EP MedSystems Announces FDA Market Clearance
for New EP-4 Cardiac Stimulation System
WEST BERLIN, N.J.--(BUSINESS WIRE)--March 4, 2004--EP MedSystems, Inc. (NASDAQ: EPMD - News), a market leader in electrophysiology products used to diagnose and treat certain types of cardiac rhythm disorders, today announced the FDA market clearance for its new EP-4(TM) Computerized Cardiac Stimulator. The EP-4 offers further advancements in cardiac stimulation, which is an essential component of nearly all electrophysiology ("EP") procedures to diagnose and treat certain cardiac rhythm disorders. EP MedSystems also has received regulatory approval from its European Notified Body for the EP-4, allowing the sale of the EP-4 into the European Community.
The EP-4(TM) Computerized Cardiac Stimulator includes several features unique in the EP industry, consisting of a touch screen portable PC controlling a two or four channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings. The EP-4's four channel constant current output provides increased versatility for site pacing and emergency backup pacing. The system is also compatible with the majority of the industry's EP recording systems.
Reinhard Schmidt, President and CEO of EP MedSystems commented: "We are very pleased to announce the EP-4 FDA market clearance. The EP-4 offers features that are unique in the EP industry, and will benefit patients, EP lab personnel and healthcare institutions alike and is a platform for expanded capabilities in the near future. With the EP-4, EP MedSystems continues in its promise to bring innovation to the fields of cardiology and electrophysiology." About EP MedSystems:
EP MedSystems develops and markets cardiac electrophysiology ("EP") products used to diagnose and treat certain cardiac rhythm disorders. The Company's EP product line includes the EP-WorkMate® Electrophysiology Workstation with RPM(TM) Real-time Position Management(TM) navigation technology, the EP-4(TM) Computerized Cardiac Stimulator, fixed and deflectable diagnostic electrophysiology catheters and related disposable supplies, the ALERT® System and ALERT family of internal cardioversion catheters, and the ViewMate® intracardiac ultrasound catheter imaging. For more information, visit our Website at www.epmedsystems.com.
Forward Looking Statements:
This Release may contain certain statements of a forward-looking nature relating to future events or the future financial performance of the Company. Forward-looking statements include information concerning our possible or assumed future results of operations and statements preceded by, followed by or including the words "believes", "expects", "anticipates", "intends", "plans", "estimates", "see opportunities" or similar expressions. Such forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such forward-looking statements are only predictions and are subject to risks and uncertainties that could cause actual results or events to differ materially and adversely from the events discussed in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, EP MedSystems' history of losses, uncertainty of market acceptance of our products and level of sales, uncertainty of future profitability and future liquidity needs, possible costs, fines or penalties that may be incurred in connection with government inquiries and investigations and risks regarding regulatory approvals and demand for new and existing products, as stated in the Company's Annual Report filed on Form 10-KSB and quarterly reports filed on Form 10-Q and 10-QSB.
EP MedSystems cautions investors and others to review the cautionary statements set forth in this press release and in EP MedSystems' reports filed with the Securities and Exchange Commission and cautions that other factors may prove to be important in affecting the EP MedSystems' business and results of operations. Readers are cautioned not to place undue reliance on this press release and other forward-looking statements, which speak only as of the date of this release. EP MedSystems undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date of this report or to reflect the occurrence of unanticipated events. For Further Information Contact: EP MedSystems, Inc.
Matthew C. Hill
(856)753-8533
Investor Relations Firm:
MKR Group, LLC
Charles Messman, Todd Kehrli
(818)556-3700
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