,
established and developed strategic partnerships, and significantly broadened
its intellectual property portfolio. From 1976 to 1998, Mr. Merselis
held multiple positions at Boehringer Manneheim, including serving as Managing
Director of the British affiliate of Boehringer Manneheim from 1994 to 1995,
Executive Vice President and Director of Boehringer Mannheim Diagnostics USA
from 1995 to 1997, and Senior Vice President and Director Boehringer Mannheim
Diagnostics USA from 1997 to 1998. He holds an Advanced Management
Program Certificate from the Harvard Business School and a Bachelor of Science
in Pre-Medicine from Nebraska Wesleyan University.
On
March
20, 2008, Mr. Merselis was granted options to purchase 9,000 shares of the
Company’s common stock, as described in Item 3.02 herein.
ITEM
7.01. REGULATION FD DISCLOSURES.
On
March
20, 2008, the Company issued a press release titled “Chembio Appoints James D.
Merselis to Board of Directors.” A copy of the press release is furnished
herewith as Exhibit 99.1.
On
March
17, 2008, the Company issued a press release titled “Webcast Alert:
Lippert/Heilshorn Life Sciences Virtual Conference (Chembio Diagnostics,
Inc.).” A copy of the press release is furnished herewith as
Exhibit 99.2.
In
accordance with General Instruction B.2 of Form 8-K, the information in Item
7.01 and Exhibits 99.1 and 99.2 in this Current Report on Form 8-K shall not
be
deemed “filed” for the purpose of Section 18 of the Securities Exchange Act of
1934, nor shall it be deemed incorporated by reference in any
filing. This Current Report on Form 8-K does not constitute a
determination of whether any information included herein is
material.
ITEM
9.01. FINANCIAL STATEMENTS AND EXHIBITS.
Exhibit 99.1
- Press Release titled “Chembio Appoints James D. Merselis
to Board of Directors” dated March 20, 2008.
Exhibit
99.2 - Press Release titled “Webcast Alert:
Lippert/Heilshorn Life Sciences Virtual Conference (Chembio Diagnostics,
Inc.)” dated March 17, 2008.
SIGNATURES
Pursuant
to the requirements 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.
Date: March
21,
2008 Chembio
Diagnostics, Inc.
By: /s/ Lawrence A.
Siebert
Lawrence
A. Siebert
Chief
Executive Officer
Exhibit
99.1
Chembio
Appoints James D. Merselis to Board of Directors
MEDFORD,
N.Y. (March 20, 2008) – Chembio Diagnostics, Inc. (OTCC/BB: CEMI) today
announced that James D. Merselis has been appointed to the Company’s Board of
Directors, increasing the number of directors to five, including a majority
of independent directors.
From
2002
through 2007 Mr. Merselis was President, CEO and a director of HemoSense,
Inc.,
a point-of-care diagnostic company focused initially on blood coagulation
systems for monitoring patients taking warfarin. At HemoSense, he led the
Company’s development from a pre-revenue, venture-backed start-up through an
initial public offering and on to a successful organization selling products
in
more than 20 countries and a market share exceeding 25% in the U.S. professional
segment. In August 2007 Mr. Merselis negotiated the sale of HemoSense
to Inverness Medical Innovations. Previously he was President
and CEO of Micronics, Inc., where he established key relationships with Amgen,
Honeywell and Waytek, and helped transform Micronics from a research project
to
one focused on commercializing microfluidics tools. Earlier in his career
Mr.
Merselis was with Boehringer Mannheim, where he advanced through a variety
of
positions in the U.S. and Europe over a period of more than 20 years, lastly
as
Senior Vice President and Director of the Company’s U.S. Laboratory Diagnostics
business. Mr. Merselis holds a Bachelor of Science (Pre-Med) from
Nebraska Wesleyan University and an Advanced Management Program Certificate
from
Harvard Business School.
“We
are
delighted to welcome Jim to our Board of Directors as his considerable
experience and successful track record – particularly with point-of-care
clinical diagnostics – will be of great value as we expand our product
portfolio, leverage proprietary technology and establish Chembio as an industry
leader,” said Larry Siebert, Chembio’s president and chief executive
officer. “Jim’s proven abilities in organizational development,
product commercialization and financing, among other strengths, are ideal
for
Chembio, and we look forward to benefiting from his insight and
advice.”
