Conceptus Permanent Contraception Technology Featured At International Gynecology Meeting; Symposium and Live Case Demonstration Highlighted.Business/Health Editors SAN CARLOS, Calif.--(BW HealthWire)--April 26, 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 ), developer of the STOP(TM) (Selective Tubal Tubal (t `bəl), in the Bible, son of Japheth. Occlusion Procedure) non-surgical permanent contraception device for women, today announced that STOP was featured at the Annual Meeting of the International Society of Gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. Endoscopy endoscopyExamination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the (ISGE ISGE International Society for Gynecologic Endoscopy ) in Australia last week. There were four separate podium presentations on STOP and a live clinical procedure broadcast into the meeting via satellite. Professor John Kerin demonstrated the procedure in Adelaide, Australia, placing the device in an obviously comfortable woman without the use of anesthesia or analgesia analgesia /an·al·ge·sia/ (an?al-je´ze-ah) 1. absence of sensibility to pain. 2. the relief of pain without loss of consciousness. . Professor John Sciarra, President of the ISGE, delivered a paper focusing on the history of non-surgical methods for permanent contraception, including STOP. "The STOP device is a new hysteroscopic sterilization system," said Professor Sciarra. "Of the transcervical sterilization technologies that have been studied over the last 30 years, this device is one of the first that appears to have the potential for wide-spread clinical use. It is attractive to both physicians and patients since it is possible to insert the device on an ambulatory basis." In his paper he pointed out that previous attempts have not achieved acceptance by the medical community due to either clinical, technical, or biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. reasons. Professor Bruno Van Herendaal of Antwerp, Belgium delivered a podium presentation entitled Anesthesia and STOP(TM) Hysteroscopy in which he explored different types of anesthesia, including the use of no anesthesia during the deployment of the STOP device. Professor Van Herendaal's research corroborated cor·rob·o·rate tr.v. cor·rob·o·rat·ed, cor·rob·o·rat·ing, cor·rob·o·rates To strengthen or support with other evidence; make more certain. See Synonyms at confirm. Dr. Kerin's in that he found the procedure could be performed successfully without the use of anesthesia and good patient tolerance of the procedure. Other podium presentations were delivered by Asst. Professor Raphael Valle, Northwestern University, USA (Tissue Response to the STOP(TM) Long-term Intratubal Device), Dr. Jay Cooper, 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 Center, USA (A New Transcervical 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. Permanent Contraception Method: Phase II results), and Professor John Kerin, 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 (STOP(TM) Tubal Sterilization). In his presentation on the results of STOP and the Phase II clinical study, Professor John Kerin stated, "The Conceptus device has demonstrated success at key clinical parameters in the Phase II study. The procedure appears to be well within the capability of today's ob/gyn physician that has been met with a very high level of patient interest." "We are pleased that in such a prestigious meeting, STOP received abundant positive attention as a featured product in the broad range of gynecology and women's health topics that are normally discussed," commented Steven R. Bacich, Conceptus' president and chief executive officer. "With more than 1,000 physicians from 26 different countries representing the thought leaders in the field, this ISGE meeting was an ideal forum for Conceptus to introduce the scientific data supporting STOP to the International and Australian medical communities." Mr. Bacich noted that the Company has received Therapeutic Goods Authorization for STOP in Australia and plans to commence marketing there in early 2001. In addition, the Company has recently received permission to begin its pivotal trial for United States FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval and will use Australian clinical data to support its 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. More information can be found in Conceptus' web site, www.conceptus.com. STOP is a non-surgical permanent contraceptive device designed to be less invasive than the 800,000 U.S. and 16 million worldwide surgical 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. procedures performed annually. Despite the fact that it is invasive and costly, surgical tubal ligation has become the most common form of contraception worldwide. A vast majority of such 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. In contrast, because a STOP procedure does not require cutting or penetrating the abdomen, the procedure can usually be performed in about 20 minutes using local sedation, thus enabling the procedure to be performed in a less costly office setting. 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. STOP also represents a drug-free alternative to long-term use of oral contraceptives or hormonal implants. The STOP device features a proprietary micro-coil designed to be deployed permanently into each fallopian tube using the Company's minimally invasive transcervical tubal access catheter system. Once in place, clinical data 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 in the lumen of the fallopian tube. Phase II interim results with STOP include 136 women with proven fertility. There has been a low rate of adverse events, and in excess of 99% of patients rated their tolerance to wearing the STOP device as "good to excellent" at each follow-up visit conducted to date. As of March 31, 2000, and including the earliest STOP design, more than 700 woman-months of effectiveness data have been accumulated with no reported pregnancies. About Conceptus Conceptus, Inc. is developing STOP, an innovative medical device designed to provide a non-surgical alternative to surgical 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. A survey performed by the Centers for Disease Control indicates that surgical tubal ligation is the No. 1 form of contraception in the U.S., and that 35% of women age 35-44 have had a tubal ligation. 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. 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. |
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