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) |
February 7, 2006 |
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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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 Feburary 7, 2006, Biosense Webster, Inc. announced that it had received approval from the U.S. Food and Drug Administration (FDA) for the use of the NAVISTAR® RMT Diagnostic/Ablation Steerable Tip Catheter with the Niobe® Magnetic Navigation System, designed by Stereotaxis, Inc., and the CARTO™ RMT system from Biosense Webster, Inc. A copy of the press release 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 |
Biosense Webster, Inc. Press Release dated February 7, 2006. |
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: February 7, 2006 |
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 |
Biosense Webster, Inc. Press Release dated February 7, 2006. |
Exhibit 99.1
Biosense Webster, Inc. |
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3333 Diamond Canyon Rd. |
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News Release |
FOR IMMEDIATE RELEASE |
Contact:
Kim Thompson
Biosense Webster, Inc.
(909) 839-8553
E-mail: kthomps5@bwius.jnj.com
www.biosensewebster.com
BIOSENSE WEBSTER RECEIVES FDA APPROVAL FOR TECHNOLOGY
TO TREAT PATIENTS WITH HEART RHYTHM DISEASE
Navigation System and Catheters Integrate with Stereotaxis
Automated Technology for Treatment of Cardiac Arrhythmias
Diamond Bar, CA – February 7, 2006 – The U.S. Food and Drug Administration (FDA) today approved an innovative combination of technologies that will enhance a doctors’ ability to treat patients with abnormal heart rhythms (cardiac arrhythmias). The approval results in the first and only commercially available products for use during cardiac radiofrequency ablation with the Niobe® Magnetic Navigation System, designed by Stereotaxis, Inc. and the CARTO™ RMT System from Biosense Webster, Inc. Cardiac radiofrequency ablation is a non-surgical procedure during which a catheter delivers energy to damaged heart tissue to restore normal heart rhythms. Cardiac arrhythmias affect millions of people nationwide.
The FDA approval covers the use of the NAVISTAR® RMT Diagnostic/Ablation Steerable Tip Catheter with the Niobe® System. Biosense Webster offers the only products that work with the Stereotaxis system to enable electrophysiologists (doctors that treat the heart’s electrical system) to steer a catheter remotely, map the electrical activity of the heart, and ablate targeted areas that require treatment.
This technology has been used in Europe with extensive experience at San Raffaele University Hospital in Milan, Italy. “Our center has performed over 100 procedures using the combined technology of the NAVISTAR® RMT Catheter and the Niobe® System,” said Carlo Pappone, MD, PhD, FACC, Director of the Arrhythmology Department. “It is a true breakthrough technology as one can, for the first time, perform the procedure from a remote location, such as the control room.”
Biosense Webster President Roy Tanaka commented, “Since its inception, Biosense Webster has partnered with the electrophysiology community to set new standards for developing innovating products and treating patients with heart rhythm disease. The enhancements to patient care afforded by these FDA approvals are gratifying and represent the next chapter in our product development and partnering that will benefit patients and doctors now and well into the future.”
NAVISTAR® RMT Catheter can only be used with CARTO™ RMT Navigation System.
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BIOSENSE WEBSTER RECEIVES FDA APPROVALS FOR TECHNOLOGY
TO TREAT PATIENTS WITH HEART RHYTHM DISEASE
“This is good news for doctors and patients. By integrating Biosense Webster’s navigation system and catheters with Stereotaxis’ Niobe system, we get leading diagnostic and ablation technology combined with an automated mapping and steering system, resulting in greater ability to treat a broad range of patients, including the most complex cases,” said Gery F. Tomassoni, MD, Director, Central Baptist Hospital Cardiac Research, Lexington, Kentucky.
In October 2005, Biosense Webster received FDA clearance for the CARTO™ RMT Navigation System and NAVISTAR® RMT Catheter to be integrated with the Niobe® Navigation technology from Stereotaxis. In addition, the company received clearance for the REFSTAR™ RMT Catheter which provides a reliable reference point within the CARTO™ RMT System to ensure an accurate visual framework for mapping diagnostic procedures.
About Biosense Webster
Biosense Webster Inc, a Johnson & Johnson Company, pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems, Biosense Webster’s technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the CARTOMERGE™ Image Integration Software Module, the THERMOCOOL(r) Irrigated Tip Catheter and the LASSO® Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.
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