Conceptus reviews permanent birth control device for women

Conceptus, Inc., developer of the STOP (Selective Tubal Occlusion Procedure) non-surgical permanent birth control device for women, announced that the first interim review of data from the STOP pivotal trial found a reduction in average procedure time, an increase in the rate of placement in both fallopian tubes (bilateral placement), and a decrease in the adverse event rate, when compared with interim data from the Phase II study as of March 23, 2001.

At the 10th Annual Congress of the International Society for Gynecologic Endoscopy (ISGE), held in Chicago, Professor John Kerin MD, with the Ashford Community Hospital, Adelaide, Australia, and a clinical investigator in the STOP pivotal trial, presented preliminary data from the pivotal trial in which a total of 518 women were enrolled. Professor Kerin noted that when compared with the Phase II study, in which 227 women were enrolled, the pivotal trial has shown a 28% reduction in average procedure time to 13 minutes from 18 minutes and that the bilateral placement rate has improved to 90% from 88%. Using combined data from the pivotal trial and the Phase II study, more than 650 women have had bilateral placement of STOP devices. Adverse events, which consisted primarily of events associated with improper placement have decreased to 3.3% from 5.3%.

Patient tolerance with the placement procedure and subsequent use continues to be highly rated by patients. In the pivotal trial and the Phase II study, nearly 90 percent of women who had devices placed rated their tolerance of the procedure as "Good" to "Excellent". Additionally, women in the on-going Phase II study have accumulated more than 3,300 woman months of use of the STOP device, and among women who have completed the three, six, twelve, or eighteen month follow-up exams, 99% rated their satisfaction as "Good", "Very Good", or "Excellent".

"We are encouraged by this newest data which confirms and strengthens the results from the Phase II study, said Jay Cooper, MD, founder and medical director of Women's Health Research Center, Phoenix, Arizona, and the principal U.S. investigator of STOP. "I am particularly pleased because these positive results were obtained in a clinical trial that more than doubled the sample size of patients and was performed by a larger and more diverse group of physicians than the Phase II study."

Conceptus notes that the pivotal trial data presented at the ISGE are preliminary, unaudited, and not all data gathered by the Investigators has been reviewed. Therefore, the pivotal trial metrics presented may change as more follow-up data is gathered, as women continue in the pivotal trial and the other data collected by Investigators is obtained, audited, and analyzed.

Promising Results Continue

At the ISGE conference Conceptus also noted that no pregnancies have been reported among women relying on STOP devices in the pivotal trial and the on-going Phase II study, which has now accumulated more than 2,450 women months of effectiveness testing. Although no pregnancies have been reported, Conceptus cautions that no method of birth control is 100% effective and pregnancies are expected to occur in clinical testing of the STOP device. Accordingly, Conceptus has obtained an Investigational Device Exemption from the U.S. Food and Drug Administration, which can tolerate a limited number of pregnancies and still meet the effectiveness criteria of the IDE. Conceptus expects to submit a pre-market approval application to the FDA in the third quarter of 2002.

About STOP

Surgical tubal ligation has become the most common form of birth control worldwide, despite the fact that it is invasive and costly. In the U.S., about 93% of such procedures 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 penetration of the abdomen, can be performed with a local anesthetic, and can 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, with a rapid return to normal activities.

About Conceptus

Conceptus, Inc. is developing STOP, an investigational medical device and procedure in the U.S., is designed to provide a non-surgical alternative to tubal ligation, the leading form of birth control worldwide. The STOP device is a unique and 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 studies have shown that the STOP device induces an occlusive tissue response.

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 700,000 surgical tubal ligations are performed each year in the U.S. Additional information about the Company and the STOP device is available at www.conceptus.com.

Source: Conceptus, Inc.