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): January 11, 2011
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 January 11, 2011, Stereotaxis, Inc. (the “Company”) issued a press release (the “Press Release”) announcing a successful cardiac ablation procedure with the Vdrive™ robotic navigation system. A copy of the Press Release is being filed as Exhibit 99.1 hereto, and the statements contained therein are incorporated by reference herein.
Forward Looking Statements and Additional Information
Statements are 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 update or revi se 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
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Exhibits. |
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99.1 |
Stereotaxis, Inc. Press Release dated January 11, 2011. |
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: January 11, 2011 By: /s/ Daniel J. Johnston
Name: Daniel J. Johnston
Title: Chief Financial Officer
EXHIBIT INDEX
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99.1 |
Stereotaxis, Inc. Press Release dated January 11, 2011. |
Exhibit 99.1
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Company Contact: Dan Johnston Chief Financial Officer 314-678-6007
Investor Contact: EVC Group, Inc. Doug Sherk & Gregory Gin 415-896-6820
Media Contact: Rick Green Stereotaxis, Inc. 314-678-6172 |
Stereotaxis Announces CE Mark and First Human Case for VdriveTM
Breakthrough Robotic Technology a Companion to Magnetic Navigation
ST. LOUIS, MO, January 11, 2011 -- Stereotaxis, Inc. (Nasdaq: STXS) announces the first successful cardiac ablation procedure with the Vdrive™ robotic navigation system as the company received CE Mark for this latest innovation.
In the first procedure with the Vdrive system, Tamas Szili-Torok, MD, Ph.D, from the Department of Clinical Electrophysiology at the Erasmus Medical Center in The Netherlands, successfully treated atrial fibrillation in a patient with known difficult heart anatomy. Dr. Szili-Torok was able to complete the entire case without having to manually adjust the circular mapping catheter.
“This first use of the Vdrive robotic navigation system exceeded my expectations,” said Dr. Szili-Torok. “The robotic navigation of the circular mapping catheter was intuitive and allowed me to make multiple small precise adjustments from the control room to efficiently treat my patient’s atrial fibrillation.”
Stereotaxis’ Vdrive system is a robotic navigation technology that compliments the Stereotaxis Remote Magnetic Navigation System. Designed to manipulate accessory devices such as variable loop catheters, steerable sheaths, and ultrasound catheters, Vdrive combines magnetic navigation with the Odyssey information management system to bring precise control during catheter-based electrophysiology procedures.
“The Vdrive system is an extension of the magnetic navigation platform capabilities,” said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis, Inc. “Along with QuickCAS™ Catheter Advancement System, the Vdrive system represents an additional component to our expanding disposable product portfolio designed to bring compelling efficiency to the Electrophysiology lab.”
The Vdrive system is commercially available in the European Union. The Vdrive system is not currently available for purchase in the U.S. as it is still under 510(k) review by the U.S. Food and Drug Administration.
About Stereotaxis www.stereotaxis.com www.odysseyexperience.com
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, 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 regulatory 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.