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. -- endocare -- 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.
Endocare, Inc.
endocare