Exhibit 99.1
IMPORTANT FACTORS
HISTORY OF LOSSES; ANTICIPATED FUTURE LOSSES; ABILITY TO CONTINUE AS A GOING
CONCERN
The Company has experienced continued and significant operating losses since its
inception in 1984 and has an accumulated deficit. The Company anticipates
continuing operating losses for the near future. The Company's ability to,
continue as a going concern or to ultimately generate revenues from operations
and achieve profitability depend upon a number of factors, including its ability
to successfully complete development work on and commercialize the Basis(TM)
Cardiac Output Monitoring System (the "Basis System") and the costs and related
timing of implementation of its marketing, sales and manufacturing activities.
There can be no assurance that the Company will be able to successfully
introduce the Basis System or that the Company will generate revenues or achieve
profitability at any time in the future.
DEPENDENCE ON AND NEED FOR FURTHER DEVELOPMENT OF THE BASIS CARDIAC OUTPUT
MONITORING SYSTEM
The Company's success depends upon the Basis System, which currently is its sole
product. Although product prototypes were found to perform consistently with the
Company's expectations in Company lab and mammal tests, early results from the
Company's product evaluations of the Basis System and RealFlow Probe indicated
the need for modifications in order to meet the Company's product performance
expectations. While the Company believes that it has made significant progress
completing these modifications, there can be no assurance that all necessary
modifications have been or can be timely and successfully developed. Any
inability to timely and successfully make necessary product modifications could
delay or prevent successful commercialization of the Basis System, which would
have a material, adverse effect on the Company's business, financial condition
and results of operations.
FAILURE OF PRIOR CARDIAC OUTPUT MONITORING SYSTEM
In the Company's early stages - from the years 1984 to 1994 - it developed and
marketed two ultrasound-based cardiac output devices: one that was integrated
into an endotrachial tube, and the other being a predecessor to the current
Basis System. Both products were sold or distributed in the 1990's in small
quantities. After a small commercialization effort, the Company ceased marketing
due to unreliable product performance caused by a variety of factors, including
inadequate probe sensitivity and signal processing, and hardware performance
constraints. Although management believes that the Basis System incorporates
design changes that address the shortcomings of the prior systems, there can be
no assurance that performance problems will not occur in clinical use of the
Basis System.
NEED FOR ADDITIONAL FINANCING
The Company expects that additional financing will be needed in the first half
of 2000 to fund its development and product commercialization plans. If the
Company's operational plans do not progress as anticipated, the Company's
ability to attract additional financing could be impaired. No assurance can be
given that the Company will be able to obtain any additional financing on
acceptable terms or at all, and failure to do so would have a material, adverse
effect on the Company's business, financial condition and results of operations.
UNCERTAINTY OF MARKET ACCEPTANCE
The commercial success of the Company's Basis System will require acceptance by
cardiac surgeons and other medical specialists. Such acceptance will depend, in
part, upon clinical validation results and the conclusion by these medical
professionals that the Basis System is accurate, reliable and effective and that
that Basis System offers enhanced functionality relative to current cardiac
output monitoring technologies. There can be no assurance that the Basis System
will provide clinical benefits considered superior by these professionals or
that a sufficient number of such professionals will use the Basis System for
commercial success to be achieved. Because the Basis System represents a
different method of clinical assessment and an improved product compared to the
Company's earlier development efforts that failed to achieve commercial success,
there may be greater reluctance to accept this product than would occur with
products using well-established technologies. Substantial efforts may need to be
devoted to
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Exhibit 99.1
educating the market to the Company's technologically different approach and the
improvements in the Basis System over the Company's prior cardiac output
monitoring systems. Failure of the Company's product to achieve market
acceptance would have a material adverse effect on the Company's business,
financial condition and results of operations.
LACK OF MANUFACTURING EXPERIENCE
The Company's current plans call for it to manufacture the Basis System
internally. The Company has only limited manufacturing experience and could
encounter difficulties in scaling up production. These problems may include
estimating optimal product volume and mix requirements, production yields,
controlling and anticipating product costs, quality control and assurance,
component supply and contending with shortages of qualified personnel. There can
be no assurance that manufacturing difficulties will not occur. Such
difficulties could have a material adverse effect on the Company.
