EXHIBIT 99.1
CAUTIONARY STATEMENT FOR PURPOSES OF THE SAFE HARBOR PROVISIONS OF THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
FROM TIME TO TIME, IN BOTH WRITTEN REPORTS AND IN ORAL STATEMENTS BY
OUR SENIOR MANAGEMENT, EXPECTATIONS AND OTHER STATEMENTS ARE EXPRESSED REGARDING
OUR FUTURE PERFORMANCE. THESE FORWARD-LOOKING STATEMENTS ARE INHERENTLY
UNCERTAIN AND INVESTORS MUST RECOGNIZE THAT EVENTS COULD TURN OUT TO BE
DIFFERENT THAN SUCH EXPECTATIONS AND STATEMENTS. KEY FACTORS IMPACTING OUR
CURRENT AND FUTURE PERFORMANCE ARE DISCUSSED IN OUR ANNUAL REPORT ON FORM 10-K
WITH WHICH THIS EXHIBIT IS FILED AND OTHER FILINGS WITH THE SECURITIES AND
EXCHANGE COMMISSION (THE "COMMISSION"). IN ADDITION TO SUCH INFORMATION IN OUR
ANNUAL REPORT ON FORM 10-K AND OUR OTHER FILINGS WITH THE COMMISSION, INVESTORS
SHOULD CONSIDER THE FOLLOWING RISK FACTORS IN EVALUATING US AND OUR BUSINESS, AS
WELL AS IN REVIEWING FORWARD-LOOKING STATEMENTS CONTAINED IN OUR PERIODIC
REPORTS FILED WITH THE COMMISSION AND IN ORAL STATEMENTS MADE BY OUR SENIOR
MANAGEMENT. OUR ACTUAL RESULTS COULD DIFFER MATERIALLY FROM SUCH FORWARD-LOOKING
STATEMENTS DUE TO MATERIAL RISKS, UNCERTAINTIES AND CONTINGENCIES, INCLUDING,
WITHOUT LIMITATION, THOSE SET FORTH BELOW.
STRINGENT GOVERNMENT REGULATION
Our products are subject to extensive regulation by the Food and Drug
Administration (the "FDA") and, in some jurisdictions, by state, local and
foreign governmental authorities. In particular, we must obtain specific
clearance or approval from the FDA before we can market new products or certain
modified products in the United States. With the exception of one product, we
have, to date, obtained FDA marketing clearance for our products only through
the 510(k) premarket notification process. Certain of our products under
development, including the LionHeart(TM), our Left Ventricular Assist System,
and future applications, however, will require approval through the more
vigorous Premarket Approval application ("PMA") process. The process of
obtaining such clearances or approvals can be time consuming and expensive. We
cannot assure you that the FDA will grant all clearances or approvals sought by
us or that FDA review will not involve delays adversely affecting the marketing
and sale of our products. We are also required to adhere to applicable
regulations setting forth current Good Manufacturing Practices ("GMP") which
require that we manufacture our products and maintain our records in a
prescribed manner with respect to manufacturing, testing and control activities.
In addition, we are required to comply with FDA requirements for labeling and
promotion of our products.
Medical device laws are also in effect in many of the countries outside the U.S.
in which we do business. These laws range from comprehensive device approval and
quality system requirements for some or all of our products to simpler requests
for product data or certifications. The number and scope of these requirements
are increasing. In addition, we are required to notify the FDA if we export to
certain countries medical devices manufactured in the U.S. that have not been
approved by the FDA for distribution in the United States.
Failure to comply with applicable federal, state, local or foreign laws or
regulations could subject us to enforcement action, including product seizures,
recalls, withdrawal of clearances or approvals, and civil and criminal
penalties, any one or more of which could have a material adverse effect on our
business, financial condition and results of operations. Federal, state, local
and foreign laws and regulations regarding the development, manufacture,
marketing and sale of medical devices are subject to future changes. We cannot
assure you that such changes will not have a material adverse effect on our
business, financial condition and results of operations.
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SIGNIFICANT COMPETITION AND CONTINUAL TECHNOLOGICAL CHANGE
The markets for medical devices are highly competitive. We currently
compete with many companies in the development and marketing of catheters and
related medical devices. Some of our competitors have access to greater
financial and other resources than us.
