stxsform8k.htm - Generated by SEC Publisher for SEC Filing

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8‑K

 

 

CURRENT REPORT Pursuant

to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

 

      Date of report (Date of earliest event reported):  December 8, 2010                                           

 

STEREOTAXIS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

                               000-50884                                                             94-3120386

                  (Commission File Number)                              (IRS Employer Identification No.)

 

                                      

4320 Forest Park Avenue, Suite 100, St. Louis, Missouri                                    63108

       (Address of Principal Executive Offices)                                                       (Zip Code)

 

(314) 678-6100

(Registrant’s Telephone Number, Including Area Code)

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

      Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

      o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

      o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

      o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 


 

Item 7.01.       Regulation FD Disclosure.

           

On December 7, 2010, Stereotaxis, Inc. (the “Company”) issued a press release announcing that the United States Department of Veteran Affairs awarded Stereotaxis a Federal Supply Schedule Contract for its Niobe® Remote Magnetic Navigation System, related service agreement, and disposable products. The second paragraph of the press release inadvertently indicated that the Company’s Odyssey technologies will be included on the National Acquisition Center Contract Management Database and GSA Advantage Price List. A revised press release correcting this mistake is included as Exhibit 99.1 hereto and is incorporated herein by reference.

Forward Looking Statements and Additional Information

Statements made herein or incorporated herein that are “forward-looking statements” as defined by the Securities and Exchange Commission (the “SEC”). All statements, other than statements of historical fact, included or incorporated herein that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are not guarantees of future events or the Company’s future performance and are subject to risks, uncertainties and other important factors that could cause events or the Company’s actual performance or achievements to be materially different than those projected by the Company. For a full discussion of these risks, uncertainties and factors, the Company encourages you to read its documents on file with the SEC. Except as required by law, the Company does not intend to up date or revise its forward-looking statements, whether as a result of new information, future events or otherwise.

 

The information furnished in this Item 7.01 (including the press release attached as Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. In addition, this report (including the press release attached as Exhibit 99.1) shall not be deemed an admission as to the materiality of any information contained herein that is required to be disclosed solely as a requirement of this Item.

 

 

Item 9.01. Financial Statements and Exhibits.

 

(d)        Exhibits.

 

99.1    Revision to press release originally issued December 7, 2010

 

 

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

                                                                        STEREOTAXIS, INC.

                                                                                               

Date:   December 8, 2010                               By:___/s/ Daniel J. Johnston_________________

                                                            Name:  Daniel J. Johnston

                                                            Title:  Chief Financial Officer

 

                                    

 

 

 

 

 

 

 


 

EXHIBIT INDEX

 

 

 

Exhibit No.                 Document

 

99.1    Revision to press release originally issued December 7, 2010

 

 

 

stxspressrelease.htm - Generated by SEC Publisher for SEC Filing

Exhibit 99.1

 

       

Company Contact:

Dan Johnston

Chief Financial Officer

314-678-6007

 

Investor Contact:

EVC Group, Inc.

Doug Sherk & Gregory Gin

415-896-6820

 

Media Contact:

EVC Group, Inc.

Janine McCargo

646-688-0425

 

 

U.S. Veterans Affairs Awards Stereotaxis a Federal Supply Schedule Contract for Innovative EP Solutions

ST. LOUIS, MO, December 7, 2010—Stereotaxis, Inc. [NASDQ:STXS] announced that the United States Department of Veteran Affairs awarded Stereotaxis a Federal Supply Schedule Contract for its Niobe® Remote Magnetic Navigation System, related service agreement, and disposable products. This contract, effective December 15, 2010, is for five years, with a five year renewal option.    

 

The Department of Veteran Affairs (VA) manages more than 150 hospitals nationwide. Stereotaxis’ Niobe system, service agreement, and disposables will be included on the National Acquisition Center Contract Management Database and GSA Advantage Price List. Under the Federal Supply Schedule Contract, individual VA facilities may browse and purchase Stereotaxis’ products through these online tools without additional contract negotiations.  This enables the individual VA hospital to engage with Stereotaxis and acquire its technologies whenever it may be ready, easing the transaction between Stereotaxis and the individual hospital.

 

“The adoption of Stereotaxis technologies by the VA represents another important step towards setting a new global standard for the treatment of cardiac arrhythmias,” said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis. “Our technologies have long been accepted in the top academic teaching hospitals, which are typically the first to validate the clinical utility of a new medical technology. Along with community hospitals, VA hospitals represent a substantial portion of the cardiac electrophysiology market for both research and clinical use, and adoption among the VA community is a reliable measure of more mainstream acceptance of new technology.  We

 

 


 

 

expect this contract to enhance our U.S. growth opportunities. Our contract with the VA should help pave the way for many more institutions to add our game-changing technologies to their interventional labs.”

 

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Niobe® Remote Magnetic Navigation 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 computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure.

 

Stereotaxis’ Odyssey™ portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. Odyssey™ Vision integrates data for magnetic and standard interventional labs, enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey™ Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed.  Odyssey™ then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to maximize referrals and promote collaboration.

 

The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. For more information, please visit www.stereotaxis.com and www.odysseyexperience.com.

 

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, our ability to consummate an equity offering, continued acceptance of the Company's products in the marketplace, the effect of global  economic conditions on the ability and willingness of customers to purchase our systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regula tory approvals, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By


 

 

 

making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

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