RISK FACTORS
An investment in our Shares involves a high degree of risk. You should carefully consider the following
information about these risks, together with the other information contained in this Prospectus, including our
consolidated financial statements and related notes, before you decide to buy our Shares. The risks described
below are not the only risks facing us. Additional risks not presently known to us or that we currently deem
immaterial may also harm our business. If any of the following risks were to materialise, our business, financial
condition and results of operations would likely suffer. In any such case, the market price of our Shares could
decline, and you may lose all or part of the money you paid to buy our Shares.
Risks Relating To Our Business
If we fail to obtain necessary regulatory approvals to sell our proprietary drug-eluting stent products, we
will not be able to commercialise such products, we will not achieve our product revenue and profitability
goals and our business and the value of our Shares will be materially and adversely affected.
Regulatory approvals are required before we are able to market and sell our drug-eluting stent products in
most major markets throughout the world. Both we and our licensees are currently conducting clinical trials,
which are required in order to submit these products for regulatory approval. The clinical trial and regulatory
approval process is uncertain, time-consuming and expensive. We believe that our future success is substantially
dependent upon our obtaining such regulatory approvals, as we evolve from a company focused on sales of
critical care and traditional interventional cardiology products to one focused on sales of drug-eluting stent
products. We have initiated filings for regulatory approval for the marketing or sale of our drug-eluting stent
products in Europe, and our future sales of these products are subject to uncertainty with respect to whether we
will ever obtain such regulatory approvals. Our licensees have also not yet applied for regulatory approval for
any of the drug-eluting stent products that incorporate technology licensed from us. If we are unable, or if any of
our licensees is unable, to obtain such regulatory approvals, for any reason, in any one or more of our or their
target markets, we will be unsuccessful in achieving our goals for product revenue and profitability, and our
business, financial condition and results of operations and the value of our Shares would be materially and
adversely affected.
Our failure to successfully market, sell, manufacture or distribute our drug-eluting stent products will
have a material adverse effect on our business and the price of our Shares.
We have had virtually no experience marketing, selling, manufacturing or distributing the drug-eluting stent
products we intend to sell, if and when we receive the regulatory approvals required to do so. Furthermore, we
will need to substantially increase our manufacturing, marketing, sales and distribution capabilities in order to do
so successfully. If we are unsuccessful in any of these activities, our business and the value of our Shares would
be materially and adversely affected.
We expect to derive an increasing portion of our revenue from sales of our drug-eluting stent products
and licensing of our drug-eluting stent technology. If we fail to generate revenue from these sources, our
results of operations and the value of our Shares could be materially and adversely affected.
Sales of critical care and traditional interventional cardiology products have accounted for substantially all
of our past product revenue. In the future, however, we expect an increasing proportion of our revenue to be
generated from sales of our drug-eluting stent products and licensing our drug-eluting stent technology.
To date, neither we nor the licensees of our drug-eluting stent technology have received regulatory approval
for the marketing and sale of these products. Future sales of these products, if any, will be subject to commercial
and market uncertainties that are outside our control. If we fail to generate such revenues, our results of
operations and the value of our Shares could be materially and adversely affected.
Because we license our technology to third parties, we have assumed more risk than if we had maintained
exclusive control over our technology.
Our decision to license our drug-eluting stent technology to third parties means we have relinquished a
certain amount of control over how our technology is applied, exploited and perceived in the marketplace. As a
result, our company and our products may receive negative publicity as a result of the activities of our licensees,
regardless of whether such publicity is properly attributable to the merits of our licensed technology. For
example, in announcing its delayed development of an automated coating process for its CHAMPION stent,