EP MedSystems Announces Japanese Regulatory Clearance for EP-4 Computerized Cardiac Stimulator.

WEST BERLIN, N.J. -- EP MedSystems, Inc. (NASDAQ: EPMD), a market leader in electrophysiology products used in cardiac rhythm management, today announced it has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its EP-4(TM) Computerized Cardiac Stimulator. With this clearance, EP MedSystems can now market and distribute the EP-4(TM) in Japan.

Similar to the U.S. Food and Drug Administration (FDA), Japanese law dictates that all medical device manufacturers register their products with the MHLW, which is responsible for maintaining strict quality standards for these products. The Company has already received regulatory approval to market this product in the United States and Europe.

The EP-4(TM) Computerized Cardiac Stimulator is among the most technologically advanced in cardiac stimulation, an essential component of nearly all electrophysiology ("EP") procedures to diagnose and treat certain cardiac rhythm disorders. The EP-4(TM) includes several features unique in the EP industry and consists of a touch screen portable PC controlling the 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(TM)'s four channel output options provide increased versatility for site pacing and emergency backup pacing. The system is integrated with the Company's EP-WorkMate(R), as well as other diagnostic technologies used in the monitoring and diagnosis of arrhythmias in the heart.

Reinhard Schmidt, President and CEO of EP MedSystems commented: "I am very excited to announce the Japanese Shonin approval of our EP-4 Stimulator. This is one of the most sophisticated stimulators on the market today and will be the first dual output stimulator to gain approval in Japan, as it was in the U.S. EP MedSystems remains committed to providing high-quality, cost effective EP products to the most demanding EP physicians all over the World, and we look forward to seeing the EP-4 stimulator add value for Japanese cardiac patients, healthcare institutions and the Japanese EP industry in general.

Mr. Schmidt continued, "Japan represents a significant market opportunity for us in our overall global sales strategy, and this approval will allow us to begin capitalizing on this international distribution opportunity immediately both in new sales with and in leveraging our considerable install base with upgrades. We already have commitments from our Japanese distributor for the new EP-4 product bundled with its integration into the Workmate(R) recording system in excess of $1 million for the current fiscal year, which would exceed our total 2004 revenue from all of Asia. We are pleased that we can bring the newest innovation in cardiac care to the Japanese market," concluded Mr. Schmidt.

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.

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 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.