CARDIOVASCULAR DIAGNOSTICS INC /NC/
10-Q, 1998-11-12
ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS
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                       SECURITIES AND EXCHANGE COMMISSION
                              Washington, DC 20549

                                    FORM 10-Q

   [X]   Quarterly report pursuant to Section 13 or 15 (d) of the Securities
         Exchange Act of 1934. For the quarterly period ended
         September 30, 1998.

   [ ]   Transition report pursuant to Section 13 or 15(d) of the Securities
         Exchange Act of 1934. For the transition period from
         _________ to ___________.

                             Commission File Number
                                     0-26992

                        CARDIOVASCULAR DIAGNOSTICS, INC.
             (Exact Name of Registrant as Specified in its Charter)

              North Carolina                            56-1493744
    (State or other jurisdiction of         (IRS Employer Identification Number)
     Incorporation or organization)


              5301 Departure Drive
             Raleigh, North Carolina                         27616
      (Address of Principal Executive Office)             (Zip Code)

 Registrant's Telephone Number, Including Area Code       919-954-9871

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 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 the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.

          Class                             Outstanding as of November 2, 1998
Common Stock, par value $.001                            7,436,724


<PAGE>

                        CARDIOVASCULAR DIAGNOSTICS, INC.

                               INDEX TO FORM 10-Q

<TABLE>
<CAPTION>


                                                                                     PAGE
<S>          <C>                                                                     <C>
PART I.      FINANCIAL INFORMATION

             Item 1. Financial Statements

             Consolidated Balance Sheets as of September 30, 1998
             (unaudited) and December 31, 1997                                        3

             Consolidated Statements of Operations and Comprehensive Loss for
             the Three Months and Nine Months ended September 30, 1998 and 1997
             (unaudited)                                                              4

             Consolidated Statements of Cash Flows for the Nine Months ended
             September 30, 1998 and 1997 (unaudited)                                  5

             Notes to Unaudited Consolidated Financial Statements                     6

             Item 2. Management's Discussion and Analysis of Financial
             Condition and Results of Operations                                      8

PART II.     OTHER INFORMATION                                                       10

             Item 2. Changes in Securities and Use of Proceeds                       10

             Item 6. Exhibits and Reports on Form 8-K                                10

SIGNATURES                                                                           11

INDEX TO EXHIBITS                                                                    12
</TABLE>




<PAGE>



                        CARDIOVASCULAR DIAGNOSTICS, INC.

                           CONSOLIDATED BALANCE SHEETS
                        (In thousands, except share data)

<TABLE>
<CAPTION>

                                                                      SEPTEMBER 30,  DECEMBER 31,
                                                                          1998           1997
                                                                      -----------    -----------
                                                                      (UNAUDITED)
<S>                                                                   <C>            <C>
ASSETS
Current assets:
    Cash and cash equivalents                                         $     6,633    $     5,885
    Short term investments, held-to-maturity                                2,438           --
    Accounts receivable                                                     2,026          1,888
    Inventories                                                             2,415          2,998
    Other current assets                                                      314            217
                                                                      -----------    -----------

         Total current assets                                              13,826         10,988

Property and equipment, net                                                 4,704          4,938
Intangible assets, net                                                      1,620          1,568
Other assets, net                                                             146            191
                                                                      -----------    -----------

        Total assets                                                  $    20,296    $    17,685
                                                                      ===========    ===========


LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
    Accounts payable                                                  $       690    $     1,138
    Accrued expenses                                                          198            464
    Current portion of long term debt and capital lease obligations           648            539
                                                                      -----------    -----------

         Total current liabilities                                          1,536          2,141

Long term debt and capital lease obligations, less current portion          1,857          2,351
                                                                      -----------    -----------

         Total liabilities                                                  3,393          4,492
                                                                      -----------    -----------

Shareholders' equity:
   Preferred stock, $.001 par value; authorized 1,000,000 shares-
     no shares issued or outstanding at September 30, 1998 and
     December 31, 1997

