|STOP Clinical Investigators Provide Update On Phase II Study At International Medical Conference; Conceptus Reception Highlights Patients' Perspectives|
WASHINGTON--(BUSINESS WIRE)--Sept. 7, 2000--Conceptus, Inc. (NASDAQ NM: CPTS), developer of the STOP(TM) (Selective Tubal Occlusion Procedure) non-surgical permanent contraception device for women, today announced that researchers delivered three separate oral presentations on STOP at the International Federation of Gynecology and Obstetrics (FIGO) XVI World Congress held in Washington D.C. this week. In addition, Conceptus hosted a reception at which a patient described her experience undergoing the placement procedure and subsequent use of the STOP device. The Congress, which is held every three years, is among the most well attended scientific meetings in the field.
Based on audited clinical data as of July 27, 2000, Jay Cooper, M.D., University of Arizona and the principal U.S. investigator, reported that 187 women evaluated in the Phase II study have accumulated 1,520 woman-months of patient satisfaction and safety data. Additionally, 1,078 woman-months of effectiveness have been accumulated with no reported pregnancies. While there have been no reported pregnancies among these women, as with all methods of contraception, it is expected that pregnancies will occur with use of the STOP device. The adverse event rate remains low at 4.8% and as previously reported, continues to be primarily related to placement difficulties.
Dr. Cooper also reported that 99% of women described their satisfaction with the device as "Good" to "Excellent" at three to six months. At the completion of 12 months, 100% of patients rated their satisfaction as "Very Good" to "Excellent".
Theresa Calloway, a patient of Dr. Cooper, in describing her clinical experience with STOP stated, "I liked it because I did not have any incisions. I did not have general anesthesia, and I did not have to take time off work."
Commenting upon Ms. Calloway's experience, Steven Bacich, president and chief executive officer of Conceptus, said, "We are pleased that Ms. Calloway had such a positive experience both during and after the STOP procedure and we look forward to demonstrating in our pivotal trial that the majority of patients will be satisfied with their clinical experience. The responses we have received from Ms. Calloway and other patients reaffirms our conviction that this procedure will have broad appeal to women. We believe a consumer marketing strategy will be a powerful and effective means to increase acceptance of the STOP device because of its many potential benefits. The procedure is minimally invasive, can be performed with local anesthesia, and has the potential to allow women to quickly return to their normal activities."
Rafael Valle, M.D., of Northwestern University presented data on the clinical study of the mechanism of contraceptive action of the STOP device, results of which demonstrated fallopian tube occlusion. Charles S. Carignan, M.D., Conceptus' acting vice president of clinical research, in conjunction with pathologist Thomas C. Wright, M.D., of Columbia University in New York, gave a podium presentation of the Phase I histological study of the STOP tissue response. In reviewing the results of this study, Drs. Carignan and Wright reported that in each case where devices were placed correctly, tubal occlusion was observed.
Surgical tubal ligation has become the most common form of contraception 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 4-5 hours of hospital recovery time and resulting in 3-4 days off work. A STOP procedure does not require cutting or penetrating the abdomen. The procedure can be performed with local sedation, thus enabling it to be performed in a less costly office setting with reduced reliance on back-up emergency facilities and personnel. Accordingly, a woman is expected to spend about 2-3 hours of her day for a STOP procedure and have a rapid return to normal activities.
The STOP device is a unique and proprietary micro-coil that is designed to be deployed permanently into each fallopian tube using the Company's minimally invasive transcervical tubal access catheter system. Once in place, clinical studies have shown that the STOP device induces an occlusive tissue response.
Conceptus, Inc. is developing STOP, an innovative medical device and procedure designed to provide a non-surgical alternative to tubal ligation, the leading form of contraception worldwide. Data from the United Nations show that worldwide, 30% of reproductive couples using contraception rely on surgical tubal ligation. Additionally, a survey performed by the Centers for Disease Control and Prevention indicates that surgical tubal ligation continues to be the most prevalent form of contraception in the U.S., and that 35% of women age 35-44 have had a surgical tubal sterilization. An estimated 800,000 surgical tubal ligations are performed each year in the U.S., of which 93% are performed in a hospital or surgi-center and require general anesthesia. Additional information about the Company and the STOP device 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 for the year ended December 31, 1999 and other filings with the Securities and Exchange Commission.
Oliver Brouse, Director of Finance
Lippert/Heilshorn & Associates
Bruce Voss (Bruce@lhai.com)
Kim Sutton Golodetz (Kim@lhai.com)
Elissa Grabowski (Elissa@lhai.com)
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