costs could substantially increase if we receive a significant number of warranty claims.
generally warrant each of our products against defects in materials and workmanship for a period of 12 months following the installation
of our system. If product returns or warranty claims increase, we could incur unanticipated additional expenditures for parts
and service. In addition, our reputation and goodwill in the interventional lab market could be damaged. Unforeseen warranty exposure
in excess of our established reserves for liabilities associated with product warranties could materially and adversely affect
our financial condition, results of operations and cash flow.
have incurred substantial losses in the past and may not be profitable in the future.
have incurred substantial net losses since inception, and we expect to incur losses into the future as we continue the commercialization
of our products. We are still in the process of realizing the full potential of the commercialization of our technology, and will
need to continue to make improvements to that technology. Moreover, the extent of our future losses and the timing of profitability
are highly uncertain. Although we have achieved operating profitability during certain quarters, we may not achieve profitable
operations on an annual basis, and if we achieve profitable operations, we may not sustain or increase profitability on a quarterly
or annual basis. If we require more time than we expect to generate significant revenue and achieve annual profitability, or if
we are unable to sustain profitability once achieved, we may not be able to continue our operations. Our failure to achieve annual
profitability or sustain profitability on an annual or quarterly basis could negatively impact the market price of our common
stock. Furthermore, even if we achieve significant revenue, we may choose to pursue a strategy of increasing market penetration
and presence or expand or accelerate new product development or clinical research activities at the expense of profitability.
may not be able to comply with debt covenants and may have to repay outstanding indebtedness.
current borrowing agreement contains various covenants, including financial covenants under our credit agreement with our primary
lender. If we violate our covenants, it could impact our ability to borrow and we could be required to repay any related outstanding
debt. We could be unable to make these payments, which could lead to insolvency. Even if we are able to make these payments, it
will lead to the lack of availability for additional borrowings under our bank loan agreement due to our borrowing capacity. There
can be no assurance that we will be able to maintain compliance with these covenants or that we could replace this source of liquidity
if these covenants were to be violated and our loans and other borrowed amounts were forced to be repaid.
reliance on contract manufacturers and on suppliers, and in some cases, a single supplier, could harm our ability to meet demand
for our products in a timely manner or within budget.
depend on contract manufacturers to produce and assemble certain of the components of our systems and other products such as our
electrophysiology catheter advancement device and disposable devices for our Vdrive system. We also depend on various third
party suppliers for the magnets we use in our robotic magnetic system and certain components of our Odyssey Solution and
Vdrive system. In addition, some of the components necessary for the assembly of our products are currently provided to
us by a single supplier, including the magnets for our robotic magnetic system and certain components of our Odyssey Solution,
and we generally do not maintain large volumes of inventory. Our reliance on these third parties involves a number of risks, including,
among other things, the risk that:
may not be able to control the quality and cost of our system or respond to unanticipated changes and increases in customer
may lose access to critical services, materials, or components, resulting in an interruption in the manufacture, assembly
and shipment of our systems; and |
may not be able to find new or alternative components for our use or reconfigure our system and manufacturing processes in
a timely manner if the components necessary for our system become unavailable. |
any of these risks materialize, it could significantly increase our costs and impair product delivery.
times for materials and components ordered by us and our contract manufacturers vary and depend on factors such as the specific
supplier, contract terms and demand for a component at a given time. We and our contract manufacturers acquire materials, complete
standard subassemblies and assemble fully configured systems based on sales forecasts. If orders do not match forecasts, our contract
manufacturers and we may have excess or inadequate inventory of materials and components.
addition, if these manufacturers or suppliers stop providing us with the components or services necessary for the operation of
our business, we may not be able to identify alternate sources in a timely fashion. Any transition to alternate manufacturers
or suppliers would likely result in operational problems and increased expenses and could delay the shipment of, or limit our
ability to provide, our products. We cannot assure you that we would be able to enter into agreements with new manufacturers or
suppliers on commercially reasonable terms or at all. Additionally, obtaining components from a new supplier may require a new
or supplemental filing with applicable regulatory authorities and clearance or approval of the filing before we could resume product
sales. Any disruptions in product flow may harm our ability to generate revenue, lead to customer dissatisfaction, damage our
reputation and result in additional costs or cancellation of orders by our customers.
also rely on Biosense Webster and other parties to manufacture a number of disposable interventional devices for use with our
robotic magnetic system. If these parties cannot manufacture sufficient quantities of disposable interventional devices to meet
customer demand, or if their manufacturing processes are disrupted, our revenue and profitability would be adversely affected.