    Common stock, $.001 par value; authorized 10,000,000 shares;
    7,436,724 and 6,750,518 issued and outstanding at
    September 30, 1998 and December 31, 1997, respectively                      7              7
Additional paid-in capital                                                 39,997         33,827
Accumulated deficit                                                       (23,088)       (20,619)
Unearned compensation                                                         (13)           (22)
                                                                      -----------    -----------

        Total shareholders' equity                                         16,903         13,193
                                                                      -----------    -----------

        Total liabilities and shareholders' equity                    $    20,296    $    17,685
                                                                      ===========    ===========


Commitments and contingencies
</TABLE>

The accompanying notes are an integral part of the consolidated financial
statements.

                                        3


<PAGE>



                        CARDIOVASCULAR DIAGNOSTICS, INC.

     CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
                        (In thousands, except share data)

<TABLE>
<CAPTION>

                                                        THREE MONTHS ENDED           NINE MONTHS ENDED
                                                  SEPTEMBER 30,  SEPTEMBER 30,  SEPTEMBER 30,  SEPTEMBER 30,
                                                      1998          1997            1998           1997
                                                   ---------      ---------      ---------      ---------
<S>                                                   <C>            <C>            <C>            <C>
Net sales                                             $2,202         $1,677         $6,797         $5,720
Cost of goods sold                                     1,540          1,484          4,688          4,434
                                                   ---------      ---------      ---------      ---------

Gross profit                                             662            193          2,109          1,286
                                                   ---------      ---------      ---------      ---------

Operating expenses:
  General and administrative                             777            919          2,385          2,682
  Sales and marketing                                    169            318            573            942
  Research and development                               719            689          1,986          1,861
                                                   ---------      ---------      ---------      ---------

    Total operating expenses                           1,665          1,926          4,944          5,485
                                                   ---------      ---------      ---------      ---------

Operating loss                                        (1,003)        (1,733)        (2,835)        (4,199)
                                                   ---------      ---------      ---------      ---------

Other income(expense):
  Interest expense                                       (99)          --             (279)            (1)
  Interest income                                         71             70            184            278
  Grant/royalty income                                   101            133            153            271
  Development income                                    --               95            375            820
                                                   ---------      ---------      ---------      ---------

    Total other income (expense)                          73            298            433          1,368
                                                   ---------      ---------      ---------      ---------

Net loss before taxes                                   (930)        (1,435)        (2,402)        (2,831)

Provision for income taxes                               (15)           (14)           (67)           (43)
                                                   ---------      ---------      ---------      ---------

Net loss                                               ($945)       ($1,449)       ($2,469)       ($2,874)

Other comprehensive income (loss), net of tax:
  Foreign currency translation adjustments              --               (1)          --              (53)

Comprehensive loss                                     ($945)       ($1,450)       ($2,469)       ($2,927)
                                                   =========      =========      =========      =========


Basic and diluted net loss per common share           ($0.14)        ($0.22)        ($0.36)        ($0.43)
                                                   =========      =========      =========      =========


Average weighted shares outstanding                7,010,706      6,733,452      6,859,330      6,725,959
                                                   =========      =========      =========      =========
</TABLE>


The accompanying notes are an integral part of the consolidated financial
statements.

                                        4


<PAGE>



                        CARDIOVASCULAR DIAGNOSTICS, INC.

                CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
                                 (In thousands)

<TABLE>
<CAPTION>
                                                                      Nine Months Ended
                                                                      -----------------
                                                                September 30,    September 30,
                                                                    1998             1997
                                                                   ------           ------
<S>                                                               <C>              <C>
Cash flows from operating activities:
  Net loss                                                        ($2,469)         ($2,874)
  Adjustments to reconcile net loss to net cash
     used in operating activities:
      Depreciation                                                    667              498
      Amortization of intangible and other assets                     218              159
      Amortization of discount on investments                          (9)            --
      Provision for inventory                                         100             --
      Stock based compensation: general and administrative             76             --
      Change in assets and liabilities:
       Receivables                                                   (138)            (680)
       Inventories                                                    483             (985)
       Other assets                                                   (99)              82
       Accounts payable and accrued expenses                         (714)              95
                                                                   ------           ------

