SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the
SECURITIES EXCHANGE ACT OF 1934
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Date of Report (Date of earliest event reported): December 6, 2000
TCPI, INC.
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(Exact name of registrant as specified in its charter)
0-25406 65-0308922
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(Commission File Number) (I.R.S. Employer Identification No.)
3341 S.W. 15TH STREET
POMPANO BEACH, FLORIDA 33069
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code: 954/979-0400
Not Applicable
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(Former name or former address, if changed since last report)
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ITEM 5. OTHER EVENTS
TCPI Updates Total Cholesterol Home Screening Test And Noninvasive TD Glucose
Monitoring System Programs
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TCPI has updated the status and outlook of its over-the-counter ("OTC")
Total Cholesterol Home Screening Test(TM) and its noninvasive TD Glucose(TM)
Monitoring System product development programs.
Total Cholesterol Home Screening Test
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TCPI has completed pre-clinical trials for its OTC total cholesterol
screening test, including modification of the results color-chart, and is moving
ahead to perform clinical trials at several independent sites to collect the
necessary data for a 510(k) submission to the United States Food & Drug
Administration seeking marketing clearance. TCPI has retained the services of
mdi Consultants, Inc. of Great Neck, NY, a firm that specializes in assisting
developers of diagnostic products in submitting and obtaining FDA approval of
healthcare products. mdi has obtained more than 900 510(k) approvals for its
client companies over the last 15 years.
With the assistance of mdi Consultants, a highly qualified, specialized
organization, TCPI expects to begin accessing patients after the New Year and
filing a submission to the FDA upon completion of the required clinical work.
The clinical trials will conform to the FDA Guidance for 510(k)s on Cholesterol
Tests, and, based on the results, TCPI will request clearance to market this
product as a home screening test sold in pharmacies under its own HealthCheck(R)
brand in the United States and internationally as well as on an OEM (original
equipment manufacture) basis.
TD Glucose Monitoring System
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Following a recent review of the development project to date, TCPI has
determined that the clinical trials for its TD Glucose Monitoring System ended
in January 2000 and that no subsequent clinical activity was undertaken. Since
that time TCPI has been focused on further refinements of the optical TD Glucose
meters that the Company believes are necessary to achieve greater precision
before initiating expanded clinical trials required to obtain FDA consideration
of this device. The optical meters measure the color produced on the membrane in
the noninvasive patch in response to the level of glucose present. At this time
the Company cannot determine when clinical trials will resume.
Management believes that, although it is disappointing that the
expanded clinical trials will not be conducted this year, it is critical that
the total system is in its final format before TCPI initiates expensive clinical
trials with hundreds of diabetic patients. The Company's evaluation of the
current prototype meters that incorporate new optics and software has indicated
a substantial increase in precision from some prior versions of the meters and
TCPI is currently working to optimize these meters. Meanwhile, exploratory
discussions with potential strategic partners remain ongoing and the engineering
phase of the TD Glucose patch manufacturing scale-up process for the design of
high-speed, automated manufacturing equipment is near completion.
Early last month, the results of a clinical study related to TCPI's
noninvasive TD Glucose Monitoring System conducted at the Washington University
School of Medicine were presented at the 17th International Diabetes Federation
Congress held in Mexico City. This study demonstrated a high degree of
correlation between the TD Glucose Monitoring System and both the finger-stick
and venous blood glucose methods across the hypoglycemic to normal to
hyperglycemic levels. This study concluded that pain-free glucose monitoring
using the TD Glucose Monitoring System is possible with accuracy comparable to
capillary (finger-stick) and venous blood glucose measurements.
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Forward Looking Statements
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Information in this Form 8-K, including any information incorporated by
reference herein, includes "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Act of 1934, as amended, and is subject to the safe-harbor created by
such sections. The Company's actual results may differ significantly from the
results discussed in such forward-looking statements.
