Category: Uncategorized
March 7, 2003

News Release: Freezor(TM) Catheter Recommended For Approval By FDA Expert Panel

CryoCath Technologies Inc., the global leader in cryotherapy products to treat cardiovascular disease, announced that late yesterday its

Freezor(TM) Cryoablation System was recommended for approval to treat AtrioVentricular Node Reentry Tachycardia (AVNRT), currently the most prevalently ablated cardiac arrhythmia, by the Food and Drug Administration's (FDA) Circulatory System Devices Panel. 'This positive panel recommendation is an outstanding result for our Company and brings us significantly closer to launching Freezor into the lucrative U.S. market,'said Steven G. Arless, President & CEO of CryoCath. 'Upon ultimate FDA approval, Freezor will become a profitable and solid addition to our growing U.S. base of operations as we continue to build a dominant global franchise in cardiac ablation.'

The approval came with four reasonable panel conditions, all acceptable to the Company and which have no material impact on the Company's timetable to introduce Freezor in the U.S. or alters its expectations for revenue growth.

This recommendation will be given strong consideration by the FDA in its final review of CryoCath's pre-market approval (PMA) application. A final FDA decision is expected some time before the end of June 2003. If positive, CryoCath will be in a position to launch Freezor in the U.S. in the second half of 2003 as originally planned. Of historical note, upon approval, CryoCath will become the first Canadian company ever to receive a full PMA approval for a therapeutic medical device.

'We believe the panel's decision was based on the strength of the Company's presentation that not only confirmed Freezor's safety and efficacy but, moreover, clearly articulated the device's innovative clinical utility for practicing electrophysiologists,'said Jean-Pierre Desmarais, Vice President Scientific Affairs of CryoCath.

AVNRT's represent almost two thirds of all current ablations, approximating 70,000 annual ablation procedures in the U.S., representing a US$70 million market opportunity for Freezor in this initial indication alone.

'Most impressively, in these 103 AVNRT procedures in this trial and consistent with the more than 600 reported procedures across Europe and elsewhere, Freezor has not resulted in a single case of heart block, which routinely occurs in 1-4% of AVNRT's ablated with RF catheters,'said co-principal investigators Drs. Marc Dubuc of the Montreal Heart Institute and Peter Friedman of Brigham & Women's Hospital. 'This fundamental safety advantage underlies Freezor's clinical utility and we believe make it ideally suited to more safely ablate as many as 50% of all currently performed cardiac ablations.'

Freezor(TM) is a flexible, single use, minimally invasive cryoablation catheter specifically designed to create focal lesions to treat high-risk arrhythmias near the AV node where precision is of critical importance. Freezor(TM) can reach temperatures at its tip as low as -80 degrees C inside a beating heart.

Freezor will be the second ablation device CryoCath launches in the U.S. In 2002, the Company launched a surgical tool, SurgiFrost, to ablate cardiac arrhythmias. A growing sales team that has already been on the ground building awareness of the Company and its products for more than a year will support Freezor's launch. There are approximately 800 centers that could routinely use the Freezor Cryoablation System.

The Company will be hosting a conference call to discuss the panel meeting on Friday, March 7 at 8:30 a.m. EST. The call will be audio-cast live and archived for 90 days at www.financialdisclosure.ca and www.cryocath.com.

About CryoCath(R)

CryoCath - www.cryocath.com - is a medical technology company that leads the world in creating minimally invasive, catheter-based cryotherapy products to treat cardiovascular disease across three broad indications: tachyarrhythmia (CryoCath's primary focus), ischemia and restenosis. CryoCath has already successfully launched its first product, the Freezor(R) CryoAblation System in Europe and is developing additional products to expand its pipeline of products to treat tachyarrhythmia. CryoCath expects to achieve U.S. commercialization for Freezor in 2003. As well, it co-developed and is now globally launching the SurgiFrost(TM) CryoSurgical Probe System to treat cardiac arrhythmias.

This press release includes 'forward looking statements'that are subject to risks and uncertainties. For information identifying legislative or regulatory, economic, climatic, currency, technological, competitive and other important factors that could cause actual results to differ materially from those anticipated in the forward looking statements, see CryoCath's Annual Report under the heading Risks and Uncertainties in the Management's Discussion and Analysis section.

CONTACT: TEL: (514) 694-1212 ext. 224 Steven G. Arless, President & CEO,

CryoCath Technologies Inc.

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Internet: www.cryocath.com

TEL: (416) 815-0700 ext. 231 Mike Polonsky, Investor Relations

FAX: (416) 815-0080

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