            Net cash used in operating activities                  (1,885)          (3,705)
                                                                   ------           ------

Cash flows from investing activities:
    Payments for purchase of property and equipment                  (433)            (818)
    Costs incurred to obtain patents and intangibles                 (214)             (35)
    Purchase of investments                                        (2,429)          (5,827)
    Proceeds from maturities of investments                          --             10,044

           Net cash (used in) provided by investing activities     (3,076)           3,364
                                                                   ------           ------

Cash flows from financing activities:
    Principal payments on long-term debt and capital lease
        obligations                                                  (385)             (27)
    Net proceeds from issuance of stock                             6,094              108
                                                                   ------           ------

          Net cash provided by financing activities                 5,709               81
                                                                   ------           ------

Effect of  foreign exchange rates on cash                               0              (53)
                                                                   ------           ------
         Net increase (decrease) in cash and cash equivalents      $  748           $ (313)
Cash and cash equivalents at beginning of period                    5,885            2,716
                                                                   ------           ------

Cash and cash equivalents at end of period                         $6,633           $2,403
                                                                   ======           ======
</TABLE>


The accompanying notes are an integral part of the consolidated financial
statements.

                                        5


<PAGE>



                        CARDIOVASCULAR DIAGNOSTICS, INC.

                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
                                   (unaudited)

Note 1.  Organization and Basis of Presentation


Cardiovascular Diagnostics, Inc. (the "Company" or "CVDI") develops,
manufactures and markets rapid turnaround, point-of-care diagnostic tests to
assess blood clot formation and dissolution. These tests are based on the
Company's proprietary, dry chemistry Thrombolytic Assessment System ("TAS"). The
Company's wholly-owned subsidiary, Coeur Laboratories ("Coeur"), manufactures
and sells disposable power injection syringes and manifolds. The consolidated
financial statements include the accounts of the Company and the wholly-owned
subsidiary. All intercompany activity has been eliminated. The consolidated
financial statements included herein as of any date other than December 31 have
been prepared by the Company without audit, pursuant to the rules and
regulations of the Securities and Exchange Commission. Financial information as
of December 31 has been derived from the audited financial statements of the
Company, but does not include all disclosures required by generally accepted
accounting principles. In the opinion of management, the accompanying unaudited
consolidated financial statements include all adjustments (consisting only of
normal recurring adjustments) necessary to present fairly the consolidated
financial position, results of operations and cash flows of the Company. For
further information regarding the Company's accounting policies, refer to the
Consolidated Financial Statements and related notes included in the Company's
Annual Report on Form 10-K for the year ended December 31, 1997. Results for the
interim period are not necessarily indicative of the results for any other
interim period or for the full fiscal year.

Note 2.  Income Taxes


No federal income tax provision or benefit has been provided for income tax
purposes, as the Company has not realized net income for the quarter ended
September 30, 1998 and has net operating loss carryforwards to offset any net
income when realized. Income tax expense recognized represents Coeur's state
income tax expense.

Note 3.  Cash Equivalents


The Company considers all highly liquid investments with a maturity of three
months or less at the date of purchase to be cash equivalents.

Note 4.  Inventory

Inventories consisted of the following:

                                September 30, 1998       December 31, 1997
                                ------------------       -----------------

       Raw materials               $1,882,000                   $2,122,000
       Finished goods                 533,000                      876,000
                                      -------                      -------

                                   $2,415,000                   $2,998,000
                                   ==========                   ==========


Note 5.  Loss Per Common Share

On December 31, 1997, the Company adopted Statement of Financial Accounting
Standards ("SFAS") No. 128, "Earnings Per Share" ("EPS"). In accordance with
SFAS No. 128, the Company is required to present both basic and diluted EPS on
the face of the Statement of Operations and Comprehensive Loss. Basic EPS
excludes dilution and is computed by dividing income (loss) available to common
shareholders by the weighted average number of common shares outstanding for the
period. Diluted EPS is the same as basic EPS because, for loss periods,
potential common shares (such as options) are not included in computing diluted
EPS since the effect would be antidilutive.

