StatSure Diagnostic Systems (SSUR)

[Ubertino]

Saliva Diagnostic Systems, Inc. and StatSure Diagnostic Systems - SSUR

From
http://sec.edgar-online.com/2007/03/08/0001144204-07-011794/Section3.asp

At the beginning of business on January 24, 2006, the Company effected a name
change from Saliva Diagnostic Systems, Inc. to StatSure Diagnostic Systems,
Inc., and the shares of the Company have been trading under that name, with the
new symbol SSUR, since March 22, 2006. Coinciding with our corporate name
change, the Company has changed the brand of its Hema-Strip Product line, in
general, to StatSure(TM), and the name of its Hema-Strip HIV test to
StatSure(TM) HIV.


StatSure(TM) Diagnostic Systems, Inc., (SDS), a Delaware corporation (the
"Company"), is primarily engaged in the development and marketing of oral fluid
collection devices for the drugs of abuse market, and rapid, point-of-care
immunoassays for use in the detection of infectious diseases. The Company
believes that its patented, proprietary platform offers significant advantages
over the existing products, including ease-of-use, lower costs, and
significantly reduced risk of infection from collecting and handling specimens.
In the oral fluid collection market, the Company's platform has a patented
internal quality control that indicates sufficient volume of the oral fluid
("volume adequacy indicator").


The Company was incorporated in California in 1986 as E&J Systems, Inc. In
January 1992, the Company merged into a Delaware corporation and, at that time,
changed its name to Saliva Diagnostic Systems, Inc. The Company completed an
initial public offering of its common stock in March 1993. In January, 2006, the
Company changed its name to StatSure Diagnostic Systems, Inc. The Company's
principal executive offices are located at 1Clarks Hill Rd. Framingham, MA.
01702.


In May 2002, the Company received its Investigational Device Exemption (IDE)
from the U.S. Food and Drug Administration (FDA) for its Rapid Stat-Sure(TM) HIV

Test [THE PRODUCT BRAND NAME WAS FORMERLY KNOWN AS HEMA-STRIP HIV; THIS PRODUCT LINE WILL HEREAFTER BE REFERRED TO AS THE STATSURE PRODUCT LINE AND THIS PRODUCT WILL BE KNOWN AS STATSURE HIV]. Upon termination of all business relationships with its then contract manufacturer, Chembio Diagnostic Systems, (CEMI.OB) the
Company signed a Manufacturing / Research & Development Agreement with American
Bio Medica Corporation, Nasdaq SC (ABMC), of Kinderhook, NY. Responsibilities of
ABMC include the manufacture of the Company's StatSure(TM) HIV test and other
products under appropriate and applicable regulatory compliance standards. The
Company filed a new IDE with the FDA naming ABMC as its contract manufacturer.
This IDE submission to the FDA was made in October 2003. Thereafter, the Company
conducted its clinical trials and submitted all the modules of the Pre-Market
Approval (PMA) to the FDA. The FDA requested certain additional testing and the
Company completed this work in the summer of 2005 and a Supplemental Study to
the PMA was submitted in October 2005 to satisfy this request. The Company is
currently waiting for the FDA to complete its audits of certain clinical sites
and of the Company's contract manufacturer. Should the Company receive PMA
approval for its rapid HIV test, it will also file for a CLIA (Clinical
Laboratory Improvements Amendments) waiver. During the past year, the Company
has received regulatory approval to markets its StatSure(TM) HIV product in
South Africa and Guatemala and expects to receive similar approvals in several
other countries in 2006. (See also Item 6- Management's Discussion And Analysis
of Financial Condition And Results of Operations; Subsequent Events)


SDS is committed to and focused on the completion of the necessary requirements
towards obtaining U.S. Food and Drug Administration (FDA) PMA marketing approval
of our rapid Stat-Sure(TM) HIV diagnostic tests in the United States. Although
there is no assurance that we will receive approval, we believe that the
StatSure(TM) HIV device format, if approved for detecting antibodies to HIV-1 in
fingerstick and venipuncture whole blood, serum and plasma samples, will have
certain competitive advantages in the market for rapid HIV testing both in the
United States and internationally.

Ref:
STATSURE DIAGNOSTIC (OTC BB:SSUR.OB)
http://finance.yahoo.com/q?s=SSUR.OB
NB:
Our business model calls for rapidly expanding our business. We feel the Inverness/Chembio agreement, validated our barrel patent and the commercial potential of the technology platform. There is a broad menu of potential products that we are candidates for development using the barrel assay format. They include hepatitis B and C, SARS, bird-flu, and others. The Company is currently seeking funds to use to target the development of one or more of these product opportunities. While we are very excited about the potential of the base HIV business, we also want to leverage our technology platform to broaden this product base.
http://www.statsurediagnostics.com/index.php?press
(Kinda reminds me of NNVC at 10¢ - time for ANOTHER flier??!! Bid: 0.14 x 5000 Ask: 0.20 x 5000)

US Patent 5,935,864 - StatSure Hemastrip:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fne....