Conceptus Receives Canadian Approval To Market Essure; Company Submits First Pre-Market Approval Module to the U.S. FDA.

Business Editors/Health & Medical Writers

SAN CARLOS, Calif.--(BW HealthWire)--Nov. 27, 2001

Conceptus, Inc. (Nasdaq:CPTS), developer of the non-incisional permanent birth control procedure Essure(TM), today announced that it has received clearance from Health Canada to market Essure in Canada.

The Company estimates that there are approximately 122,000 surgical tubal ligation procedures performed in Canada each year.

Separately, Conceptus announced that it has submitted its first Pre-Market Approval (PMA) module to the U.S. Food and Drug Administration (FDA).

"We are very pleased to have received Canadian approval almost a full year ahead of our expected timeline," stated Cindy Domecus, Senior Vice President of Clinical Research & Regulatory Affairs for Conceptus. "Our original timeline included the assumption that Health Canada and the U.S. FDA would require the same amount of clinical data. However, based on the strength of our clinical data to date, we were confident in pursuing Canadian marketing approval sooner than we had expected."

Steven Bacich, Conceptus' chief executive officer, added, "On behalf of everyone on the Conceptus team, I'd like to congratulate Cindy and her staff on this significant accomplishment. Our sales plans call for partnering out Essure in Canada and as a result of this speedy approval, we have stepped up discussions with potential marketing partners. In preparation for the U.S. market, we continue to make progress on our domestic regulatory pathway. Our first PMA module has been submitted to the FDA with a goal of completing our PMA submission by the end of the second quarter of 2002."

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% of the procedures in the U.S. are performed in a hospital or surgi-center under general anesthesia, requiring between four to five hours of hospital recovery time and an average of three to ten days before returning to regular activities. An Essure 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 procedure, and to have a rapid return to regular activities. Reliance on Essure does not involve taking drugs or hormones, which can interfere with the body's natural menstruation cycle.

About Conceptus

Conceptus, Inc. is developing Essure, an investigational medical device and procedure in the U.S., which is designed to provide a non-incisional alternative to tubal ligation, the leading form of contraception worldwide. Data from the United Nations show that worldwide, 33% of reproductive couples using contraception rely on surgical tubal ligation. Additionally, a survey performed by the United States Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of contraception in the United States, and that 35% of women age 35-44 have had a surgical tubal sterilization. An estimated 700,000 surgical tubal ligations are performed each year in the United States.

The Essure procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access. Additional information about Conceptus and the Essure 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 our product, 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 for the year ended December 31, 2000 and other filings with the Securities and Exchange Commission.