PRORHYTHM GETS EUROPEAN CE MARK FOR HIFU ABLATION.

ProRhythm, Inc., Ronkonkoma, N.Y., a developer and manufacturer of medical devices for the treatment of atrial fibrillation (AF) has received the European CE Mark for its High Intensity Focused Ultrasound (HIFU) Ablation System for the treatment of AF. The CE Mark certification allows ProRhythm to begin marketing its system throughout the European Union.

ProRhythm's proprietary balloon catheter to treat tissue in the left atrium of the heart is used in an AF ablation procedure commonly called pulmonary vein isolation. The HIFU balloon is inserted through a vein in the leg of the patient and advanced into the left atrium. Controlled, discrete ablation lesions around the pulmonary veins, created with the HIFU catheter and controlled by ProRhythm's proprietary automated system, stop unwanted electrical impulses from disrupting the heart's normal rhythm.

Unlike other energy forms used for this procedure, HIFU energy is non-thrombogenic and is "focused" in order to create transmural lesions within the myocardium. European clinical trials have demonstrated that a significant percentage of patients undergoing the HIFU ablation procedure have experienced a complete elimination of AF episodes with a single treatment procedure.

The HIFU system will be marketed through ProRhythm's exclusive distributor for Europe, SJM International, Inc., a subsidiary of St. Jude Medical, Inc.

"I am very pleased with the results of our clinical trial and look forward to the next stage of market development activities and European sales of the HIFU Ablation System," said Reinhard Warnking, president and CEO of ProRhythm. "We have long been convinced that HIFU is the ideal energy for the treatment of atrial fibrillation. Our HIFU technology, along with St. Jude Medical's strong sales and distribution capabilities, provide us with the potential to establish HIFU as the standard of care for catheter-based treatment of atrial fibrillation, providing a permanent cure to patients that suffer from this debilitating disease."

Prof. Karl-Heinz Kuck, of St. Georg Hospital in Hamburg, Germany, who acted as the principal investigator for the European clinical study stated, "Our clinical experience with the HIFU System has demonstrated the ability of HIFU to isolate pulmonary veins and reduce or eliminate atrial fibrillation. The HIFU Ablation System provides the clinician with a promising tool to treat patients who suffer from atrial fibrillation."

About ProRhythm

Since 1997, ProRhythm has pioneered the application of HIFU to advance the minimally invasive treatment of complex medical conditions. In recent years ProRhythm has concentrated its efforts on the development of HIFU for the treatment of a debilitating arrhythmia, atrial fibrillation (AF). AF is an uncontrollable, rapid, heartbeat that results in a significant decline in the quality of life and may lead to serious complications. Globally, in excess of 6 million people are afflicted with AF and the current treatment options are expensive, often inadequate and non-curative, as with the case of drug therapy.

ProRhythm's HIFU system is currently under investigation in clinical trials in the United States to treat AF. ProRhythm believes that its technology may eventually play a significant role in improving the lives of countless individuals who are afflicted by atrial fibrillation.

For more information, visit http://www.prorhythm.com or call 631/689-2002, ext. 34.