Medical Device Link.

Originally Published MX January/February 2006

MARKET ANALYSIS

Although cryoablation products currently represent only a small fraction of the total energy-based surgical product market, recent reports on the technique's safety and its potential entry into new lucrative markets indicate a sector that is ready to grow in 2006 and beyond.

Cryoablation, reported to be the fastest-growing minimally invasive option for treating prostate cancer, continues to play an increasingly significant role in the overall U.S. tumor ablation systems market. And, due to its safety profile, cryoablation is expected to extend its reach in cardiac applications as well.

"Cryogenic energy, or the extreme absence of heat, is expected to enjoy growth rates in excess of 20% over the next 10 years," says Patrick Driscoll, president of MedMarket Diligence LLC (Foothill Ranch, CA). "This is an attractive modality as it is relatively safe. Cryoablation may eliminate many of the problems seen with heat-related ablation therapies, as cooling does not seem to cause extracellular matrix changes or damage surrounding tissue, which may lower collateral complications. The clinical experience with cryoablation has so far been very positive with few side effects."

In 2003, cryogenic therapy products, with a U.S. market size of about $39 million, represented about 0.5% of the overall $8 billion energy-based ablation product market in the United States. While the overall cryogenic product market is expected to see a compound annual growth rate (CAGR) of about 21%, cryosurgery applications within the tumor ablation systems market are expected to see a CAGR of about 27% through 2013. At this rate, cryosurgery applications for tumor ablation will grow from their $18 million U.S. footprint in 2003 to close to $200 million within the next decade.¹

In addition to the cancer market, cryogenic modalities are expected to see significant growth in the cardiovascular market as well. CryoCor Inc. (San Diego), a medical device company that develops cryogenic technology to treat cardiac arrhythmias, has been receiving favorable attention from analysts in recent months due to its expected entry into the atrial flutter and atrial fibrillation markets in the United States. Atrial flutter and atrial fibrillation represent two of the most common yet difficult-to-treat arrhythmias.

Although CryoCor will be facing crucial U.S. regulatory approvals over the next few years, analysts report that preliminary data show promise for cryoablation as a safe and effective treatment for both types of arrhythmia. Furthermore, analysts note that the company has a significant head start over its competitors in targeting these potentially significant niches.

CryoCor has submitted the final module of its premarket approval (PMA) application for atrial flutter and hopes to receive FDA approval in 2006. The company is currently enrolling patients in its atrial fibrillation clinical trial in the United States, and analysts report the company could enter this market in 2008. The majority of products currently being used or developed for treatment of atrial fibrillation are ultrasonic or radio-frequency-based devices (see table).

"The potential to treat atrial fibrillation safely with cryoablation is a tremendous growth opportunity," says Greg Tibbits, CryoCor's chief financial officer. "Ablation of atrial fibrillation with heat-based devices has resulted in reports of moderate to severe complications, none of which have been seen with cryoablation. We believe a safe and effective treatment for atrial fibrillation is one of the most sought-after treatments in the cardiovascular space."

Reference

1. Trends and Opportunities in the U.S. Markets for Ablation Technologies and Other Energy-Based Therapies (Foothill Ranch, CA: MedMarket Diligence, 2004).

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