About
Chembio Diagnostics
Chembio
Diagnostics, Inc., a developer and manufacturer of proprietary rapid diagnostic
tests, participates in the growing $5 billion point-of-care testing
market. Chembio’s two U.S. Food and Drug Administration (FDA)
PMA-approved, CLIA-waived, rapid HIV tests are marketed in the U.S. by a
third-party company. Chembio markets its HIV STAT-PAK® line of rapid HIV tests
internationally to government and donor-funded programs directly and through
distributors. Chembio also has rapid tests for veterinary
tuberculosis and Chagas disease. In 2007 Chembio received a U.S. patent
for its Dual Path Platform (DPP™) technology, which has significant advantages
over currently available lateral-flow technologies. This technology
is providing Chembio with a significant pipeline of business opportunities
for
the development and manufacture of new products based on
DPP™. Headquartered in Medford, N.Y. with approximately 100
employees, Chembio is licensed by the FDA as well as the U. S. Department
of
Agriculture, and is certified for the global market under the International
Standards Organization (ISO) directive 13.485.
Forward-Looking
Statements
Statements
contained herein that are not historical facts may be forward-looking statements
within the meaning of the Securities Act of 1933, as amended. Forward-looking
statements include statements regarding the intent, belief or current
expectations of the Company and its management. Such statements reflect
management's current views, are based on certain assumptions and involve
risks
and uncertainties. Actual results, events or performance may differ materially
from forward-looking statements due to a number of important factors, and
will
be dependent upon a variety of factors including, but not limited to, Chembio's
ability to obtain additional financing, to obtain regulatory approvals for
its
products in a timely manner and the demand for Chembio's products. Chembio
undertakes no obligation to publicly update these forward-looking statements
to
reflect events or circumstances that occur after the date hereof, or to reflect
any change in Chembio's expectations with regard to these forward-looking
statements or the occurrence of unanticipated events. Factors that may
impact Chembio's success are more fully disclosed in Chembio's filings with
the
U.S. Securities and Exchange Commission.
Contacts:
Company
Contact: Investor
Relations Contacts:
Chembio
Diagnostics,
Inc. Lippert/Heilshorn
& Associates, Inc.
Matty
Arce
Anne Marie Fields (afields@lhai.com)
(631)
924-1135, ext.
123 (212)
838-3777
www.chembio.com Bruce Voss
(bvoss@lhai.com)
(310) 691-7100
Exhibit
99.2
Webcast
Alert: Lippert/Heilshorn Life Sciences Virtual Conference (Chembio Diagnostics,
Inc.)
Monday
March 17, 10:00 am ET
NEW
YORK--(BUSINESS WIRE)--Chembio Diagnostics, Inc. (OTCBB:CEMI - News) announces
the following Webcast:
What:
Lippert/Heilshorn Life Sciences Virtual Conference
When:
March 18, 2008 @ 10:00 AM Eastern
Where:
http://www.investorcalendar.com/ClientPage.asp?ID=127008
How:
Live
over the Internet -- Simply log on to the web at the address above.
Contact:
Ben Carmichael, 212-838-3777, bcarmichael@lhai.com
If
you
are unable to participate during the live webcast, the call will be available
for replay at http://www.investorcalendar.com/ClientPage.asp?ID=127008 or
http://www.investorcalendar.com/
Chembio
Diagnostics, Inc. and its subsidiaries develop, manufacture, and market rapid
diagnostic tests for the detection of HIV antibodies in whole blood, serum,
and
plasma samples and other infectious diseases. Its products utilize various
forms
of in-licensed lateral flow technology, including Dual Path Platform (DPP).
The
company primarily markets three rapid HIV tests, which include SURE CHECK
HIV
1/2, HIV 1/2 STAT-PAK, and HIV 1/2 STAT-PAK Dipstick. It also manufactures
rapid
tests for other infectious diseases for human and veterinary tuberculosis.
In
addition, the company develops an oral fluid HIV antibody detection test,
as
well as offers PrimaTB STAT-PAK for detecting active pulmonary tuberculosis
in
non-human primates, primarily monkeys. Chembio Diagnostics sells its tests
to
medical laboratories and hospitals, governmental and public health entities,
nongovernmental organizations, medical professionals, and retail establishments
worldwide. It has a cooperative research and development agreement with the
United States Centers for Disease Control to develop a rapid, point of care
combination screening and confirmatory test for Syphilis; with the Infectious
Disease Research Institute for the development of rapid diagnostic tests
for
Leishmaniasis and Leprosy; a marketing partnership with Inverness Medical
Innovations, Inc. for Chembio's FDA-approved rapid HIV tests; and a research
and
development agreement with Pall Corp. The company was founded in 1985 and
is
headquartered in Medford, New York.
Contact:
For
Lippert/Heilshorn Life Sciences Virtual Conference
Ben
Carmichael, 212-838-3777
bcarmichael@lhai.com