Company Background

Founded in Phoenix Arizona, Operculum, Inc. is presently a developmental-stage medical device company established to develop and market its proprietary, non-incisional tubal ligation/contraceptive device, the ZRO®. The ZRO is a small, trans-cervical occlusion device designed for insertion in the uterus at the entry duct of the fallopian tube. This procedure is easily performed in a physician’s office setting under local anesthesia or often times requiring no anesthesia at all. The ZRO has the ability to replace traditional tubal ligation which requires a hospital surgical environment and lengthy recovery.

The ZRO prevents pregnancy by utilizing the body’s own mechanisms to achieve in-growth with a safe biocompatible polyester matrix which completely occludes the fallopian tubes resulting in a healthy barrier for preventing pregnancy. For bilateral placement of the ZRO, existing hysteroscopes and hysteroscopic instrumentation is used, further reducing expensive barriers to market entry and the need for complex and sophisticated application procedures. Operculum expects that the ease with which the ZRO can be inserted will allow for a total procedural time in minutes with virtually no recovery time necessary.

The company believes that the permanent birth control market is transitioning from costly, conventional tubal ligation surgery to cost-effective, non-surgical approaches, such as the next generation ZRO device, administered under the care of women’s gynecologists in the comfort of their office. Additionally, the company believes that non-surgical removal of a tubal-occlusion device should be an option for women and may be successfully performed with the ZRO device. It must be noted however: that while the device may be removed it cannot be directly inferred that fertility would resume.

The ZRO provides a cost-effective solution, particularly in highly populated, emerging growth countries such as China, India and Brazil. ZRO offers a woman freedom from hormone-based contraception or less effective, burdensome barrier type contraception. The company believes that the ZRO’s most unique design feature allows for the removal of the implant allowing the fallopian tube to return to its normal, non-occluded anatomical state. The ZRO addresses an unmet market need for a permanent, less invasive, less costly option to tubal ligation and an alternative to  temporary modern contraception methods used by women who have finished having children.

The company’s growing portfolio of patents is strong and consists of five issued domestic patents, four of which remain active and current today.

In 1994-1996, more than two million tubal sterilizations were performed in the USA. The market has shown a pattern of steady growth with evidence that a device of this caliber can stand alone as a unique and truly innovative product. The potential commercial impact of the ZRO device is recognized not only in health cost containment economies but also in developing countries due to the lower costs and the ease of adoption through its use of standard, existing instrumentation that physicians use today.

The two most common forms of contraception in the USA are female sterilization and oral hormones, “the pill”. Women worldwide seek alternative methods of contraception as evidenced by the steady decline of the use of contraceptive pills. Pill usage is down from 35% of all contraceptive users in the 1990’s to about 27% in 2004.

This device is not FDA approved. Not for sale in the U.S.