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To: TARIQ STOCKS who wrote (1384)	4/30/1998 10:42:00 AM
From: Paul Tran	Respond to of 25711

FDA Grants Clearance to Endocare For BPH Device Innovative, Low Cost 'Freezing' Technology Provides New Option To Millions of Men Suffering From Enlarged Prostate Disease Symptoms IRVINE, Calif., April 29 /PRNewswire/ -- The Food and Drug Administration (FDA) has granted specific labeling clearance to Irvine, California based Endocare, Inc. (Nasdaq: ENDO - news), for the company's treatment technology for benign prostatic hyperplasia (BPH - a disease that causes swelling of the prostate). The FDA's clearance of Endocare's 510(k) notification for the new CRYOcare surgical system, marks the arrival of an innovative approach towards a cost effective, minimally invasive, technology designed specifically to treat BPH. The new device's minimally invasive two-probe system will enable surgeons to perform targeted ablations of specific portions of a swollen prostate. The system utilizes extremely cold temperature to quickly and safely freeze and destroy a selected volume of the prostate's tissue, thereby removing the obstruction. Targeted ablation of portions of the prostate is a natural next step for Endocare. The company has already introduced its life- saving CRYOcare technology designed for targeted ablation of the entire prostate in cases of malignant prostate cancer (the second most common cancer in all men). Endocare anticipates initiating market development clinical studies at some of the nation's premier centers of medical excellence before the end of the second quarter of this year. Aaron E. Katz, M.D., Assistant Professor of Urology at Columbia University is among the surgeons who will be involved with testing the new technology and is hopeful that the new device will provide patients with an efficient and comfortable alternative to the current standard of treatment. ''This temperature-based technology has provided us with consistent success in the destruction of prostate cancer cells,'' said Katz, ''and therefore should be equally successful in destroying the benign cells associated with BPH.'' Recent three-year study results from Douglas Chinn, M.D. of Southern California's Alhambra Hospital revealed that 96% of patients who have received this temperature-based treatment for prostate cancer remain cancer- free three years after treatment. The new device is the latest in a growing series of temperature-based technologies developed by Endocare. This latest CRYOcare technology opens the door for a less invasive and cost effective procedure as compared to the current standards of treatment for BPH and provides the medical community with what the company believes is the only upgradeable technology platform available for treating benign and malignant prostate disease. Currently pending IDE approval from the FDA, the company's ''Horizon'' Temporary Stent device is designed to provide BPH sufferers with immediate, office-based relief of bladder outlet obstructions. Coupled with the company's BPH Cryocare technology, Endocare's products are expected to provide both temporary and long-term relief for BPH sufferers. BPH, or enlarged prostate, is a non-cancerous growth of the prostate tissue that obstructs bladder function, causing discomfort and lifestyle complications for afflicted men. Approximately 50% of men in their 50s suffer from BPH, and almost 80% of men over 80 years old are symptomatic. Estimates of American men displaying symptoms of BPH approach 15 million, with over 2.3 million of these cases classified as severe. ''We're confident that our new CRYOcare system will be received by physicians and patients alike as a welcome treatment alternative,'' said Paul Mikus, Endocare's Chairman and CEO. ''Preliminary data and the success of our other CRYOcare systems suggest that the device will be cost effective and particularly useful in providing physicians with a safer and more consistently effective method of treating BPH. The minimally invasive aspects of temperature-based technology also provide tremendous comfort and convenience benefits for the patient.'' Endocare develops, manufactures and markets an array of innovative, temperature-based surgical devices and technologies. The company is currently developing an innovative stent technology that may provide immediate and long- term relief for prostate obstruction. Additionally, clinical studies are currently planned for the use of Endocare's single-probe CRYOcare System for the treatment of abnormal uterine bleeding and breast tumor ablation. Any statements in this release that are not historical facts are forward- looking statements that involve risks and uncertainties; actual results may differ from the forward-looking statements. Words such as ''expect, suggest, may, believe, could, might, will, continue, should, planned, anticipated, designed'' indicate forward-looking statements but their absences does not mean that a statement is not forward-looking. Factors that could materially and adversely impact revenues and profitability are detailed from time to time in the Company's periodic reports, including Quarterly Reports on Form 10-Q, the Annual Report on Form 10-K and the Registration Statement on Form S-3, filed with the Securities and Exchange Commissions. In particular, no assurance can be given that clinical studies mentioned will be successful, that the FDA will approve devices for commercial sale, or that such devices or the Company's new BPH device will ultimately receive commercial acceptance. The Company undertakes no obligation to update forward-looking statements. SOURCE: Endocare, Inc.