Furthermore, the markets for medical devices are characterized by rapid
product development and technological change. Technological advances by one or
more of our current or future competitors could render our present or future
products obsolete or uneconomical. Our future success will depend upon our
ability to develop new products and technology to remain competitive with other
developers of catheters and related medical devices. Our business strategy
emphasizes the continued development and commercialization of new products and
the enhancement of existing products for the critical care and interventional
procedure markets. We cannot assure you that we will be able to continue to
successfully develop new products and to enhance existing products, to
manufacture these products in a commercially viable manner, to obtain required
regulatory approvals or to gain satisfactory market acceptance for our products.
HEALTH CARE COST CONTAINMENT AND THIRD PARTY REIMBURSEMENT
Our products are purchased principally by hospitals, hospital networks
and hospital buying groups. Although our products are used primarily for
non-optional medical procedures, we believe that the overall escalating cost of
medical products and services has led and will continue to lead to increased
pressures upon the health care industry to reduce the cost or usage of certain
products and services. In the United States, these cost pressures have led to
increased emphasis on the price and cost-effectiveness of any treatment regimen
and medical device. Third party payors, such as governmental programs (e.g.,
Medicare and Medicaid), private insurance plans and managed care plans, which
are billed by hospitals for such health care services, are increasingly
negotiating the prices charged for medical products and services and may deny
reimbursement if they determine that a device was not used in accordance with
cost-effective treatment methods as determined by the payor, was experimental,
unnecessary or used for an unapproved indication. In international markets,
reimbursement systems vary significantly by country. Many international markets
have government managed health care systems that control reimbursement for
certain medical devices and procedures and, in most such markets, there also are
private insurance systems which impose similar cost restraints. We cannot assure
you that hospital purchasing decisions or government or private third party
reimbursement policies in the United States or in international markets will not
adversely affect the profitability of our products.
In keeping with the increased emphasis on cost-effectiveness in health
care delivery, the current trend among hospitals and other customers of medical
device manufacturers is to consolidate into larger purchasing groups to enhance
purchasing power. The medical device industry has also experienced some
consolidation, partly in order to offer a broader range of products to large
purchasers. As a result, transactions with customers tend to be larger, more
complex and involve more long-term contracts than in the past. The enhanced
purchasing power of these larger customers may also increase the pressure on
product pricing, although we are unable to estimate the potential impact on us
at this time. Several comprehensive health care reform proposals have been, and
continue to be, considered by the U.S. Congress. While none of these proposals
have to date been adopted, the intent of these proposals was, generally, to
expand health care coverage for the uninsured and reduce the rate of growth of
total health care expenditures. In addition, certain states have made
significant changes to their Medicaid programs and have adopted various measures
to expand coverage and limit costs. Several foreign countries in which we do
business are also considering, and in some countries have already adopted,
similar reforms to limit the growth of health care costs, including price
regulation. Implementation of government health care reform and other efforts to
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control costs may limit the price of, or the level at which reimbursement is
provided for, our products. We anticipate that the U.S. Congress, state
legislatures, foreign governments and the private sector will continue to review
and assess alternative health care delivery and payment systems. We cannot
predict what additional legislation or regulation, if any, relating to the
health care industry may be enacted in the future or what impact the adoption of
any federal, state or foreign health care reform, private sector reform or
market forces may have on our business. We cannot assure you that any such
reforms will not have a material adverse effect on our business, financial
condition or results of operations.
DEPENDENCE ON PATENTS AND PROPRIETARY RIGHTS
We own numerous U.S. and foreign patents and have several U.S. and
foreign patent applications pending. We also have exclusive license rights to
certain patents held by third parties. These patents relate to aspects of the
technology used in certain of our products. From time to time, we are subject to
legal actions involving patent and other intellectual property claims.
Successful litigation against us regarding our patents or infringement of the
patent rights of others could have a material adverse effect on our business,
financial condition and results of operations. In addition, we cannot assure you
that pending patent applications will result in issued patents or that patents
issued to or licensed-in by us will not be challenged or circumvented by
competitors or found to be valid or sufficiently broad to protect our technology
or to provide it with any competitive advantage. We also rely on trade secrets
and proprietary technology that we seek to protect, in part, through
confidentiality agreements with employees, consultants and other parties. We
cannot assure you that these agreements will not be breached, that we will have
adequate remedies for any breach, that others will not independently develop
substantially equivalent proprietary information or that third parties will not
otherwise gain access to our trade secrets.
