ATS MEDICAL INC
10-Q, 1999-11-09
ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES
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                       SECURITIES AND EXCHANGE COMMISSION
                             WASHINGTON, D.C. 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, 1999
                           COMMISSION FILE NO. 0-18602

                                ATS MEDICAL, INC.
             (Exact name of registrant as specified in its charter)


                 MINNESOTA                             41-1595629
      (state or other jurisdiction of     (I.R.S. Employer Identification No.)
      incorporation or organization)

      3905 ANNAPOLIS LANE, SUITE 105                      55447
          MINNEAPOLIS, MINNESOTA                       (Zip Code)
(Address of principal executive offices)

Registrant's telephone number, including area code: (612) 553-7736

Former name, if changed since last report: N/A

        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 _____

        The number of shares outstanding of each of the registrant's classes of
common stock as of November 1, 1999 was:

                  Common Stock $.01 par value 17,884,253 shares

<PAGE>


                                ATS MEDICAL, INC.

                                      INDEX


PART I.       FINANCIAL INFORMATION                                         PAGE

Item 1.       Statements of Financial Position -                              3
              September 30, 1999 (unaudited) and
              December 31, 1998

              Statements of Operations -                                      4
              Three Months and Nine Months Ended
              September 30, 1999 and 1998 (unaudited)

              Statements of Cash Flows -                                      5
              Nine Months Ended September 30, 1999 and
              1998 (unaudited)

              Notes to Financial Statements                                   6

Item 2.       Management's Discussion and Analysis of                         7
              Financial Condition and Results of Operations

Item 3.       Quantitative and Qualitative Disclosures About                 14
              Market Risk

PART II.      OTHER INFORMATION                                              15

              Signatures                                                     16

<PAGE>


Item 1     Financial Statements


ATS MEDICAL, INC.

CONSOLIDATED CONDENSED STATEMENTS OF FINANCIAL POSITION

<TABLE>
<CAPTION>
                                                             SEPTEMBER 30,      DECEMBER 31,
                                                                 1999               1998
                                                           ----------------------------------
                                                             (Unaudited)          (Note)
<S>                                                          <C>                <C>
ASSETS

Current assets:
   Cash & cash equivalents                                   $  6,914,943       $  7,754,077
   Short-term investments                                       9,511,595         12,852,885
                                                           ----------------------------------
                                                               16,426,538         20,606,962
   Accounts receivable, less allowance of $200,000
      in 1999 and $185,000 in 1998                              6,382,436          5,820,699
   Inventories                                                 36,311,187         29,954,718
   Prepaid expenses                                               326,892            458,663
                                                           ----------------------------------
Total current assets                                           59,447,053         56,841,042

Furniture, machinery and equipment                              2,532,104          2,596,311
   Less accumulated depreciation                                1,602,740          1,393,527
                                                           ----------------------------------
                                                                  929,364          1,202,784

Other assets                                                      398,068            387,550
                                                           ----------------------------------
Total assets                                                 $ 60,774,485       $ 58,431,376
                                                           ==================================

LIABILITIES AND SHAREHOLDERS' EQUITY

Current liabilities:
   Accounts payable                                          $  2,302,952       $  2,355,443
   Accrued payroll and expenses                                   329,705            256,358
                                                           ----------------------------------
Total current liabilities                                       2,632,657          2,611,801

Long-term debt                                                          0                  0

Shareholders' equity:
   Common Stock, $.01 par value:
     Authorized 40,000,000 shares; Issued and
      outstanding 17,871,503 & 17,824,137 at
      September 30, 1999 and Dec 31, 1998, respectively           178,715            178,241
   Additional paid-in capital                                  71,448,685         71,249,846
   Stock subscriptions receivable                                       0                  0
   Accumulated other comprehensive income                          43,494             43,799
   Accumulated deficit                                        (13,529,066)       (15,652,311)
                                                           ----------------------------------
Total shareholders' equity                                     58,141,828         55,819,575
                                                           ----------------------------------
Total liabilities and shareholders' equity                   $ 60,774,485       $ 58,431,376
                                                           ==================================
</TABLE>

Note:   The balance sheet at December 31, 1998 has been derived from the audited
        financial statements at that date but does not include all of the
        information and footnotes required by generally accepted accounting
        principles for complete financial statements.