                                          6


<PAGE>


Note 6.  New Accounting Pronouncements

The Company has adopted SFAS No. 130 "Reporting Comprehensive Income" beginning
January 1, 1998. SFAS No. 130 requires the Company to display an amount
representing total comprehensive income (loss) for all periods presented. The
Company has elected to display this information in a Statement of Operations and
Comprehensive Loss. All prior period data has been restated to conform to the
provisions of this statement.

The Company will adopt SFAS No. 131 "Disclosures about Segments of an Enterprise
and Related Information" beginning in 1998. SFAS No. 131 requires the Company to
report selected information about operating segments beginning as of December
31, 1998. It also establishes standards for related disclosures about products
and services, geographic areas and major customers. The Company will disclose
additional information concerning segments in its December 31, 1998 financial
statements.

Note 7.  Distribution Agreement

In August 1998, the Company signed a five-year distribution agreement with
Chiron Diagnostics ("Chiron"), a division of Chiron Corporation, subject to
minimum annual sales, to distribute the Company's PT, aPTT, HMT, and LHMT test
cards in North America and certain South American, European and Asian countries.
At that time, the Company received an equity investment of $6 million from
Chiron.

Note 8.  Legal Proceedings

As reported in its filings on Form 10-K for the period ended December 31, 1997,
in March 1997, the Company filed suit in the U. S. District Court, Eastern
District of North Carolina, against Boehringer Mannheim Corporation ("BMC")
located in Indiana. The suit charged BMC with misappropriation of CVDI's trade
secrets by improper disclosure, breach of contract, breach of fiduciary duty,
unfair and deceptive trade practices, and constructive fraud. In addition, CVDI
requested a declaratory judgment that neither the products nor activities of
CVDI infringe U.S. Patents purportedly owned by BMC. On April 9, 1997 BMC
answered the claims made by CVDI and submitted a counterclaim against CVDI. Each
party filed a motion for judgment on the pleading with respect to all claims
asserted by the other party. On November 10, 1997, the Court issued a Judgement
and Order granting CVDI's motion for judgment on the pleadings, holding that
CVDI has an implied license, until June 21, 1999, or until the last of the
patents expire, to the patents at issue. It dismissed all other claims of the
parties. Both parties have appealed and are awaiting the Court's decision. It is
management's opinion that the disposition of this matter will not have a
material adverse impact on the consolidated financial position, results of
operations or liquidity of the Company.

                                        7



<PAGE>


ITEM 2.   MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
                              RESULTS OF OPERATIONS

                                  INTRODUCTION

This Management's Discussion and Analysis of Financial Condition and Results of
Operations contains forward-looking statements. The actual results might differ
materially from those projected in the forward-looking statements due to any
number of factors, including those set forth below under "--Factors That May
Affect Future Results". Additional information concerning factors that could
cause actual results to materially differ from those in the forward-looking
statements is contained in the Company's other SEC filings, copies of which are
available upon request from the Company.

The following discussion should be read in conjunction with the unaudited
Consolidated Financial Statements and Notes thereto appearing elsewhere in this
report. Unless the context indicates otherwise, all references to the Company
include Cardiovascular Diagnostics, Inc. ("CVDI") and its subsidiary, Coeur
Laboratories, Inc.("Coeur").

The Company develops, markets and manufactures a Thrombolytic Assessment System
("TAS"), consisting of a compact, portable analyzer and disposable test cards
which are inserted into the analyzer to perform a variety of hemostasis tests.
Coeur currently manufactures and sells a line of disposable syringes used in
angiography injectors, as well as a line of angiographic procedure kit manifolds
(collectively, "Imaging Products").

