associated with international manufacturing and trade could negatively impact the availability and cost of our products because
materials used to manufacture our magnets, one of our key system components, are sourced from overseas.
purchase the permanent magnets for our robotic magnetic system from a manufacturer that uses material produced in Japan, and we
anticipate that certain of the production work for these magnets will be performed for this manufacturer in China. In addition,
our subcontractor purchases magnets for our disposable interventional devices directly from a manufacturer in Japan. Any event
causing a significant increase in price or a disruption of imports, including the imposition of import restrictions, could adversely
affect our business. The flow of components from our vendors could also be adversely affected by financial or political instability
in any of the countries in which the goods we purchase are manufactured, if the instability affects the production or export of
product components from those countries. Trade restrictions in the form of tariffs or quotas, or both, could also affect the importation
of those product components and could increase the cost and reduce the supply of products available to us. In addition, decreases
in the value of the U.S. dollar against foreign currencies could increase the cost of products we purchase from overseas vendors.
may encounter problems at our manufacturing facilities or those of our subcontractors or otherwise experience manufacturing delays
that could result in lost revenue.
subcontract all or part of the manufacture and assembly of components of our Niobe ES system, Odyssey Solution,
and Vdrive system, and all of our disposable devices. The products we design may not satisfy all of the performance requirements
of our customers and we may need to improve or modify the design or ask our subcontractors to modify their production process
in order to do so. In addition, we or our subcontractors may experience quality problems, substantial costs and unexpected delays
related to efforts to upgrade and expand manufacturing, assembly and testing capabilities. If we incur delays due to quality problems
or other unexpected events, our revenue may be impacted.
breaches and other disruptions to our information technology infrastructure could interfere with our operations, compromise confidential
information, and expose us to liability which could materially adversely impact our business and reputation.
breaches and other disruptions to our information technology infrastructure could interfere with our operations; compromise information
belonging to us, our employees, customers, and suppliers; and expose us to liability which could adversely impact our business
and reputation. In the ordinary course of business, we rely on information technology networks and systems, some of which are
managed by third parties, to process, transmit, and store electronic information, and to manage or support a variety of business
processes and activities. Additionally, we collect and store certain data, including proprietary business information and customer
and employee data, and may have access to confidential or personal information in certain of our businesses that is subject to
privacy and security laws, regulations, and customer-imposed controls. Despite our cyber security measures (including employee
and third-party training, monitoring of networks and systems, and maintenance of backup and protective systems) which are continuously
reviewed and upgraded, our information technology networks and infrastructure may still be vulnerable to damage, disruptions,
or shutdowns due to attack by hackers, breaches, employee error or malfeasance, power outages, computer viruses, telecommunication
or utility failures, systems failures, natural disasters, or other catastrophic events. Any such events could result in legal
claims or proceedings, liability or penalties under privacy laws, disruption in operations, and damage to our reputation, which
could materially adversely affect our business. While we have experienced, and expect to continue to experience, these types of
threats to our information technology networks and infrastructure, to date none of these threats has had a material impact on
our business or operations.
may be unable to protect our technology from use by third parties.
commercial success depends in part on obtaining patent and other intellectual property right protection for the technologies contained
in our products and on successfully defending these rights against third party challenges. The patent positions of medical device
companies, including ours, can be highly uncertain and involve complex and evolving legal and factual questions. We cannot assure
you that we will obtain the patent protection we seek, that any protection we do obtain will be found valid and enforceable if
challenged or that it will confer any significant commercial advantage. U.S. patents and patent applications may also be subject
to interference proceedings and U.S. patents may be subject to re-examination proceedings in the U.S. Patent and Trademark Office,
and foreign patents may be subject to opposition or comparable proceedings in the corresponding foreign patent office, which proceedings
could result in either loss of the patent, or denial of the patent application, or loss or reduction in the scope of one or more
of the claims of the patent or patent application. In addition, such interference, re-examination, and opposition proceedings
may be costly. Thus, any patents that we own or license from others may not provide any protection against competitors. Our pending
patent applications, those we may file in the future, or those we may license from third parties may not result in patents being
issued and certain foreign patent applications for medical related devices and methods may be found unpatentable. If issued, they
may not provide us with proprietary protection or competitive advantages against competitors with similar technology.
of our technology was developed in conjunction with third parties, and thus there is a risk that a third party may claim rights
in our intellectual property. Outside the U.S., we rely on third-party payment services for the payment of foreign patent annuities
and other fees. Non-payment or delay in payment of such fees, whether intentional or unintentional, may result in loss of patents
or patent rights important to our business. Many countries, including certain countries in Europe, have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties (for example, the patent owner has failed to “work”
the invention in that country, or the third party has patented improvements). In addition, many countries limit the enforceability
of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies,
which could materially diminish the value of the patent. We also cannot assure you that we will be able to develop additional
patentable technologies. If we fail to obtain adequate patent protection for our technology, or if any protection we obtain becomes
limited or invalidated, others may be able to make and sell competing products, impairing our competitive position.
trade secrets, nondisclosure agreements and other contractual provisions to protect unpatented technology provide only limited
and possibly inadequate protection of our rights. As a result, third parties may be able to use our unpatented technology, and
our ability to compete in the market would be reduced. In addition, employees, consultants and others who participate in developing
our products or in commercial relationships with us may breach their agreements with us regarding our intellectual property, and
we may not have adequate remedies for the breach.