MOUNTAIN VIEW, Calif., Nov. 14, 2012 (GLOBE NEWSWIRE) -- In a release issued earlier today by Conceptus, Inc. (Nasdaq:CPTS), the date for the UNCAM decision to be effective was incorrect in the first paragraph. The correct date is December 14, 2012. The corrected release follows:
Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the leading surgery-free permanent birth control method, today praised the decision by France's UNCAM (Union nationale des caisses d'assurance maladie) to remove reimbursement restrictions on the placement of the intra-tubal insert Essure for all women seeking permanent contraception. The decision is effective December 14, 2012.
This decision overturns a previous ruling that restricted French health insurance reimbursement of the hysteroscopic sterilization procedure for women under the age of 40, which went into effect on October 1, 2010.
"We are pleased that all women seeking permanent contraception who are done having children once again have the freedom of choice," said D. Keith Grossman, president and chief executive officer of Conceptus. "Essure has been available in France since 2002 and became the country's standard of care for permanent contraception in 2010. Essure provides women the most reliable form of permanent birth control without the need for incisions, hormones or general anesthesia."
France is Conceptus' largest market outside the United States and represented 15% of total net sales in 2011. The Company has trained more than 1,400 surgeons in France to perform the Essure procedure, which has received a favorable appraisal by HAS (Haute Autorité de Santé) and is reimbursed in France. Approximately 30% of patients seeking permanent birth control in France are under the age of 40.
All female permanent contraception procedures in France require a four-month waiting period from the time the physician approves the procedure for the patient. As such, Conceptus believes this new ruling will begin to have a positive impact on the Company's net sales in the second quarter of 2013.
About the Essure® Procedure
The Essure procedure, CE Mark approved since 2001 and FDA approved since 2002, is the only surgery-free and hormone-free 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 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 works with the inserts to form a natural barrier in the fallopian tubes to prevent sperm from reaching the egg. Three months after the Essure procedure, an Essure Confirmation Test is given to confirm that the inserts are in place and that the fallopian tubes are blocked, verifying that the patient can rely on 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 permanent birth control available. 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 approximately 690,000 women worldwide have undergone the procedure.
About Conceptus®, Inc.
Conceptus, Inc. is the global leader in the development and commercialization of innovative device-based solutions in permanent birth control. The Company manufactures and markets the Essure Permanent Birth Control System.
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.
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Forward Looking Statement
Except for the historical information contained herein, the matters discussed in this press release include a forward-looking statement, the accuracy of which is subject to known and unknown risks and uncertainties. This forward-looking statement includes, without limitation, a discussion regarding the potential impact on our financial statements as a result of a favorable reimbursement decision in France. This discussion 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 the introduction of competitive products, 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. This forward-looking statement speaks only as to the date on which the statement was made. We undertake 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.
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