may lose key personnel or fail to attract and retain replacement or additional personnel.
are highly dependent on the principal members of our management, as well as our scientific and sales staff. Attracting and retaining
qualified personnel will be critical to our success, and competition for qualified personnel is intense. We may not be able to
attract and retain personnel on acceptable terms given the competition for qualified personnel among technology and healthcare
companies and universities. The loss of personnel or our inability to attract and retain other qualified personnel could harm
our business and our ability to compete. In addition, the loss of members of our scientific staff may significantly delay or prevent
product development and other business objectives. A loss of key sales personnel could result in a reduction of revenue. In addition,
if we outsource certain employee functions that were formerly handled in-house, our personnel costs could increase.
decision-makers may not purchase our Niobe, Odyssey, or Vdrive systems or may think that such systems are
achieve and grow sales, hospitals must purchase our products, and in particular, our robotic magnetic system. The robotic magnetic
system is a novel device, and hospitals and physicians are traditionally slow to adopt new products and treatment practices. In
addition, hospitals may delay their purchase or installation decision for the robotic magnetic system based on the disposable
interventional devices that have received regulatory clearance or approval. Moreover, the robotic magnetic system is an expensive
piece of capital equipment, representing a significant portion of the cost of a new or replacement interventional lab. Although
priced significantly below a robotic magnetic system, the Odyssey Solution and Vdrive system are still expensive
products. If hospitals do not widely adopt our systems, or if they decide that they are too expensive, we may never become profitable.
Any failure to sell as many systems as our business plan requires could also have a seriously detrimental impact on our results
of operations, financial condition, and cash flow.
we are unable to fulfill our current purchase orders and other commitments on a timely basis or at all, we may not be able to
achieve future sales growth.
backlog, which consists of purchase orders and other commitments, is considered by some investors to be a significant indicator
of future performance. Consequently, negative changes to this backlog or its failure to grow commensurate with expectations could
negatively impact our future operating results or our share price. Our backlog includes those outstanding purchase orders and
other commitments that management believes will result in recognition of revenue upon delivery or installation of our systems.
We cannot assure you that we will recognize revenue in any particular period or at all because some of our purchase orders and
other commitments are subject to contingencies that are outside our control. In addition, these orders and commitments may be
revised, modified or cancelled, either by their express terms, as a result of negotiations or by project changes or delays. System
installation is by its nature subject to the interventional lab construction or renovation process which comprises multiple stages,
all of which are outside of our control. Although the actual installation of our robotic magnetic system requires only a few weeks,
and can be accomplished by either our staff or by subcontractors, successful installation of our system can be subjected to delays
related to the overall construction or renovation process. If we experience any failures or delays in completing the installation
of these systems, our reputation would suffer and we may not be able to sell additional systems. We have experienced situations
in which our purchase orders and other commitments did not result in recognizing revenue from placement of a system with a customer.
In addition to construction delays, there are risks that an institution will attempt to cancel a purchase order as a result of
subsequent project review by the institution or the departure from the institution of physicians or physician groups who have
expressed an interest in purchasing our products.
in our backlog have occurred in the past and could occur in the future, causing delays in revenue recognition or even removal
of orders and other commitments from our backlog. Such events would have a negative effect on our revenue and results of operations.
will likely experience long and variable sales and installation cycles, which could result in substantial fluctuations in our
quarterly results of operations.
anticipate that our robotic magnetic system will continue to have a lengthy sales cycle because it consists of a relatively expensive
piece of capital equipment, the purchase of which requires the approval of senior management at hospitals, inclusion in the hospitals’
interventional lab budget process for capital expenditures, and, in some instances, a certificate of need from the state or other
regulatory approval. In addition, historically the majority of our Niobe ES systems and Odyssey systems have been
delivered less than one year after the receipt of a purchase order from a hospital, with the timing being dependent on the construction
cycle for the new or replacement interventional suite in which the equipment will be installed. In some cases, this time frame
has been extended further because the interventional suite construction is part of a larger construction project at the customer
site (typically the construction of a new building), which may occur with our existing and future purchase orders. We cannot assure
you that the time from purchase order to delivery for systems to be delivered in the future will be consistent with our historical
experience. Moreover, a global economic slowdown may cause our customers to further delay construction or significant capital
purchases, which could further lengthen our sales cycle. This may contribute to substantial fluctuations in our quarterly operating
results. As a result, in future quarters our operating results could fall below the expectations of securities analysts or investors,
in which event our stock price would likely decrease.