Conceptus(R) Begins Clinical Trial With Next-Generation Essure(R) to Provide Immediate Contraception
July 09 2012 - 4:30PM
Conceptus, Inc. (Nasdaq:CPTS), developer of the
Essure® procedure, the leading non-surgical permanent birth control
method, today announced that it has begun patient enrollment in a
60-patient clinical trial at two medical centers in Canada and
Mexico with its next-generation Essure device. The new Essure
device is designed to offer not only all the advantages of the
current Essure procedure, but also immediate, permanent
contraception without a three-month waiting period or 90-day
confirmation test.
In most cases a non-invasive transvaginal ultrasound is all that
will be required to confirm placement immediately following the new
Essure procedure. Like the Essure procedure itself, this test may
be performed in the physician's office. A satisfactory confirmation
of proper placement will provide the patient the ability to rely
upon Essure for immediate permanent contraception without the need
for a secondary method of contraception for the first three months
of wear.
The clinical trial will evaluate the safety of the
next-generation Essure device placement procedure and the
three-month effectiveness of the new contraception technology.
Data from the clinical trial will be used to initiate the IDE
and CE Mark studies in 2013 for U.S. PMA supplement and CE Mark
applications.
The first placement of the new Essure device was performed on
July 3, 2012 by John Thiel, M.D., principal investigator, at Regina
Central Hospital in Canada. "We are pleased to be involved in
the clinical efforts to evaluate a device that could address an
unmet need for immediate, highly reliable permanent birth
control."
"While still early, this next-generation Essure device is
designed to offer an even more compelling value proposition for
female permanent birth control, particularly as compared to
surgical tubal ligation," said D. Keith Grossman, president and
chief executive officer of Conceptus. "Immediate contraception and
the elimination of a 90-day confirmation test will dramatically
strengthen our competitive positioning and enable us to further
penetrate the permanent birth control market for years to come. If
successful, this will be an important achievement as we advance our
vision of making Essure the standard of care in permanent birth
control and position Conceptus for long-term growth."
About the Essure® Procedure
The Essure procedure, FDA approved since 2002, is the first
permanent birth control method that can be performed in the comfort
of a physician's office in less than 10 minutes (average
hysteroscopic time) without hormones, cutting, burning or the risks
associated with general anesthesia or tubal ligation. Soft,
flexible inserts are placed in a woman's fallopian tubes through
the cervix without incisions. Over the next three months, the body
forms a natural barrier around and through the inserts to prevent
sperm from reaching the egg. Three months after the Essure
procedure, a doctor is able to perform an Essure Confirmation Test
to confirm that the inserts are properly placed and that the
fallopian tubes are fully blocked, allowing the patient to rely
upon Essure for permanent birth control.
The Essure procedure is 99.83% effective based on five years of
follow up with zero pregnancies reported in clinical trials, making
it the most effective form of permanent birth control on the
market. Essure's 10-year commercial data tracks closely with
its five-year clinical results, and Essure has been proven and
trusted by physicians since 2002. The Essure procedure is
covered in the U.S. by most public and private insurance plans and
more than 625,000 women worldwide have undergone the
procedure.
About Conceptus®, Inc.
Conceptus, Inc. is the leader in the development of innovative
device-based solutions in permanent birth control. The Company
manufactures and markets the Essure procedure, which is available
in the United States, Europe, Australia, New Zealand, Canada,
Mexico, Central and South America and the Middle East.
The Conceptus, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Please visit www.essure.com for more information on the Essure
procedure. Patients may call the Essure Information Center at
1-877-ESSURE-1 with questions or to find a physician in their
area.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, the accuracy of which is subject to known and unknown
risks and uncertainties. These forward-looking statements include,
without limitation, discussions regarding results and timing of
clinical trial activities, expected market acceptance of the
next-generation Essure procedure, our ability to improve our
competitive positioning and our ability to make the Essure
procedure the standard of care in permanent birth
control. These discussions and other forward-looking
statements included herein may differ significantly from actual
results. Such differences may be based upon factors such as changes
in strategic planning decisions by management, re-allocation of
internal resources, changes in the impact of domestic and global
macroeconomic pressures, reimbursement decisions by insurance
companies and domestic and foreign governments, scientific advances
by third parties, litigation risks, and attempts to amend or repeal
all or part of the Patient Protection and Affordable Care Act of
2010 as amended, as well as those factors set forth in the
Company's most recent Annual Report on Form 10-K and most recent
Quarterly Report on Form 10-Q, and other filings with the
Securities and Exchange Commission. These forward-looking
statements speak only as to the date on which the statements were
made. The Company undertakes no obligation to update or revise
publicly any forward-looking statements, whether as a result of new
information, future events, or otherwise.
© 2012 Conceptus, Inc. – All rights reserved.
CONTACT: Investor and Public Relations Contact:
Cindy Klimstra
(650) 962-4032
cindy_klimstra@conceptus.com
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