Conceptus Appoints Susan M. Aloyan Vice President of Regulatory Affairs.Health/Medical Writers & Business Editors SAN CARLOS, Calif.--(BW HealthWire)--Aug. 2, 2001 Conceptus Inc. (Nasdaq: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 the appointment of Susan M. Aloyan to the newly created position of vice president of Regulatory Affairs. Aloyan, who will report to Cindy Domecus, the company's senior vice president of Clinical Research & Regulatory Affairs, has nearly 20 years of regulatory and 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. (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 ) experience, much of it in the field 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. . She will be responsible for regulatory submissions for Essure pbc both in the United States and in the international arena. Most recently, from 1996 to the present Aloyan was corporate director, Regulatory Affairs, Quality Assurance and Clinical Affairs with Gynecare/Ethicon, a Johnson & Johnson company. While at Gynecare/Ethicon, she was responsible for the approval of the ThermaChoice(TM) product. She also worked with foreign regulatory bodies to obtain product approval and permission to conduct clinical trials. Aloyan established and managed systems for complaint handling, developed product labeling and had responsibility for promotional materials. "Susan submitted the PMA for ThermaChoice when I was an 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. Panel member, and I was very impressed with the PMA application and the panel presentation for this `first of a kind' device," commented Domecus. "We are very fortunate to have someone as experienced as Susan joining our team to focus not only on U.S. regulatory submissions, but also on international submissions in the numerous markets we plan to pursue." Prior to joining Gynecare/Ethicon, from 1995 to 1996 Aloyan was the associate director for Regulatory Affairs for CardioGenesis Corp. of Sunnyvale, Calif. While there, she was responsible for regulatory submissions including IDEs and PMAs, as well as international product registrations and export documentation. From 1983 through 1995, Aloyan held progressively responsible positions in regulatory affairs for companies such as Syntex Pharmaceuticals and Barnes Hind Corp. Steven Bacich, chief executive officer of 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. , said, "The combination of Cindy Domecus and Susan Aloyan creates, in my opinion, the strongest regulatory team in women's health imaginable. We are looking forward to Susan's contribution towards smooth approval processes as we seek to bring Essure pbc to women around the globe desiring permanent birth control. This addition to the management team represents the company's full commitment to obtaining regulatory approvals as expeditiously ex·pe·di·tious adj. Acting or done with speed and efficiency. See Synonyms at fast1. ex as possible." Permanent Birth Control 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. 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 United States 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 between four to five hours of hospital recovery time and three to 10 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 investigational medical device and procedure in the United States, 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 percent of reproductive couples using contraception 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 contraception in the United States, and that 35 percent 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 pbc procedure is based on a unique and proprietary catheter delivery system for minimally invasive transcervical tubal access. 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 news 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 Dec. 31, 2000, and other filings with the Securities and Exchange Commission. |
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