Stereotaxis
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10-K
STEREOTAXIS, INC. filed this Form 10-K on 03/15/2019
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Certificate of Need Laws

 

In a number of states in the U.S., a certificate of need or similar regulatory approval is required prior to the acquisition of high-cost capital items or various types of advanced medical equipment, such as our robotic magnetic system. Many of the states in which we sell robotic magnetic systems have laws that require institutions located in those states to obtain a certificate of need in connection with the purchase of our system, and some of our purchase orders are conditioned upon our customer’s receipt of necessary certificate of need approval.

 

Employees

 

As of December 31, 2018, we had 119 employees, 31 of whom were engaged directly in research and development, including those related to regulatory and clinical research, 53 in sales and marketing activities, 18 in manufacturing and service, and 17 in general administrative activities including finance, information systems, legal and general management. A significant majority of our employees is not covered by a collective bargaining agreement, and we consider our relationship with our employees to be good.

 

Availability of Information

 

We make certain filings with the SEC, including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments and exhibits to those reports, available free of charge in the Investors section of our website, http://www.stereotaxis.com, as soon as reasonably practicable after they are filed with the SEC. Further, these filings are available on the Internet at http://www.sec.gov. Information contained on our website is not part of this report and such information is not incorporated by reference into this report.

 

Executive Officers

 

See Part III – Item 10 for information about our Executive Officers.

 

ITEM 1A. RISK FACTORS

 

The following uncertainties and factors, among others, could affect future performance and cause actual results to differ materially from those expressed or implied by forward looking statements.

 

We may not generate cash from operations or be able to raise the necessary capital to continue operations.

 

We may require additional funds to meet our operational, working capital and capital expenditure needs in the future. We cannot be certain that we will be able to obtain additional funds on favorable terms or at all. If we cannot raise capital on acceptable terms, we will not be able to, among other things:

 

  maintain customer and vendor relationships;
     
  hire, train and retain employees;
     
  maintain or expand our operations;
     
  enhance our existing products or develop new ones;
     
  respond to competitive pressures; or
     
  service our debt obligations and meet our financial covenants.

 

Our failure to do any of these things could result in lower revenue and adversely affect our financial condition and results of operations, and we may have to curtail or cease operations.

 

We may not be able to continue as a going concern if we do not improve the operating performance of the Company or raise additional capital.

 

The Company has sustained operating losses throughout its corporate history and expects that its 2019 expenses will exceed its 2019 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 our robotic magnetic system as well as by new placements of capital systems. The Company’s plans for improving the liquidity conditions primarily include its ability to control the timing and spending of its operating expenses and raising additional funds through debt or equity financing.

 

There can be no assurance that any of our plans will be successful or that additional capital will be available to us on reasonable terms, or at all, when needed. If we are unable to improve the operating performance of the Company or if we are unable to obtain sufficient additional capital, it may impair our ability to raise new capital, obtain new customers, and hire and retain employees, which could force us to substantially revise our business plan or cease operations, which may reduce or negate the value of your investment.

 

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