The Company began marketing TAS products in May 1995. In October 1996, the
Company signed an exclusive, five-year development and distribution agreement
with Dade International, Inc. ("Dade"). At that time, the marketing focus was
shifted to begin targeting major corporate accounts and integrated health
networks (IHNs"). The Company also entered into an agreement with Avecor
Cardiovascular to distribute the Company's Heparin Management Test ("HMT") to
hospitals. In August 1998, the agreements with Dade and Avecor were terminated
effective December 1998, at which time Chiron Diagnostics ("Chiron") will become
the Company's new distribution partner pursuant to the agreement discussed
below. In connection with the Company's termination of the Dade agreement, the
Company agreed to continue to supply Dade's existing customers for three years.
In August 1998, the Company signed a five-year distribution agreement, subject
to minimum annual sales by Chiron to distribute the Company's PT, aPTT, HMT, and
LHMT test cards in North America and certain South American, European and Asian
countries. At that time, the Company received an equity investment of $6 million
from Chiron. In September 1998, Bayer Group agreed to acquire Chiron
Diagnostics. The Company believes Bayer's position as a global leader in
diagnostics will make it a good partner.

Results of Operations

THREE MONTHS ENDED SEPTEMBER 30, 1998 VS SEPTEMBER 30, 1997

Net sales for the quarter ended September 30, 1998 were $2,202,000, an increase
of approximately $525,000 compared to the same period in 1997. Revenues from TAS
analyzer sales increased $582,000 due to a large shipment of TAS analyzers to
Knoll AG as part of the large order received from it in the first quarter. Test
card revenue increased $157,000 principally due to higher orders from the
Company's current distributor, Dade/Behring. Sales of Imaging Products for the
quarter were $979,000 compared to $1,249,000 for the three months ended
September 30, 1997. Sales of Imaging Products in 1997 were higher as a major
customer secured a new contract with a large purchasing group which led to some
large initial orders for Company products.

Cost of goods sold of $1,540,000 represented an increase of $56,000 from the
comparable period in 1997. The resulting 30% gross profit for the third quarter
of 1998 was an improvement from the 12% gross profit percentage for the
corresponding period in 1997 and was mainly due to the increased volumes and
average sales price of TAS analyzers which carry higher margins, and increased
volumes of test cards which led to lower unit costs due to manufacturing
efficiencies.

Total operating expenses for the quarter ended September 30, 1998 were
$1,665,000, a $261,000 decrease from the third quarter of 1997. General and
administrative and sales and marketing expenses decreased due to lower
litigation expenses, fewer personnel in 1998 and reduced travel costs associated
with fewer sales and marketing personnel. Research and development expenses for
the quarter ended September 30, 1998 were $719,000, a 4% increase compared to
the quarter ended September 30, 1997.

Interest expense for the quarter ended September 30, 1998 was $99,000 compared
to $0 in the prior year period. The increase was related to long-term debt
obtained by the Company in December 1997. Interest income increased $1,000 for
the quarter ended September 30, 1998 compared to the same period in 1997.
Although funds were used to support operations during the quarter, the Company
obtained and invested an equity investment near the end of the quarter.

                                          8


<PAGE>


As anticipated, no development income was recorded during the quarter ended
September 30, 1998 because the Company did not achieve milestones included in
current collaborative agreements and did not enter into any new collaborative
agreements during the quarter. Development income of $95,000 was recorded in the
quarter ended September 30, 1997 resulting from the achievement of a milestone
related to a collaborative agreement entered into earlier in 1997.

For the three months ended September 30, 1997, other comprehensive income
(loss), net, consists of foreign currency translation adjustments related to a
foreign subsidiary. Operations of the subsidiary were ceased during the year
ended December 31, 1997. The Company had no items of other comprehensive income
(loss) during the three months ended September 30, 1998.

