Healthcare Industry News:  Renal Ablation 

Devices Oncology

 News Release - July 26, 2006

Cryoablation Studies Published in July Supplement to Journal UROLOGY Demonstrate Effectiveness of Treatment for Kidney Cancer

First Five-Year Data Shows Survival Rate of 100 Percent

IRVINE, Calif., July 26 (HSMN NewsFeed) -- 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 that six studies and papers demonstrating the effectiveness of cryoablation for treating kidney, or renal, cancer were published in a supplement to the July 2006 UROLOGY journal. The studies also help show that renal cryoablation, which involves freezing and destroying the diseased tissue using an Endocare cryoablation device, is a less invasive treatment option than the standard surgical procedure, which involves full or partial removal of the affected kidney, and generally results in less morbidity, faster recovery and fewer complications. It is estimated that over 30,000 renal tumors will be diagnosed each year in the U.S.

Taken as a whole, the six published papers, which include 379 patients and comparisons between cryoablation and other ablative treatments, show that cryoablation can be a safe and effective treatment for renal cancer with few serious complications and can be repeated if the disease reoccurs. The physicians participating in the papers come from a variety of the country's leading medical institutions including the Cleveland Clinic, Johns Hopkins, UCI Medical Center and Hahnemann University Hospital, among others.

"It has already been well documented that cryoablation is an effective treatment for prostate cancer, but these studies and papers show that a growing number of physicians from some of the leading medical institutions are using our tumor-freezing technology for the ablation of renal cancers as well," said Craig T. Davenport, Chairman and Chief Executive Officer of Endocare. "This is further evidence that the advances we have made in targeting the tumors throughout the body and accurately destroying the diseased tissue without damaging surrounding healthy tissue are providing better outcomes for patients battling the often deadly effects of cancer."

A brief synopsis of the studies includes:

* Long-Term Results of Cryoablation for Renal Cancer and Complex Renal Masses by Patrick E. Davol, Brant R. Fulmer and Daniel B. Rukstalis. The first ever five-year study of 48 patients (with a median follow-up of 64 months) showed a cancer specific survival rate of 100 percent and no major complications. Persistent disease was noted in 6 of the patients (12.5 percent). After a repeat procedure, 5 of the 6 now show no evidence of disease yielding a 97.5 percent cancer free survival rate for all patients in the study. The paper concludes: "Our clinical experience validates the use of both open and laparoscopic cryoablation procedures in the treatment of kidney cancer."

* Probe-Ablative Nephron-Sparing Surgery: Cryoablation versus Radiofrequency Ablation by Nicholas J. Hegarty, Inderbir S. Gill, Mihir M. Desai, Erick M. Remer, Charles M. O'Malley and Jihad H. Kaouk. A 246-patient study comparing the outcomes of laparoscopic cryoablation and percutaneous radiofrequency ablation (RF) of patients at the Cleveland Clinic showed no difference in terms of morbidities, which were minimal for both procedures, or impact on renal function. The most significant finding was the recurrence rate for cryoablation was only 1.8 percent compared to 11.1 percent for RF.

* Cryoablation of Small Peripheral Renal Masses: A Retrospective Analysis by Bradley F. Schwartz, John C. Rewcastle, Timothy Powell, Christopher Whelan, Ted Manny, Jr., and J. Clifton Vestal. In a study of 85 patients with a mean follow-up of 15 months, enhancement was seen for 2.4 percent of the patients and biopsy-confirmed recurrence was observed in 1.2 percent. Although follow-up was relatively short, short-term results are indicative of long-term efficacy because it has been documented that the median time to failure is only 12 months.

* Percutaneous Renal Cryoablation by Sompol Permpongkosol, Matthew E. Nielsen and Stephen B. Solomon. This article reviews the evolution of cryoablation and offers promising results for percutaneous cryoablation in terms of both efficacy and morbidity. The cost effectiveness of the procedure was also cited and longer term outcomes noted as key to defining the role of CT-guided percutaneous renal cryoablation.

* Review of Minimally Invasive Renal Therapies: Needle-Based and Extracorporeal by Leslie A. Deane and Ralph V. Clayman. In a review of the different approaches to Renal Ablation, the paper shows that cryoablation and radiofrequency offer the most potential.

* Cryotherapy: Clinical End Points and Their Experimental Foundations by Jihad H. Kaouk, Monish Aron, John C. Rewcastle and Inderbir S. Gill. In a review of the cryobiologic foundation upon which renal cryoablation is built and the interactions of ice and tissue, this paper notes that cryoablation has minimal impact on renal function and does not damage the collecting system.

About Endocare

Endocare, Inc. -- -- is an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation. Endocare has initially concentrated on developing technologies for the treatment of prostate cancer and believes that its proprietary technologies have broad applications across a number of markets, including the ablation of tumors in the kidney, lung and liver.

Statements contained in this release that are not historical facts are forward-looking statements that involve risks and uncertainties. Among the important factors which could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, those discussed in "Risk Factors" in the Company's Forms 10-K, Forms 10-Q, and other filings with the Securities and Exchange Commission. Such risk factors include, but are not limited to: uncertainty regarding the Company's liquidity and ability to reach and maintain profitability; the risk that the Company may be required to make state and local tax payments that exceed the Company's settlement estimates; uncertainty regarding the Company's re-listing on a national stock exchange; uncertainty regarding the effects of effectuating the Company's proposed reverse stock split, in particular the possibility that the market may react negatively to the Company's effectuation of a reverse stock split; uncertainty regarding market acceptance of the Company's products; uncertainty of product development and the associated risks related to clinical trials; uncertainty relating to third party reimbursement; uncertainty regarding the ability to convince health care professionals and third party payers of the medical and economic benefits of the Company's products; the Company's limited sales, marketing and manufacturing experience; uncertainty regarding the ability to attract and retain key personnel; uncertainty regarding the ability to secure and protect intellectual property rights relating to the Company's technology; the rapid pace of technological change in the Company's industry; fluctuations in the Company's order levels; and the risk that the Company may be subject to civil and criminal liability in the future if it is found to have violated the terms of the Company's recent settlements with the Securities and Exchange Commission and the Department of Justice. The actual results that the Company achieves may differ materially from any forward-looking statements due to such risks and uncertainties. The Company undertakes no obligation to revise, or update publicly, any forward-looking statements for any reason.

Source: Endocare

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