Endocare Inc announced that the U.S. Food and Drug Administration (FDA) has granted the Company 510(k) clearance to market its new Cryocare CS system. This breakthrough system provides physicians an easy-to-use, flexible and more precise minimally invasive treatment for all forms of localized prostate cancer by integrating into one system the most advanced components of cryoablation, including the availability of an integrated biplane ultrasound system with precise color Doppler visualization. First shipments are expected to begin in the fourth quarter of 2003.

Cryocare CS will make targeted cryoablation of the prostate (TCAP) easier and faster for physicians to learn and safer and more cost effective to perform, said William J. Nydam, President of Endocare. The new system, an inclusive combination of all the recent significant technical and procedural advances in cryoablation, will help to further accelerate the growth of cryoablation as a safe, effective and repeatable therapy for all types of localized prostate cancer from the lowest risk to the highest risk patients.

"Cryocare CS is the culmination of everything we have learned about cryoablation in the past decade, including customizing the procedure for the individual patient, placing the cryoprobes properly within the prostate with the aid of integrated ultrasound visualization and freezing the cancer precisely-all in one system," Nydam said. "Cryocare CS brings cryoablation squarely into the next generation of minimally invasive prostate cancer treatments and allows us to offer a product that is user friendly, cost effective and precise for the physician while also providing the most advanced treatment for the patient."

In addition to the integrated ultrasound system, which simplifies the procedure and reduces the overall cost outlay for the technology, Cryocare CS also incorporates the Company's automated freezing system, AutoFreeze. With AutoFreeze, physicians can utilize a precise, computer-operated temperature control technology that, along with a new onboard urethral warming system, helps ensure effective freezing of the prostate without compromising sensitive adjacent healthy tissues such as the external sphincter, urethra and rectum.