New Patient Database Enables Presentation Of Safety, Efficacy Data For Cryoablation

Endocare, Inc. (OTC Bulletin Board: ENDO), an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation, announced today promising results gathered from a new, extensive database of patients who have chosen cryoablation as their treatment for prostate cancer. J. Stephen Jones, M.D., Vice Chairman, Glickman Urological Institute of Cleveland Clinic, presented the results at the recent national meeting of the Society of Urologic Oncology.

Dr. Jones is the coordinating principle investigator of the database, called the Cryo On-Line Database (COLD). It is the largest database of cryoablation patients ever compiled and is based on an Institutional Review Board (IRB) approved protocol. The data in his presentation were based on the first 1,002 patients in the COLD registry who underwent cryoablation as a primary treatment for prostate cancer. The registry now contains data from more than 2,000 patients from across the U.S.

The average age of the patients in the Society of Urologic Oncology presentation was 70.4 years and they were followed for up to 10 years. The biochemical survival rate of all patients was 76.1 percent with 84 percent of low risk patients, 70.5 percent of moderate risk patients and 71.7 percent of high risk patients showing no biochemical (PSA) evidence of disease recurrence five years following treatment. The positive biopsy rate was 5.9 percent and the incontinence rates at six and 12 months were 4.5 percent and 2.0 percent, respectively.

“These are encouraging results and should help to continue to build the growing acceptance of cryoablation as a primary treatment for prostate cancer patients,” Dr. Jones said. “Furthermore, while attending the meeting I found a significant growth in interest not only in cryoablation, but in the COLD registry. Many physicians I have spoken to who perform cryoablation expressed a desire to add their patient data to the registry. With any form of cancer therapy, data on large numbers of patients with at least five year survival information are crucial to widespread adoption. We are building a very important resource of information that greatly improves our understanding of cryotherapy outcomes, and now demonstrates that this minimally invasive treatment should be seriously considered as an option for increasing numbers of patients diagnosed with localized prostate cancer.”

“We are confident that the COLD registry will prove to be a valuable tool to demonstrate the effectiveness of cryoablation,” said Craig T. Davenport, Chairman, Chief Executive Officer and President of Endocare. “The data collection is ongoing and we expect to have 5,000 patients in the database in the near future. We believe this will offer us important clinical information including longer term follow-up of both morbidity and disease control and we look forward to presenting this information to the medical community.”

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