See notes to condensed financial statements.

<PAGE>


ATS MEDICAL, INC.

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

<TABLE>
<CAPTION>
                                                    Three months ended September 30,    Nine months ended September 30,
                                                         1999             1998              1999              1998
                                                    ------------      -------------     ------------      ------------
<S>                                                 <C>               <C>               <C>               <C>
Net sales                                           $  4,258,127      $  4,138,721      $ 13,170,277      $ 12,953,042
Less cost of goods sold                                2,639,250         2,593,159         8,124,129         8,048,109
                                                    ------------      ------------      ------------      ------------
Gross profit                                           1,618,877         1,545,562         5,046,148         4,904,933

Expenses:
  Research, development and engineering                  335,485           355,462           952,202         1,096,218
  Selling, general and administrative                    852,358           827,812         2,677,975         2,650,014
                                                    ------------      ------------      ------------      ------------
Total expenses                                         1,187,843         1,183,274         3,630,177         3,746,232
                                                    ------------      ------------      ------------      ------------
Operating income                                         431,034           362,288         1,415,971         1,158,701

Interest income                                          224,682           344,951           707,275         1,042,713
                                                    ------------      ------------      ------------      ------------
Net income                                          $    655,716      $    707,239      $  2,123,246      $  2,201,414
                                                    ============      ============      ============      ============

Net income per share:
    Basic                                           $       0.04      $       0.04      $       0.12      $       0.12
    Diluted                                         $       0.04      $       0.04      $       0.12      $       0.12

Weighted average number of shares outstanding:
    Basic                                             17,867,803        17,777,790        17,849,877        17,722,858
    Diluted                                           18,459,324        18,107,666        18,320,618        18,153,622
</TABLE>

<PAGE>


ATS MEDICAL, INC.

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)

<TABLE>
<CAPTION>
                                                      NINE MONTHS ENDED SEPTEMBER 30,
                                                          1999               1998
                                                      ------------       ------------
<S>                                                   <C>                <C>
OPERATING ACTIVITIES
Net income                                            $  2,123,246       $  2,201,414
Adjustments to reconcile net loss to net cash
  used in operating activities:
    Depreciation                                           215,966            196,090
    Loss on disposal of equipment                          186,037              1,420
    Changes in operating assets and liabilities:
        Accounts receivable                               (561,737)        (1,625,426)
        Prepaid expenses                                   131,771             48,796
        Other assets                                       (10,518)           (11,549)
        Inventories                                     (6,356,469)        (3,750,305)
        Accounts payable and accrued expenses               20,856          1,739,580
                                                      ------------       ------------
Net cash used in operating activities                   (4,250,848)        (1,199,980)

INVESTING ACTIVITIES
Purchase of marketable securities                       (8,906,182)       (16,737,404)
Sale of marketable securities                           12,247,472         23,372,536
Purchases of property, plant and equipment                (128,583)          (356,298)
                                                      ------------       ------------
Net cash provided by investing activities                3,212,707          6,278,834

FINANCING ACTIVITIES
Net proceeds from sale of common stock                     199,312           (576,106)
                                                      ------------       ------------
Net cash provided by financing activities                  199,312           (576,106)

Effect of exchange rate changes on cash                       (305)             5,230
                                                      ------------       ------------
Increase (decrease) in cash and cash equivalents          (839,134)         4,507,978
Cash and cash equivalents at beginning of period         7,754,077          4,568,332
                                                      ------------       ------------
Cash and cash equivalents at end of period            $  6,914,943       $  9,076,310
                                                      ============       ============
</TABLE>

<PAGE>


ATS MEDICAL, INC.

