Healthcare Industry News:  cryoablation 

Devices FDA

 News Release - September 12, 2006

Endocare Receives FDA 510K Clearance to Market New Nitrogen-Based Cryoablation System for Destroying Tissue and Cancerous Tumors

Nitrogen Allows New Non-Surgical Cryocare CN2 System to Freeze, Destroy Tumors Faster

IRVINE, Calif., Sept. 12 (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 it has received 510K clearance from the U.S. Food and Drug Administration to market its new Cryocare CN2 System, a potentially much faster and easier-to-operate cryoablation system for freezing cancerous tumors and tissue. This new system uses nitrogen as the freezing and tumor-destroying element. The nitrogen, called "critical nitrogen" because it works in a unique form at the critical point where gas nearly becomes liquid, is also more powerful and more readily available in surgical suites than argon, the freezing element in Endocare's current market-leading cryoablation systems.

Endocare Chairman and CEO, Craig T. Davenport said, "The new Cryocare CN2 System, when commercialized, is expected to become the new technology platform for interventional radiology and oncology markets, allow access to cryoablation in new international geographies and open up new markets because of the unique characteristics of this new patented technology. Additionally, nitrogen should result in lower costs to customers and the Company." Davenport added that the speed and precision of the nitrogen-based system may also help physicians reduce the time required for current procedure techniques, may influence physicians to adopt new minimally invasive techniques and might lead to expanded application into new procedures.

"Our proprietary Cryocare CN2 System represents a significant advancement in cryoablation because it is more powerful and can get the tumor-ablating job done faster and more effectively than current systems using argon," Davenport said. "We believe that the physicians who know our system will welcome the nitrogen technology because it is easy to work with and delivers a colder, more powerful ice ball at the end of the probes. The nitrogen technology may drive more widespread adoption of cryoablation internationally given that, in many countries, nitrogen is more readily available and less expensive than argon. We believe that the Cryocare CN2 System is the cryoablation system of the future and in the near term should supplant many of the older systems used by our interventional radiology and oncology customers for addressing liver, lung and bone cancers."

cryoablation, as a treatment for cancer and its symptoms, has become an important and often used tool for urologists and interventional radiologists. Domestically, through the first six months of 2006 almost 3,700 patients with prostate, renal and other cancers were treated with cryoablation, compared with less than 1,600 procedures performed in all of 2001. In addition, the clinical data demonstrate that cryoablation is a very efficacious treatment for killing cancer and yet, potentially provides the patient with less morbidity and side effects than other cancer treatments for kidney, lung and liver cancers. Also, cryoablation is currently being studied for the alleviation of bone pain associated with bone cancers.

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.

Except for historical facts, the matters discussed in this press release are forward-looking statements. The forward-looking statements reflect current expectations and assumptions and involve risks and uncertainties that may affect the Company's business, forecasts, projections and prospects, and cause actual results to differ materially from those stated or suggested in these forward-looking statements. These forward-looking statements include, but are not limited to, statements relating to the clinical and commercial potential of the nitrogen technology discussed in this press release. 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. Other risk factors include, but are not limited to: uncertainty regarding the outcome of ongoing studies relating to the nitrogen technology; uncertainty regarding market acceptance of the nitrogen technology; uncertainty relating to third party reimbursement for certain potential applications of the nitrogen technology; uncertainty regarding the ability to convince health care professionals and third party payers of the medical and economic benefits of the nitrogen technology; uncertainty regarding the Company's lack of sales and marketing experience in several of the markets to which the nitrogen technology may be applicable; the risk that the Company may not have adequate capital resources to commercialize the nitrogen technology effectively; uncertainty regarding the Company's ability to manufacture products utilizing the nitrogen technology; uncertainly regarding the Company's ability to protect, defend and maintain its intellectual property rights to the nitrogen technology, including, without limitation, the exclusive license granted to the Company by its collaboration partner; the risk that the Company's relationship with its collaboration partner could deteriorate; and uncertainty regarding other technological developments that may adversely impact the value of the nitrogen technology. 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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