There has been substantial litigation regarding patent and other
intellectual property rights in the medical devices industry. Historically,
litigation has been necessary to enforce certain patent and trademark rights
held by us. Future litigation may be necessary to enforce patent and other
intellectual property rights belonging to us, to protect our trade secrets or
other know-how owned by us, or to defend ourself against claimed infringement of
the rights of others and to determine the scope and validity of our and others'
proprietary rights. Any such litigation could result in substantial cost to and
diversion of effort by us. Adverse determinations in any such litigation could
subject us to significant liabilities to third parties, require us to seek
licenses from third parties and prevent us from manufacturing, selling or using
certain of our products, any one or more of which could have a material adverse
effect on our business, financial condition and results of operations.
RISKS ASSOCIATED WITH INTERNATIONAL OPERATIONS
Because we generate significant sales outside of the United States and
many of our manufacturing facilities and suppliers are located outside of the
U.S., we are subject to risks generally associated with international
operations, such as: unexpected changes in regulatory requirements; tariffs,
customs, duties and other trade barriers; difficulties in staffing and managing
foreign operations; differing labor regulations; longer payment cycles and
problems in collecting accounts receivable; risks arising from a specific
country's or region's political or economic conditions; fluctuations in currency
exchange rates; foreign exchange controls which restrict or prohibit
repatriation of funds; export and import restrictions or prohibitions; delays
from customs brokers or government agencies; differing protection of
intellectual property; and
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potentially adverse tax consequences resulting from operating in multiple
jurisdictions with different tax laws. Any one or more of these risks could
materially adversely impact the success of our international operations. As our
revenues from international operations increase, an increasing portion of our
revenues and expenses will be denominated in currencies other than U.S. dollars
and, consequently, changes in exchange rates could have a greater effect on our
future operations. We cannot assure you that such factors will not have a
material adverse effect on our business, financial condition and results of
operations. In addition, we cannot assure you that laws or administrative
practices relating to regulation of medical devices, labor, taxation, foreign
exchange or other matters of countries within which we operate will not change.
Any such change could also have a material adverse effect on our business,
financial condition and results of operations.
POTENTIAL PRODUCT LIABILITY
Our business exposes us to potential product liability risks which are
inherent in the design, manufacture and marketing of catheters and related
medical devices. Our products are often used in surgical and intensive care
settings with seriously ill patients. In addition, many of the medical devices
manufactured and sold by us are designed to be implanted in the human body for
long periods of time and component failures, manufacturing flaws, design defects
or inadequate disclosure of product-related risks with respect to these or other
products manufactured or sold by us could result in an unsafe condition or
injury to, or death of, the patient. The occurrence of such a problem could
result in product liability claims and/or a recall of, or safety alert relating
to, one or more of our products. We cannot assure you that the product liability
insurance maintained by us will be available or sufficient to satisfy all claims
made against us or that we will be able to obtain insurance in the future at
satisfactory rates or in adequate amounts. Product liability claims, safety
alerts or product recalls in the future, regardless of their ultimate outcome,
could result in costly litigation and could have a material adverse effect on
our business, reputation, our ability to attract and retain customers for our
products and our results of operations. In recent years, physicians, hospitals
and other medical service providers who are users of our products have become
subject to an increasing number of lawsuits alleging medical malpractice.
Medical malpractice suits often involve large claims and substantial defense
costs.
RISKS ASSOCIATED WITH DERIVATIVE FINANCIAL INSTRUMENTS
As a partial hedge against adverse fluctuations in exchange rates, we
periodically enter into foreign currency exchange contracts with certain major
financial institutions. By their nature, all such contracts involve risk,
including the risk of nonperformance by counterparties. Accordingly, losses
relating to these contracts could have a material adverse effect upon our
business, financial condition and results of operations. Our policy prohibits
the use of derivative instruments for speculative purposes.
DEPENDENCE ON KEY MANAGEMENT
Our success depends upon the continued contributions of key members of
our senior management team, certain of who have been with us since our inception
in 1975. Accordingly, loss of the services of one or more of these key members
of management could have a material adverse effect on our business. None of
these individuals has an employment agreement with us.
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