NOTES TO FINANCIAL STATEMENTS (UNAUDITED)

September 30, 1999


Note A - BASIS OF PRESENTATION

The accompanying unaudited financial statements have been prepared in accordance
with generally accepted accounting principles for interim financial information
and with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all of the information and footnotes required
by generally accepted accounting principles for complete financial statements.
In the opinion of management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included.
Operating results for the three-month and nine-month periods ended September 30,
1999 are not necessarily indicative of the results that may be expected for the
year ended December 31, 1999.

<PAGE>


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

ATS Medical, Inc. (the "Company") is engaged in the manufacturing and marketing
of a pyrolytic carbon bileaflet mechanical heart valve. The Company sells the
ATS Open Pivot TM valve (the "ATS Valve" or the "Valve") in international
markets and is conducting a clinical study in the United States and Canada for
the purpose of obtaining regulatory approval.

RESULTS OF OPERATIONS

Net sales for the quarter ended September 30, 1999 increased 2.9% to
$4,258,127,compared to $4,138,721 for the quarter ended September 30, 1998. Unit
sales increased 11% in 1999 compared to 1998. The continued volatility in
foreign exchange rates, the pressure from hospital administrators for lower
prices and the willingness of competitors to reduce prices put pressure on
revenue growth and margins. This pressure, which is expected to continue for the
remainder of 1999, caused the average selling price of the Valve to decrease
for the quarter ended September 30, 1999 compared to the quarter ended September
30, 1998.

Net sales for the nine months ended September 30, 1999 totaled $13,170,277 which
represented a 1.7% increase over the net sales of $12,953,042 reported for the
nine months ended September 30, 1998. Unit sales for the first nine months of
1999 increased 4.9% compared to the first nine months of 1998.

The Company sells to independent distributors with assigned territories
(generally a specific country or region) who in turn sell the Valve to hospitals
or clinics. The Company sells in U.S. dollars, so currency risk is borne by the
distributor. As the dollar increases in value against the distributor's local
currency, the cost of the Valve increases for the distributor even though ATS
does not change the selling price. For the nine months ended September 30, 1999
the Company's sales efforts were challenged by significant price competition
from other valve manufacturers and the increased strength of the U.S. dollar
relative to almost all foreign currencies. During 1999 and 1998 the Company was
selling Valves in most developed countries and several lesser-developed
countries ("LDC's").

Since January 1997, the Company has been conducting a clinical study of the
Valve at fifteen hospitals in the United States. During the study, Valves are
provided to the hospitals at prices designed to recover some of the costs of the
clinical study. On August 3, 1999 the Company submitted a PreMarket Approval
Application ("PMA") to the U.S. Food and Drug Administration ("FDA"). The FDA
will review the information included in the application and if it demonstrates
the safety and effectiveness of the Valve, the FDA will allow the Company to
market the Valve in the United States. Although it is not possible to predict
how long this process may take in this case, it often takes from nine months to
over one year.

Cost of sales for the three months ended September 30,1999 totaled $2,639,250 or
62% of sales compared to $2,593,159 or 62.7% of sales for the three months ended
September 30, 1998. Cost of goods sold totaled $8,124,129 or 61.7% of sales for
the first nine months of 1999 compared to $8,048,109 or 62.1% for the first nine
months of 1998.

<PAGE>


Beginning in January, 1999 the Company increased production/assembly levels of
the Valve. During the first nine months of 1999 the Company assembled 142% more
Valves than in the first nine months of 1998. The increased levels are in excess
of the Company's current sales levels and are in anticipation of eventual FDA
PreMarket approval of the Valve. The benefit of increased production volumes is
increased absorption of overhead costs leading to slightly lower cost of goods
sold. However, unless the Company is able to increase sales following FDA
approval, it would not be practical to continue to assemble Valves at these
levels. While the price of the carbon components contained in the Valves sold in
the first quarter of 1999 were 6% lower as compared to the cost of carbon
components contained in the Valves sold in the first quarter of 1998, the price
of components sold for most of the second and third quarter 1999 were 3% higher
than the cost of components contained in the Valves sold in the second and third
quarter 1998. Based upon the Company's internal sales projections, the price of
the carbon contained in Valves sold in the remainder of 1999 is expected to be
3% higher than in 1998. The Company purchases pyrolytic carbon components for
the Valve from CarboMedics, Inc. ("CMI"). Approximately 80% of the total cost of
a valve is contained in the cost of the carbon components. The price of the
components is set under a multi-year supply agreement between the Company and
CMI. The price was established in 1990, and varies according to annual volume
and is adjusted annually according to increases in the U.S. Department of Labor
Employment Cost Index. The Company uses the first-in first-out ("FIFO") method
of accounting for inventory.

