Profile: Conceptus Inc (CPTS.O)

Conceptus, Inc., incorporated on September 18, 1992, develops, manufactures and markets the Essure permanent birth control system, a medical device for women that is approved for marketing in the United States by the United States Food and Drug Administration (FDA). The Essure system uses a soft and flexible micro-insert that is delivered into a woman's fallopian tubes to provide permanent birth control by causing benign tissue in-growth that blocks the fallopian tubes. A properly placed Essure micro-insert and the subsequent tissue growth prohibits the egg from traveling through the fallopian tubes and therefore prevents fertilization. On January 7, 2008, the Company acquired all of the outstanding shares of Conceptus SAS. Through Conceptus SAS, it sells Essure directly in France and uses distributors to sell Essure throughout the rest of Europe.

The Essure procedure is typically performed in the office setting. The Essure procedure does not require cutting or penetrating the abdomen. The majority of the Essure procedures are performed in a doctor's office using local anesthesia. The Essure system is effective without drugs or hormones. There is a three-month waiting period after the procedure, during which the woman must use another form of birth control while tissue in-growth occurs. At three months following the procedure, the United States patients complete a confirmation test called a hysterosalpingogram (HSG), which can determine whether the device was placed successfully and whether the fallopian tubes are occluded. Outside of the United States, patients are required to return for a pelvic x-ray at three months post-procedure with a subsequent HSG if device location on the initial radiographic image appears suspicious.

The Essure micro-insert is designed to be placed into each fallopian tube during a single procedure using a hysteroscope, an instrument that allows visual examination of the cervix and uterine cavity, and the Company’s minimally invasive tubal access delivery system. The delivery system is a disposable plastic handle with a thumb-wheel that is connected to the Company’s guidewire and catheter system. The micro-insert is constructed of a stainless steel inner coil, a dynamic outer coil made from a nickel titanium alloy, called Nitinol, and a layer of polyethylene terephthalate, or polyester fibers, wound between the inner coils. An Essure micro-insert is deployed into each of the woman's fallopian tubes using a hysteroscope. Using the hysteroscope for guidance, the delivery catheter is guided through the uterus and the opening of the fallopian tube. Once the physician has properly positioned the delivery system in the fallopian tube, the physician releases the micro-insert. When released, the micro-insert automatically expands to the contours of the fallopian tube. Over a three-month time frame, the polyester fibers within the micro-insert elicit a localized, benign tissue in-growth that occludes, or blocks, the fallopian tubes, thereby preventing conception. The Company has a manufacturing facility at its headquarters in Mountain View, California, which it uses only for pilot-line manufacturing. It has a third-party original equipment manufacturer (OEM), which manufactures Essure devices at their manufacturing facility located in Mexico.

The Company competes with Hologic, Inc.