EPMD EP Medsystems (MM)

EP MedSystems, Inc. (NASDAQ: EPMD) today announced its intention to expand the market for its ALERT(R) product platform with the submission of the ALERT(R) CS/RA premarket approval supplement to the Food and Drug Administration. The ALERT(R) CS/RA Catheter System replaces existing electrophysiology catheters, allowing the EP physician to not only perform routine diagnostic procedures with the patented CS/RA, but also easily cardiovert atrial fibrillation to normal heart rhythm during the procedure. The ALERT(R) CS/RA Catheter System offers the advantage to cardiovert internally, via the catheter itself, without the need to interrupt the procedure for external cardioversion or the side effects associated with the use of an external defibrillator. The ALERT(R) CS/RA Catheter System consists of a family of catheters to be used during an electrophysiology procedure to treat certain arrhythmias, including atrial fibrillation. The catheters are placed in the coronary sinus vessel and the right atrium to allow the physician to pace, record and cardiovert the heart. Cardioversion is a method whereby an electric shock is delivered to convert an abnormal rhythm to a normal rhythm of the heart. The ALERT(R) CS/RA Catheters are used in conjunction with the ALERT(R) Companion, a bi-phasic energy source manufactured and marketed by EP MedSystems. Over 135 ALERT(R) Companion devices are already in use in Europe and the United States with over 4000 of the PA ALERT(R) Catheters used to treat atrial fibrillation Atrial fibrillation is an irregular rhythm of the heart affecting millions of people worldwide and is one of the leading causes of strokes in the United States. Reinhard Schmidt, President and CEO of EP MedSystems, commented: "We are very excited about this submittal as it represents yet another milestone for EP MedSystems. These catheters represent additional product to expand the use of our existing ALERT(R) platform and we anticipate the launch in the United States during the first quarter of next year. We believe these new consumables have the potential to be used in a significant number of the over 400,000 cardiac electrophysiology procedures performed worldwide each year. We are quite excited over the growth potential of these new multi use products and look forward to their launch." 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(R) 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(R) System and ALERT family of internal cardioversion catheters, and the ViewMate(R) intracardiac ultrasound catheter imaging system. 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", 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; 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 Form 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.