Gross profit totaled $1,618,877 for the quarter ended September 30, 1999 or 38%
of sales, compared to gross profit of $1,545,562 or 37.3% of sales for the
quarter ended September 30, 1998. Gross profit totaled $5,046,148 for the first
nine months of 1999 or 38.3% of sales compared to $4,904,933 for the nine months
ended September 30, 1998 or 37.9% of sales. Although the average selling price
per unit decreased in the first nine months of 1999 compared to 1998, the
average cost per unit sold decreased even more, improving gross margin.

Research, development and engineering expenses totaled $335,485 for the quarter
ended September 30, 1999 versus $355,462 for the quarter ended September 30,
1998. The major portion of the decrease is related to the costs associated with
the Company's U.S. clinical study. Approximately 27% and 25% of research and
development expenses for the quarters ended September 30, 1999 and 1998,
respectively, were for testing and outside consulting services related to the
Valve.

The Company began human implants in the United States under an Investigational
Device Exemption ("IDE") in January 1997. The Company sells the Valves to the
hospitals involved in the study and the cost of the Valve is eligible for
reimbursement by Medicare and most private pay insurance companies. The Company
is responsible for reimbursing the hospital for certain additional tests and
procedures required by the clinical protocol. The estimated total cost of
follow-up is accrued at the time of the sale as research and development
expense.

Selling, general and administrative expenses totaled $852,358 for the three
months ended September 30, 1999, a $24,546 increase from $827,812 reported for
the three months ended September 30, 1998. Selling, general and administrative
expenses totaled $2,677,975 for the first nine months of 1999 compared to
$2,650,014 for the first nine months of 1998. The Company

<PAGE>


had 88 employees at September 30, 1999 compared to 72 employees at September 30,
1998. The absorption of labor into inventory offset the increased payroll
expenses. For the quarter ended September 30, 1999 the Company accrued 50% less
for incentive compensation than in the quarter ended September 30, 1998.

Interest income totaled $224,682 for the quarter ended September 30, 1999
compared to $344,951 for the quarter ended September 30, 1998. The decrease in
interest income in 1999 was the result of lower average investable cash balances
during 1999 and lower interest rates. Cash on hand at September 30, 1999 is less
than the amount on hand at December 31, 1998. Interest income in 1999 is
expected to be approximately 50% less than in 1998. The Company is investing
cash in carbon and the completion of a large quantity of Valves in anticipation
of the market release of the Valve in the United States.

Net income totaled $655,716 for the quarter ended September 30,1999 compared to
$707,239 for the quarter ended September 30, 1998. Net income for the first nine
months of 1999 totaled $2,123,246 compared to $2,201,414 for the first nine
months of 1998. The increases in operating income for the quarter and first nine
months of 1999 as compared to 1998 were more than offset by the decreases in
interest income.

The Company has accumulated approximately $15 million of net operating loss
carryforwards for U.S. tax purposes. The Company believes that its ability to
fully utilize the existing net operating loss carryforwards will be restricted
to approximately $3 million per year. Although the Company can offset a
significant portion of pretax income with the net operating losses from prior
years the Company is subject to alternative minimum taxes and accrued $50,234 to
cover state and federal income taxes for the nine months ended September 30,
1999.

LIQUIDITY AND CAPITAL RESOURCES

Cash, cash equivalents and marketable securities decreased by $4,180,424 from
$20,606,962 at December 31, 1998 to $16,426,538 at September 30, 1999. Inventory
purchases and the pay-down in accounts payable caused the Company to have
negative cash flow from operations.

