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Conceptus Pivotal Trial Data Show 92 Percent of Women Return to Work in One Day or Less of Permanent Birth Control Procedure; Stop Now Branded Globally as Essure pbc.


Business & Health Editors

SAN CARLOS, Calif.--(BUSINESS WIRE)--July 11, 2001

Conceptus conceptus /con·cep·tus/ (-tus) the product of the union of oocyte and spermatozoon at any stage of development from fertilization until birth, including extraembryonic membranes as well as the embryo or fetus. , Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 NM: CPTS CPTS Certified Penetration Testing Specialist (network security)
CPTS Comptroller Squadron
CPTS Computer Program Test Specifications
CPTS Catastrophe Personnel Tracking System
CPTS Claims Procedure Training Specialist
), developer of the non-incisional permanent birth control procedure Essure(TM) pbc, previously known as STOP (Selective Tubal Tubal (t`bəl), in the Bible, son of Japheth.  Occlusion occlusion /oc·clu·sion/ (o-kloo´zhun)
1. obstruction.

2. the trapping of a liquid or gas within cavities in a solid or on its surface.

3.
 Procedure), today announced that excluding the day of the procedure, data show that 92 percent of Essure pbc patients who are employed returned to work in one day or less of undergoing the procedure.

Further results indicate that nearly 60 percent of Essure pbc patients were back to their regular physical activities within one day, and within two days 76 percent had resumed regular activities. A comparison to laparoscopic Laparoscopic
A minimally-invasive surgical or diagnostic procedure that uses a flexible endoscope (laparoscope) to view and operate on structures in the abdomen.

Mentioned in: Obstetrical Emergencies
 tubal ligation ligation /li·ga·tion/ (li-ga´shun) the application of a ligature.

tubal ligation  sterilization of the female by constricting, severing, or crushing the uterine tubes.
 was not performed in the pivotal trial; however, published reports show that women who undergo surgical tubal ligation - the only permanent birth control option currently available for women in the U.S. - return to regular physical activities in three to 10 days.

"These results speak to the unique advantages of the Essure pbc procedure that women currently do not enjoy from surgical tubal ligation," said Steve Bacich, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Conceptus, Inc. "Essure pbc is designed to eliminate incisions and avoid general anesthesia Anesthesia, General Definition

General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs.
, and these results indicate the benefit for women in getting back to their daily lives."

Data from the Pivotal Trial also show that 95 percent of patients would recommend the procedure to a friend. In addition, 99 percent of women who have relied on the Essure micro-insert for birth control rated their long-term satisfaction as `good' to `excellent'. To date, in more than 350 woman-years of effectiveness testing, there has not been a pregnancy with Essure pbc. Like all birth control methods, Essure pbc is not expected to be 100 percent effective, and pregnancies are expected. Adverse events in clinical trials ranged from 4 - 6 percent, and are primarily due to improper device placement.

The availability of Essure pbc in the U.S. is projected for 2003 and is expected to open up a market currently occupied by surgical tubal ligation and vasectomy vasectomy, male sterilization by surgical excision of the vas deferens, the thin duct that carries sperm cells from the testicles to the prostate and the penis. , which combined account for over 1 million procedures in the United States.

Essure(TM) pbc: New Name Highly Rated by Women

Conceptus also announced today that Essure pbc is the new name for its non-incisional permanent birth control procedure. It is pronounced `assure', and the pbc stands for `permanent birth control'. As part of the Company's in-depth market research, the brand name Essure pbc was highly rated by women as communicating a positive image of assurance, femininity and safety.

"This is an important part of the extensive market research that Conceptus has completed in preparation for high visibility consumer awareness programs," said Stan Van Gent, Vice President, Marketing and Sales. "In-depth interviews with over 2,500 women in Australia and the United States provided key insights into not only what are women's major concerns with current choices, but why they feel strongly that a non-incisional, no general anesthesia approach has significant advantages for them. These concepts are embodied in the new name Essure pbc."

Permanent Birth Control

Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive and costly. About 93 percent of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring between four and five hours of hospital recovery time and three to10 days before returning to regular activities. An Essure pbc procedure does not require cutting or penetrating the abdomen and can be performed in a less costly procedure setting without general anesthesia. Accordingly, a woman is expected to spend about two to three hours of her day for an Essure pbc procedure and have a rapid return to regular activities. Essure pbc does not involve taking drugs or hormones, which can interfere with the body's natural menstruation menstruation, periodic flow of blood and cells from the lining of the uterus in humans and most other primates, occurring about every 28 days in women. Menstruation commences at puberty (usually between age 10 and 17).  cycle.

About Conceptus

Conceptus, Inc. is developing Essure pbc, an innovative medical procedure, designed to provide a non-incisional alternative to tubal ligation, the leading form of birth control worldwide. Essure pbc is currently an investigational device in the United States, and studies are ongoing to support the product's safety and effectiveness for purposes of filing a Premarket Approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device.  Application with the U.S. Food and Drug Administration.

Data from the United Nations show that worldwide, 33 percent of reproductive couples using birth control rely on surgical tubal ligation. Additionally, a survey performed by the United States Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center.  indicates that surgical tubal ligation continues to be the most prevalent form of birth control in the U.S., and that 35 percent of women age 35-44 have had a surgical tubal sterilization sterilization

Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system).
. An estimated 700,000 surgical tubal ligations are performed each year in the United States.

The Essure pbc procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access. The system is used to deploy the Essure micro-insert into the fallopian tube fallopian tube (fəlō`pēən), either of a pair of tubes extending from the uterus to the paired ovaries in the human female, also called oviducts, technically known as the uterine tube. . Once in place, the micro-insert elicits tissue in-growth throughout and around the device to the fallopian tube. Additional information about Conceptus and the Essure pbc procedure is available at www.conceptus.com.

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, and clinical efficacy of and market demand for products, among other matters discussed in this release, may differ significantly from the discussion of such matters in the forward-looking statements. Such differences may be based upon factors within the Company's control, such as strategic planning decisions by management and re-allocation of internal resources, or on factors outside of the Company's control, such as delays by regulatory authorities, scientific advances by third parties and introduction of competitive products, as well as those factors set forth in the Company's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2000 and other filings with the Securities and Exchange Commission.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 11, 2001
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