2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
following discussion and analysis should be read in conjunction with our financial statements and notes thereto included in this
report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2017. Operating results are not necessarily
indicative of results that may occur in future periods.
report includes various forward-looking statements that are subject to risks and uncertainties, many of which are beyond our control.
Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors,
including those set forth in “Item 1A. Risk Factors.” Forward-looking statements discuss matters that are not historical
facts. Forward-looking statements include, but are not limited to, discussions regarding our operating strategy, sales and marketing
strategy, regulatory strategy, industry, economic conditions, financial condition, liquidity, capital resources, and results of
operations. Such statements include, but are not limited to, statements preceded by, followed by, or that otherwise include the
words “believe”, “expects”, “anticipates”, “intends”, “estimates”,
“projects”, “can”, “could”, “may”, “would”, or similar expressions.
For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. You should not unduly rely on these forward-looking statements, which speak only as of the date
on which they are made. They give our expectations regarding the future, but are not guarantees. We undertake no obligation to
update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise,
unless required by law.
designs, manufactures and markets the Epoch Solution, which is an advanced cardiology instrument control system for use
in a hospital’s interventional surgical suite to enhance the treatment of arrhythmias and coronary artery disease. The Epoch
Solution is comprised of the Niobe ES robotic system, Odyssey Solution, and the Vdrive system. We believe
that the Epoch Solution represents a revolutionary technology in the interventional surgical suite, or “interventional
lab,” and has the potential to become the standard of care for a broad range of complex cardiology procedures. We also believe
that our technology represents an important advance in the ongoing trend toward digital instrumentation in the interventional
lab and provides substantial, clinically important improvements, and cost efficiencies over manual interventional methods, which
require years of physician training and often result in long and unpredictable procedure times and sub-optimal therapeutic outcomes.
Niobe ES system is the latest generation of the Niobe Remote Magnetic Navigation System (“Niobe system”).
This system is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery
of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally
applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation,
efficient procedures and reduced x-ray exposure. The core components of the Niobe system have received regulatory clearance
in the U.S., Canada, Europe, China, Japan, and various other countries. As of June 30, 2018, the Company had an installed base
of 127 Niobe ES systems.