NINE MONTHS ENDED SEPTEMBER 30, 1998 VS SEPTEMBER 30, 1997

Net sales for the nine months ended September 30, 1998 were $6,797,000, an
increase of 19% compared to the same period of 1997. TAS analyzer revenue
increased approximately $300,000 and test card revenue increased approximately
$520,000, principally due to the large order received from Knoll in the first
quarter of 1998. Year-to-date revenues from Imaging Products increased
approximately $279,000 or 9% compared to the same period in 1997, mainly due to
larger volumes of orders from significant customers early in 1998.

Cost of goods sold increased 6%, and the 1998 year-to-date gross profit of 31%
was an improvement from the 23% in the prior year mainly due to higher average
sale prices for TAS analyzers and certain test cards in 1998 and manufacturing
efficiencies gained as a result of higher volumes of test cards and Imaging
Products.

Total operating expenses of $4,944,000 represents a decrease of $541,000 or 10%
compared to the same period in 1997. General and administrative expenses
declined due to lower litigation expenses and fewer personnel. Sales and
marketing expenses also declined due to fewer personnel and due to the
elimination of a sales office in Germany in late 1997. The reduction in
personnel also led to decreased travel costs compared to the same period in
1997. Research and development expenses increased 7% compared to the same period
in 1997 due to higher cost of supplies, personnel and validation processes
related to on-going development projects.

Interest expense for the period ended September 30, 1998 was $279,000, compared
to $1,000 in the prior year period. The increase was due to long-term debt
obtained by the Company in December 1997. Interest income decreased $94,000
compared to the same period in 1997 due to decreased investments as funds were
used to support operations.

The Company recorded development income of $375,000 for the nine months ended
September 30, 1998. This compares to $820,000 of development income recorded in
the period ended September 30, 1997. Development income in 1997 resulted from
entering three new collaborations with pharmaceutical companies. The development
income in 1998 resulted from the achievement of milestones related to these
collaborations.

For the nine months ended September 30, 1997, other comprehensive income (loss),
net, consists of foreign currency translation adjustments related to a foreign
subsidiary. Operations of the subsidiary were ceased during the year ended
December 31, 1997. The Company had no items of other comprehensive income (loss)
during the nine months ended September 30, 1998.

Liquidity and Capital Resources

From December 31, 1997 to September 30, 1998, cash, cash equivalents and
investments increased $3,186,000. During the quarter ended September 30, 1998,
the Company signed a five-year distribution agreement with Chiron Diagnostics to
distribute the Company's PT, aPTT, HMT and LHMT test cards in North America, and
certain South American, European and Asian countries. Upon signing the
agreement, the Company received $6 million from Chiron in exchange for 600,000
shares of the Company's common stock. This increase was offset by the
utilization of cash for operations, capital expenditures of $433,000, patent
expenditures of $214,000 and repayment of long-term debt of $385,000.

The Company expects to incur additional operating losses during the remainder of
1998 and 1999. The Company's working capital requirements will depend on many
factors, primarily the volume of subsequent orders of TAS products from
distributors, including Chiron Diagnostics. In addition, the Company expects to
incur costs associated with clinical trials for new test cards. The Company may
acquire other products, technologies or businesses that complement the Company's
existing and planned products, although the Company currently has no
understanding, commitment or agreement with respect to any such acquisitions. In
addition, the Company may consider a joint venture or the sale of manufacturing
rights to complete the commercialization of its routine anticoagulant monitoring
tests. Management believes that its existing capital resources and the cash
flows from operations will be adequate to

                                          9


<PAGE>


satisfy its planned capital requirements through 1999. To enhance liquidity in
future years, the Company plans to consider external sources of financing as
needed. In addition to other debt financings such as a working capital line of
credit, the Company also plans to consider equity financings such as a private
placement, a follow-on public offering of Common Stock or additional equity
infusions from collaborative partners.