Statements regarding development and FDA clearance of future products,
future prospects, business plans and strategies, future revenues and revenue
sources, the resolution of pending litigation, future liquidity and capital
resources, healthcare market directions, future acceptance of the Company's
products, possible recommendations of healthcare professionals or governmental
agencies regarding use of diagnostic products, possible growth in markets for
at-home diagnostic testing, the possibility and timing of additional equity
investments, mergers, acquisitions or other strategic transactions, as well as
other statements contained in this report that address activities, events or
developments that the Company expects, believes or anticipates will or may occur
in the future, and similar statements are forward-looking statements. These
statements are based upon assumptions and analyses made by the Company in light
of current conditions, future developments and other factors the Company
believes are appropriate in the circumstances, or information obtained from
third parties and are subject to a number of assumptions, risks and
uncertainties. Readers are cautioned that forward-looking statements are not
guarantees of future performance and that actual results might differ materially
from those suggested or projected in the forward-looking statements. Factors
that may cause actual future events to differ significantly from those predicted
or assumed include, but are not limited to: the satisfactory conduct and
completion of clinical trials demonstrating efficacy of the Company's Products
including TD Glucose(TM) Monitoring System and Total Cholesterol Home Screening
Test; FDA and foreign regulatory clearance of the TD Glucose Monitoring System
and Total Cholesterol Home Screening Test; delays in product development; risks
associated with the Company's ability to successfully develop and market new
products on a profitable basis or at all; the Company's ability to finance and
complete the acquisition of certain assets of Roche Diagnostics GmbH,
availability of labor and sufficient parts and materials to complete the design,
construction and manufacturing scale-up of required equipment; ability to
complete the design, construction and manufacturing scale-up on a timely basis
within budget parameters; receipt of any required regulatory approvals for
manufacturing equipment or related facilities; future advances in technologies
and medicine; the uncertainties of healthcare reform; risks related to the early
stage of the Company's existence and its products' development; the Company's
ability to execute its business plans; engineering development; lead time for
delivery of equipment; the Company's dependence on outside parties such as its
key customers, suppliers, licensing and alliance partners; competition from
major pharmaceutical, medical and diagnostic companies; risks and expense of
government regulation and effects of changes in regulation (including risks
associated with obtaining requisite FDA and other governmental approvals for the
Company's products); the limited experience of the Company in manufacturing and
marketing products; uncertainties connected with product liability exposure and
insurance; risks associated with domestic and international growth and
expansion; risks associated with international operations (including risk
associated with international economies, currencies and business conditions);
risks associated with obtaining and maintaining patents and other protections of
intellectual property; risks associated with uncertainty of litigation and
appeals, and the payment of judgments not reversed on appeal or otherwise; the
Company's limited cash reserves and sources of liquidity, including the
satisfaction of terms and conditions relating to funding, and timing and receipt
of proceeds from any funding; uncertainties regarding timing and effectiveness
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of registration statements; uncertainties in availability of expansion capital
in the future and other risks associated with capital markets, including funding
of ongoing operations, risks associated with the Company's ability to negotiate
and obtain additional financing, equity investments or strategic transactions on
favorable terms or at all and the influence, if any, a delay in developing the
Company's products, including the TD Glucose Monitoring System and Total
Cholesterol Home Screening Test may have on such funding of operations and for
obtaining additional financing, equity investments or strategic transactions, as
well as those listed in the Company's other press releases and in its other
filings with the Securities and Exchange Commission. The Company may determine
to discontinue or delay the development of any or all of its products under
development at any time. Moreover, the Company may not be able to successfully
develop and market new products, complete planned acquisitions, enter into
strategic alliances or implement any or all of its operating strategy unless it
is able to generate additional liquidity and working capital. For a complete
description of the Company's business, products and liquidity, see the Company's
Annual Report on Form 10-K for the year ended December 31, 1999 and subsequent
quarterly reports on Form 10-Q.
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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.
Dated: December 6, 2000 TCPI, INC.
By: /s/ Walter V. Usinowicz, Jr.
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Walter V. Usinowicz, Jr.
Vice President of Finance and Chief Financial
Officer (Chief Accounting Officer)
