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SEC Filings Annual Report |
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 A Market Need Conceptus (CPTS) manufactures and markets Essure, an innovative and proprietary non-incisional permanent birth control procedure for women. The Essure procedure delivers a soft and flexible micro-insert into a woman's fallopian tubes. The micro-insert is designed to provide permanent birth control by causing a tissue in-growth that blocks the fallopian tubes. Reliance on Essure does not involve taking drugs or hormones. Essure addresses the market need for a permanent, less invasive, and less costly alternative to tubal ligation, the most common form of permanent birth control worldwide. A Non-incisional Option Tubal ligation involves general or regional anesthesia, abdominal incisions, four to six days of recovery time, and the risks associated with an incisional procedure. The Essure procedure does not require incisions or general anesthesia. Essure may appeal to women who have completed childbearing but elect to use temporary methods of birth control to avoid incisional tubal ligation. Essure may also appeal to couples that are considering a vasectomy. In clinical testing, the Essure procedure averaged 35 minutes and women were typically discharged 45 minutes after the procedure. Benefits to Physicians, Hospitals, and Payors Essure should appeal to physicians because it is a less invasive option, which has unique benefits. Most gynecologists will be able to perform the procedure after completing the Essure training program. Hospitals should be able to utilize their facilities more cost effectively with the Essure placement procedure than with tubal ligation. We expect payors to experience cost reductions resulting from the elimination of overhead and procedural costs related to general anesthesia and post-operative hospital stays associated with tubal ligations. In addition, payors may also benefit from the reduction of unplanned pregnancies among women who elect to use Essure, who would have otherwise used less effective temporary methods of birth control. U.S. Market Opportunity Permanent birth control such as tubal ligation and vasectomy are relied upon by 39% of women 18 - 44 who use any form of birth control. Several published papers have estimated 700,000 annual tubal ligation procedures and we estimate that there are approximately 400,000 vasectomy procedures performed each year in the U.S. In addition, a 1995 study by the Centers for Disease Control estimated that 21 million women use temporary methods of birth control, such as oral contraceptives, implants and injectables. Included in this group are approximately 7 million women who may consider a permanent form of birth control. Global Market Opportunity In the European Union alone, we estimate there are more than 10 million women who are potential candidates for the Essure procedure. According to the Population Council, there were more than 14 million tubal ligation procedures performed annually in developing countries in the 1990's. |
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