rate of technological innovation of our products might not keep pace with the rest of the market.
rate of innovation for the market in which our products compete is fast-paced and requires significant resources and innovation.
If other products and technologies are developed that compete with, or may compete with, the Niobe, Odyssey and
Vdrive systems, it could be difficult for us to maintain our advantages associated with being an early developer of this
technology. In addition, connectivity with other devices in the electrophysiology lab is a key driver of value. If the Company
is not able to continue to commit sufficient resources to ensure that its products are compatible with other products within the
electrophysiology lab, this could have a negative impact on revenue.
economic conditions could materially adversely impact us.
operating performance is dependent upon economic conditions in the United States and in other countries in which we operate. Uncertainty
about current global economic conditions and future global economic conditions may cause customers to delay purchasing or installation
decisions or cancel existing orders. The Niobe ES system, Odyssey Solution and Vdrive system are typically
purchased as part of a larger overall capital project and an economic downturn or the lack of a robust recovery might make it
more difficult for our customers, including distributors, to obtain adequate financing to support the project or to obtain requisite
approvals. Any delay in purchasing decisions or cancellation of purchasing commitments may result in a decrease in our revenues.
A credit crisis could further affect our business if key suppliers are unable to obtain financing to manufacture our products
or become insolvent and we are unable to manufacture product to meet customer demand. If the United States and global economy
becomes sluggish or deteriorates for a longer period than we anticipate, we may experience a material negative decrease on the
demand for our products which may, in turn, have a material adverse effect on our revenue, profitability, financial condition,
ability to raise additional capital and the market price of our stock.
may not use our products if they do not believe they are safe, efficient and effective.
believe that physicians will not use our products unless they determine that the Niobe ES system and Vdrive system
provide a safe, effective and preferable alternative to interventional methods in general use today. If longer-term patient studies
or clinical experience indicate that treatment with our system or products is less effective, less efficient or less safe than
our current data suggest, our sales would be harmed, and we could be subject to significant liability. Further, unsatisfactory
patient outcomes or patient injury could cause negative publicity for our products, particularly in the early phases of product
introduction. In addition, physicians may be slow to adopt our products if they perceive liability risks arising from the use
of these new products. It is also possible that as our products become more widely used, latent defects could be identified, creating
negative publicity and liability problems for us and adversely affecting demand for our products. If physicians do not use our
products, we likely will not become profitable or generate sufficient cash to survive as a going concern.
collaborations with fluoroscopy system manufacturers and providers of catheters and electrophysiology mapping systems or other
parties may fail, or we may not be able to enter into additional collaborations in the future.
have collaborated with and are continuing to collaborate with fluoroscopy system manufacturers and providers of catheters and
electrophysiology mapping systems and other parties to make our instrument control technology compatible with their respective
imaging products or disposable interventional devices and to co-develop additional disposable interventional devices for use with
our products. A significant portion of our revenue from system sales is derived from these integrated products. The maintenance
of these collaborations, or the establishment of equivalent alternatives, is critical to our commercialization efforts. The commercial
availability of currently compatible digital imaging fluoroscopy systems is unlikely to continue and efforts are being made to
ensure the availability of integrated next generation systems and/or equivalent alternatives; however, we cannot assure as to
the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive
terms or at all.
product commercialization plans could be disrupted, leading to lower than expected revenue and a material and adverse impact on
our results of operations and cash flow, if:
fail to or are unable to maintain adequate compatibility of our products with the most prevalent imaging products or disposable
interventional devices expected by our customers for their clinical practice;|
of our collaboration partners delays or fails in the integration of its technology or new products with our robotic magnetic
of our collaboration partners fails to develop or commercialize the integrated products in a timely manner; or|
become involved in disputes with one or more of our collaboration partners regarding our collaborations. |
of our collaborators are large, global organizations with diverse product lines and interests that may diverge from our interests
in commercializing our products. Accordingly, our collaborators may not devote adequate resources to our products, or may experience
financial difficulties, change their business strategy or undergo a business combination that may affect their willingness or
ability to fulfill their obligations to us.
failure of one or more of our collaborations could have a material adverse effect on our financial condition, results of operations
and cash flow. In addition, if we are unable to enter into additional collaborations in the future, or if these collaborations
fail, our ability to develop and commercialize products could be impacted negatively and our revenue could be adversely affected.