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
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Date of report (Date of earliest event reported) |
April 3, 2007 |
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STEREOTAXIS, INC. |
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(Exact Name of Registrant as Specified in Its Charter) |
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Delaware |
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(State or Other Jurisdiction of Incorporation) |
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000-50884 |
94-3120386 |
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(Commission File Number) |
(IRS Employer Identification No.) |
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4320 Forest Park Avenue, Suite 100, St. Louis, Missouri |
63108 |
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(Address of Principal Executive Offices) |
(Zip Code) |
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(314) 678-6100 |
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(Registrant’s Telephone Number, Including Area Code) |
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(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 April 3, 2007, Stereotaxis, Inc. announced that its partnered magnetically enabled 8mm ablation catheter has received FDA approval and will soon be commercially available in the U.S. A copy of a press release relating to the announcement is attached hereto as Exhibit 99.1.
This information furnished in this Item 7.01, including Exhibit 99.1 attached hereto, 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 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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(d) |
Exhibits |
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99.1 |
Stereotaxis, Inc. Press Release dated April 3, 2007. |
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.
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STEREOTAXIS, INC. | |
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Date: April 3, 2007 |
By: |
/s/ James M. Stolze |
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Name: |
James M. Stolze |
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Title: |
Vice President and Chief Financial Officer |
EXHIBITS
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99.1 |
Stereotaxis, Inc. Press Release dated April 3, 2007. |
Exhibit 99.1
Contacts:
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Stereotaxis, Inc. |
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Noonan Russo |
Stereotaxis Announces FDA Approval of Partnered 8mm Ablation Catheter
- Significant Milestones Achieved With FDA Approval and Completion of Successful Complex Ablations at Leading European Electrophysiology Centers
St Louis, MO, April 3, 2007 – Stereotaxis, Inc. (NASDAQ: STXS) announced today that its partnered magnetically enabled 8mm ablation catheter has received FDA approval and will soon be commercially available in the US. Two leading European electrophysiology centers have been building successful clinical experience using this catheter to treat atrial cardiac arrhythmias.
The 8mm catheter significantly expands electrophysiology applications for the Stereotaxis Magnetic Navigation system by providing physicians the ability to deliver high power ablations for the treatment of atrial arrhythmias. Atrial flutter, a common atrial arrhythmia estimated to represent 25% of the over 400,000 ablation procedures performed worldwide each year, is routinely treated with 8mm catheters.
Successful European cases have been completed at San Raffaele University Hospital in Milan, Italy and the Hanseatic Heart Center/St. Georg, Hamburg, Germany.
The 8mm catheter has been used at San Raffaele University Hospital for the treatment of atrial fibrillation. “The 8mm catheter is an important step toward improving the effectiveness and efficiency of atrial fibrillation procedures. The power of the 8mm catheter, combined with the safety of precise and soft contact in critical areas of the heart, simplifies the treatment of complex atrial arrhytmias,” said Professor Carlo Pappone, MD PhD, FACC, Director of the Arrhythmology Department.
Cases performed with the 8mm catheter have been very successful at the Hanseatic Heart Center/St Georg. “The catheter allows us to deliver increased power and has been extremely effective during our preliminary experience in patients with atrial flutter,” said Dr. Sabine Ernst MD. “We look forward to continue clinical ablation procedures with this catheter.”
Bevil Hogg, CEO of Stereotaxis, stated, “We are very excited about the completion of these important milestones. US regulatory approval of the 8mm catheter for ablation, combined with successful clinical experience in Europe, dramatically increases the clinical applications of magnetic navigation for complex EP procedures. We look forward to further increasing clinical utilization with the expected release later this year of the irrigated magnetic catheter, which has been submitted for European and FDA regulatory review.”
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 Stereotaxis 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. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe and Canada.
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, competitive factors, changes in government reimbursement procedures, dependence upon third-party vendors, 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 we will recognize revenue related to our 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 our control. In addition, these orders and commitments may be revised, modified or canceled, either by their express terms, as a result of negotiations, or by project changes or delays.
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