EP MedSystems Files Alert System IDE With FDA

Business Wire, August 21, 1997

BUDD LAKE, N.J.--(BUSINESS WIRE)--Aug. 21, 1997--

New Device May Minimize Health Risks Associated With Prolonged

Atrial Fibrillation

EP MedSystems Inc. today announced that it has filed an application for an Investigational Device Exemption ("IDE") with the Food and Drug Administration ("FDA").

Upon receipt of FDA approval of the IDE submission, the company expects to begin US clinical trials of the ALERT System. The ALERT System uses a proprietary catheter to deliver low energy electrical impulses directly to the inside of the heart in order to convert atrial fibrillation to a normal heart rhythm.

The company hopes that "clinical trials can begin later this year and may be concluded within the first half of 1998," stated David A. Jenkins, president and chief executive officer of EP MedSystems.

Jenkins continued, "We have developed a state of the art system in terms of supplying both a proprietary catheter and the accompanying ALERT Companion hardware, the device which delivers the defribillation current to the patient via the catheter."

EP MedSystems estimates that there are close to 2 million people in the US with atrial fibrillation, a disease associated with reduced cardiac output and strokes.

"We are convinced that the ALERT System will offer the physician a new and effective tool in minimizing the health risks associated with prolonged episodes of atrial fibrillation. We look forward to beginning the clinical trials," Jenkins concluded.

EP MedSystems develops and markets a full line of cardiac electrophysiology ("EP") products used to diagnose, monitor and treat certain cardiac disorders. The company's EP product line includes the EP WorkMate(TM) computerized electrophysiology workstation, the EP-3(TM) computerized electrophysiology stimulator and a broad line of EP catheters. -0- Cautionary statement under the "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995: This release contains certain statements of a forward looking nature relating to future events or the future financial performance of the company. 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 results discussed in the forward-looking statements. The words "believe", "expect", "anticipate", and similar expressions identify forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks regarding the success of new product developments, clinical results and government regulation as well as those discussed in the company's 10-KSB and Forms 10-QSB filed with the SEC. Readers are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this report. 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 anticipated events.

CONTACT: EP MedSystems Inc., Budd Lake

James J. Caruso, 201/691-6400