competitors may independently develop similar or alternative technologies or products that are equal or superior to our technology
and products without infringing any of our patent or other intellectual property rights, or may design around our proprietary
technologies. Our competitors may acquire similar or even the same technology components that are utilized in our current offering
eroding some differentiation in the marketplace. In addition, the laws of some foreign countries do not protect intellectual property
rights to the same extent, as do the laws of the U.S., particularly in the field of medical products and procedures.
parties may assert that we are infringing their intellectual property rights.
commercializing our products depends in part on not infringing patents held by third parties. It is possible that one or more
of our products, including those that we have developed in conjunction with third parties, infringes existing patents. We may
also be liable for patent infringement by third parties whose products we use or combine with our own and for which we have no
right to indemnification. In addition, because patent applications are maintained under conditions of confidentiality and can
take many years to issue, there may be applications now pending of which we are unaware and which may later result in issued patents
that our products infringe. Determining whether a product infringes a patent involves complex legal and factual issues and may
not become clear until finally determined by a court in litigation. Our competitors may assert that our products infringe patents
held by them. Moreover, as the number of competitors in our market grows the possibility of a patent infringement claim against
us increases. If we were not successful in obtaining a license or redesigning our products, we could be subject to litigation.
If we lose in this kind of litigation, a court could require us to pay substantial damages or prohibit us from using technologies
essential to our products covered by third-party patents. An inability to use technologies essential to our products would have
a material adverse effect on our financial condition, results of operations and cash flow and could undermine our ability to continue
operating as a going concern.
intellectual property litigation is frequent in the medical device industry.
actions, validity challenges and other intellectual property claims and proceedings, whether with or without merit, can be expensive
and time-consuming and would divert management’s attention from our business. We have incurred, and expect to continue to
incur, substantial costs in obtaining patents and may have to incur substantial costs defending our proprietary rights. Incurring
such costs could have a material adverse effect on our financial condition, results of operations and cash flow.
may not be able to maintain all the licenses or rights from third parties necessary for the development, manufacture, or marketing
of new and existing products.
we develop additional products and improve or maintain existing products, we may find it advisable or necessary to seek licenses
or otherwise make payments in exchange for rights from third parties who hold patents covering certain technology. If we cannot
obtain or maintain the desired licenses or rights for any of our products, we could be forced to try to design around those patents
at additional cost or abandon the product altogether, which could adversely affect revenue and results of operations. If we have
to abandon a product, our ability to develop and grow our business in new directions and markets would be adversely affected.
If we do not maintain licenses or exclusivity with suppliers of certain components of our Odyssey Solution, competitors
may enter the market, negatively impacting our ability to develop and commercialize the Odyssey Solution.
products and related technologies can be applied in different medical applications, and we may fail to focus on the most profitable
robotic magnetic system is designed to have the potential for expanded applications beyond electrophysiology and interventional
cardiology, including congestive heart failure, structural heart repair, interventional neurosurgery, interventional neuroradiology,
peripheral vascular, pulmonology, urology, gynecology and gastrointestinal medicine. We continue to develop the Odyssey
Solution and Vdrive system for interventional labs that have a robotic magnetic system installed as well as those standard
interventional labs that do not have a robotic magnetic system installed. However, we have limited financial and managerial resources
and, therefore, may be required to focus on products in selected industries and sites and to forego efforts with regard to other
products and industries. Our decisions may not produce viable commercial products and may divert our resources from more profitable
market opportunities. Moreover, we may devote resources to developing products in these additional areas but may be unable to
justify the value proposition or otherwise develop a commercial market for products we develop in these areas, if any. In that
case, the return on investment in these additional areas may be limited, which could negatively affect our results of operations.
may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets
of their former employers.
of our employees were previously employed at hospitals, universities or other medical device companies, including our competitors
or potential competitors. We could, in the future, be subject to claims that these employees or we have used or disclosed trade
secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims.
If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights
or personnel. Even if we are successful in defending against these claims, litigation could result in substantial costs and be
a distraction to management. Incurring such costs could have a material adverse effect on our financial condition, results of
operations and cash flow.