During 1999 the Company is obligated to purchase $14.4 million of components in
accordance with the terms of its long-term supply agreement with CMI (the
"Supply Agreement"). The Company is obligated to purchase $18.6 million of
components in the year 2000. These minimum purchases under the Supply Agreement
are not tied to sales of the Company's Valve and the Company does not expect
sales of the Valve to exceed the minimum purchase requirements under the Supply
Agreement until the Valve is approved for sale in the United States. After the
Company purchases the minimum required Valves under the Supply Agreement for the
year 2000, the Company will be obligated under the Supply Agreement only to buy
what it sells through year 2007.

Accounts receivable increased from $5,820,699 at December 31, 1998 to $6,382,436
at September 30, 1999. Most of the Company's sales have been to customers in
international markets and while the Company attempts to set standard 60 day
terms for accounts receivable, competitive pressures and geographical economic
situations have caused the Company to

<PAGE>


selectively extend the terms for payment. At December 31, 1998 and September 30,
1999, the account balance for one customer was 26% and 27.8%, respectively, of
outstanding receivables. The Company has done business with this customer since
1992 and the size of the receivable, while substantial, is consistent with the
growth of business in this market and in line with the size of the customer's
overall business.

Current liabilities increased slightly from $2,611,801 at December 31, 1998 to
$2,632,657 at September 30, 1999. The majority is in accounts payable and is
related to the amount owing to CarboMedics, Inc. under the Supply Agreement.

Based upon the Company's current rate of sales, its expected obligations under
the Supply Agreement and its expected expenses, the Company anticipates that
existing cash, cash equivalents and short-term investments will be sufficient to
satisfy its capital requirements through 2000. Beyond 2000 the Company should be
cash flow positive or at worst cash flow neutral barring a significant change in
the Company's business plan.

The Company does not use derivatives and therefore does not face market risk
from currency or interest rate changes on these types of instruments. There
would be no impact on the Company's operations from interest rate changes on
debt instruments since the Company has not used debt to finance its operations.
Assuming that interest rates on investment grade securities were to decrease by
10%, the Company's annual interest income would decrease by approximately
$100,000 based on the level of investable funds available to the Company at
December 31, 1998.

YEAR 2000 SITUATION

The "Year 2000 Problem" refers to a complex set of problems which may arise when
computer hardware or software is unable to distinguish between 21st century
dates and 20th century dates because the date code fields have been abbreviated
into two digits, i.e. 00. This problem could result in system failures or
miscalculations causing disruptions of business operations (including, among
other things, a temporary inability to process transactions, send invoices or
engage in other similar business activities). As a result, many companies'
computer systems and software will need to be upgraded or replaced in order to
comply with Year 2000 requirements. The potential global impact of the Year 2000
problem is not known, and, if not corrected in a timely manner, could affect the
Company and the U.S. and world economy generally.

The Company's products, including the ATS Medical heart valve, do not contain
any electronics or software and therefore will not be affected by the "Year 2000
Problem".

The Company's internal financial, manufacturing and other computer systems are
being reviewed to assess and remediate Year 2000 problems. The Company's
assessment of internal systems includes its information technology ("IT") as
well as non-IT systems (systems which contain embedded technology and are used
in manufacturing or process control equipment containing microprocessors or
other similar circuitry). As a result of this review the Company determined that
some of its equipment and software needed to be upgraded or replaced. During
1998 the Company spent approximately $59,000 on hardware and software some of
which was necessary to eliminate potential Year 2000 problems. During the first
nine months of 1999 the

<PAGE>


Company purchased $58,268 of computer equipment and software. The Company's 1999
budget for hardware and software is $164,528 including the replacement or
upgrade of personal computers, workstations and software which are not currently
Year 2000 compliant.

Shortly after the close of the quarter ended March 31, 1999 the Company took
delivery on custom measuring equipment. The primary purpose of this equipment
was to improve processing of the Company's products but it also contained Year
2000 compliant software. Vendor personnel installed and attempted to debug the
equipment and software. The equipment was not able to perform up to
specification. During the quarter ended June 30, 1999, the Company expensed the
$186,000 prepaid in 1998.