LACK OF MARKETING EXPERIENCE
The Company has no experience in marketing the Basis System and no current sales
capabilities. There can be no assurance that the Company's marketing efforts
will result in commercial sales or that the Company will be able to develop an
effective sales force and distribution network without incurring substantial
delays or costs or at all. Failure to develop an effective direct sales
organization or an effective distribution network would have a material adverse
effect on the Company.
COMPETITION
Competition in the medical device industry in general and in the market for
cardiac output monitoring in particular is intense. Edwards Critical Care (a
division of Baxter Healthcare Corporation), Johnson and Johnson and Abbott
Critical Care currently dominate the cardiac output monitoring market. These
companies make and sell catheters, thermodilution cardiac monitors and
peripheral products used to measure cardiac output by the widely used
thermodilution method. While the Company believes its Basis System represents
significant improvements over existing products in the marketplace, the Company
must be able to effectively demonstrate the beneficial features of the Basis
System and must maintain competitive pricing in order to successfully sell its
products. Competition in the Company's market may result in pricing pressures
that may adversely affect product gross margins. The Company competes with the
companies listed above and other large companies, many of which have greater
resources and established operations. These competitors also have greater depth
in research and development, manufacturing and marketing and sales capabilities.
The ability of the Company to compete effectively will depend upon the
advantages and proprietary nature of the Basis System, on the Company's ability
to attain and maintain technological leadership and to generate sales. There can
be no assurance that the Company will be able to successfully compete against
its current or future competitors.
LIMITED HUMAN USE OF THE BASIS CARDIAC OUTPUT MONITORING SYSTEM
To date, the Company has completed extensive research, conducted lab and animal
testing and conducted limited human clinical use of the Basis System. Although
the Company believes that its research and testing provide support for the Basis
System's performance in humans, there can be no assurance that research and
animal testing alone will identify all the technical issues or potential
problems with use of the Basis System in humans in generally, or in any subset
of humans having differing anatomical structures or disease characteristics. The
Company began product evaluations of the Basis System and RealFlow Probe at one
clinical site in the U.S. Early results from these evaluations indicated the
need for modifications to the Basis System in order to meet the Company's
product performance expectations. While the Company believes that it has made
significant progress completing these modifications, there can be no assurance
that all necessary modifications can be timely and successfully developed. Any
failure of the Basis System to achieve acceptable results in future evaluations
could lead to delays in the introduction and market acceptance of the Basis
System. A delay in market introduction of the Basis System would have a material
adverse effect on the Company's business, financial condition and results of
operations.
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Exhibit 99.1
TECHNOLOGICAL OBSOLESCENCE; DEVELOPMENT OF NEW PRODUCTS
Rapid technological advances characterize the medical device market. Even if the
Basis System is successfully developed and accepted, it may be rendered obsolete
by technological developments, new innovations or changes in the medical
marketplace. The Company's success will depend in part on its ability to respond
quickly to medical and technological changes and to develop and introduce new,
cost-effective versions of its Basis System in response to competitive
innovations. Development and commercialization of new products will require
additional research and development expenditures and may require new regulatory
approvals. There can be no assurance that the Company will successfully identify
new market opportunities and develop new products or that these new products
will receive necessary regulatory approvals or be successfully received by the
marketplace or, if so, that the Company's products will not be rendered obsolete
by changes in technology.
LIMITATIONS ON THIRD PARTY REIMBURSEMENT
The Basis System will generally be purchased by hospitals which then seek
reimbursement from various public and private third party payers covering
cardiac surgery patients, such as Medicare, Medicaid and private insurers, for
the health care services provided to patients. There can be no assurance that
these third party payers will consider use of the Basis System cost-effective.
