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FDA Advisory Panel Finds Hologic's Adiana(R) Permanent Contraception Approvable
Date:12/13/2007

two incisions in the abdomen. This usually requires approximately four to five days of recuperation.

In contrast, Adiana is a minimally-invasive, non-incisional alternative. This procedure uses hysteroscopy, generally requires only local anesthesia, and can be performed in a physician's office. Patients are typically able to return to work or resume their everyday activities within a day.

"Contraception is obviously a critical decision for any woman," said Sue Knapton, a 46-year-old woman who participated in the clinical trial of Adiana. "This seemed to me to be the better choice than more invasive surgery or long- term use of oral contraceptives. I am glad I was able to participate in the Adiana trial and hope other women will benefit from Adiana in the future."

"Today represents a tremendous milestone in enabling us to realize our goal in making Adiana a viable and better alternative for women looking for permanent contraception. We will work closely with the FDA to address any remaining issues and expedite final approval. We are confidently on course to provide women with an important new treatment option," said Tony Kingsley, President, Hologic GYN Surgical Products.

The pivotal clinical trial to demonstrate the safety and effectiveness of Adiana in providing permanent contraception was conducted in the U.S., Australia, and Mexico. As part of the clinical trial, 645 women between the ages of 21 and 45 had treatment attempted with Adiana. The procedure showed a strong safety profile, with very high device placement success, patient tolerance, comfort and satisfaction. A pregnancy prevention efficacy rate of 98.9 percent after 12 months of reliance on Adiana was demonstrated, successfully meeting the trial's primary endpoint. This efficacy result also compares favorably with the results of the CREST Study (U.S. Collaborative Review of Sterilization), which examined the long-term failure of tubal ligation for sterilization.

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SOURCE Hologic, Inc.
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