Since substantially all of this hardware and software is being purchased from
large, industry-leading vendors (i.e. Compaq, Lotus, and Microsoft), the Company
will rely on vendor certification and internal tests to determine Year 2000
compliance as opposed to hiring consultants to perform reviews. Such
certifications and tests were obtained or completed by the end of the second
quarter 1999.

In addition, during the first quarter of 1999 the Company has requested
assurances from its major suppliers that they are addressing the Year 2000
problem and that products purchased by the Company from such suppliers will
function properly in the Year 2000. The Company has a significant inventory of
product components on hand, however, certain key components for the Valve are
available from a single supplier and a protracted Year 2000 problem for this
vendor could have an adverse impact on the Company. Contacts have been made with
the Company's major customers. These contacts with the Company's suppliers and
customers are intended to help mitigate the possible external impact of the Year
2000 problem. However, it is impossible to fully assess the potential
consequences in the event service interruption from suppliers occur or in the
event that there are disruptions in such infrastructure areas as utilities,
communications, transportation, banking and government.

The total estimated cost for resolving the Company's Year 2000 issues is
approximately $223,500, of which approximately $169,000 has been spent through
September 30, 1999. The total cost estimate includes the cost of replacing
non-compliant systems as a remediation cost in cases where the Company has
accelerated plans to replace such systems. Estimates of Year 2000 costs are
based on numerous assumptions, and there can be no assurance that the estimates
are correct or that actual costs will not be materially greater than
anticipated.

Based upon its assessments to date, the Company believes it will not experience
any material disruption in its operations as a result of Year 2000 problems to
internal financial, manufacturing and other process control systems, or in its
interface with major customers and suppliers. However, if major suppliers,
including those providing component parts, electricity, communications and
transportation services, experience difficulties resulting in disruption of
critical supplies or services to the Company, a shutdown of the Company's
operations could occur for the duration of the disruption. The Company has
developed contingency plans to help provide continuity of normal business
operations in the event that problem scenarios arise. Assuming no major
disruption in service from critical third party providers, the Company believes
that it will be able to manage the Year 2000 transition without any material
effect on the

<PAGE>


Company's results of operations or financial position. There can be no
assurance, however, that unexpected difficulties will not arise and, if so, that
the Company will be able to timely develop and implement an effective
contingency plan.

THE SINGLE EUROPEAN CURRENCY

A significant portion of the Company's sales occur in Europe. Effective January
1, 1999 various European countries began utilizing a single currency, the
"Euro". From January 1999 through December 2001, merchants will be encouraged to
discontinue using local country currencies and begin using the Euro to transact
business. Beginning in 2002, it will be required that business in the European
Community be conducted using the Euro. The Company sells to all of its customers
in U.S. Dollars and does not expect to have accounting system issues relative to
currency translation. The Company's selling prices are similar to most of its
European distributors and therefore should not cause significant disruption
whether in dollars or Euros. Europe is a very important market for the Company's
Valve. Disruption or loss of a portion of the Company's European business could
have a material and adverse impact on the Company's financial position. The Euro
has declined in value relative to the dollar by 10% from its introduction
January 1, 1999 to September 30, 1999. The Company sells in U.S. Dollars so the
price of the Valve to Distributors in countries covered by the Euro has in
effect increased by 10%. Transactionally the introduction of the Euro has not
been a problem for the Company and its European distributors, but economically
the weakness in the Euro has put pressure on the Company's pricing.

