February
9, 1999
Endocare Announces National Medicare
Coverage for its Prostate Cancer Treatment Procedure
Irvine, CA-February 9, 1999-/Wired Bird at PSA Rising/ Endocare,
Inc. (NASDAQ: ENDO), a leading developer of prostate cancer and
prostatic stent technologies, today announced that it has been informed
by the Health Care Financing Administration (HCFA) of the decision
to implement national Medicare coverage for cryosurgical procedures
for prostate cancer performed with FDA cleared devices. Endocare's
Cryocare System, used for minimally invasive targeted cryoablation
prostate cancer procedures, is the only temperature monitored cryosurgical
system specifically cleared by the FDA for the treatment of prostate
cancer.
"As the leader in targeted cryoablation technology, Endocare
has been working with HCFA for the last nine months to establish
national coverage and implement a Medicare policy to provide reimbursement
for cryosurgical procedures as a primary treatment alternative for
localized prostate cancer. We have been very encouraged by the open
and clear process HCFA has developed to allow rapid and fair assessments
of new technologies," said Paul Mikus, president and chief
executive officer. "We believe this national coverage decision
will provide a treatment alternative to millions of male Medicare
beneficiaries suffering from prostate cancer."
The recommendation was made by HCFA following its review of scientific
evidence on the medical effectiveness of cryosurgery for prostate
cancer. HCFA rescinded the current Medicare national noncoverage
instruction and issued a new coverage policy based on the recently
compiled long-term results for the procedure.
The results were heralded at the 9th International Prostate Cancer
Update last month, where John Long, M.D., Director of Urological
Oncology at New England Medical Center, presented 800 patient, multi-site
study in which targeted cryoablation was revealed as the equivalent
to brachytherapy (permanent radioactive implants, or "seeds")
in low risk prostate cancer patients and superior to brachytherapy
in high risk patients.
"Our most recent findings indicate that targeted cryoablation
is indeed a viable prostate cancer treatment alternative,"
said Dr. Long. "Approximately 80% of the low-risk patients
treated with targeted cryoablation are projected to remain disease
free 5 years after their treatments."
Cancer of the prostate is the second most common malignancy in men
and the third most common cause of death. In the U.S., the disease
afflicts approximately five million men.
Endocare (www.ecare.org)
develops, manufactures, and markets an array of innovative, temperature-based
surgical devices and technologies, including those used in targeted
cryoablation for treatment of prostate cancer. The company is also
developing innovative stent technologies for prostate obstruction.
Any statements in this release that are not historical
facts are forward-looking statements that involve risks and uncertainties.
Actual results may differ from those indicated by forward-looking
statements as a result of a variety of factors, including competitive
developments, regulatory approval requirements, the ability to convince
health care professionals and third party payers of the medical
and economic benefits of the Cryocare System, uncertainty as to
whether payers will reimburse health care providers who perform
prostate cancer cryosurgical procedures or that reimbursement, if
provided, will be adequate. These and other 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.
The Company undertakes no obligation to update forward-looking statements.
SOURCE Endocare
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