If the Basis System is not considered cost-effective and not approved for
reimbursement, this will materially adversely affect the prospects of the Basis
System and the Company itself. Even if the third party payers approve the Basis
System for reimbursement, there can be no assurance that the level of
reimbursement approved will be high enough to make the Company a profit from
selling the Basis System. Furthermore, the amount of reimbursement for treatment
for various cardiac diseases could decrease in the future and reduce the amount
paid for the Basis System. Failure by hospitals and other users of the Company's
products to obtain sufficient reimbursement for use of the Basis System in
cardiac output monitoring could have a material adverse effect on the Company.
PATENTS AND PROPRIETARY RIGHTS
The Company's success depends in part on its ability to obtain and maintain
patent protection for its products, to preserve its trade secrets and to operate
without infringing the proprietary rights of third parties. The Company has U.S.
and foreign patents and patents pending, which relate to devices and methods
used to measure blood flow through a major mammalian artery using ultrasound
technology, the release mechanism employed by the RealFlow probe, and certain
methods and techniques which relate to minimally invasive surgery, beating heart
surgery and advanced signal processing.. The validity and breadth of claims
covered in medical technology patents involve complex legal and factual
questions and, therefore, may be highly uncertain. No assurances can be given
that any current patents will be maintained, that patents under pending
applications or any future patent applications will be issued, that the scope of
any patent protection will exclude competitors or provide competitive advantages
to the Company, that any of the Company's patents will be held valid if
subsequently challenged, that others will not claim rights in or ownership of
the patents and other proprietary rights held by the Company or that the Basis
System or other products and processes will not infringe, or be alleged to
infringe, the proprietary rights of others.
If the Company is found to have infringed on the rights of a third party, the
Company may be unable to market its products without a license from such third
party. There can be no assurance that the Company would be able to obtain such a
license on satisfactory terms, or at all. Furthermore, there can be no assurance
that others have not developed or will not develop similar products or
manufacturing processes, duplicate any of the Company's products or
manufacturing processes, or design around the Company's patents. In addition,
whether or not additional patents are issued to the Company, others may hold or
receive patents that contain claims having a scope that covers products
subsequently developed by the Company.
The Company also relies on unpatented trade secrets to protect its proprietary
technology, and no assurance can be given that others will not independently
develop or otherwise acquire substantially equivalent technologies or otherwise
gain access to the Company's proprietary technology or disclose such technology
or that the Company can ultimately protect meaningful rights to such unpatented
proprietary technology.
There has been substantial litigation regarding patent and other intellectual
property rights in the medical device industry. Litigation, which could result
in substantial cost to and diversion of effort by the Company, may be necessary
to enforce patents issued to the Company, to protect trade secrets or know-how
owned by the Company, to defend the Company against claimed infringement of the
rights of others or to determine the ownership, scope or
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Exhibit 99.1
validity of the proprietary rights of the Company and others. An adverse
determination in such litigation could subject the Company to significant
liabilities to third parties, require the Company to seek licenses from third
parties and prevent the Company from manufacturing, selling or using its
products, any of which could have a material adverse effect on the Company's
business, financial condition and results of operations.
GOVERNMENTAL REGULATION
As a medical device company, the Company is subject to extensive and rigorous
regulation by the FDA in the United States and by comparable agencies in foreign
countries. The FDA regulates the introduction of medical devices as well as
manufacturing, labeling, distribution, sale, marketing, advertising, promotion
and record keeping procedures for such products.
Although the 510(k) marketing clearance received from the FDA in 1991 for the
Company's trans-aortic system was confirmed in 1996 and then again in May of
1999, using both internal and external consulting evaluations and is believed to
be valid for the Basis System, such clearance can be withdrawn temporarily or
permanently by the FDA due to failure to comply with regulatory standards or the
occurrence of unforeseen problems with the Basis System. The FDA also has the
power to limit or prevent the manufacture or distribution of the Basis System
and could require its recall. FDA regulations depend heavily on administrative
interpretation, and there can be no assurance that future interpretation made by
the FDA or other regulatory bodies, with possible retroactive effect, will not
adversely affect the Company. The FDA and various agencies inspect the Company
and its facilities from time to time to determine whether the Company is in
compliance with regulations relating to medical device manufacturing, including
regulations concerning manufacturing, testing, quality control and product
labeling practices. A determination that the Company is in material violation of
such regulations could lead to the imposition of civil penalties, including
fines, product recalls, product seizures, or, in extreme cases, criminal
sanctions. In addition, there can be no assurance that the government
regulations will not change, and thereby prevent the Company from temporarily or
permanently marketing the Basis System. The withdrawal by the FDA of its
marketing approval for the Basis System, the recall of the Basis System or
similar regulatory action would have a material adverse effect on the Company's
business, financial condition and results of operations.