CAUTIONARY STATEMENT PURSUANT TO THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995

The Private Securities Litigation Reform Act of 1995 (the "Act") provides a
"safe harbor" for forward-looking statements to encourage companies to provide
prospective information about their business, so long as those statements are
identified as forward-looking and are accompanied by meaningful cautionary
statements identifying important factors that could cause actual results to
differ materially from those discussed in the statement. ATS Medical, Inc.
desires to take advantage of the safe harbor provisions with respect to any
forward-looking statements it may make in this filing, other filings with the
Securities and Exchange Commission and any public oral statements or written
releases. The words or phrases "will likely," "is expected," "will continue,"
"is anticipated," "estimate," "projected," "forecast," or similar expressions
are intended to identify forward-looking statements within the meaning of the
Act. Such statements are subject to certain risks and uncertainties that could
cause actual results to differ materially from those projected. The Company
cautions readers not to place undue reliance on any such forward-looking
statements, which speak only as of the date made.

In accordance with the Act, the Company identifies the following important
general factors which if altered from the current status could cause the
Company's actual results to differ from those described in any forward-looking
statements: the continued acceptance of the Company's mechanical heart Valve in
international markets, the acceptance by the U.S. FDA of the Company's
regulatory submissions, the continued performance of the Company's mechanical
heart valve without structural failure, the actions of the Company's competitors
including pricing changes and new product introductions, the continued
performance of the Company's

<PAGE>


independent distributors in selling the Valve, the actions of the Company's
supplier of pyrolytic carbon components for the Valve and the effect of the Year
2000 problem on the Company, its suppliers and its customers. This list is not
exhaustive, and the Company may supplement this list in any future filing or in
connection with the making of any specific forward-looking statement.

<PAGE>


ITEM 3   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The Company does not use derivatives and therefore does not face market risk
from currency or interest rate changes on these types of instruments. There
would be no impact on the Company's operations from interest rate changes on
debt instruments since the Company has not used debt to finance its operations.
Assuming that interest rates on investment grade securities were to decrease by
10%; the Company's annual interest income would decrease by approximately
$100,000 based on the level of investable funds available to the Company at
December 31, 1998.

<PAGE>


                           PART II. OTHER INFORMATION

Item 1.       Legal Proceedings
              None

Item 2.       Changes in Securities
              None

Item 3.       Defaults Upon Senior Securities
              None

Item 4.       Submission of Matters to a Vote of Security Holders
              None

Item 5.       Other Information
              None

Item 6.       Exhibits and Reports on Form 8-K

              (a) Exhibits

              Number      Description
              ------      -----------
               27.1       Financial Data Schedule

              (b) Reports on Form 8-K

                  None

<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.


Date:  November 5, 1999                    ATS MEDICAL, INC.


                                      By:  /s/ John H. Jungbauer
                                           -------------------------------------
                                           John H. Jungbauer, Vice President/CFO
                                           (Principal Financial Officer and
                                           Authorized Signatory)

<PAGE>


                                  EXHIBIT INDEX



                        Number          Description
                        ------          -----------

                         27.1           Financial Data Schedule


<TABLE> <S> <C>


<ARTICLE> 5

<S>                             <C>
<PERIOD-TYPE>                   9-MOS
<FISCAL-YEAR-END>                          DEC-31-1999
<PERIOD-END>                               SEP-30-1999
<CASH>                                       6,914,943
<SECURITIES>                                 9,511,595
<RECEIVABLES>                                6,382,436
<ALLOWANCES>                                         0
<INVENTORY>                                 36,311,187
<CURRENT-ASSETS>                            59,447,053
<PP&E>                                       2,532,104
<DEPRECIATION>                               1,602,740
<TOTAL-ASSETS>                              60,774,485
<CURRENT-LIABILITIES>                        2,632,657
<BONDS>                                              0
                                0
                                          0
<COMMON>                                       178,715
<OTHER-SE>                                  57,963,113
<TOTAL-LIABILITY-AND-EQUITY>                60,774,485
<SALES>                                     13,170,277
<TOTAL-REVENUES>                            13,170,277
<CGS>                                        8,124,129
<TOTAL-COSTS>                                8,124,129
<OTHER-EXPENSES>                                     0
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                                   0
<INCOME-PRETAX>                              2,123,246
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                          2,123,246
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                                 2,123,246
<EPS-BASIC>                                        .12
<EPS-DILUTED>                                      .12



</TABLE>


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