FDA Recommends Hologic’s Non-Incisional Approach to Tubal Ligation

Hologic’s Adiana provides a permanent transcervical alternative to tubal ligation. The procedure takes approximately 15 minutes and carries few of the side effects experienced during a more invasive surgical procedure. To date, Adiana has been evaluated in more than 600 women.

Cytyc (subsequently acquired by Hologic for $6.2 billion) acquired Adiana, Inc., developer of the device, back in February of this year. If the terms of the agreement are any indicator, Cytyc brass had the utmost confidence in the product’s immediate viability: Cytyc executives expected the acquisition to break even in terms of earnings per share within three quarters of FDA approval.

The Cytyc-Adiana deal specified $60 million upfront in cash plus milestone payments. The milestones include a potential FDA milestone payment and a four-year earnout based on sales growth. Total payments, including the four-year earnout, will not exceed $215 million.

Bilateral tubal ligation remains the most common form of contraception used throughout the world. In the U.S. approximately 700,000 tubal ligation procedures are performed annually. The surgery is most often performed in a hospital setting under general anesthesia and requires that the physician make one or two incisions in the abdomen. Tubal ligation requires approximately four to five days of recuperation.

During the Adiana procedure, a catheter is positioned in the patient’s fallopian tube using a hysteroscope, eliminating the need for incisions. The catheter applies radiofrequency energy to remove a thin layer of cells inside of the fallopian tube. The catheter then delivers a soft polymer matrix, smaller than a grain of rice, which remains within the tube. The procedure is performed on both fallopian tubes.

As part of the body’s normal healing process, tissue grows into the polymer matrix, obstructing the tube. A confirmatory test is conducted at three months post-procedure to ensure the fallopian tubes are completely blocked.

The FDA Obstetrics and Gynecology Devices Advisory Panel voted 10 to 3 to recommend the PMA for Adiana contingent upon several conditions, including long-term follow up of current pivotal trial patients, a new post approval study of new patients and physicians, and more specific labeling recommendations. The FDA traditionally follows the recommendations of its advisory panels.

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