As part of its strategy, the Company expects to pursue commercialization of its
products in international markets, and therefore, the Company's products will be
subject to regulations that vary from country to country. The process of
obtaining foreign regulatory approvals in certain countries can be lengthy and
require the expenditure of substantial resources. There can be no assurance that
the Company will be able to obtain necessary regulatory approvals or clearances
on a timely basis or at all, and delays in receipt of or failure to receive such
approvals or clearances, or failure to comply with existing or future regulatory
requirements, could have a material adverse effect on the Company's business,
financial condition and results of operations.
UNCERTAINTY OF HEALTH CARE REFORM
The levels of revenue and profitability of medical device companies may be
affected by the continuing efforts of government and third party payers to
contain or reduce the costs of health care through various means. In the United
States there have been, and the Company expects that there will continue to be,
a number of federal and state proposals to control health care costs. These
proposals contain measures intended to control public and private spending on
health care as well as to provide universal public access to the health care
system. If enacted, such proposals may result in a substantial restructuring of
the health care delivery system. Significant changes in the nation's health care
system are likely to have a substantial impact on the manner in which the
Company conducts its business and could have a material adverse effect on the
Company's business, financial condition and results of operations. Similarly,
the marketing and sale of the Company's products in foreign countries could be
materially adversely affected by health care reform in such countries.
NEED TO EXPAND; DEPENDENCE ON KEY PERSONNEL
The Company needs to expand its management, research and development,
manufacturing and sales and marketing personnel in order to support development
and commercialization of the Basis System. The inability to hire personnel as
needed may have a material adverse effect on the Company. The success of the
Company will depend in part upon its ability to attract and retain capable
technical staff as well as sales and marketing personnel in the
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Exhibit 99.1
future. The Company is currently dependent on the services of Andrew M. Weiss,
the Company's President and Chief Executive Officer, and Steven R. Wedan, the
Company's Vice-President, Engineering. The loss of either of Messrs. Weiss or
Wedan could have a material adverse effect on the Company.
RISKS RELATED TO INTERNATIONAL SALES
The Company's plan to distribute the Basis System in international markets
involves certain risks, including the impact of any tariffs, quotas and taxes
which may be imposed by foreign governments on international sales of the Basis
System, the impact of potential political and economic instability on demand for
the Basis System, restrictions on import or export of technology which could
prohibit or restrict international sales, and potentially limited intellectual
property protection which could cause the Company to refrain from selling in
certain international markets. Currency fluctuations could also cause the Basis
System to become less affordable or less price competitive in international
markets. Any of these factors would adversely impact the Company's ability to
sell the Basis System internationally, and could in turn have a material,
adverse impact on the Company's business, financial condition and results of
operations.
DEPENDENCE ON KEY SUPPLIERS
There are multiple sources for most of the components used in the Basis System.
Several components, however, are currently available from only a limited number
of vendors or are nearing the end of their product life cycle and availability.
The inability to obtain such components on a timely basis or to identify,
validate and procure alternative components would have an adverse impact on the
Company's ability to fill orders from customers.
PRODUCT LIABILITY; AVAILABILITY OF INSURANCE
The medical device industry is subject to substantial litigation, and the
Company faces an inherent business risk of exposure to product liability claims
in the event that the use of the Basis System is alleged to have resulted in
adverse effects to a patient. Although the Company maintains product liability
insurance, there can be no assurance that the coverage limits of its insurance
policies will be adequate, or that such insurance will be available in the
future on acceptable terms, if at all. A product liability claim or other claim
with respect to uninsured liabilities or in excess of insured liabilities could
have a material adverse effect on the business, financial conditions and results
of operations of the Company.
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