Year 2000

Computers, software and microprocessors that use only two digits to identify a
year in a date field may be unable to process accurately certain date-based
information at or after the year 2000. This is commonly referred to as the "Year
2000 issue". The Company is addressing the issue in several ways. First, the
Company has established a team to monitor product compliance and believes that
all Company products are Year 2000 compliant. Secondly, the Company is in the
process of seeking Year 2000 compliance certification from its major suppliers
and vendors related to their products and internal business applications.
Finally, the Company has established a team to coordinate Year 2000 compliance
related to internal systems. Many of the Company's systems use vendor-provided
software and Year 2000 compliance will be achieved through vendor-provided
upgrades. For other internal systems, testing will be completed internally to
ensure Year 2000 compliance. As of September 30, 1998, the Company has completed
it assessment of Year 2000 compliance with respect to all of its own products,
none of its internal systems and approximately 30% of its vendor provided
systems and applications. The Company anticipates all of its internal systems
will have been assessed and updated through vendor provider upgrades or through
completion of internal testing prior to June 30, 1999. The Company does not
believe that the cost of its Year 2000 compliance program will be material to
its financial condition or results of operations or its business will be
adversely affected by the Year 2000 issue. However, the Company continues to
bear risk related to the Year 2000 and could be adversely affected if
significant customers or suppliers fail to address the issue or if vendor
upgrades are not provided to the Company as required. In a worst case scenario,
the Company could be forced to spend significant resources and funds to find
alternative providers of systems and applications used by the Company. If
completion of the Company's assessment of vendor-provided systems reveals Year
2000 non-compliance, the Company's contingency plan is to insist upon vendor
compliance by a reasonable time in advance of Year 2000 and to pursue
arrangements with other vendors.

Factors That May Affect Future Results

A number of uncertainties exist that may affect the Company's future operating
results and stock price, including managed care, FDA regulations, and other
regulatory guidelines affecting the Company. The market price of the Common
Stock could be subject to significant fluctuations in response to variations in
the Company's quarterly operating results, as well as other factors which may be
unrelated to the Company's performance. The stock market in recent years has
experienced extreme price and volume fluctuations that often have been unrelated
or disproportionate to the operating performance of or announcements concerning
public companies. Such broad fluctuations may adversely affect the market price
of the Company's Common Stock. Securities of issuers having relatively limited
capitalization are particularly susceptible to volatility based on short-term
trading strategies of certain investors.

Part II. OTHER INFORMATION

Item 2.  Changes in Securities and Use of Proceeds

         (a)   No modifications
         (b)   No limitations or qualifications
         (c) During the quarter ended September 30, 1998, the Company issued the
         following unregistered securities: 600,000 shares of Common Stock in a
         Section 4(2) private placement to Chiron Diagnostics Corporation for an
         aggregate of $6,000,000 in cash. No underwriters were used or
         commissions paid in connection with this transaction.

Item 6. Exhibits and Reports on Form 8-K

         (a) Exhibits 27.1 Financial Data Schedule

         (b) No reports on Form 8-K were filed during the period.

                                          10




<PAGE>



                                   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.

                                  CARDIOVASCULAR DIAGNOSTICS, INC.

Date: November 12, 1998           By: /s/ Paul Storey
                                      --------------------------------

                                  Paul Storey
                                  Treasurer
                                  (Principal Financial and Accounting Officer)

                                       11




<PAGE>



                                INDEX TO EXHIBITS

Exhibit         Description
- -------         -----------

  27.1      Financial Data Schedule


                                       12





<TABLE> <S> <C>

<ARTICLE>                     5
       
<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                              DEC-31-1998
<PERIOD-START>                                 JAN-01-1998
<PERIOD-END>                                   SEP-30-1998
<CASH>                                         6,633
<SECURITIES>                                   2,438
<RECEIVABLES>                                  2,041
<ALLOWANCES>                                   (15)
<INVENTORY>                                    2,415
<CURRENT-ASSETS>                               314
<PP&E>                                         8,840
<DEPRECIATION>                                 (4,136)
<TOTAL-ASSETS>                                 20,296
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