also has developed the Odyssey Solution which consolidates all lab information enabling doctors to focus on the patient
for optimal procedure efficiency. The system also features a remote viewing and recording capability called Odyssey Cinema,
which is an innovative solution delivering synchronized content for optimized workflow, advanced care, and improved productivity.
This tool includes an archiving capability that allows clinicians to store and replay entire procedures or segments of procedures.
This information can be accessed from locations throughout the hospital local area network and over the global Odyssey
Network providing physicians with a tool for clinical collaboration, remote consultation, and training. The Odyssey Solution
may be acquired in conjunction with a Niobe system or on a stand-alone basis for installation in interventional labs and
other locations where clinicians often desire the benefits of the Odyssey Solution that we believe can improve clinical
workflows and related efficiencies.
Vdrive system provides navigation and stability for diagnostic and therapeutic devices designed to improve interventional
procedures. The Vdrive system complements the Niobe ES system control of therapeutic catheters for fully remote
procedures and enables single-operator workflow and is sold as two options, the Vdrive system and the Vdrive Duo
system. In addition to the Vdrive system and the Vdrive Duo system, we also manufacture and market various disposable
components (V-Loop, V-Sono, V-CAS, and V-CAS Deflect) which can be manipulated by these systems.
have successfully integrated our Niobe system with digital fluoroscopy systems to provide advanced interventional lab visualization
and instrument control through user-friendly computerized interfaces. The maintenance of these arrangements, or the establishment
of equivalent alternatives, is critical to our commercialization efforts. The commercial availability of both currently compatible
digital imaging fluoroscopy systems is unlikely to continue for multiple years and efforts are being made to ensure the availability
of integrated next generation systems and/or equivalent alternatives; however, we cannot provide assurance as to the timeline
of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or
Concern, Liquidity and Management’s Plan
Company believes the cash on hand at June 30, 2018 will be sufficient to meet its obligations as they become due in the ordinary
course of business for at least 12 months following the date these financial statements are issued. The Company has sustained
operating losses throughout its corporate history and expects that its 2018 expenses will exceed its 2018 gross margin. The Company
expects to continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing
operations or expense reductions are in place. The Company’s liquidity needs will be largely determined by the success of
clinical adoption within the installed base of Niobe systems as well as by new placements of capital systems.
Accounting Policies and Estimates
discussion and analysis of our financial condition and results of operations are based on our financial statements, which have
been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements
requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and
related disclosures. We review our estimates and judgments on an on-going basis. We base our estimates and judgments on historical
experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ
from these estimates. We believe the following accounting policies are critical to the judgments and estimates we use in preparing
our financial statements. For a complete listing of our critical accounting policies, please refer to our Annual Report on Form
10-K for the year ended December 31, 2017.
Company adopted ASC 606, Revenue from Contracts with Customers, on January 1, 2018. We generate revenue from the initial capital
sales of the Niobe, Odyssey, and Vdrive systems as well as recurring revenue from the sale of our proprietary disposable
devices from royalties paid to the Company on the sale by Biosense Webster of co-developed catheters, and from other recurring
revenue including ongoing license and service contracts.
account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the
rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration
is probable. We record our revenue based on consideration specified in the contract with each customer, net of any taxes collected
from customers that are remitted to government authorities.
contracts containing multiple products and services the Company accounts for individual products and services as separate performance
obligations if they are distinct, which is if a product or service is separately identifiable from other items in the bundled
package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer.
The Company recognizes revenues as the performance obligations are satisfied by transferring control of the product or service
to a customer.
multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price.
Standalone selling prices are based on observable prices at which the Company separately sells the products or services. If a
standalone selling price is not directly observable, then the Company estimates the standalone selling price considering market
conditions and entity-specific factors including, but not limited to, features and functionality of the products and services
and market conditions. The Company regularly reviews standalone selling prices and updates these estimates if necessary.