Conceptus Achieves Milestone With Stop--tm-- Phase II Data.Business & Health Editors SAN CARLOS, Calif.--(BW HealthWire)--May 22, 2000 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 ) announced the achievement of an important corporate milestone in the development of the STOP non-surgical permanent contraception device. 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. , stated, "Statistical analysis of interim Phase II study results allows us to quantify a confidence level in moving forward with the pivotal trial and plans to commercialize STOP internationally within a year." Conceptus' consulting biostatistician, Daniel Cher, M.D. stated, "Women in the Phase II study have accumulated over 750 woman-months of effectiveness without a reported pregnancy. Based on statistical analysis of the interim Phase II study results to date, the projected one-year effectiveness rate of the STOP device in this trial has already reached 95%. Further, with each passing month without a pregnancy, this statistically projected rate becomes even more compelling and provides further confidence that the effectiveness criteria approved as part of the IDE submission for the pivotal trial will be met or exceeded. Mr. Bacich added, "We are hopeful that our pivotal trial will demonstrate that the first year effectiveness rate of the STOP device exceeds the typical use rate of the pill (95%) and matches the 99% rate of surgical tubal Tubal (t `bəl), in the Bible, son of Japheth. 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. ." Mr. Bacich noted that these results include both the current and an earlier design of the STOP device and also clarified that as is true of all methods of birth control, STOP cannot be expected to be 100% effective. It should also be noted that the data gathered in the pivotal trial will be required to support a final effectiveness rate for pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) submission. The Company made today's announcement at an investment community lunch presentation in San Francisco featuring guest speakers John F. Kerin For the Australian politician, see . Professor John F. Kerin MBBS, MD, FRANZCOG (1), CREI (2) (died 25 January 2006) was a medical doctor of reproductive medicine who died as a result of an accident on his hobby farm at Eden Valley, South Australia on 25 January 2006. , M.D., and Jay M. Cooper, M.D. Dr. Kerin, a leading clinical expert on STOP, is Professor, Reproductive Medicine Unit, University of Adelaide Its main campus is located on the cultural boulevard of North Terrace in the city-centre alongside prominent institutions such as the Art Gallery of South Australia, the South Australian Museum and the State Library of South Australia. , Australia and Dr. Cooper is founder and medical director of Women's Health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. Research in Phoenix, Arizona and the U.S. principal investigator for the STOP pivotal study. A recording of today's investment community meeting will be available on the Company's Web site, www.conceptus.com. About STOP 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 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. , requiring 4-5 hours of hospital recovery time and resulting in 3-4 days off work. In contrast, because a STOP procedure does not require cutting or penetrating the abdomen, the procedure is performed with local sedation, thus enabling the procedure 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 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 occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion. oc·clu·sive adj. 1. Occluding or tending to occlude. 2. tissue response. About Conceptus 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 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 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 Conceptus or 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. |
|
||||||||||||||

`bəl)
Printer friendly
Cite/link
Email
Feedback
Reader Opinion