Healthcare Industry News: cryoablation
News Release - September 28, 2006
Published Study Shows Focal Cryoablation Effective in Destroying Prostate Cancer, Preserving Potency, ContinenceAfter 70 Months, 92.8 Percent of Patients Remained Disease Free, 88.9 Percent Retained Potency Following Targeted, Minimally Invasive Treatment
IRVINE, Calif., Sept. 28 (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 new study has demonstrated that specially targeted cryoablation, known as "focal cryoablation," may effectively destroy cancerous tumors in the prostate while preserving a patient's potency and continence. Focal cryoablation is an innovative and non-surgical type of cryoablation that uses the Endocare Cryocare Surgical SystemŽ to precisely target, freeze and destroy only cancerous tissue while sparing surrounding nerve structures and healthy tissue.
The study, published in the September issue of The Journal of Endourology, consisted of 31 men with a mean age of 63 who underwent the focal cryoablation procedure and whose disease was believed, through targeted and systematic biopsies, to be unilateral or confined to one sector of the prostate gland. At a mean follow-up of 70 months, 92.8 percent (26 of 28) remained biochemically disease-free and 96 percent (24 of 25) had no evidence of cancer on post-treatment biopsy. The one biopsy-positive patient had his prostate subsequently treated with full gland cryoablation and currently remains biochemically disease-free. Follow-up for the study consisted of PSA measurement every three months for one year and every six months thereafter, with biopsies at six months, one year, two years, five years and following any three consecutive PSA rises.
Potency was completely maintained in 41.8 percent (13 of 27) of the patients and 40.7 percent of the others (11 of 27) were potent with erectile dysfunction drugs, for a total potency preservation rate of 88.9 percent. The patients experienced no other complications, such as incontinence. Potency was determined with a patient questionnaire, and only disease stage, not preoperative PSA or tumor differentiation was considered a potential contraindication.
"Today, we are much more vigilant in diagnosing prostate cancer and as a result we are identifying the disease earlier and in younger men," said Duke K. Bahn, M.D., the lead investigator of the study and director of the Prostate Institute of America based at Community Memorial Hospital in Ventura, California. "Unfortunately, until now, this growing population has had few options: either doing nothing, which we often call 'watchful waiting,' or choosing one of several fairly radical procedures, including prostatectomy and radiation treatment. The outcomes we are seeing from focal cryoablation demonstrate that many of these patients now have a new option that not only is minimally invasive, but it destroys the cancer, maintains their potency and quality of life, and can even be performed as an outpatient procedure in many cases."
Endocare's Chairman, President and Chief Executive Officer, Craig T. Davenport, noted that the new data demonstrate that it is possible for certain prostate cancer patients to go on to lead normal and sexually active lives following focal cryoablation, which is a potential option for men whose tumor is confined to only a portion of the prostate.
"Studies continue to demonstrate what we have been hearing first-hand from a variety of urologists -- that focal cryoablation can destroy the disease while preserving the surrounding healthy tissue that is critical to normal sexual function," Davenport said. "This is very significant news for any man diagnosed with prostate cancer who is concerned about surgery or the side effects of radiation because it represents a new, minimally invasive, non-surgical option and does not include many of the debilitating side effects, such as impotence and incontinence, which can occur with more aggressive therapies. We believe that focal cryoablation fills a void in the treatment options available to patients and signals a tremendous advance in the treatment of prostate cancer."
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: uncertainty regarding the Company's liquidity and ability to reach and maintain profitability; risks relating to the fact that the Company's largest customer accounts for a significant percentage of the Company's sales and accounts receivable; 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.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.