Healthcare Industry News:  cryoablation 

Devices Oncology Urology

 News Release - May 22, 2007

First Randomized Head-to-Head Study Shows Cryoablation at Least as Effective as External Beam Radiation for Treating Localized Prostate Cancer

Data From Randomized Trial, Plus 12 Other Clinical Studies on cryoablation to Be Presented at National Urological Conference

IRVINE, Calif., May 22 (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 a randomized clinical trial of 244 men with localized prostate cancer demonstrated that cryoablation, a minimally invasive method of freezing cancerous tumors to destroy them, is at least as effective as external beam radiation when used to treat localized prostate cancer. The trial is the first North American randomized clinical trial comparing two definitive prostate cancer treatments in the past 25 years to enroll more than 100 patients. In addition, it is one of 13 studies of the use of cryoablation for treating prostate and renal cancer scheduled to be presented this week at the American Urological Association (AUA) Annual Meeting that runs from May 19-24 at the Anaheim Convention Center in Anaheim, CA.

The head-to-head trial, led by Bryan J. Donnelly, M.D., a urologist at the University of Calgary, also showed that after 36 months, only 6.6 percent of the cryoablation patients had positive biopsy findings compared to 26.3 percent of the patients who underwent the radiation therapy.

"This study demonstrates that cryoablation is equivalent to external beam radiation when used to treat localized prostate cancer," said Dr. Donnelly, who presented the study at the conference. "Furthermore, the positive biopsy rates three years after treatment were significantly higher for patients who underwent radiation therapy. A positive biopsy alerts a physician to recurrent or residual disease within the prostate and indicates that additional treatment may be necessary. Like radiation therapy, cryoablation is a treatment option that should be considered by all patients who are diagnosed with localized prostate cancer."

Jay Fahrer, a spokesman for the Washington, D.C.-based Men's Health Network, a non-profit group of health professionals committed to improving the health and wellness of men, applauded the use of head-to-head, randomized studies of cancer treatment options.

"The decision that men face when diagnosed with prostate cancer is extremely difficult. This is largely because of the absence of studies directly comparing different treatment options. This landmark study settles the question of whether or not cryoablation is as effective as radiation therapy and solidifies its role as a primary treatment for prostate cancer. It is a much needed milestone in the collection of high-quality information regarding prostate cancer treatments and men's health choices," Fahrer said.

Other studies to be presented at the AUA were conducted by leading physicians from The Cleveland Clinic, MD Anderson Cancer Center, UC San Francisco Medical Center, Columbia University and other prestigious health care facilities. The studies include:

* Primary Prostate cryoablation: Results from 1,198 Patients Tracked with the COLD Registry: A retrospective study of 1,198 patients with an average age of 69 pooled from data of 27 physicians with a median follow-up of 25 months. The cryoablation patients had a positive biopsy rate of 6.8 percent, an ASTRO biochemical failure rate of 22.9 percent after five years, an incontinence rate of 2.9 percent and a fistula rate of 0.04 percent. The COLD Registry (also called the Cryo On-Line Database) is the largest database of cryoablation patients ever compiled and is based on an Institutional Review Board (IRB) approved protocol. J. Stephen Jones, M.D. of the Cleveland Clinic is the lead investigator.

* Salvage cryoablation for Recurrent Localized Prostate Cancer following Definitive Radiation Therapy (from COLD Registry): A retrospective study of 277 patients with an average age of 70 (all who had previously undergone radiation therapy and the cancer had recurred) pooled from data of 27 physicians with a median follow up of 25 months. The cryoablation patients had a positive biopsy rate of 6 percent, an ASTRO biochemical failure rate of 40 percent after five years, an incontinence rate of 3.4 percent and a fistula rate of 1.2 percent. Louis L. Pisters, M.D. of the University of Texas, M.D. Anderson Cancer Center is the presenting investigator.

* Pre-operative Nomogram for Predicting Biochemical-Free Probability following Salvage Cryotherapy for Prostate Cancer: An analysis of 276 patients with locally recurrent prostate cancer who underwent salvage cryoablation therapy following the return of their cancer after radiation therapy (the majority had been treated with external beam radiation). The data suggest a pre-operative nomogram can be successful in predicting the success of salvage cryoablation in these patients. Philippe E. Spiess, M.D., of the University of Texas, MD Anderson Cancer Center is the lead investigator.

In addition to these and other studies highlighted at the Conference, the AUA is also offering a number of post-graduate courses and workshops that feature training and information on the use of cryoablation in the urology suite.

Endocare Chairman and Chief Executive Craig Davenport commented, "The continued production of quality data by leading physicians and the presence of AUA-sponsored cryoablation courses at this year's Annual Meeting mark the emergence of the cryoablation technology further into the mainstream of Urology and indeed all areas of medicine where minimally invasive treatments for cancer are needed."

About Endocare

Endocare, Inc. (www.endocare.com) 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: uncertainly regarding the future availability of funds under the Company's common stock purchase agreement with Fusion Capital and credit facility with Silicon Valley Bank; the risk that the Company's sale of common stock to Fusion Capital may cause dilution; the risk that sales of common stock by Fusion Capital may cause the market price of the Company's common stock to decline; the risk that, even despite the Company's financing arrangements with Fusion Capital and Silicon Valley Bank, the Company's independent auditor may issue a qualified opinion, to the effect that there is a substantial doubt about the Company's ability to continue as a going concern; uncertainty regarding the Company's ability to reach and maintain profitability; risks relating to the loss of the Company's largest customer or the reduction, delay or cancellation of orders from this customer; 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 or criminal liability if the Company violates the terms of its settlements with the SEC and the DOJ. 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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